A Randomized, Double-Blind Phase 3 Study Of Gemcitabine Plus AG-013736 Versus Gemcitabine Plus Placebo For The First-Line Treatment Of Patients With Locally Advanced, Unresectable Or Metastatic Pancreatic Cancer.
18 Years
N/A
Both
Carcinoma, Pancreatic Ductal
Trial Information
A Randomized, Double-Blind Phase 3 Study Of Gemcitabine Plus AG-013736 Versus Gemcitabine Plus Placebo For The First-Line Treatment Of Patients With Locally Advanced, Unresectable Or Metastatic Pancreatic Cancer.
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
Overall Survival (OS)
Outcome Description:
Time in weeks from randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).
Outcome Time Frame:
Baseline until death or at least 1 year after the randomization of last participant
Safety Issue:
No
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
A4061028
NCT ID:
NCT00471146
Start Date:
July 2007
Completion Date:
November 2010
Related Keywords:
- Carcinoma, Pancreatic Ductal
- Randomized Study Of Gemcitabine Plus AG-013736 Versus Gemcitabine Plus Placebo For Advanced Pancreatic Cancer.
- Carcinoma
- Pancreatic Neoplasms
- Carcinoma, Pancreatic Ductal
Name | Location |
|---|---|
| Pfizer Investigational Site | Blendora, California 91740 |
| Pfizer Investigational Site | Atlanta, Georgia 30342 |
| Pfizer Investigational Site | Crestview Hills, Kentucky 41017 |
| Pfizer Investigational Site | Detroit, Michigan 48201 |
| Pfizer Investigational Site | Cincinnait, Ohio 45236 |
| Pfizer Investigational Site | Springfield, Illinois 62701-1014 |
| Pfizer Investigational Site | Bronx, New York 10461 |
| Pfizer Investigational Site | Houston, Texas 77030 |
| Pfizer Investigational Site | Richmond, Virginia 23249 |
| Pfizer Investigational Site | Federal Way, Washington 98003 |
| Pfizer Investigational Site | Clearwater, Florida 33761 |
| Pfizer Investigational Site | Carmel, Indiana 46032 |
| Pfizer Investigational Site | Westminster, Maryland 21157 |
| Pfizer Investigational Site | North Adams, Massachusetts 01247 |
| Pfizer Investigational Site | Columbia, Missouri 65201 |
| Pfizer Investigational Site | Las Vegas, Nevada 89128 |
| Pfizer Investigational Site | Eugene, Oregon 97401 |
| Pfizer Investigational Site | Shreveport, Louisiana 71103 |
| Pfizer Investigational Site | Omaha, Nebraska 68198 |
| Pfizer Investigational Site | Bristol, Tennessee 37620 |
| Pfizer Investigational Site | Olive Branch, Mississippi 38654 |
| Pfizer Investigational Site | Salt Lake City, Utah 84112 |
| Pfizer Investigational Site | Billings, Montana 59101 |
| Pfizer Investigational Site | Lewistown, Idaho 83501 |
