Know Cancer

or
forgot password

A Randomized Phase 2 Study Of The Anti-Angiogenesis Agent AG-013736 In Combination With Gemcitabine In Patients With Chemotherapy Naive Advanced Pancreatic Cancer Preceded By A Phase 1 Portion


Phase 2
18 Years
N/A
Not Enrolling
Both
Pancreatic Neoplasms

Thank you

Trial Information

A Randomized Phase 2 Study Of The Anti-Angiogenesis Agent AG-013736 In Combination With Gemcitabine In Patients With Chemotherapy Naive Advanced Pancreatic Cancer Preceded By A Phase 1 Portion


Inclusion Criteria:



- patients with advanced (localized but surgically unresectable or metastatic)
histologically/cytologically proven epithelial cancer of the exocrine pancreas

- no prior therapy for metastatic disease

Exclusion Criteria:

- patients with locally advanced disease who are candidates for radiation therapy.

- uncontrolled brain metastases (a controlled brain metastasis must be previously
treated, asymptomatic, and without growth for 4 months)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival (OS)

Outcome Description:

Time in days from randomization to date of death due to any cause. OS was calculated as the death date minus the the date of randomization plus 1. 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 of Phase 2 to death or until at least 1 year after the randomization of the 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:

A4061016

NCT ID:

NCT00219557

Start Date:

July 2005

Completion Date:

March 2008

Related Keywords:

  • Pancreatic Neoplasms
  • Randomized Phase 2 Study of AG-013736 in Combination with Gemcitabine versus Gemcitabine Alone in Advanced Pancreatic Cancer
  • Neoplasms
  • Pancreatic Neoplasms

Name

Location

Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteClearwater, Florida  33761
Pfizer Investigational SiteColumbia, Missouri  65201
Pfizer Investigational SiteAsheville, North Carolina  28801
Pfizer Investigational SiteFarmington, Connecticut  06030-3805
Pfizer Investigational SiteMilwaukee, Wisconsin  53215
Pfizer Investigational SiteOmaha, Nebraska  68198
Pfizer Investigational SiteBangor, Maine  04401