Trial Outcomes & Findings for A Dose Escalation, Dose Expansion Study to Evaluate the Safety, Tolerability, and Antitumor Activity of MEDI-575, in Subjects With Advanced Tumors. (NCT NCT00816400)
NCT ID: NCT00816400
Last Updated: 2018-06-26
Results Overview
An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. Treatment-emergent AEs (TEAEs) are events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug, for the period extending to 30 days after the last dose of study drug. Participants were counted only once for each event and by the highest event severity, regardless of how many events the participant experienced. The AEs were summarized using Medical Dictionary for Regulatory Activities (MedDRA) version 14.1.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
49 participants
Primary outcome timeframe
From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
Results posted on
2018-06-26
Participant Flow
Participants were recruited at 5 centers in the United States between March 2009 and January 2012.
A total of 49 participants were screened, out of these, 35 participants were randomized.
Participant milestones
| Measure |
MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)
Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days \[QWk\]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)
MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)
MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)
MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)
MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)
MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days \[Q3Wk\]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)
MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 9.0 mg/kg QWk Expansion Phase
MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 25 mg/kg Q3Wk Expansion Phase
MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
5
|
3
|
3
|
3
|
3
|
6
|
6
|
|
Overall Study
COMPLETED
|
1
|
0
|
0
|
0
|
1
|
0
|
1
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
5
|
3
|
2
|
3
|
2
|
5
|
6
|
Reasons for withdrawal
| Measure |
MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)
Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days \[QWk\]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)
MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)
MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)
MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)
MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)
MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days \[Q3Wk\]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)
MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 9.0 mg/kg QWk Expansion Phase
MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 25 mg/kg Q3Wk Expansion Phase
MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
2
|
3
|
3
|
3
|
2
|
3
|
2
|
5
|
6
|
|
Overall Study
In hospice care at the end of the study
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Dose Escalation, Dose Expansion Study to Evaluate the Safety, Tolerability, and Antitumor Activity of MEDI-575, in Subjects With Advanced Tumors.
Baseline characteristics by cohort
| Measure |
MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)
n=3 Participants
Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days \[QWk\]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)
n=3 Participants
MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)
n=5 Participants
MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)
n=3 Participants
MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)
n=3 Participants
MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)
n=3 Participants
MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days \[Q3Wk\]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)
n=3 Participants
MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 9.0 mg/kg QWk Expansion Phase
n=6 Participants
MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 25 mg/kg Q3Wk Expansion Phase
n=6 Participants
MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
58.0 Years
STANDARD_DEVIATION 16.5 • n=99 Participants
|
65.0 Years
STANDARD_DEVIATION 8.5 • n=107 Participants
|
60.2 Years
STANDARD_DEVIATION 8.5 • n=206 Participants
|
66.3 Years
STANDARD_DEVIATION 9.1 • n=7 Participants
|
67.0 Years
STANDARD_DEVIATION 10.5 • n=31 Participants
|
58.0 Years
STANDARD_DEVIATION 8.5 • n=30 Participants
|
68.3 Years
STANDARD_DEVIATION 8.4 • n=3 Participants
|
68.2 Years
STANDARD_DEVIATION 15.1 • n=6 Participants
|
59.3 Years
STANDARD_DEVIATION 6.6 • n=114 Participants
|
63.3 Years
STANDARD_DEVIATION 10.3
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
3 Participants
n=114 Participants
|
16 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
3 Participants
n=114 Participants
|
19 Participants
|
PRIMARY outcome
Timeframe: From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeksPopulation: Safety population: All participants who have received any treatment of MEDI-575
An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. Treatment-emergent AEs (TEAEs) are events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug, for the period extending to 30 days after the last dose of study drug. Participants were counted only once for each event and by the highest event severity, regardless of how many events the participant experienced. The AEs were summarized using Medical Dictionary for Regulatory Activities (MedDRA) version 14.1.
Outcome measures
| Measure |
MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)
n=3 Participants
Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days \[QWk\]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)
n=3 Participants
MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)
n=5 Participants
MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)
n=3 Participants
MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)
n=3 Participants
MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)
n=3 Participants
MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days \[Q3Wk\]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)
n=3 Participants
MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 9.0 mg/kg QWk Expansion Phase
n=6 Participants
MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 25 mg/kg Q3Wk Expansion Phase
n=6 Participants
MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 25 mg/kg Q3Wk Expansion Phase
MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events
|
3 Participants
|
3 Participants
|
5 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
—
|
PRIMARY outcome
Timeframe: From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeksPopulation: Safety population
A serious AE (SAE) is any AE that results in death, is immediately life threatening, require (or prolong) inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event that may jeopardize the participant or may require medical intervention to prevent one of the outcomes listed above. Treatment-emergent SAEs that emerged after start of study drug were reported. Participants were counted only once for each event and by the highest event severity, regardless of how many events the participant experienced. The SAEs were summarized using MedDRA version 14.1.
