AG-013736 In Combination With Docetaxel Versus Docetaxel Alone For Patients With Metastatic Breast Cancer

Breast Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00076024
• Other study ID #: A4061010
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 12, 2004
• Last updated: June 21, 2012
• Start date: February 2004
• Est. completion date: November 2008

Study information

• Verified date: June 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: November 2008
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• Placebo
5 mg twice daily [bid] continuous dosing
• Docetaxel
Standard of care drug administration
• AG-013736 (axitinib)
5mg twice daily [bid] continuous dosing
• Docetaxel
Standard of care drug administration

Locations

Country	Name	City	State
Canada	Pfizer Investigational Site	Edmonton	Alberta
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Ottawa	Ontario
Czech Republic	Pfizer Investigational Site	Novy Jicin
Czech Republic	Pfizer Investigational Site	Praha 8
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Essen
Germany	Pfizer Investigational Site	Frankfurt
Germany	Pfizer Investigational Site	Freiburg
Germany	Pfizer Investigational Site	Hamburg
India	Pfizer Investigational Site	Bangalore	Karnataka
India	Pfizer Investigational Site	Pune	Maharashtra
Italy	Pfizer Investigational Site	Napoli
Italy	Pfizer Investigational Site	Roma
Italy	Pfizer Investigational Site	Roma
Italy	Pfizer Investigational Site	Roma
Italy	Pfizer Investigational Site	Rozzano (Mi)
Italy	Pfizer Investigational Site	Taormina, ME
Spain	Pfizer Investigational Site	Girona
Spain	Pfizer Investigational Site	Hospitalet de Llobregat	Barcelona
Spain	Pfizer Investigational Site	Madrid
Spain	Pfizer Investigational Site	Madrid
Spain	Pfizer Investigational Site	Malaga
Spain	Pfizer Investigational Site	Sabadell	Barcelona
Spain	Pfizer Investigational Site	Valencia
Spain	Pfizer Investigational Site	Valencia
United Kingdom	Pfizer Investigational Site	Nottingham	Nottinghamshire
United Kingdom	Pfizer Investigational Site	Rickmansworth	Middlesex
United Kingdom	Pfizer Investigational Site	Sheffield	Yorkshire
United Kingdom	Pfizer Investigational Site	Southampton	Hampshire
United States	Pfizer Investigational Site	Ann Arbor	Michigan
United States	Pfizer Investigational Site	Berkeley	California
United States	Pfizer Investigational Site	Boston	Massachusetts
United States	Pfizer Investigational Site	Chicago	Illinois
United States	Pfizer Investigational Site	Chicago	Illinois
United States	Pfizer Investigational Site	Cleveland	Ohio
United States	Pfizer Investigational Site	Corvallis	Oregon
United States	Pfizer Investigational Site	Jacksonville	Florida
United States	Pfizer Investigational Site	Jacksonville	Florida
United States	Pfizer Investigational Site	Jacksonville	Florida
United States	Pfizer Investigational Site	Jacksonville Beach	Florida
United States	Pfizer Investigational Site	Melbourne	Florida
United States	Pfizer Investigational Site	Montebello	California
United States	Pfizer Investigational Site	Monterey Park	California
United States	Pfizer Investigational Site	Orange Park	Florida
United States	Pfizer Investigational Site	Palatka	Florida
United States	Pfizer Investigational Site	San Francisco	California
United States	Pfizer Investigational Site	San Gabriel	California
United States	Pfizer Investigational Site	St. Augustine	Florida
United States	Pfizer Investigational Site	Stony Brook	New York
United States	Pfizer Investigational Site	Tucson	Arizona
United States	Pfizer Investigational Site	Tucson	Arizona
United States	Pfizer Investigational Site	Whittier	California
United States	Pfizer Investigational Site	Zion	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada,  Czech Republic,  Germany,  India,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Tumor Progression (TTP)	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]).	Phase 2 double-blind baseline until tumor progression or death or discontinuation from study treatment, assessed every 9 weeks up to 129 weeks	No
Secondary	Percentage of Participants With Objective Response (OR) for Phase 2 (Double-blind)	Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.	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	No
Secondary	Percentage of Participants With Objective Response (OR) for Phase 2 (Open-label)	Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.	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	No
Secondary	Duration of Response (DR) for Phase 2 (Double-blind)	Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1. DR was calculated for the subgroup of participants with a confirmed objective tumor response.	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	No
Secondary	Duration of Response (DR) for Phase 2 (Open-label)	Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1. DR was calculated for the subgroup of participants with a confirmed objective tumor response.	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	No

External Links

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