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

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan Rogel Cancer Center
Study ID
NCT01663272
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jul 31, 2012
Status verified
Sep 2018
Primary completion
Jan 31, 2015
Completion
Mar 1, 2017

Study Design

Enrollment
12 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Maximum Tolerated Dose [ Time Frame: 5 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Michigan Comprehensive Cancer CenterAnn ArborMichigan48109-

Find similar trials in Ann Arbor, MI

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
University of Michigan Comprehensive Cancer Center· Ann Arbor, MI

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