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| Sponsored by: |
Pfizer |
| Information provided by: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00471146 |
Purpose
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.
| Condition | Intervention | Phase |
|
Carcinoma, Pancreatic Ductal |
Drug: AG-013736 Drug: Gemcitabine Drug: placebo |
Phase III |
| MedlinePlus related topics: | Cancer Pancreatic Cancer |
| ChemIDplus related topics: | Gemcitabine hydrochloride Gemcitabine Axitinib |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
| Official Title: | 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. |
| Estimated Enrollment: | 596 |
| Study Start Date: | August 2007 |
| Estimated Study Completion Date: | August 2009 |
| Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
| A: Experimental |
Drug: AG-013736
oral administration, starting dose 5 mg BID every day until unacceptable toxicity or tumor progression.
Drug: Gemcitabine
intravenous administration at 1,000 mg/m2 day 1, day 8 and day 15 every 4 weeks (conventional dose) until unacceptable toxicity or tumor progression.
|
| B: Active Comparator |
Drug: Gemcitabine
intravenous administration at 1,000 mg/m2 day 1, day 8 and day 15 every 4 weeks (conventional dose) until unacceptable toxicity or tumor progression.
Drug: placebo
placebo
|
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Pfizer Oncology Clinical Trial Information Service | 1-877-369-9753 | PfizerCancerTrials@emergingmed.com |
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
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Show 233 Study Locations |
| Pfizer |
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
To obtain contact information for a study center near you, click here. 
  |
| Responsible Party: | Pfizer Inc ( Director, Clinical Trial Disclosure Group ) |
| Study ID Numbers: | A4061028 |
| First Received: | May 7, 2007 |
| Last Updated: | August 30, 2008 |
| ClinicalTrials.gov Identifier: | NCT00471146 |
| Health Authority: | United States: Food and Drug Administration |
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