Outcome measures
| Measure |
MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)
n=3 Participants
Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days \[QWk\]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)
n=3 Participants
MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)
n=5 Participants
MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)
n=3 Participants
MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)
n=3 Participants
MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)
n=3 Participants
MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days \[Q3Wk\]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)
n=3 Participants
MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 9.0 mg/kg QWk Expansion Phase
n=6 Participants
MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 25 mg/kg Q3Wk Expansion Phase
n=6 Participants
MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 25 mg/kg Q3Wk Expansion Phase
MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeksPopulation: Safety population
Laboratory evaluations of blood and urine samples were performed, including hematology (complete blood count, differential, and platelet count); serum chemistry (SrChem) aspartate transaminase (AST), alanine transaminase, total bilirubin, creatinine, alkaline phosphatase, sodium, potassium, chloride, phosphorus, calcium, glucose, magnesium, albumin, and lactate dehydrogenase); and routine urinalysis. Number of participants with TEAEs related to laboratory evaluations were reported.
Outcome measures
| Measure |
MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)
n=3 Participants
Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days \[QWk\]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)
n=3 Participants
MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)
n=5 Participants
MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)
n=3 Participants
MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)
n=3 Participants
MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)
n=3 Participants
MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days \[Q3Wk\]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)
n=3 Participants
MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 9.0 mg/kg QWk Expansion Phase
n=6 Participants
MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 25 mg/kg Q3Wk Expansion Phase
n=6 Participants
MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 25 mg/kg Q3Wk Expansion Phase
MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Treatment-emergent Adverse Events Related to Laboratory Parameters
SrChem: Blood creatinine increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Treatment-emergent Adverse Events Related to Laboratory Parameters
Hematology: Anaemia
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
|
Treatment-emergent Adverse Events Related to Laboratory Parameters
Hematology: Leukocytosis
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Treatment-emergent Adverse Events Related to Laboratory Parameters
Hematology: Thrombocytopenia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Treatment-emergent Adverse Events Related to Laboratory Parameters
SrChem: AST increased
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Treatment-emergent Adverse Events Related to Laboratory Parameters
SrChem: Blood Alkaline phosphatase increased
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Treatment-emergent Adverse Events Related to Laboratory Parameters
SrChem: Hypercalcaemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Treatment-emergent Adverse Events Related to Laboratory Parameters
SrChem: Hyperglycaemia
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Treatment-emergent Adverse Events Related to Laboratory Parameters
SrChem: Hyperkalaemia
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Treatment-emergent Adverse Events Related to Laboratory Parameters
SrChem: Hypokalaemia
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Treatment-emergent Adverse Events Related to Laboratory Parameters
SrChem: Hypomagnesaemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Treatment-emergent Adverse Events Related to Laboratory Parameters
SrChem: Hyponatraemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Treatment-emergent Adverse Events Related to Laboratory Parameters
SrChem: Hypophosphataemia
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Treatment-emergent Adverse Events Related to Laboratory Parameters
Urinalysis: Urine colour abnormal
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Treatment-emergent Adverse Events Related to Laboratory Parameters
Urinalysis:Urobilinogen urine increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Treatment-emergent Adverse Events Related to Laboratory Parameters
Urinalysis:Haematuria
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Treatment-emergent Adverse Events Related to Laboratory Parameters
Urinalysis:Proteinuria
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeksPopulation: Safety population
All 12-lead electrocardiograms (ECGs) performed during the study were obtained in triplicate (ie, 3 ECGs were obtained within a 5-minute time interval) and analyzed. ECG parameters included heart rate (high and low), QT interval, QTcB (corrected QT interval per Bazett's formula), and QTcF (corrected QT interval per Fridericia's formula). Number of participants with TEAEs related to ECG after the start of study drug were reported.
Outcome measures
| Measure |
MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)
n=3 Participants
Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days \[QWk\]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)
n=3 Participants
MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)
n=5 Participants
MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)
n=3 Participants
MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)
n=3 Participants
MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)
n=3 Participants
MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days \[Q3Wk\]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)
n=3 Participants
MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 9.0 mg/kg QWk Expansion Phase
n=6 Participants
MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 25 mg/kg Q3Wk Expansion Phase
n=6 Participants
MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 25 mg/kg Q3Wk Expansion Phase
MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Treatment-emergent Adverse Events Related to Electrocardiogram Evaluations
Supraventricular tachycardia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Treatment-emergent Adverse Events Related to Electrocardiogram Evaluations
Tachycardia
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeksPopulation: Safety population
Vital signs (temperature, blood pressure, pulse rate, and respiratory rate) were performed throughout the study. The TEAEs related to vital signs in participants were reported.
Outcome measures
| Measure |
MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)
n=3 Participants
Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days \[QWk\]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)
n=3 Participants
MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)
n=5 Participants
MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)
n=3 Participants
MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)
n=3 Participants
MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)
n=3 Participants
MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days \[Q3Wk\]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)
n=3 Participants
MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 9.0 mg/kg QWk Expansion Phase
n=6 Participants
MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 25 mg/kg Q3Wk Expansion Phase
n=6 Participants
MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 25 mg/kg Q3Wk Expansion Phase
MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Treatment-emergent Adverse Events Related to Vital Sign Parameters
Hypotension
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Treatment-emergent Adverse Events Related to Vital Sign Parameters
Pyrexia
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Treatment-emergent Adverse Events Related to Vital Sign Parameters
Hypertension
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeksPopulation: MTD evaluable population includes all participants in the dose escalation phase who have received at least 1 full cycle of MEDI-575 and have completed the safety follow-up through the DLT-evaluation period, or who experienced a DLT. The MTD dose was not evaluated as there were no DLTs reported in this study.
