Trial Outcomes & Findings for Open Label Dose-Finding Study of TRC105 Plus Capecitabine for Metastatic Breast Cancer (NCT NCT01326481)
NCT ID: NCT01326481
Last Updated: 2019-03-18
Results Overview
Assess safety and dose limiting toxicity by dose cohort and coding all terms utilized MedDRA version 14.1.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
19 participants
Primary outcome timeframe
1.5 years
Results posted on
2019-03-18
Participant Flow
Participant milestones
| Measure |
Carotuximab (TRC105) Plus Capecitabine
All patients received TRC105 + capecitabine
TRC105: IV (7.5 or 10 mg/kg weekly)
Capecitabine: oral (1,000 mg/m2 BID)
|
|---|---|
|
7.5 mg/kg TRC105, 1000 mg/m2 Cape
STARTED
|
4
|
|
7.5 mg/kg TRC105, 1000 mg/m2 Cape
COMPLETED
|
3
|
|
7.5 mg/kg TRC105, 1000 mg/m2 Cape
NOT COMPLETED
|
1
|
|
10 mg/kg TRC105, 1000 mg/m2 Cape
STARTED
|
15
|
|
10 mg/kg TRC105, 1000 mg/m2 Cape
COMPLETED
|
15
|
|
10 mg/kg TRC105, 1000 mg/m2 Cape
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
Carotuximab (TRC105) Plus Capecitabine
All patients received TRC105 + capecitabine
TRC105: IV (7.5 or 10 mg/kg weekly)
Capecitabine: oral (1,000 mg/m2 BID)
|
|---|---|
|
7.5 mg/kg TRC105, 1000 mg/m2 Cape
Adverse Event
|
1
|
Baseline Characteristics
Open Label Dose-Finding Study of TRC105 Plus Capecitabine for Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Single
n=19 Participants
All patients received TRC105 + capecitabine TRC105: IV (7.5 or 10 mg/kg weekly) Capecitabine: oral (1,000 mg/m2 BID)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=39 Participants
|
|
Age, Continuous
|
53 years
n=39 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: 1.5 yearsPopulation: All patients who received at least a portion of a dose of TRC105 enrolled in the dose escalation portion of the study
Assess safety and dose limiting toxicity by dose cohort and coding all terms utilized MedDRA version 14.1.
Outcome measures
| Measure |
Carotuximab (TRC105) Plus Capecitabine
n=6 Participants
All patients received TRC105 + capecitabine TRC105: IV (7.5 or 10 mg/kg weekly) Capecitabine: oral (1,000 mg/m2 BID)
|
|---|---|
|
Determine Maximum Tolerated Dose of TRC105 in Combination With Capecitabine
Patients with DLT at 7.5 mg/kg
|
0 Participants
|
|
Determine Maximum Tolerated Dose of TRC105 in Combination With Capecitabine
Patients without DLT at 7.5 mg/kg
|
3 Participants
|
|
Determine Maximum Tolerated Dose of TRC105 in Combination With Capecitabine
Patients with DLT at 10 mg/kg
|
0 Participants
|
|
Determine Maximum Tolerated Dose of TRC105 in Combination With Capecitabine
Patients without DLT at 10 mg/kg
|
3 Participants
|
SECONDARY outcome
Timeframe: Cycle 2 day 1 (3 weeks)Population: All patients who received full TRC105 doses of 10 mg/kg in cycle 1.
Mean trough concentration for patients dosed at 10 mg/kg at cycle 2 day 1
Outcome measures
| Measure |
Carotuximab (TRC105) Plus Capecitabine
n=15 Participants
All patients received TRC105 + capecitabine TRC105: IV (7.5 or 10 mg/kg weekly) Capecitabine: oral (1,000 mg/m2 BID)
|
|---|---|
|
TRC105 Steady State Pharmacokinetic Trough Concentration at the RP2D
|
66668.75 ng/mL
Interval 200.0 to 129000.0
|
SECONDARY outcome
Timeframe: 1.5 yearsPopulation: All patients who received at least a portion of a dose of TRC105
Serial blood samples will be tested for anti-drug antibody (ADA) immune response to TRC105. Patients who are positive at baseline (prior to receiving TRC105) are excluded from analysis.
Outcome measures
| Measure |
Carotuximab (TRC105) Plus Capecitabine
n=19 Participants
All patients received TRC105 + capecitabine TRC105: IV (7.5 or 10 mg/kg weekly) Capecitabine: oral (1,000 mg/m2 BID)
|
|---|---|
|
Number of Patients With Positive Immune Response to TRC105
Post-Dose Positive Anti-Drug Antibody
|
3 Participants
|
|
Number of Patients With Positive Immune Response to TRC105
Post-Dose Negative Anti-Drug Antibody
|
16 Participants
|
SECONDARY outcome
Timeframe: 1.5 yearsPopulation: Patients who had measurable disease at baseline and received at least one follow up scan were evaluable for the primary efficacy outcome of ORR by RECIST 1.1
The best response according to RECIST 1.1 for each patient with measurable disease who received at least one dose of study drug will be listed by cohort and tumor type
Outcome measures
| Measure |
Carotuximab (TRC105) Plus Capecitabine
n=16 Participants
All patients received TRC105 + capecitabine TRC105: IV (7.5 or 10 mg/kg weekly) Capecitabine: oral (1,000 mg/m2 BID)
|
|---|---|
|
Number of Patients With Objective Response According to RECIST 1.1
Partial Response
|
1 Participants
|
|
Number of Patients With Objective Response According to RECIST 1.1
Stable Disease
|
3 Participants
|
|
Number of Patients With Objective Response According to RECIST 1.1
Progressive Disease
|
12 Participants
|
Adverse Events
Single
Serious events: 6 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Single
n=19 participants at risk
All patients received TRC105 + capecitabine
TRC105: IV
Capecitabine: oral
|
|---|---|
|
General disorders
Fatigue
|
5.3%
1/19 • Number of events 1 • Adverse events are collected for each patient from the time of informed consent through 28 days following the last dose of study drug. Patients were eligible for participation in the trial until they progressed. The longest duration of AE collection for a given patient was 1 year.
