Trial Outcomes & Findings for Epacadostat and Vaccine Therapy in Treating Patients With Stage III-IV Melanoma (NCT NCT01961115)
NCT ID: NCT01961115
Last Updated: 2018-06-08
Results Overview
Immunohistochemistry: Tumors were assessed by IHC for pattern of T-cell distribution and infiltration of cells expressing CD3 and CD8.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
11 participants
Primary outcome timeframe
Baseline to up to day 21
Results posted on
2018-06-08
Participant Flow
Patients with advanced melanoma were enrolled at 4 comprehensive cancer centers in the U.S. from Sept.., 2013-Jan., 2017. Patients who failed previous standard therapies for melanoma participated in the study.
Participant milestones
| Measure |
Cohort A
Cohort A - Pts. enrolled \>6 wks after failing anti-PD-1/PDL-1 received 300 mg INCB024360 po BID every day for 98 days Cohort B - Pts. enrolled 2-6 weeks after failing anti-PD-1/PDL-1 received 100 mg INCB024360 po BID every day for 98 days All other pts. - received 300 mg po BID
All pts received MELITAC 12.1 intradermal/subcutaneous on days 21, 28, 35, 56, 77, 98
|
Cohort B
Pts. enrolled 2-6 wks after failing anti-PD-1/PDL-1 received 300 mg INCB024360 po BID every day for 98 days Cohort B - Pts. enrolled 2-6 weeks after failing anti-PD-1/PDL-1 received 100 mg INCB024360 po BID every day for 98 days
|
All Other Patients
All advanced melanoma patients not previously treated with anti-PD-1 \& anti-PD-L1 who meet protocol entry criteria
Pts. will receive 300 mg INCB024360 po bid for 98 days + MELITAC 12. 1 vaccine on days 21, 28, 35, 56, 77 \& 98
|
|---|---|---|---|
|
Overall Study
STARTED
|
2
|
0
|
9
|
|
Overall Study
COMPLETED
|
0
|
0
|
5
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
4
|
Reasons for withdrawal
| Measure |
Cohort A
Cohort A - Pts. enrolled \>6 wks after failing anti-PD-1/PDL-1 received 300 mg INCB024360 po BID every day for 98 days Cohort B - Pts. enrolled 2-6 weeks after failing anti-PD-1/PDL-1 received 100 mg INCB024360 po BID every day for 98 days All other pts. - received 300 mg po BID
All pts received MELITAC 12.1 intradermal/subcutaneous on days 21, 28, 35, 56, 77, 98
|
Cohort B
Pts. enrolled 2-6 wks after failing anti-PD-1/PDL-1 received 300 mg INCB024360 po BID every day for 98 days Cohort B - Pts. enrolled 2-6 weeks after failing anti-PD-1/PDL-1 received 100 mg INCB024360 po BID every day for 98 days
|
All Other Patients
All advanced melanoma patients not previously treated with anti-PD-1 \& anti-PD-L1 who meet protocol entry criteria
Pts. will receive 300 mg INCB024360 po bid for 98 days + MELITAC 12. 1 vaccine on days 21, 28, 35, 56, 77 \& 98
|
|---|---|---|---|
|
Overall Study
Disease Progression
|
1
|
0
|
3
|
|
Overall Study
Adverse Event
|
1
|
0
|
1
|
Baseline Characteristics
Epacadostat and Vaccine Therapy in Treating Patients With Stage III-IV Melanoma
Baseline characteristics by cohort
| Measure |
Cohort A
n=2 Participants
Pts. enrolled \>6 wks after failing anti-PD-1/PDL-1 INCB024360 - 300 mg po bid continuous for 98 days MELITAC 12.1 - Intradermal/subcutaneous Days 21, 28, 35, 56, 77, 98
|
Cohort B
Pts.enrolled 2-6 wks after failing anti-PD-1/PDL-1
* INCB024360 - 100 mg po bid continuous for 98 days
* MELITAC 12.1 - Intradermal/subcutaneous Days 21, 28, 35, 56, 77, 98
|
All Other Patients
n=9 Participants
All advanced melanoma patients not previously treated with anti-PD-1 \& anti-PD-L1 who meet protocol entry criteria INCB024360 - 300 mg po bid continuous for 98 days MELITAC 12.1 - Intradermal/subcutaneous Days 21, 28, 35, 56, 77, 98
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Age, Continuous
|
70.5 years
STANDARD_DEVIATION 3.5 • n=99 Participants
|
—
|
60.3 years
STANDARD_DEVIATION 14.1 • n=206 Participants
|
62.2 years
STANDARD_DEVIATION 13.3 • n=7 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=99 Participants
|
—
|
9 participants
n=206 Participants
|
11 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline to up to day 21Population: For one subject in cohort A day 21 tumor biopsy material was not obtained (For analysis of Cohort A n = 1). For analysis of Cohort "All Other Patients" n = 7 due to day 21 biopsy not being obtained in 2 other subjects. In addition, for one of those subjects there was no baseline tumor biopsy obtained.
