Study Of Gemcitabine Plus AG-013736 Versus Gemcitabine For Advanced Pancreatic Cancer.
Status and phase
Conditions
Treatments
Details and patient eligibility
About
The purpose of this study is to determine whether investigational study drug, AG-013736, and gemcitabine are effective in the first-line treatment of advanced pancreatic cancer.
Full description
This study was prematurely discontinued for futility on 23 January 2009, based on a planned interim analysis by an independent Data Safety Monitoring Board (DSMB) that found no evidence of improvement in the primary endpoint (survival) in patients treated with axitinib and gemcitabine compared to gemcitabine alone. Enrollment on this study has been discontinued.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Histologically or cytologically confirmed, metastatic or locally-, advanced pancreatic adenocarcinoma not amenable to curative resection.
- Adequate renal, hepatic and bone marrow function.
- Performance status 0 or 1.
Exclusion criteria
- Prior treatment with any systemic chemotherapy for metastatic disease.
- Prior treatment with gemcitabine, AG-013736, or other vascular endothelial growth factor inhibitors.
- Current or recent bleeding, thromboembolic event and or use of a thrombolytic agent.
- Inability to take oral medication.
Trial design
Primary purpose
Allocation
Interventional model
Masking
630 participants in 2 patient groups
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal