Clinical trial NCT00076024: AG-013736 In Combination With Docetaxel Versus Docetaxel Alone For Patients With Metastatic Breast Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Breast Neoplasms
Keywords: metastatic breast cancer
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2004-01-14
Enrollment: 174
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of the study is to determine the time to progression of the combination of study drug (AG-013736) and docetaxel versus docetaxel alone in patients who have not received prior chemotherapy for metastatic breast cancer. The secondary purpose of the study is to determine the dose of study drug that can be given with docetaxel administered on an every 3 week schedule.


Eligibility criteria: 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

Primary outcomes:
measure: Time to Tumor Progression (TTP)
timeFrame: Phase 2 double-blind baseline until tumor progression or death or discontinuation from study treatment, assessed every 9 weeks up to 129 weeks
Secondary outcomes:
measure: Percentage of Participants With Objective Response (OR) for Phase 2 (Double-blind)
timeFrame: Phase 2 double- blind baseline until the date of first documented progression or discontinuation from the study treatment due to any cause, assessed every 9 weeks up to 129 weeks
measure: Percentage of Participants With Objective Response (OR) for Phase 2 (Open-label)
timeFrame: Phase 2 open-label baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 58 weeks
measure: Duration of Response (DR) for Phase 2 (Double-blind)
timeFrame: Phase 2 double-blind baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 9 weeks up to 129 weeks
measure: Duration of Response (DR) for Phase 2 (Open-label)
timeFrame: Phase 2 open-label baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 58 weeks
Other outcomes:
measure: Population Pharmacokinetics of Axitinib (AG-013736) for Phase 2 (Double-blind)
timeFrame: Day 1 (pre-dose), Day 22 and Day 43 and then every 9 weeks up to 129 weeks
Locations:
city: Tucson
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Berkeley
country: United States
facility: Pfizer Investigational Site
state: California
city: Montebello
country: United States
facility: Pfizer Investigational Site
state: California
city: Monterey Park
country: United States
facility: Pfizer Investigational Site
state: California
city: San Francisco
country: United States
facility: Pfizer Investigational Site
state: California
city: San Gabriel
country: United States
facility: Pfizer Investigational Site
state: California
city: Whittier
country: United States
facility: Pfizer Investigational Site
state: California
city: Jacksonville Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Melbourne
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Orange Park
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Palatka
country: United States
facility: Pfizer Investigational Site
state: Florida
city: St. Augustine
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Zion
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Stony Brook
country: United States
facility: Pfizer Investigational Site
state: New York
city: Cleveland
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Corvallis
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Edmonton
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Ottawa
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Novy Jicin
country: Czech Republic
facility: Pfizer Investigational Site
city: Praha 8
country: Czech Republic
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Essen
country: Germany
facility: Pfizer Investigational Site
city: Frankfurt
country: Germany
facility: Pfizer Investigational Site
city: Freiburg
country: Germany
facility: Pfizer Investigational Site
city: Hamburg
country: Germany
facility: Pfizer Investigational Site
city: Bangalore
country: India
facility: Pfizer Investigational Site
state: Karnataka
city: Pune
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Napoli
country: Italy
facility: Pfizer Investigational Site
city: Roma
country: Italy
facility: Pfizer Investigational Site
city: Roma
country: Italy
facility: Pfizer Investigational Site
city: Roma
country: Italy
facility: Pfizer Investigational Site
city: Rozzano (Mi)
country: Italy
facility: Pfizer Investigational Site
city: Taormina, ME
country: Italy
facility: Pfizer Investigational Site
city: Hospitalet de Llobregat
country: Spain
facility: Pfizer Investigational Site
state: Barcelona
city: Sabadell
country: Spain
facility: Pfizer Investigational Site
state: Barcelona
city: Girona
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Malaga
country: Spain
facility: Pfizer Investigational Site
city: Valencia
country: Spain
facility: Pfizer Investigational Site
city: Valencia
country: Spain
facility: Pfizer Investigational Site
city: Southampton
country: United Kingdom
facility: Pfizer Investigational Site
state: Hampshire
city: Rickmansworth
country: United Kingdom
facility: Pfizer Investigational Site
state: Middlesex
city: Nottingham
country: United Kingdom
facility: Pfizer Investigational Site
state: Nottinghamshire
city: Sheffield
country: United Kingdom
facility: Pfizer Investigational Site
state: Yorkshire
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: