Trial Outcomes & Findings for A Phase I/II Study of Ganetespib in Combination With Doxorubicin (NCT NCT02261805)
NCT ID: NCT02261805
Last Updated: 2018-04-23
Results Overview
The dose of ganetespib at which 1 or more out of 3-6 patients experiences a dose-limiting toxicity
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
11 participants
Primary outcome timeframe
1 year
Results posted on
2018-04-23
Participant Flow
Participant milestones
| Measure |
Ganetespib and Doxorubicin - Phase Ib Dose Level 1
Ganetespib 100 mg/m2 IV on days 1 and 8 of a 21-day cycle Doxorubicin 50 mg/m2 IV on day 1 of a 21-day cycle
|
Ganetespib and Doxorubicin - Phase Ib Dose Level 2
Ganetespib 150 mg/m2 IV on days 1 and 8 of a 21-day cycle Doxorubicin 50 mg/m2 IV on day 1 of a 21-day cycle
|
Ganetespib and Doxorubicin - Phase II Expansion
Ganetespib 150 mg/m2 IV on days 1 and 8 of a 21-day cycle Doxorubicin 50 mg/m2 IV on day 1 of a 21-day cycle
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
6
|
2
|
|
Overall Study
COMPLETED
|
3
|
6
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase I/II Study of Ganetespib in Combination With Doxorubicin
Baseline characteristics by cohort
| Measure |
Ganetespib and Doxorubicin
n=11 Participants
Ganetespib 100 or 150 mg/m2 IV on days 1 and 8 of a 21-day cycle Doxorubicin 50 mg/m2 IV on day 1 of a 21-day cycle Ganetespib and doxorubicin
Ganetespib and doxorubicin: IV ganetespib and doxorubicin
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearThe dose of ganetespib at which 1 or more out of 3-6 patients experiences a dose-limiting toxicity
Outcome measures
| Measure |
Ganetespib and Doxorubicin - Phase Ib Dose Level 1
n=3 Participants
Ganetespib 100 mg/m2 IV on days 1 and 8 of a 21-day cycle Doxorubicin 50 mg/m2 IV on day 1 of a 21-day cycle
|
Ganetespib and Doxorubicin - Phase Ib Dose Level 2
n=6 Participants
Ganetespib 150 mg/m2 IV on days 1 and 8 of a 21-day cycle Doxorubicin 50 mg/m2 IV on day 1 of a 21-day cycle
|
Ganetespib and Doxorubicin - Phase II Expansion
Ganetespib 150 mg/m2 IV on days 1 and 8 of a 21-day cycle Doxorubicin 50 mg/m2 IV on day 1 of a 21-day cycle
|
|---|---|---|---|
|
Maximum Tolerated Dose
|
100 mg/m^2
|
150 mg/m^2
|
—
|
SECONDARY outcome
Timeframe: 2 yearsObjective response rate included the count of confirmed complete responses (CR) and partial responses (PR) and was based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Outcome measures
| Measure |
Ganetespib and Doxorubicin - Phase Ib Dose Level 1
n=3 Participants
Ganetespib 100 mg/m2 IV on days 1 and 8 of a 21-day cycle Doxorubicin 50 mg/m2 IV on day 1 of a 21-day cycle
|
Ganetespib and Doxorubicin - Phase Ib Dose Level 2
n=6 Participants
Ganetespib 150 mg/m2 IV on days 1 and 8 of a 21-day cycle Doxorubicin 50 mg/m2 IV on day 1 of a 21-day cycle
|
Ganetespib and Doxorubicin - Phase II Expansion
n=2 Participants
Ganetespib 150 mg/m2 IV on days 1 and 8 of a 21-day cycle Doxorubicin 50 mg/m2 IV on day 1 of a 21-day cycle
|
|---|---|---|---|
|
Objective Response Rate
|
1 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
Ganetespib and Doxorubicin
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ganetespib and Doxorubicin
n=11 participants at risk
Ganetespib 100 or 150 mg/m2 IV on days 1 and 8 of a 21-day cycle Doxorubicin 50 mg/m2 IV on day 1 of a 21-day cycle
|
|---|---|
|
Immune system disorders
Neutrophil count decreased
|
9.1%
1/11 • Number of events 1
Adverse events were reported as pooling all subjects together and were not broken out by group.
|
Other adverse events
| Measure |
Ganetespib and Doxorubicin
n=11 participants at risk
Ganetespib 100 or 150 mg/m2 IV on days 1 and 8 of a 21-day cycle Doxorubicin 50 mg/m2 IV on day 1 of a 21-day cycle
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
27.3%
3/11 • Number of events 3
Adverse events were reported as pooling all subjects together and were not broken out by group.
|
|
Nervous system disorders
Dysgeusia
|
9.1%
1/11 • Number of events 1
Adverse events were reported as pooling all subjects together and were not broken out by group.
|
|
General disorders
Fatigue
|
54.5%
6/11 • Number of events 7
Adverse events were reported as pooling all subjects together and were not broken out by group.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
18.2%
2/11 • Number of events 2
Adverse events were reported as pooling all subjects together and were not broken out by group.
|
|
Blood and lymphatic system disorders
Alkaline phosphatase increased
|
18.2%
2/11 • Number of events 2
Adverse events were reported as pooling all subjects together and were not broken out by group.
|
|
Blood and lymphatic system disorders
Anemia
|
27.3%
3/11 • Number of events 4
Adverse events were reported as pooling all subjects together and were not broken out by group.
|
|
Psychiatric disorders
Depression
|
9.1%
1/11 • Number of events 1
Adverse events were reported as pooling all subjects together and were not broken out by group.
