Trial Outcomes & Findings for Gemcitabine and Pazopanib in Metastatic Pancreatic Cancer (NCT NCT01080248)
NCT ID: NCT01080248
Last Updated: 2015-06-09
Results Overview
* Response rate = complete response + partial response per RECIST * Complete response - disappearance of all target and non-target lesions. * Partial response - at least a 30% decrease in the sum of the longest diameter of the target lesions, taking as reference the baseline sum longest diameter
TERMINATED
PHASE2
2 participants
Follow-up was approximately 9 weeks
2015-06-09
Participant Flow
The study opened to participant enrollment on 08/26/2010 and closed to participant enrollment on 09/27/2011.
Participant milestones
| Measure |
Arm 1 (Gemcitabine & Pazopanib)
Gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of each 28 day cycle.
Pazopanib 800 mg PO daily of each 28 day cycle.
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gemcitabine and Pazopanib in Metastatic Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Arm 1 (Gemcitabine & Pazopanib)
n=2 Participants
Gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of each 28 day cycle.
Pazopanib 800 mg PO daily of each 28 day cycle.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Follow-up was approximately 9 weeksPopulation: One participant was removed from study for adverse event prior to first response assessment. The remaining participant had progressive disease per RECIST while on treatment.
* Response rate = complete response + partial response per RECIST * Complete response - disappearance of all target and non-target lesions. * Partial response - at least a 30% decrease in the sum of the longest diameter of the target lesions, taking as reference the baseline sum longest diameter
Outcome measures
| Measure |
Arm 1 (Gemcitabine & Pazopanib)
n=1 Participants
Gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of each 28 day cycle.
Pazopanib 800 mg PO daily of each 28 day cycle.
|
|---|---|
|
Response Rate by RECIST Criteria.
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Follow-up was approximately 9 weeksPopulation: One participant was removed from study for adverse event prior to first response assessment.
* PFS is defined as the duration of time from start of treatment to time to progression. * Progressive disease - at least a 20% increase in the sum of the longest diameter of the target lesions taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.
Outcome measures
| Measure |
Arm 1 (Gemcitabine & Pazopanib)
n=1 Participants
Gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of each 28 day cycle.
Pazopanib 800 mg PO daily of each 28 day cycle.
|
|---|---|
|
Progression-free Survival (PFS)
|
8 weeks
|
SECONDARY outcome
Timeframe: Length of follow-up was 35 weeksOutcome measures
| Measure |
Arm 1 (Gemcitabine & Pazopanib)
n=2 Participants
Gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of each 28 day cycle.
Pazopanib 800 mg PO daily of each 28 day cycle.
|
|---|---|
|
Median Survival
|
34 weeks
Interval 33.0 to 35.0
|
SECONDARY outcome
Timeframe: 1 yearOutcome measures
| Measure |
Arm 1 (Gemcitabine & Pazopanib)
n=2 Participants
Gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of each 28 day cycle.
Pazopanib 800 mg PO daily of each 28 day cycle.
|
|---|---|
|
Overall Survival
|
0 participants
|
Adverse Events
Arm 1 (Gemcitabine & Pazopanib)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm 1 (Gemcitabine & Pazopanib)
n=2 participants at risk
Gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of each 28 day cycle.
Pazopanib 800 mg PO daily of each 28 day cycle.
|
|---|---|
|
General disorders
Pain
|
50.0%
1/2
|
|
Investigations
SGOT/SGPT
|
100.0%
2/2
|
|
General disorders
Sweating
|
100.0%
2/2
|
|
Infections and infestations
Urinary tract infection
|
50.0%
1/2
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
1/2
|
|
Investigations
Granulocytes
|
50.0%
1/2
|
|
Blood and lymphatic system disorders
Hemoglobin
|
100.0%
2/2
|
|
Investigations
Leukopenia
|
100.0%
2/2
|
|
Investigations
Platelets
|
100.0%
2/2
|
|
Investigations
Alkaline phosphatase
|
50.0%
1/2
|
|
Gastrointestinal disorders
Bloating
|
50.0%
1/2
|
|
General disorders
Chills
|
100.0%
2/2
|
|
Gastrointestinal disorders
Constipation
|
50.0%
1/2
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
2/2
|
|
Nervous system disorders
Dizziness
|
100.0%
2/2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
50.0%
1/2
|
|
General disorders
Edema
|
50.0%
1/2
|
|
General disorders
Fatigue
|
100.0%
2/2
|
|
General disorders
Fever
|
50.0%
1/2
|
|
Gastrointestinal disorders
Gastrointestinal bleed
|
50.0%
1/2
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
50.0%
1/2
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
50.0%
1/2
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
50.0%
1/2
|
|
Metabolism and nutrition disorders
Hypokalemia
|
50.0%
1/2
|
|
Metabolism and nutrition disorders
Hyponatremia
|
50.0%
1/2
|
|
Psychiatric disorders
Insomnia
|
50.0%
1/2
|
Additional Information
Joel Picus, M.D.
Washington University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place