Immunohistochemistry: Tumors were assessed by IHC for pattern of T-cell distribution and infiltration of cells expressing CD3 and CD8.
Outcome measures
| Measure |
Cohort A
n=1 Participants
Pts.enrolled \>6 wks after failing anti-PD-1/PDL-1
Pts will receive 300mg INCB024360 p.o. bid continuous for 98 days + MELITAC 12.1 vaccine on days 21, 28, 35, 56, 77 \& 98
|
Cohort B
Pts.enrolled 2-6 wks after failing anti-PD-1/PDL-1
Pts. receive 100 mg po bid INCB024360 continuous for 98 days + MELITAC 12.1 vaccine on days 21, 28, 35, 56, 77 \& 98
|
All Other Patients
n=7 Participants
All advanced melanoma patients not previously treated with anti-PD-1 \& anti-PD-L1 who meet protocol entry criteria
Pts. will receive 300 mg INCB024360 po bid for 98 days + MELITAC 12. 1 vaccine on days 21, 28, 35, 56, 77 \& 98
|
|---|---|---|---|
|
Changes in the Concentration and Number of CD8+ Cells Infiltrating Tumor by IHC by Normalization of Kyn/Trp Ratios.
|
0.5 Ratio: Day21CD8s/Day0CD8s
|
—
|
4.0 Ratio: Day21CD8s/Day0CD8s
Interval 0.0 to 20.2
|
PRIMARY outcome
Timeframe: Day 21 up to Day 42Population: Neither subject in cohort A had day 42 tumor biopsy material available. For analysis of Cohort "All Other Patients" n = 6 due to either a day 21 biopsy missing or a missing day 42 biopsy.
Immunohistochemistry: Tumors (day 21 \& day 42) were assessed by IHC for pattern of T-cell distribution and infiltration of cells expressing CD3 and CD8.
Outcome measures
| Measure |
Cohort A
Pts.enrolled \>6 wks after failing anti-PD-1/PDL-1
Pts will receive 300mg INCB024360 p.o. bid continuous for 98 days + MELITAC 12.1 vaccine on days 21, 28, 35, 56, 77 \& 98
|
Cohort B
Pts.enrolled 2-6 wks after failing anti-PD-1/PDL-1
Pts. receive 100 mg po bid INCB024360 continuous for 98 days + MELITAC 12.1 vaccine on days 21, 28, 35, 56, 77 \& 98
|
All Other Patients
n=6 Participants
All advanced melanoma patients not previously treated with anti-PD-1 \& anti-PD-L1 who meet protocol entry criteria
Pts. will receive 300 mg INCB024360 po bid for 98 days + MELITAC 12. 1 vaccine on days 21, 28, 35, 56, 77 \& 98
|
|---|---|---|---|
|
Changes in the Concentration and Number of CD8+ Cells Infiltrating Tumor by IHC by Normalization of Kyn/Trp Ratios in Combination With MELITAC 12.1
|
—
|
—
|
3.9 Mean Ratio: Day42CD8s/Day21CD8s
Interval 0.5 to 16.8
|
SECONDARY outcome
Timeframe: Baseline to up to 16 weekPopulation: Data were not collected
Analysis of PBMC gene signature. This may be compared to immunologic response, tumor biopsy data and clinical response
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to up to 1 yearPopulation: Data were not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to up to 16 weeksPopulation: Data were not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to up to 16 weeksPopulation: Data were not collected
Assessment of immunologic response will be based on a fold-increase measure from baseline as well as using a positivity threshold
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Data were not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Data were not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the time measurement criteria are met for complete response or partial response until the first date that recurrent and progressive disease is objectively documented, assessed up to 1 yearPopulation: Data were not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Data were not collected
Outcome measures
Outcome data not reported
Adverse Events
Cohort A
Serious events: 2 serious events
Other events: 2 other events
Deaths: 2 deaths
Cohort B
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
All Other Patients
Serious events: 0 serious events
Other events: 9 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Cohort A
n=2 participants at risk
Pts. enrolled \>6 wks after failing anti-PD-1/PDL-1
|
Cohort B
Pts. enrolled 2-6 wks after failing anti-PD-1/PDL-1
|
All Other Patients
n=9 participants at risk
Pts. enrolled who have not been treated with check point inhibition
* 100 mg INCB024360 po bid continuous for 98 days
* MELITAC 12.1 intradermal/subcutaneous on days 21, 28, 35, 56, 77, 98
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|---|
|
Gastrointestinal disorders
Ascites
|
100.0%
2/2 • Number of events 2 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
—
0/0 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
0.00%
0/9 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
|
Nervous system disorders
Syncope
|
100.0%
2/2 • Number of events 2 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
—
0/0 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
0.00%
0/9 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
Other adverse events
| Measure |
Cohort A
n=2 participants at risk
Pts. enrolled \>6 wks after failing anti-PD-1/PDL-1
|
Cohort B
Pts. enrolled 2-6 wks after failing anti-PD-1/PDL-1
|
All Other Patients
n=9 participants at risk
Pts. enrolled who have not been treated with check point inhibition
* 100 mg INCB024360 po bid continuous for 98 days
* MELITAC 12.1 intradermal/subcutaneous on days 21, 28, 35, 56, 77, 98
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
1/2 • Number of events 1 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
—
0/0 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
55.6%
5/9 • Number of events 5 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/2 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
