A Trial of Cabozantinib (XL184) and Gemcitabine in Advanced Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT01663272|
Recruitment Status : Completed
First Posted : August 13, 2012
Results First Posted : September 19, 2018
Last Update Posted : September 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: CABOZANTINIB Drug: gemcitabine||Phase 1|
Preclinical work at the University of Michigan has demonstrated that inhibition of c-Met with cabozantinib prevented the development of metastatic disease in an intra-cardiac injection model in NOD/SCID mice. Additionally, the combination of cabozantinib and gemcitabine demonstrated improved tumor control compared to either agent alone in a relevant orthotopic implantation mouse model.
Combining gemcitabine with the c-Met inhibitor cabozantinib in advanced pancreatic cancer is a novel strategy that takes advantage of an established cytotoxic agent with one that targets a pathway known to be important for the growth, dissemination, and resistance of this disease.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Trial of Cabozantinib (XL184) and Gemcitabine in Advanced Pancreatic Cancer|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||March 1, 2017|
Experimental: cabozantinib with gemcitabine
The Study Treatment Period will consist of continued treatment during which time patients will receive cabozantinib and gemcitabine until either disease progression or the occurrence of unacceptable drug-related toxicity
Daily oral cabozantinib administered days -7 until disease progression, intolerable adverse event(s) or patient choice.
Other Name: XL184
Gemcitabine administered intravenously on days 1, 8, and 15 every 28 days.
Other Name: Gemzar
- Maximum Tolerated Dose [ Time Frame: 5 weeks ]The MTD is defined at the highest dose level at which ≤25% of patients experience a dose-limiting toxicity (DLT).
- Median Progression-free Survival (PFS) [ Time Frame: day-7 of cycle 1 until 30 days post treatment ]Progression-free survival (PFS, a secondary endpoint) will be calculated from day-7 of cycle 1 of study treatment, until documented disease progression or death. Patients removed from treatment for progression or other reasons will be followed for 30 days after their last dose.
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): NCT01663272
|United States, Michigan|
|University of Michigan Comprehensive Cancer Center|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Mark Zalupski, MD||University of Michigan Rogel Cancer Center|