For the dose escalation phase, a minimum of 21 evaluable participants (3 participants each in Dose Cohorts 1 through 7) were required for this study if Dose Limiting Toxicities (DLTs) do not occur. If a DLT does occur among the first 3 participants in a cohort, 3 additional participants were to be added to the cohort; 3 more participants were to be added to a cohort to determine the MTD if only 3 participants have been previously treated at that dose. The MTD is the maximum dose at which no more than 1 out of 6 participants experienced a DLT. A DLT is defined as any grade 3 or higher hematologic toxicity or any grade 3 or higher non-hematologic toxicity except grade 3 fever (in the absence of neutropenia) or grade 3 rigors/chills.
Outcome measures
| Measure |
MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)
n=3 Participants
Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days \[QWk\]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)
n=3 Participants
MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)
n=5 Participants
MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)
n=3 Participants
MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)
n=3 Participants
MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)
n=3 Participants
MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days \[Q3Wk\]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)
n=3 Participants
MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 9.0 mg/kg QWk Expansion Phase
MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 25 mg/kg Q3Wk Expansion Phase
MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 25 mg/kg Q3Wk Expansion Phase
MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD)
|
NA Milligrams per kilogram (mg/kg)
There are no observations for this Table
|
NA Milligrams per kilogram (mg/kg)
There are no observations for this Table
|
NA Milligrams per kilogram (mg/kg)
There are no observations for this Table
|
NA Milligrams per kilogram (mg/kg)
There are no observations for this Table
|
NA Milligrams per kilogram (mg/kg)
There are no observations for this Table
|
NA Milligrams per kilogram (mg/kg)
There are no observations for this Table
|
NA Milligrams per kilogram (mg/kg)
There are no observations for this Table
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: For 0.5/3, 6, 9, 12, 15 mg/kg: Cycle 1: Day 1 (pre- and end of infusion, 2 and 6 hours post infusion), Days 2, 3 and 8 (pre-dose); For 25 and 35 mg/kg: Cycle 1: Day 1 (pre- and end of infusion, 2 and 6 hours post infusion), Days 2, 3, 8 and 15.Population: All the participants who received first dose of MEDI-575 and for whom PK blood samples were collected and evaluated.
The concentration of MEDI-575 quantitatively determined in serum samples using a validated electrochemiluminescence (ECL) PK assay. The Cmax after the first dose was obtained directly from the measured concentration-time curves. The concentration-time curve is the result of blood sampling at specified time points and its measured concentration of MEDI-575.
Outcome measures
| Measure |
MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)
n=3 Participants
Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days \[QWk\]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)
n=3 Participants
MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)
n=5 Participants
MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)
n=3 Participants
MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)
n=3 Participants
MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)
n=3 Participants
MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days \[Q3Wk\]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)
n=3 Participants
MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 9.0 mg/kg QWk Expansion Phase
n=3 Participants
MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 25 mg/kg Q3Wk Expansion Phase
n=6 Participants
MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 25 mg/kg Q3Wk Expansion Phase
n=6 Participants
MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK) of MEDI-575 After the First Dose: Observed Maximum Serum Concentration (Cmax)
|
72.6 Micrograms per milliliter (μg/mL)
Standard Deviation 7.00
|
154 Micrograms per milliliter (μg/mL)
Standard Deviation 44.9
|
239 Micrograms per milliliter (μg/mL)
Standard Deviation 98.1
|
590 Micrograms per milliliter (μg/mL)
Standard Deviation 124
|
632 Micrograms per milliliter (μg/mL)
Standard Deviation 20.0
|
670 Micrograms per milliliter (μg/mL)
Standard Deviation 131
|
918 Micrograms per milliliter (μg/mL)
Standard Deviation 111
|
10.9 Micrograms per milliliter (μg/mL)
Standard Deviation 0.512
|
240 Micrograms per milliliter (μg/mL)
Standard Deviation 44.1
|
549 Micrograms per milliliter (μg/mL)
Standard Deviation 143
|
SECONDARY outcome
Timeframe: For 0.5/3, 6, 9, 12, 15 mg/kg: Cycle 1: Day 1 (pre- and end of infusion, 2 and 6 hours post infusion), Days 2, 3 and 8 (pre-dose); For 25 and 35 mg/kg: Cycle 1: Day 1 (pre- and end of infusion, 2 and 6 hours post infusion), Days 2, 3, 8 and 15.Population: All the participants who received first dose of MEDI-575 and for whom PK blood samples were collected and evaluated.
The time to reach maximum serum concentration after the first dose of MEDI-575 was obtained directly from the measured concentration-time curves. The concentration-time curve is the result of blood sampling at specified time points and its measured concentration of MEDI-575.
