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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.


Phase 3
18 Years
N/A
Not Enrolling
Both
Carcinoma, Pancreatic Ductal

Thank you

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 SiteBlendora, California  91740
Pfizer Investigational SiteAtlanta, Georgia  30342
Pfizer Investigational SiteCrestview Hills, Kentucky  41017
Pfizer Investigational SiteDetroit, Michigan  48201
Pfizer Investigational SiteCincinnait, Ohio  45236
Pfizer Investigational SiteSpringfield, Illinois  62701-1014
Pfizer Investigational SiteBronx, New York  10461
Pfizer Investigational SiteHouston, Texas  77030
Pfizer Investigational SiteRichmond, Virginia  23249
Pfizer Investigational SiteFederal Way, Washington  98003
Pfizer Investigational SiteClearwater, Florida  33761
Pfizer Investigational SiteCarmel, Indiana  46032
Pfizer Investigational SiteWestminster, Maryland  21157
Pfizer Investigational SiteNorth Adams, Massachusetts  01247
Pfizer Investigational SiteColumbia, Missouri  65201
Pfizer Investigational SiteLas Vegas, Nevada  89128
Pfizer Investigational SiteEugene, Oregon  97401
Pfizer Investigational SiteShreveport, Louisiana  71103
Pfizer Investigational SiteOmaha, Nebraska  68198
Pfizer Investigational SiteBristol, Tennessee  37620
Pfizer Investigational SiteOlive Branch, Mississippi  38654
Pfizer Investigational SiteSalt Lake City, Utah  84112
Pfizer Investigational SiteBillings, Montana  59101
Pfizer Investigational SiteLewistown, Idaho  83501