NCT01663272

A Trial of Cabozantinib (XL184) and Gemcitabine in Advanced Pancreatic Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of Michigan Rogel Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Gemcitabine is considered one of the standard drugs for advanced pancreatic cancer and is approved by the FDA to treat it. Cabozantinib is a new drug that has demonstrated effectiveness against pancreatic cancer in laboratory experiments, especially when given with gemcitabine. Initial studies with cabozantinib in pancreatic cancer have shown some activity against the disease. The purpose of this study is to determine the safest and highest dose of cabozantinib that can be given together with standard doses of gemcitabine in patients with pancreatic cancer. This study will determine the safety and tolerability of this two drug combination.

Detailed description

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.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	CABOZANTINIB	Daily oral cabozantinib administered days -7 until disease progression, intolerable adverse event(s) or patient choice.
DRUG	gemcitabine	Gemcitabine administered intravenously on days 1, 8, and 15 every 28 days.

Timeline

• Start date: 2012-07-01
• Primary completion: 2015-01-01
• Completion: 2017-03-01
• First posted: 2012-08-13
• Last updated: 2018-09-19
• Results posted: 2018-09-19

Locations

1 site across 1 country: United States