Outcome measures
| Measure |
MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)
n=3 Participants
Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days \[QWk\]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)
n=3 Participants
MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)
n=5 Participants
MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)
n=3 Participants
MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)
n=3 Participants
MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)
n=3 Participants
MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days \[Q3Wk\]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)
n=3 Participants
MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 9.0 mg/kg QWk Expansion Phase
n=3 Participants
MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 25 mg/kg Q3Wk Expansion Phase
n=6 Participants
MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 25 mg/kg Q3Wk Expansion Phase
n=6 Participants
MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
PK of MEDI-575 After the First Dose: Time to Maximum Concentration (Tmax)
|
0.0759 Day
Standard Deviation 0.0545
|
0.0479 Day
Standard Deviation 0.00318
|
0.0618 Day
Standard Deviation 0.0381
|
0.130 Day
Standard Deviation 0.142
|
0.106 Day
Standard Deviation 0.0381
|
0.227 Day
Standard Deviation 0.142
|
0.0639 Day
Standard Deviation 0.00139
|
0.103 Day
Standard Deviation 0.0498
|
0.139 Day
Standard Deviation 0.0804
|
0.118 Day
Standard Deviation 0.0941
|
SECONDARY outcome
Timeframe: For 0.5/3, 6, 9, 12, 15 mg/kg: Cycle 1: Day 1 (pre- and end of infusion, 2 and 6 hours post infusion), Days 2, 3 and 8 (pre-dose); For 25 and 35 mg/kg: Cycle 1: Day 1 (pre- and end of infusion, 2 and 6 hours post infusion), Days 2, 3, 8 and 15.Population: All the participants who received first dose of MEDI-575 and for whom PK blood samples were collected and evaluated.
The Cmax/dose after the first dose of MEDI-575 was obtained directly from the measured concentration-time curves. The concentration-time curve is the result of blood sampling at specified time points and its measured concentration of MEDI-575.
Outcome measures
| Measure |
MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)
n=3 Participants
Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days \[QWk\]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)
n=3 Participants
MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)
n=5 Participants
MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)
n=3 Participants
MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)
n=3 Participants
MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)
n=3 Participants
MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days \[Q3Wk\]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)
n=3 Participants
MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 9.0 mg/kg QWk Expansion Phase
n=3 Participants
MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 25 mg/kg Q3Wk Expansion Phase
n=6 Participants
MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 25 mg/kg Q3Wk Expansion Phase
n=6 Participants
MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
PK of MEDI-575 After the First Dose: Dose-normalized Maximum Serum Concentration (Cmax/Dose)
|
0.292 μg/mL/mg
Standard Deviation 0.0404
|
0.402 μg/mL/mg
Standard Deviation 0.125
|
0.335 μg/mL/mg
Standard Deviation 0.107
|
0.638 μg/mL/mg
Standard Deviation 0.171
|
0.655 μg/mL/mg
Standard Deviation 0.191
|
0.360 μg/mL/mg
Standard Deviation 0.0908
|
0.259 μg/mL/mg
Standard Deviation 0.0614
|
0.262 μg/mL/mg
Standard Deviation 0.0294
|
0.372 μg/mL/mg
Standard Deviation 0.103
|
0.357 μg/mL/mg
Standard Deviation 0.112
|
SECONDARY outcome
Timeframe: For 0.5/3, 6, 9, 12, 15 mg/kg: Cycle 1: Day 1 (pre- and end of infusion, 2 and 6 hours post infusion), Days 2, 3 and 8 (pre-dose); For 25 and 35 mg/kg: Cycle 1: Day 1 (pre- and end of infusion, 2 and 6 hours post infusion), Days 2, 3, 8 and 15.Population: All the participants who received first dose of MEDI-575 and from whom PK blood samples were collected and evaluated. Excluded participants were for whom it cannot be calculated (either number of doses received was less than 2 or standard deviation equals 0.000) or where dosing interval is more than 7 days or samples only collected up to 14 days.
The Ctrough ie, measured concentration at the end of a dosing interval (taken directly before next dose administration) of MEDI-575 was obtained directly from the measured concentration-time curves. The concentration-time curve is the result of blood sampling at specified time points and its measured concentration of MEDI-575.
Outcome measures
| Measure |
MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)
n=3 Participants
Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days \[QWk\]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)
n=3 Participants
MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)
n=4 Participants
MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)
n=3 Participants
MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)
n=3 Participants
MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)
n=3 Participants
MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days \[Q3Wk\]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)
n=3 Participants
MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 9.0 mg/kg QWk Expansion Phase
n=3 Participants
MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 25 mg/kg Q3Wk Expansion Phase
n=4 Participants
MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 25 mg/kg Q3Wk Expansion Phase
n=4 Participants
MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
PK of MEDI-575 After the First Dose: Trough Serum Concentration (Ctrough)
|
8.97 μg/mL
Standard Deviation 2.85
|
41.5 μg/mL
Standard Deviation 13.8
|
72.6 μg/mL
Standard Deviation 35.3
|
144 μg/mL
Standard Deviation 18.0
|
199 μg/mL
Standard Deviation 55.3
|
85.4 μg/mL
Standard Deviation 40.8
|
223 μg/mL
Standard Deviation 25.2
|
NA μg/mL
Standard Deviation NA
The mean was below limit of quantification and standard deviation cannot be calculated.
|
59.0 μg/mL
Standard Deviation 4.14
|
74.9 μg/mL
Standard Deviation 22.6
|
SECONDARY outcome
Timeframe: For 0.5/3, 6, 9, 12, 15 mg/kg: Cycle 1: Day 1 (pre- and end of infusion, 2 and 6 hours post infusion), Days 2, 3 and 8 (pre-dose); For 25 and 35 mg/kg: Cycle 1: Day 1 (pre- and end of infusion, 2 and 6 hours post infusion), Days 2, 3, 8 and 15.Population: All the participants who received first dose of MEDI-575 and from whom PK blood samples were collected and evaluated. Excluded participants were for whom it cannot be calculated (either number of doses received was less than 2 or standard deviation equals 0.000) or where dosing interval is more than 7 days or samples only collected up to 14 days.
The AUCτ was obtained directly from the measured concentration-time curves. The concentration-time curve is the result of blood sampling at specified time points and its measured concentration of MEDI-575.
Outcome measures
| Measure |
MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)
n=3 Participants
Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days \[QWk\]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)
n=3 Participants
MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)
n=4 Participants
MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)
n=3 Participants
MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)
n=3 Participants
MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)
n=3 Participants
MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days \[Q3Wk\]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)
n=3 Participants
MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 9.0 mg/kg QWk Expansion Phase
n=3 Participants
MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 25 mg/kg Q3Wk Expansion Phase
n=4 Participants
MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 25 mg/kg Q3Wk Expansion Phase
n=4 Participants
MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
PK of MEDI-575 After the First Dose: Area Under the Serum Concentration-time Curve Over the Dosing Interval (AUCτ)
|
201 μg·day/mL
Standard Deviation 12.5
|
524 μg·day/mL
Standard Deviation 166
|
835 μg·day/mL
Standard Deviation 339
|
1870 μg·day/mL
Standard Deviation 277
|
2080 μg·day/mL
Standard Deviation 205
|
5100 μg·day/mL
Standard Deviation 275
|
8340 μg·day/mL
Standard Deviation 372
|
25.3 μg·day/mL
Standard Deviation 7.69
|
763 μg·day/mL
Standard Deviation 144
|
3760 μg·day/mL
Standard Deviation 625
|
SECONDARY outcome
Timeframe: For 0.5/3, 6, 9, 12, 15 mg/kg: Cycle 1: Day 1 (pre- and end of infusion, 2 and 6 hours post infusion), Days 2, 3 and 8 (pre-dose); For 25 and 35 mg/kg: Cycle 1: Day 1 (pre- and end of infusion, 2 and 6 hours post infusion), Days 2, 3, 8 and 15.Population: All the participants who received first dose of MEDI-575 and from whom PK blood samples were collected and evaluated. Excluded participants were for whom it cannot be calculated (either number of doses received was less than 2 or standard deviation equals 0.000) or where dosing interval is more than 7 days or samples only collected up to 14 days.
The AUCτ/dose was obtained directly from the measured concentration-time curves. The concentration-time curve is the result of blood sampling at specified time points and its measured concentration of MEDI-575.
Outcome measures
| Measure |
MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)
n=3 Participants
Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days \[QWk\]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)
n=3 Participants
MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)
n=4 Participants
MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)
n=3 Participants
MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)
n=3 Participants
MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)
n=3 Participants
MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days \[Q3Wk\]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)
n=3 Participants
MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 9.0 mg/kg QWk Expansion Phase
n=3 Participants
MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 25 mg/kg Q3Wk Expansion Phase
n=4 Participants
MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 25 mg/kg Q3Wk Expansion Phase
n=4 Participants
MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
PK of MEDI-575 After the First Dose: Dose-normalized Area Under the Serum Concentration-time Curve (AUCτ/Dose)
|
0.804 μg·day/mL/mg
Standard Deviation 0.0392
|
1.36 μg·day/mL/mg
Standard Deviation 0.441
|
1.19 μg·day/mL/mg
Standard Deviation 0.437
|
2.01 μg·day/mL/mg
Standard Deviation 0.418
|
2.12 μg·day/mL/mg
Standard Deviation 0.442
|
2.78 μg·day/mL/mg
Standard Deviation 0.767
|
2.35 μg·day/mL/mg
Standard Deviation 0.464
|
0.607 μg·day/mL/mg
Standard Deviation 0.197
|
1.15 μg·day/mL/mg
Standard Deviation 0.281
|
2.70 μg·day/mL/mg
Standard Deviation 0.438
|
SECONDARY outcome
Timeframe: Preinfusion on Cycle 1 Day 1 and 30 days after the last dose, up to 112 weeksPopulation: Safety population
Blood samples for immunogenicity assessments were collected from participants prior to the initiation of infusion of each treatment cycle of MEDI-575. Anti-MEDI-575 antibodies were analyzed using the electro-chemiluminescence (ECL) based method. Only the number of participants positive for anti-MEDI-575 antibodies at any visit are presented.
