At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed advanced epithelial cancer of the exocrine pancreas (localized but surgically unresectable or metastatic)
- ✓No prior chemotherapy for metastatic disease
- ✕Locally advanced disease amenable to radiation therapy
- ✕Uncontrolled brain metastases
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A RANDOMIZED PHASE 2 STUDY OF THE ANTI-ANGIOGENESIS AGENT AG-013736 IN COMBINATION WITH GEMCITABINE IN PATIENTS WITH CHEMOTHERAPY-NAIVE ADVANCED PANCREATIC CANCER PRECEDED BY A PHASE 1 PORTION
In Brief
A Phase 2 clinical trial evaluating Gemcitabine and AG-013736 for Pancreatic Neoplasms. Completed, enrolled 111 participants across 38 sites in 8 countries.
Detailed Summary
This is a Phase 2 study being conducted at multiple centers in the United States, Europe and Canada. Patients having pancreatic cancer that is locally advanced or that has spread to other parts of the body (i.e., metastatic) are eligible to participate. Patients must have not had any prior systemic treatment for advanced disease. The purpose of the study is to test whether the angiogenesis inhibitor Axitinib \[AG-013736\] in combination with gemcitabine is an effective treatment for advanced pancreatic cancer vs. gemcitabine alone by overall survival.
Study Details
Timeline
Interventions
Gemcitabine 1000 mg/m\^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks
Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 4 weeks.
Gemcitabine 1000 mg/m\^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.