| Study Of Gemcitabine Plus AG-013736 Versus Gemcitabine For Advanced Pancreatic Cancer. |
| 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. |
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. |
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| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
| Overall survival is the primary endpoint. A total of 596 patients and 460 events are required for a log rank test to have an overall 1 sided significance level of 0.025 and power of 0.90. [ Time Frame: 23 months ] [ Designated as safety issue: Yes ] |
Duration of response (the time from the first documentation of objective tumor response to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first). [ Time Frame: 23 months ] [ Designated as safety issue: No ]
Health-related quality of life, pain ratings, and health status of patients in each arm as measured by the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire Core 30 (EORTC QLQ C30) and Pancreatic 26 (PAN26), [ Time Frame: 23 months ] [ Designated as safety issue: Yes ]
BPI sf, and EQ 5D. Questionnaires will be completed prior to dosing and ideally before any clinical assessments. [ Time Frame: 23 months ] [ Designated as safety issue: Yes ]
Population pharmacokinetic analysis using AG-013736 plasma concentrations. [ Time Frame: 23 months ] [ Designated as safety issue: No ]
Progression free survival (the time from randomization to first documentation of objective tumor progression or to death due to any cause, whichever occurs first). [ Time Frame: 23 months ] [ Designated as safety issue: Yes ]
Objective response rate (the proportion of patients with confirmed response according to RECIST, relative to all randomized patients who have baseline measurable disease). [ Time Frame: 23 months ] [ Designated as safety issue: No ]
Safety and tolerability of AG-013736 plus gemcitabine. All patients who receive any study treatment will be included in the final summaries and listings of safety data. [ Time Frame: 23 months ] [ Designated as safety issue: Yes ] |
| Carcinoma, Pancreatic Ductal |
Drug: AG-013736
Drug: Gemcitabine
Drug: placebo |
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To obtain contact information for a study center near you, click here.  |
|
| Recruiting |
| 596 |
| August 2007 |
| August 2009 |
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.
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| Both |
| 18 Years and older |
| No |
|
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| United States, Argentina, Australia, Austria, Belgium, Canada, France, Germany, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Republic of, Netherlands, Portugal, Russian Federation, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom |
|
| NCT00471146 |
| A4061028 |
|
| Pfizer |
|
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
|
| Pfizer |
| November 2008 |
| May 7, 2007 |
| November 21, 2008 |