Outcome measures
| Measure |
MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)
n=3 Participants
Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days \[QWk\]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)
n=3 Participants
MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)
n=5 Participants
MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)
n=3 Participants
MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)
n=3 Participants
MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)
n=3 Participants
MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days \[Q3Wk\]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)
n=3 Participants
MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 9.0 mg/kg QWk Expansion Phase
n=6 Participants
MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 25 mg/kg Q3Wk Expansion Phase
n=6 Participants
MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 25 mg/kg Q3Wk Expansion Phase
MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Positive for Anti-drug Antibodies Formation for MEDI-575 at Any Visit
CYCLE 1 DAY 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants Positive for Anti-drug Antibodies Formation for MEDI-575 at Any Visit
30 DAY POST
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: From study entry through the end of the study, up to 34 monthsPopulation: Efficacy evaluable population: All participants who have received any treatment of MEDI-575 and at least one tumor assessment after the initiation of MEDI-575.
Objective response rate is defined as the proportion of participants with confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Confirmed responses are those that persist on repeat imaging study at least 4 weeks after the initial documentation of response. The CR is defined as disappearance of all target and non-target lesions, and normalization of tumor marker level. The PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Outcome measures
| Measure |
MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)
n=3 Participants
Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days \[QWk\]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)
n=3 Participants
MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)
n=4 Participants
MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)
n=3 Participants
MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)
n=3 Participants
MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)
n=3 Participants
MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days \[Q3Wk\]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)
n=3 Participants
MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 9.0 mg/kg QWk Expansion Phase
n=3 Participants
MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 25 mg/kg Q3Wk Expansion Phase
n=4 Participants
MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 25 mg/kg Q3Wk Expansion Phase
MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Objective Response
|
0 Percentage of participants
Interval 0.0 to 70.8
|
0 Percentage of participants
Interval 0.0 to 70.8
|
0 Percentage of participants
Interval 0.0 to 60.2
|
0 Percentage of participants
Interval 0.0 to 70.8
|
0 Percentage of participants
Interval 0.0 to 70.8
|
0 Percentage of participants
Interval 0.0 to 70.8
|
0 Percentage of participants
Interval 0.0 to 70.8
|
0 Percentage of participants
Interval 0.0 to 70.8
|
0 Percentage of participants
Interval 0.0 to 60.2
|
—
|
SECONDARY outcome
Population: Efficacy evaluable population with an objective response. Time to response was not estimable as there were no participants with an objective response.
Time to response was measured from the start of treatment with MEDI-575 to the first documentation of objective response (confirmed CR or PR). The time to response is assessed only for the participants who have achieved the objective response.
Outcome measures
Outcome data not reported
SECONDARY outcome
Population: Efficacy evaluable population with an objective response. Duration of response was not estimable as there were no participants with an objective response.
Duration of response is defined as the duration from the first documentation of objective response to the first documented disease progression. Disease progression is defined according to RECIST guidelines (ie, at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions). The duration of response was censored on the date of last tumor assessment documenting absence of disease progression for participants who have no documented progression prior to data cutoff, dropout, or the initiation of alternate anticancer treatment. Duration of response was calculated for the subgroup of participants with an objective response.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Start of treatment with MEDI-575 until the documentation of disease progression, up to 24 monthsPopulation: Efficacy evaluable population. N= number of participants analyzed for this outcome measure
Time to progression (TTP) is defined as time from the start of treatment with MEDI-575 until the documentation of disease progression. Disease progression is defined according to RECIST guidelines (ie, at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions). The TTP was censored on the date of last tumor assessment documenting absence of tumor progression for participants who have no documented progression prior to data cutoff, dropout, or the initiation of alternate anticancer treatment. TTP was censored on the first date of treatment for the participants with no tumor assessments after the start of MEDI-575 treatment.
Outcome measures
| Measure |
MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)
n=3 Participants
Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days \[QWk\]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)
n=2 Participants
MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)
n=3 Participants
MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)
n=3 Participants
MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)
n=2 Participants
MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)
n=3 Participants
MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days \[Q3Wk\]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)
n=3 Participants
MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 9.0 mg/kg QWk Expansion Phase
n=3 Participants
MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 25 mg/kg Q3Wk Expansion Phase
n=4 Participants
MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 25 mg/kg Q3Wk Expansion Phase
MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Progression
|
1.8 Months
Interval 1.5 to 24.8
|
1.4 Months
Interval 1.2 to
The upper limit was not estimable
|
1.2 Months
Interval 0.5 to
The upper limit was not estimable
|
1.4 Months
Interval 1.4 to 1.4
|
5.0 Months
Interval 1.2 to 8.8
|
2.9 Months
Interval 1.4 to 2.9
|
1.2 Months
Interval 1.0 to 1.4
|
1.4 Months
Interval 1.3 to 2.9
|
1.3 Months
Interval 1.2 to 5.7
|
—
|
SECONDARY outcome
Timeframe: Start of treatment with MEDI-575 until the documentation of disease progression or death due to any cause whichever occurs first, up to 24 monthsPopulation: Efficacy evaluable population. N= number of participants analyzed for this outcome measure
Progression-free survival (PFS) is defined as time from the start of treatment with MEDI-575 until the documentation of disease progression or death due to any cause, whichever occurred first. Disease progression is defined according to RECIST guidelines (ie, at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions). PFS was censored on the date of last tumor assessment documenting absence of tumor progression for participants who have no documented progression and were still alive prior to data cutoff, dropout, or the initiation of alternate anticancer treatment. PFS was censored on the first date of treatment for the participants with no tumor assessments after the start of MEDI-575 treatment.