|
|
Gastrointestinal disorders
Diarrhea
|
45.5%
5/11 • Number of events 10
Adverse events were reported as pooling all subjects together and were not broken out by group.
|
|
Gastrointestinal disorders
Dyspepsia
|
9.1%
1/11 • Number of events 1
Adverse events were reported as pooling all subjects together and were not broken out by group.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
18.2%
2/11 • Number of events 2
Adverse events were reported as pooling all subjects together and were not broken out by group.
|
|
Nervous system disorders
Headache
|
9.1%
1/11 • Number of events 1
Adverse events were reported as pooling all subjects together and were not broken out by group.
|
|
General disorders
Nausea
|
72.7%
8/11 • Number of events 8
Adverse events were reported as pooling all subjects together and were not broken out by group.
|
|
Immune system disorders
Neutrophil count decreased
|
36.4%
4/11 • Number of events 4
Adverse events were reported as pooling all subjects together and were not broken out by group.
|
|
Nervous system disorders
Pain
|
18.2%
2/11 • Number of events 2
Adverse events were reported as pooling all subjects together and were not broken out by group.
|
|
General disorders
Anorexia
|
27.3%
3/11 • Number of events 4
Adverse events were reported as pooling all subjects together and were not broken out by group.
|
|
Hepatobiliary disorders
Aspartate aminotransferase increased
|
18.2%
2/11 • Number of events 3
Adverse events were reported as pooling all subjects together and were not broken out by group.
|
|
Blood and lymphatic system disorders
Hyponatremia
|
9.1%
1/11 • Number of events 1
Adverse events were reported as pooling all subjects together and were not broken out by group.
|
|
General disorders
Insomnia
|
9.1%
1/11 • Number of events 1
Adverse events were reported as pooling all subjects together and were not broken out by group.
|
|
Immune system disorders
Lymphocyte count decreased
|
9.1%
1/11 • Number of events 2
Adverse events were reported as pooling all subjects together and were not broken out by group.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
1/11 • Number of events 1
Adverse events were reported as pooling all subjects together and were not broken out by group.
|
|
Gastrointestinal disorders
Gastrointestinal anastomotic leak
|
9.1%
1/11 • Number of events 1
Adverse events were reported as pooling all subjects together and were not broken out by group.
|
|
Hepatobiliary disorders
Hypoalbuminemia
|
9.1%
1/11 • Number of events 1
Adverse events were reported as pooling all subjects together and were not broken out by group.
|
|
Gastrointestinal disorders
Weight loss
|
27.3%
3/11 • Number of events 3
Adverse events were reported as pooling all subjects together and were not broken out by group.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
9.1%
1/11 • Number of events 1
Adverse events were reported as pooling all subjects together and were not broken out by group.
|
|
Blood and lymphatic system disorders
Hypokalemia
|
27.3%
3/11 • Number of events 3
Adverse events were reported as pooling all subjects together and were not broken out by group.
|
|
Blood and lymphatic system disorders
Hypophosphatemia
|
18.2%
2/11 • Number of events 2
Adverse events were reported as pooling all subjects together and were not broken out by group.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
9.1%
1/11 • Number of events 1
Adverse events were reported as pooling all subjects together and were not broken out by group.
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
9.1%
1/11 • Number of events 1
Adverse events were reported as pooling all subjects together and were not broken out by group.
|
|
Immune system disorders
White blood cell decreased
|
9.1%
1/11 • Number of events 1
Adverse events were reported as pooling all subjects together and were not broken out by group.
|
|
Hepatobiliary disorders
AST elevation
|
18.2%
2/11 • Number of events 2
Adverse events were reported as pooling all subjects together and were not broken out by group.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
9.1%
1/11 • Number of events 1
Adverse events were reported as pooling all subjects together and were not broken out by group.
|
|
Eye disorders
Blurred vision
|
9.1%
1/11 • Number of events 1
Adverse events were reported as pooling all subjects together and were not broken out by group.
|
|
Gastrointestinal disorders
Epigastric pain
|
9.1%
1/11 • Number of events 1
Adverse events were reported as pooling all subjects together and were not broken out by group.
|
|
General disorders
Infusion related reaction
|
9.1%
1/11 • Number of events 1
Adverse events were reported as pooling all subjects together and were not broken out by group.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
9.1%
1/11 • Number of events 1
Adverse events were reported as pooling all subjects together and were not broken out by group.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
9.1%
1/11 • Number of events 1
Adverse events were reported as pooling all subjects together and were not broken out by group.
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
1/11 • Number of events 2
Adverse events were reported as pooling all subjects together and were not broken out by group.
|
|
Blood and lymphatic system disorders
Elavated LDH
|
9.1%
1/11 • Number of events 1
Adverse events were reported as pooling all subjects together and were not broken out by group.
|
|
Blood and lymphatic system disorders
Hypermagnesemia
|
9.1%
1/11 • Number of events 1
Adverse events were reported as pooling all subjects together and were not broken out by group.
|
|
Skin and subcutaneous tissue disorders
Mucositis oral
|
9.1%
1/11 • Number of events 1
Adverse events were reported as pooling all subjects together and were not broken out by group.
|
|
Musculoskeletal and connective tissue disorders
Back stiffness
|
9.1%
1/11 • Number of events 1
Adverse events were reported as pooling all subjects together and were not broken out by group.
|
|
Blood and lymphatic system disorders
Hypomagnesemia
|
18.2%
2/11 • Number of events 2
Adverse events were reported as pooling all subjects together and were not broken out by group.
|
|
Blood and lymphatic system disorders
Leukopenia
|
9.1%
1/11 • Number of events 1
Adverse events were reported as pooling all subjects together and were not broken out by group.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place