—
0/0 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
—
0/0 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
55.6%
5/9 • Number of events 5 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
|
Gastrointestinal disorders
constipation
|
50.0%
1/2 • Number of events 1 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
—
0/0 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
22.2%
2/9 • Number of events 2 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/2 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
—
0/0 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
22.2%
2/9 • Number of events 2 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
|
Gastrointestinal disorders
diarrhea
|
0.00%
0/2 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
—
0/0 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
22.2%
2/9 • Number of events 2 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
|
Gastrointestinal disorders
bloating
|
0.00%
0/2 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
—
0/0 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
|
Gastrointestinal disorders
dyspepsia
|
0.00%
0/2 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
—
0/0 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/2 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
—
0/0 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
|
General disorders
injection site reaction
|
50.0%
1/2 • Number of events 1 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
—
0/0 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
100.0%
9/9 • Number of events 9 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
|
General disorders
fatigue
|
50.0%
1/2 • Number of events 1 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
—
0/0 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
44.4%
4/9 • Number of events 4 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
|
General disorders
chills
|
0.00%
0/2 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
—
0/0 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
22.2%
2/9 • Number of events 2 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
|
General disorders
flu like symptoms
|
0.00%
0/2 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
—
0/0 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
22.2%
2/9 • Number of events 2 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
|
General disorders
fever
|
0.00%
0/2 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
—
0/0 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
|
General disorders
edema
|
0.00%
0/2 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
—
0/0 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
|
General disorders
pain
|
0.00%
0/2 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
—
0/0 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
|
Immune system disorders
cytokine release syndrome
|
0.00%
0/2 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
—
0/0 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
|
Infections and infestations
left eyelid stye
|
50.0%
1/2 • Number of events 1 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
—
0/0 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
0.00%
0/9 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
|
Infections and infestations
cellulitis
|
50.0%
1/2 • Number of events 1 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
—
0/0 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
0.00%
0/9 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
|
Investigations
aspartate aminotransferase increased
|
50.0%
1/2 • Number of events 1 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
—
0/0 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
|
Investigations
Creatinine increased
|
50.0%
1/2 • Number of events 1 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
—
0/0 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/2 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
—
0/0 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
22.2%
2/9 • Number of events 2 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
|
Investigations
Platelet count decreased
|
0.00%
0/2 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
—
0/0 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
22.2%
2/9 • Number of events 2 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
|
Investigations
White blood cell decreased
|
0.00%
0/2 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
—
0/0 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
22.2%
2/9 • Number of events 2 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/2 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
—
0/0 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/2 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
—
0/0 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
|
Investigations
Investigations - Other,
|
0.00%
0/2 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
—
0/0 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/2 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
—
0/0 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
|
Metabolism and nutrition disorders
hyperglycemia
|
50.0%
1/2 • Number of events 1 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
—
0/0 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
55.6%