Outcome measures
| Measure |
MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)
n=3 Participants
Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days \[QWk\]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)
n=2 Participants
MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)
n=3 Participants
MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)
n=3 Participants
MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)
n=2 Participants
MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)
n=3 Participants
MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days \[Q3Wk\]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)
n=3 Participants
MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 9.0 mg/kg QWk Expansion Phase
n=3 Participants
MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 25 mg/kg Q3Wk Expansion Phase
n=4 Participants
MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 25 mg/kg Q3Wk Expansion Phase
MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Progression-free Survival
|
1.8 Months
Interval 1.5 to 24.8
|
1.4 Months
Interval 1.2 to
The upper limit was not estimable
|
1.2 Months
Interval 0.5 to
The upper limit was not estimable
|
1.4 Months
Interval 1.4 to 1.4
|
5.0 Months
Interval 1.2 to 8.8
|
2.9 Months
Interval 1.4 to 2.9
|
1.2 Months
Interval 1.0 to 1.4
|
1.4 Months
Interval 1.3 to 2.9
|
1.3 Months
Interval 1.2 to 5.7
|
—
|
SECONDARY outcome
Timeframe: From the start of treatment with MEDI-575 until death or end of study, up to 33 monthsPopulation: Efficacy evaluable population. N= number of participants analyzed for this outcome measure
Overall survival (OS) is defined as the time from the start of treatment with MEDI-575 until death. For the participants who were alive at the end of study or lost to follow-up, OS was censored on the last date when participants were known to be alive.
Outcome measures
| Measure |
MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)
n=2 Participants
Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days \[QWk\]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)
n=3 Participants
MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)
n=2 Participants
MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)
n=3 Participants
MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)
n=2 Participants
MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)
n=3 Participants
MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days \[Q3Wk\]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)
n=2 Participants
MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 9.0 mg/kg QWk Expansion Phase
n=2 Participants
MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 25 mg/kg Q3Wk Expansion Phase
n=4 Participants
MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 25 mg/kg Q3Wk Expansion Phase
MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Survival
|
9.0 Months
Interval 3.5 to
The upper limit was not estimable
|
3.7 Months
Interval 3.6 to 9.0
|
17.2 Months
Interval 7.4 to 27.0
|
5.5 Months
Interval 3.5 to 14.1
|
19.4 Months
Interval 3.4 to
The upper limit was not estimable
|
8.7 Months
Interval 1.8 to 10.5
|
10.3 Months
Interval 1.8 to
The upper limit was not estimable
|
5.4 Months
Interval 2.6 to
The upper limit was not estimable
|
5.9 Months
Interval 2.4 to 15.3
|
—
|
Adverse Events
MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
MEDI-575, 9.0 mg/kg QWk Escalation/Expansion Phase (Cohort 3)
Serious events: 8 serious events
Other events: 10 other events
Deaths: 0 deaths
MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
MEDI-575, 25 mg/kg Q3Wk Escalation/Expansion Phase (Cohort 6)
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)
n=3 participants at risk
Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days \[QWk\]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)
n=3 participants at risk
MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 9.0 mg/kg QWk Escalation/Expansion Phase (Cohort 3)
n=11 participants at risk
MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21 day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)
n=3 participants at risk
MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)
n=3 participants at risk
MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 25 mg/kg Q3Wk Escalation/Expansion Phase (Cohort 6)
n=9 participants at risk
MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)
n=3 participants at risk
MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/9 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/9 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/11 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/9 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
33.3%
1/3 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
33.3%
1/3 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/11 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/9 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
|
General disorders
Multi-organ failure
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/11 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/9 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
33.3%
1/3 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/9 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/11 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/9 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
33.3%
1/3 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/9 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/9 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/11 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/9 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
33.3%
1/3 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/9 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
27.3%
3/11 • Number of events 3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
11.1%
1/9 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/9 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/11 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/9 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
33.3%
1/3 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/9 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/11 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
11.1%
1/9 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/9 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
18.2%
2/11 • Number of events 2 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/9 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/9 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
Other adverse events
| Measure |
MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)
n=3 participants at risk
Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days \[QWk\]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)
n=3 participants at risk
MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 9.0 mg/kg QWk Escalation/Expansion Phase (Cohort 3)
n=11 participants at risk
MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21 day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)
n=3 participants at risk
MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)
n=3 participants at risk
MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 25 mg/kg Q3Wk Escalation/Expansion Phase (Cohort 6)
n=9 participants at risk
MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)
n=3 participants at risk
MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
33.3%
1/3 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
33.3%
3/9 • Number of events 3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
11.1%
1/9 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
18.2%
2/11 • Number of events 2 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/9 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/11 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
33.3%
1/3 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
11.1%
1/9 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Number of events 2 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
33.3%
1/3 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/11 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
33.3%
1/3 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
33.3%
3/9 • Number of events 4 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
33.3%
1/3 • Number of events 2 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
|
Gastrointestinal disorders
Constipation
|
66.7%
2/3 • Number of events 2 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
66.7%
2/3 • Number of events 2 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/11 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
33.3%
1/3 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
11.1%
1/9 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
