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Study Of Gemcitabine Plus AG-013736 Versus Gemcitabine For Advanced Pancreatic Cancer.

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Antioch, California, 94531 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pancreatic Ductal Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00471146
Pfizer
Completed
Study Of Gemcitabine Plus AG-013736 Versus Gemcitabine For Advanced Pancreatic Cancer.

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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.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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1-800-718-1021

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