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Randomized, Placebo-Controlled, Double-Blind, Phase 2 Study Of AG-013736 In Combination With Docetaxel Versus Docetaxel Alone In Patients With Metastatic Breast Cancer Preceded By A Phase 1 Evaluation Of The Combination


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Neoplasms

Thank you

Trial Information

Randomized, Placebo-Controlled, Double-Blind, Phase 2 Study Of AG-013736 In Combination With Docetaxel Versus Docetaxel Alone In Patients With Metastatic Breast Cancer Preceded By A Phase 1 Evaluation Of The Combination


Inclusion Criteria:



- Female patients with histologically/cytologically proven metastatic breast carcinoma
(stage IV, or recurrent with local or regional spread or distant metastatic disease)

- Adequate bone marrow, liver, and renal function

Exclusion Criteria:

- Adjuvant chemotherapy given in the past 12 months

- Uncontrolled brain metastases

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:

Time to Tumor Progression (TTP)

Outcome Description:

Time in days from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP was calculated as first event date minus the date of first dose of study medication plus 1. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]).

Outcome Time Frame:

Phase 2 double-blind baseline until tumor progression or death or discontinuation from study treatment, assessed every 9 weeks up to 129 weeks

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:

A4061010

NCT ID:

NCT00076024

Start Date:

February 2004

Completion Date:

November 2008

Related Keywords:

  • Breast Neoplasms
  • metastatic breast cancer
  • Breast Neoplasms
  • Neoplasms

Name

Location

Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteDetroit, Michigan  48201
Pfizer Investigational SiteCincinnait, Ohio  45236
Pfizer Investigational SiteSpringfield, Illinois  62701-1014
Pfizer Investigational SiteBronx, New York  10461
Pfizer Investigational SiteFlagstaff, Arizona  86001
Pfizer Investigational SiteClearwater, Florida  33761
Pfizer Investigational SiteNorth Adams, Massachusetts  01247
Pfizer Investigational SiteEugene, Oregon  97401