33.3%
1/3 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
33.3%
1/3 • Number of events 3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
33.3%
1/3 • Number of events 2 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
22.2%
2/9 • Number of events 2 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
33.3%
1/3 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/11 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
33.3%
1/3 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
11.1%
1/9 • Number of events 2 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • Number of events 4 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
33.3%
1/3 • Number of events 4 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
18.2%
2/11 • Number of events 2 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
33.3%
1/3 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
33.3%
1/3 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
33.3%
3/9 • Number of events 3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
66.7%
2/3 • Number of events 3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
11.1%
1/9 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
33.3%
1/3 • Number of events 3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
33.3%
1/3 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
33.3%
1/3 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
44.4%
4/9 • Number of events 6 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
66.7%
2/3 • Number of events 2 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
|
General disorders
Asthenia
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
33.3%
3/9 • Number of events 3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
|
General disorders
Chills
|
33.3%
1/3 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
18.2%
2/11 • Number of events 2 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/9 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
|
General disorders
Early satiety
|
33.3%
1/3 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/11 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
33.3%
1/3 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/9 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
|
General disorders
Fatigue
|
66.7%
2/3 • Number of events 2 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
66.7%
2/3 • Number of events 4 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
45.5%
5/11 • Number of events 6 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
66.7%
2/3 • Number of events 2 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
66.7%
6/9 • Number of events 9 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
66.7%
2/3 • Number of events 2 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
|
General disorders
Oedema peripheral
|
33.3%
1/3 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
33.3%
1/3 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
11.1%
1/9 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/11 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
33.3%
1/3 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
11.1%
1/9 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
|
Investigations
Weight decreased
|
33.3%
1/3 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
33.3%
1/3 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/11 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
33.3%
1/3 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
22.2%
2/9 • Number of events 2 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
66.7%
2/3 • Number of events 2 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
33.3%
1/3 • Number of events 4 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
33.3%
1/3 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
33.3%
3/9 • Number of events 3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
33.3%
1/3 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
66.7%
2/3 • Number of events 2 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
22.2%
2/9 • Number of events 2 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
33.3%
1/3 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
36.4%
4/11 • Number of events 5 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
66.7%
2/3 • Number of events 10 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
22.2%
2/9 • Number of events 6 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
33.3%
1/3 • Number of events 7 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
11.1%
1/9 • Number of events 2 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
33.3%
1/3 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
18.2%
2/11 • Number of events 2 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/9 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
33.3%
1/3 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
11.1%
1/9 • Number of events 2 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
33.3%
1/3 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
33.3%
1/3 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/11 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
11.1%
1/9 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
33.3%
1/3 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
66.7%
2/3 • Number of events 3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
33.3%
3/9 • Number of events 3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
33.3%
1/3 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
1/3 • Number of events 3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
33.3%
1/3 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/11 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/9 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
1/3 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/11 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
33.3%
1/3 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/9 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
33.3%
1/3 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/9 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
33.3%
1/3 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/11 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
11.1%
1/9 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
|
Psychiatric disorders
Anxiety
|
33.3%
1/3 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/9 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
18.2%
2/11 • Number of events 2 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
33.3%
1/3 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
100.0%
3/3 • Number of events 3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/9 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
33.3%
1/3 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
66.7%
2/3 • Number of events 2 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/11 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/9 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
27.3%
3/11 • Number of events 3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
33.3%
1/3 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/9 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
66.7%
2/3 • Number of events 2 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
36.4%
4/11 • Number of events 5 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
22.2%
2/9 • Number of events 2 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
11.1%
1/9 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
18.2%
2/11 • Number of events 2 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/9 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
33.3%
1/3 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
11.1%
1/9 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
11.1%
1/9 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
33.3%
1/3 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
33.3%
1/3 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/11 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/9 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
33.3%
1/3 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
11.1%
1/9 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
11.1%
1/9 • Number of events 2 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
0.00%
0/3 • From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks
For treatment arms 9 mg/kg QWk and 25 mg/kg Q3Wk, both Escalation and Expansion Phase data are presented together for the Serious Adverse Events and Other Adverse Events.
|
Additional Information
A Dose-escalation Study to Evaluate the Safety, Tolerability, and Antitumor Activity of MEDI-575
MedImmune
Phone: 1-877-240-9479
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
- Publication restrictions are in place
Restriction type: OTHER