Trial Outcomes & Findings for Paclitaxel and Ganetespib in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (NCT NCT01962948)
NCT ID: NCT01962948
Last Updated: 2024-03-26
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
12 participants
Primary outcome timeframe
Up to 28 days
Results posted on
2024-03-26
Participant Flow
Participant milestones
| Measure |
Phase 1: 100 mg/m2 Ganetespib, 80 mg/m2 Paclitaxel
Patients receive paclitaxel IV over 1 hour and ganetespib IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Ganetespib escalation will follow a modified 3+3 design and escalate from 100mg/m2 to 125mg/m2 to 150mg/m2.
|
Phase 1: 125 mg/m2 Ganetespib, 80 mg/m2 Paclitaxel
Patients receive paclitaxel IV over 1 hour and ganetespib IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Ganetespib escalation will follow a modified 3+3 design and escalate from 100mg/m2 to 125mg/m2 to 150mg/m2.
|
Phase 1: 150 mg/m2 Ganetespib, 80 mg/m2 Paclitaxel
Patients receive paclitaxel IV over 1 hour and ganetespib IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Ganetespib escalation will follow a modified 3+3 design and escalate from 100mg/m2 to 125mg/m2 to 150mg/m2.
|
Phase II: MTD/MED of Ganetespib, 80 mg/m2 Paclitaxel
Paclitaxel IV given over 1 hour at 80 mg/m2 days 1, 8 and 15 of a 28-day cycle. PLUS ganetespib IV at MTD/MED from Phase I on days 1, 8 and 15 of a 28-day cycle.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
6
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
6
|
0
|
Reasons for withdrawal
| Measure |
Phase 1: 100 mg/m2 Ganetespib, 80 mg/m2 Paclitaxel
Patients receive paclitaxel IV over 1 hour and ganetespib IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Ganetespib escalation will follow a modified 3+3 design and escalate from 100mg/m2 to 125mg/m2 to 150mg/m2.
|
Phase 1: 125 mg/m2 Ganetespib, 80 mg/m2 Paclitaxel
Patients receive paclitaxel IV over 1 hour and ganetespib IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Ganetespib escalation will follow a modified 3+3 design and escalate from 100mg/m2 to 125mg/m2 to 150mg/m2.
|
Phase 1: 150 mg/m2 Ganetespib, 80 mg/m2 Paclitaxel
Patients receive paclitaxel IV over 1 hour and ganetespib IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Ganetespib escalation will follow a modified 3+3 design and escalate from 100mg/m2 to 125mg/m2 to 150mg/m2.
|
Phase II: MTD/MED of Ganetespib, 80 mg/m2 Paclitaxel
Paclitaxel IV given over 1 hour at 80 mg/m2 days 1, 8 and 15 of a 28-day cycle. PLUS ganetespib IV at MTD/MED from Phase I on days 1, 8 and 15 of a 28-day cycle.
|
|---|---|---|---|---|
|
Overall Study
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
3
|
3
|
6
|
0
|
Baseline Characteristics
Paclitaxel and Ganetespib in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Baseline characteristics by cohort
| Measure |
Phase 1: 100 mg/m2 Ganetespib, 80 mg/m2 Paclitaxel
n=3 Participants
Patients receive paclitaxel IV over 1 hour and ganetespib IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Ganetespib escalation will follow a modified 3+3 design and escalate from 100mg/m2 to 125mg/m2 to 150mg/m2.
|
Phase 1: 125 mg/m2 Ganetespib, 80 mg/m2 Paclitaxel
n=3 Participants
Patients receive paclitaxel IV over 1 hour and ganetespib IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Ganetespib escalation will follow a modified 3+3 design and escalate from 100mg/m2 to 125mg/m2 to 150mg/m2.
|
Phase 1: 150 mg/m2 Ganetespib, 80 mg/m2 Paclitaxel
n=6 Participants
Patients receive paclitaxel IV over 1 hour and ganetespib IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Ganetespib escalation will follow a modified 3+3 design and escalate from 100mg/m2 to 125mg/m2 to 150mg/m2.
|
Phase II: MTD/MED of Ganetespib, 80 mg/m2 Paclitaxel
Paclitaxel IV given over 1 hour at 80 mg/m2 days 1, 8 and 15 of a 28-day cycle. PLUS ganetespib IV at MTD/MED from Phase I on days 1, 8 and 15 of a 28-day cycle.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White Non-Hispanic
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
—
|
12 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to 28 daysOutcome measures
| Measure |
Treatment (Paclitaxel, Ganetespib)
n=12 Participants
Patients receive paclitaxel IV over 1 hour and ganetespib IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
paclitaxel: Given IV
ganetespib: Given IV
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Recommended Phase II Dose of Ganetespib With Weekly Paclitaxel, Based on the Incidence of Dose-limiting Toxicity (DLT) Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 (Phase I)
|
150 mg/m2 ganetespib
|
PRIMARY outcome
Timeframe: From start of treatment to time of progression or death, whichever occurs first, assessed at 6 monthsPopulation: The study was suspended prematurely due to halt in drug production and data were not analyzed
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 4 yearsPopulation: The study was suspended prematurely due to halt in drug production and data were not analyzed
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From start of treatment to time of progression or death, whichever occurs first, assessed up to 4 yearsPopulation: The study was suspended prematurely due to halt in drug production and data were not analyzed
Outcome measures
Outcome data not reported
Adverse Events
Phase 1: 100 mg/m2 Ganetespib, 80 mg/m2 Paclitaxel
Serious events: 0 serious events
Other events: 3 other events
Deaths: 3 deaths
Phase 1: 125 mg/m2 Ganetespib, 80 mg/m2 Paclitaxel
Serious events: 0 serious events
Other events: 3 other events
Deaths: 1 deaths
Phase 1: 150 mg/m2 Ganetespib, 80 mg/m2 Paclitaxel
Serious events: 0 serious events
Other events: 6 other events
Deaths: 4 deaths
Phase II: MTD/MED of Ganetespib, 80 mg/m2 Paclitaxel
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Phase 1: 100 mg/m2 Ganetespib, 80 mg/m2 Paclitaxel
n=3 participants at risk
Patients receive paclitaxel IV over 1 hour and ganetespib IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Ganetespib escalation will follow a modified 3+3 design and escalate from 100mg/m2 to 125mg/m2 to 150mg/m2.
