| 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. |
| 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. |
| Interventional |
| Phase 3 |
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment |
| Carcinoma, Pancreatic Ductal |
- Drug: AG-013736
oral administration, starting dose 5 mg twice daily [BID] every day until unacceptable toxicity or tumor progression.
- Drug: Gemcitabine
intravenous administration at 1,000 mg/m^2 day 1, day 8 and day 15 every 4 weeks (conventional dose) until unacceptable toxicity or tumor progression.
- Drug: placebo
placebo
|
- Experimental: A
Interventions:
- Drug: AG-013736
- Drug: Gemcitabine
- Active Comparator: B
Interventions:
- Drug: Gemcitabine
- Drug: placebo
|
| Kindler HL, Ioka T, Richel DJ, Bennouna J, Létourneau R, Okusaka T, Funakoshi A, Furuse J, Park YS, Ohkawa S, Springett GM, Wasan HS, Trask PC, Bycott P, Ricart AD, Kim S, Van Cutsem E. Axitinib plus gemcitabine versus placebo plus gemcitabine in patients with advanced pancreatic adenocarcinoma: a double-blind randomised phase 3 study. Lancet Oncol. 2011 Mar;12(3):256-62. doi: 10.1016/S1470-2045(11)70004-3. |
| |
| Completed |
| 630 |
| November 2010 |
| January 2009 (Final data collection date for primary outcome measure) |
|
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.
|
| Sexes Eligible for Study: |
All |
|
| 18 Years and older (Adult, Senior) |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Argentina, Australia, Austria, Belgium, Canada, France, Germany, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Republic of, Netherlands, Russian Federation, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States |
| Portugal |
| |
| NCT00471146 |
| A4061028 |
| Yes |
| Not Provided |
| Not Provided |
| Pfizer |
| Pfizer |
| Not Provided |
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
| Pfizer |
| June 2012 |
