Pancreatic Cancer Research

Clinical trialPhase 1Completed

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

NCT01663272↗ ClinicalTrials.gov, retrieved 6 November 2026

Outcome
Outcome unknown
Phase
Phase 1
Status
Completed
Study type
Interventional
Start
July 2012
Expected end
1 March 2017
Enrollment
12 participants
Sites
1
Primary outcomes
Maximum Tolerated Dose
Sponsor
Other
Results posted
2018-09-19
Last update
19 September 2018

These are registry fields. A trial card, with population, design, endpoints and result direction each tied to a quote, is not in the data yet.

Ask this document

Answers come only from this document’s own text, as highlighted quotes. If it doesn’t say, you are told so instead of given a guess.

Try

Source text

Brief summary public domain (ClinicalTrials.gov)

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 public domain (ClinicalTrials.gov)

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.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Maximum Tolerated Dose [5 weeks]. Number, mg. Cabozantinib With Gemcitabine (n=12): NA [The MTD could not be determined as too many patients experienced toxicity at all dose levels.].

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Median Progression-free Survival (PFS) [day-7 of cycle 1 until 30 days post treatment]. Median, months (95% Confidence Interval). Cabozantinib With Gemcitabine (n=12): 4.7 (1.4 to 9.7).

Papers 1

The registry lists these as results papers; in a hand check of 27 such links about 78% reported the trial’s results, so read the paper before treating it as the outcome.