|
Phase 1: 125 mg/m2 Ganetespib, 80 mg/m2 Paclitaxel
n=3 participants at risk
Patients receive paclitaxel IV over 1 hour and ganetespib IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Ganetespib escalation will follow a modified 3+3 design and escalate from 100mg/m2 to 125mg/m2 to 150mg/m2.
|
Phase 1: 150 mg/m2 Ganetespib, 80 mg/m2 Paclitaxel
n=6 participants at risk
Patients receive paclitaxel IV over 1 hour and ganetespib IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Ganetespib escalation will follow a modified 3+3 design and escalate from 100mg/m2 to 125mg/m2 to 150mg/m2.
|
Phase II: MTD/MED of Ganetespib, 80 mg/m2 Paclitaxel
Paclitaxel IV given over 1 hour at 80 mg/m2 days 1, 8 and 15 of a 28-day cycle. PLUS ganetespib IV at MTD/MED from Phase I on days 1, 8 and 15 of a 28-day cycle.
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
50.0%
3/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
16.7%
1/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
Gastrointestinal disorders
Diarrhea
|
66.7%
2/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
33.3%
2/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
33.3%
1/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
50.0%
3/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
Gastrointestinal disorders
Constipation
|
66.7%
2/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
33.3%
1/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
66.7%
4/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
33.3%
1/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
33.3%
1/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
0.00%
0/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
16.7%
1/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
16.7%
1/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
Gastrointestinal disorders
Ascite
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
33.3%
1/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
0.00%
0/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
33.3%
1/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
16.7%
1/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
33.3%
2/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
Gastrointestinal disorders
Dyspepsia
|
33.3%
1/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
33.3%
2/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
Gastrointestinal disorders
Flatulence
|
33.3%
1/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
0.00%
0/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
General disorders
Fatigue
|
66.7%
2/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
66.7%
2/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
83.3%
5/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
General disorders
Gait disturbance
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
16.7%
1/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
General disorders
Malaise
|
33.3%
1/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
0.00%
0/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
100.0%
3/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
33.3%
1/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
50.0%
3/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
33.3%
1/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
16.7%
1/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
16.7%
1/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
16.7%
1/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
33.3%
1/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
33.3%
2/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
33.3%
1/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
33.3%
1/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
16.7%
1/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
33.3%
1/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
33.3%
2/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
16.7%
1/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
Blood and lymphatic system disorders
Anemia
|
66.7%
2/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
33.3%
1/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
50.0%
3/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
33.3%
2/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
33.3%
2/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
33.3%
2/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
16.7%
1/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
33.3%
1/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
0.00%
0/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
1/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
33.3%
1/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
33.3%
2/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
33.3%
1/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
33.3%
2/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
Vascular disorders
Thromboembolic event
|
33.3%
1/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
0.00%
0/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
16.7%
1/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
16.7%
1/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
Reproductive system and breast disorders
Vaginal pain
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
16.7%
1/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
Cardiac disorders
Hypertension
|
66.7%
2/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
50.0%
3/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
Metabolism and nutrition disorders
Type II Diabetes
|
33.3%
1/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
0.00%
0/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
Gastrointestinal disorders
Gerd
|
33.3%
1/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
0.00%
0/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
Ear and labyrinth disorders
Hearing loss
|
33.3%
1/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
16.7%
1/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
Blood and lymphatic system disorders
Leukopenia
|
33.3%
1/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
0.00%
0/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
Blood and lymphatic system disorders
Neutropenia
|
66.7%
2/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
33.3%
2/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
General disorders
Hot flashes
|
33.3%
1/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
0.00%
0/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
Blood and lymphatic system disorders
Edema
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
33.3%
2/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
Psychiatric disorders
Depression
|
33.3%
1/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
33.3%
2/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
General disorders
Neck pain
|
33.3%
1/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
0.00%
0/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
33.3%
2/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
16.7%
1/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
Skin and subcutaneous tissue disorders
Brittle finger nails
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
16.7%
1/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
16.7%
1/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
Gastrointestinal disorders
Oral thrush
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
16.7%
1/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
Injury, poisoning and procedural complications
Ecchymosis
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
16.7%
1/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
General disorders
Jitters
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
16.7%
1/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
Renal and urinary disorders
Bladder pain
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
16.7%
1/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
General disorders
Sweats
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
33.3%
2/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
Cardiac disorders
Heart palpitations
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
16.7%
1/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
16.7%
1/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
16.7%
1/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
16.7%
1/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
General disorders
Back pain
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
16.7%
1/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
16.7%
1/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
Musculoskeletal and connective tissue disorders
Muscle aches
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
16.7%
1/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
Musculoskeletal and connective tissue disorders
Rib pain
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
16.7%
1/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
General disorders
Shakiness
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
16.7%
1/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
0.00%
0/3 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
16.7%
1/6 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
—
0/0 • 2.5 years
Study was closed because grantor stopped supplying study drug. Study did not progress to Phase II.
|
Additional Information
Protocol Development Coordinator
Fox Chase Cancer Center
Phone: 215-728-4097
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place