5/9 • Number of events 5 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
|
Metabolism and nutrition disorders
hypokalemia
|
0.00%
0/2 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
—
0/0 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
33.3%
3/9 • Number of events 3 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
|
Metabolism and nutrition disorders
hyponatremia
|
0.00%
0/2 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
—
0/0 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
22.2%
2/9 • Number of events 2 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
|
Metabolism and nutrition disorders
anorexia
|
0.00%
0/2 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
—
0/0 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
|
Metabolism and nutrition disorders
dehydration
|
0.00%
0/2 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
—
0/0 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
|
Metabolism and nutrition disorders
hyperkalemia
|
0.00%
0/2 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
—
0/0 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
|
Metabolism and nutrition disorders
hypocalcemia
|
0.00%
0/2 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
—
0/0 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
|
Metabolism and nutrition disorders
hypoglycemia
|
0.00%
0/2 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
—
0/0 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
|
Metabolism and nutrition disorders
hypophospatemia
|
0.00%
0/2 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
—
0/0 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
0.00%
0/2 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
—
0/0 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
22.2%
2/9 • Number of events 2 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
0.00%
0/2 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
—
0/0 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
|
Musculoskeletal and connective tissue disorders
back pain
|
0.00%
0/2 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
—
0/0 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/2 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
—
0/0 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
0.00%
0/2 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
—
0/0 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
tumor pain
|
0.00%
0/2 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
—
0/0 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
33.3%
3/9 • Number of events 3 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
|
Nervous system disorders
headache
|
0.00%
0/2 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
—
0/0 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
|
Nervous system disorders
numbness in leg
|
0.00%
0/2 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
—
0/0 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
|
Nervous system disorders
vasovagal reaction
|
0.00%
0/2 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
—
0/0 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
|
Reproductive system and breast disorders
breast pain
|
0.00%
0/2 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
—
0/0 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
0.00%
0/2 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
—
0/0 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
|
Respiratory, thoracic and mediastinal disorders
sore throat
|
0.00%
0/2 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
—
0/0 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
|
Skin and subcutaneous tissue disorders
skin induration
|
0.00%
0/2 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
—
0/0 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
33.3%
3/9 • Number of events 3 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
|
Skin and subcutaneous tissue disorders
pruritis
|
0.00%
0/2 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
—
0/0 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
22.2%
2/9 • Number of events 2 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
|
Skin and subcutaneous tissue disorders
dry skin
|
0.00%
0/2 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
—
0/0 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
|
Skin and subcutaneous tissue disorders
rash maculopapular
|
50.0%
1/2 • Number of events 1 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
—
0/0 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
0.00%
0/9 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
|
Skin and subcutaneous tissue disorders
rash
|
0.00%
0/2 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
—
0/0 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
|
Skin and subcutaneous tissue disorders
skin ulceration
|
0.00%
0/2 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
—
0/0 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
|
Vascular disorders
hypertension
|
50.0%
1/2 • Number of events 1 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
—
0/0 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from initiation of therapy through study post-treatment follow-up assessments, an average of one year.
|
Additional Information
Dr. Martin A. Cheever
Fred Hutchinson Cancer Research Center
Phone: 206-667-4141
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60