|
|
Nervous system disorders
Headache
|
5.3%
1/19 • Number of events 1 • Adverse events are collected for each patient from the time of informed consent through 28 days following the last dose of study drug. Patients were eligible for participation in the trial until they progressed. The longest duration of AE collection for a given patient was 1 year.
|
|
General disorders
Pyrexia
|
5.3%
1/19 • Number of events 1 • Adverse events are collected for each patient from the time of informed consent through 28 days following the last dose of study drug. Patients were eligible for participation in the trial until they progressed. The longest duration of AE collection for a given patient was 1 year.
|
|
Injury, poisoning and procedural complications
Fracture
|
5.3%
1/19 • Number of events 1 • Adverse events are collected for each patient from the time of informed consent through 28 days following the last dose of study drug. Patients were eligible for participation in the trial until they progressed. The longest duration of AE collection for a given patient was 1 year.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.3%
1/19 • Number of events 1 • Adverse events are collected for each patient from the time of informed consent through 28 days following the last dose of study drug. Patients were eligible for participation in the trial until they progressed. The longest duration of AE collection for a given patient was 1 year.
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
5.3%
1/19 • Number of events 1 • Adverse events are collected for each patient from the time of informed consent through 28 days following the last dose of study drug. Patients were eligible for participation in the trial until they progressed. The longest duration of AE collection for a given patient was 1 year.
|
Other adverse events
| Measure |
Single
n=19 participants at risk
All patients received TRC105 + capecitabine
TRC105: IV
Capecitabine: oral
|
|---|---|
|
Nervous system disorders
Headache
|
36.8%
7/19 • Number of events 7 • Adverse events are collected for each patient from the time of informed consent through 28 days following the last dose of study drug. Patients were eligible for participation in the trial until they progressed. The longest duration of AE collection for a given patient was 1 year.
|
|
General disorders
Fatigue
|
36.8%
7/19 • Number of events 7 • Adverse events are collected for each patient from the time of informed consent through 28 days following the last dose of study drug. Patients were eligible for participation in the trial until they progressed. The longest duration of AE collection for a given patient was 1 year.
|
|
Gastrointestinal disorders
Gingival bleeding
|
36.8%
7/19 • Number of events 7 • Adverse events are collected for each patient from the time of informed consent through 28 days following the last dose of study drug. Patients were eligible for participation in the trial until they progressed. The longest duration of AE collection for a given patient was 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
31.6%
6/19 • Number of events 6 • Adverse events are collected for each patient from the time of informed consent through 28 days following the last dose of study drug. Patients were eligible for participation in the trial until they progressed. The longest duration of AE collection for a given patient was 1 year.
|
|
Gastrointestinal disorders
Vomiting
|
26.3%
5/19 • Number of events 5 • Adverse events are collected for each patient from the time of informed consent through 28 days following the last dose of study drug. Patients were eligible for participation in the trial until they progressed. The longest duration of AE collection for a given patient was 1 year.
|
|
Gastrointestinal disorders
Nausea
|
26.3%
5/19 • Number of events 5 • Adverse events are collected for each patient from the time of informed consent through 28 days following the last dose of study drug. Patients were eligible for participation in the trial until they progressed. The longest duration of AE collection for a given patient was 1 year.
|
|
Injury, poisoning and procedural complications
Infusion-related reactions
|
21.1%
4/19 • Number of events 4 • Adverse events are collected for each patient from the time of informed consent through 28 days following the last dose of study drug. Patients were eligible for participation in the trial until they progressed. The longest duration of AE collection for a given patient was 1 year.
|
|
Vascular disorders
Flushing
|
15.8%
3/19 • Number of events 3 • Adverse events are collected for each patient from the time of informed consent through 28 days following the last dose of study drug. Patients were eligible for participation in the trial until they progressed. The longest duration of AE collection for a given patient was 1 year.
|
|
Skin and subcutaneous tissue disorders
Rash
|
15.8%
3/19 • Number of events 3 • Adverse events are collected for each patient from the time of informed consent through 28 days following the last dose of study drug. Patients were eligible for participation in the trial until they progressed. The longest duration of AE collection for a given patient was 1 year.
|
Additional Information
Charles Theuer, Medical Monitor
TRACON Pharmaceuticals Inc
Phone: 8585500780
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place