Gemcitabine and Pazopanib in Metastatic Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT01080248|
Recruitment Status : Terminated (Closed due to delay by GSK)
First Posted : March 4, 2010
Results First Posted : June 9, 2015
Last Update Posted : June 9, 2015
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: Gemcitabine Drug: Pazopanib||Phase 2|
To determine the response rate by RECIST criteria.
To determine the progression free survival.
To determine the median survival and overall survival at one year.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Gemcitabine and Pazopanib in Metastatic Pancreatic Cancer|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||October 2011|
Experimental: 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.
Other Name: GemzarDrug: Pazopanib
Other Name: Votrient
- Response Rate by RECIST Criteria. [ Time Frame: Follow-up was approximately 9 weeks ]
- 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
- Progression-free Survival (PFS) [ Time Frame: Follow-up was approximately 9 weeks ]
- 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.
- Median Survival [ Time Frame: Length of follow-up was 35 weeks ]
- Overall Survival [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01080248
|United States, Missouri|
|Washington University School of Medicine|
|St. Louis, Missouri, United States, 63110|
|Principal Investigator:||Joel Picus, M.D.||Washington University School of Medicine|