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

Phase 1

Completed

• Conditions: Breast Neoplasms
• Interventions: Drug: AG-013736 (axitinib); Drug: Placebo; Drug: Docetaxel

• Registration Number: NCT00076024
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2004-01-12
• Study First Submitted QC: 2004-01-13
• Study First Posted: 2004-01-14
• Study Start: 2004-02
• Primary Completion: 2007-01
• Study Completion: 2008-11
• Disposition First Submitted: 2009-03-20
• Disposition First Submitted QC: 2009-09-24
• Disposition First Posted: 2009-09-28
• Results First Submitted: 2012-02-25
• Results First Submitted QC: 2012-02-25
• Results First Posted: 2012-03-16
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-21
• Last Update Posted: 2012-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 174

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Docetaxel + AG-013736	AG-013736 (axitinib)	Docetaxel + AG-013736
Docetaxel + Placebo	Placebo	Docetaxel + Placebo
Docetaxel + AG-013736	Docetaxel	Docetaxel + AG-013736
Docetaxel + Placebo	Docetaxel	Docetaxel + Placebo

Primary Outcome Measures

Name	Time	Method
Time to Tumor Progression (TTP)	Phase 2 double-blind baseline until tumor progression or death or discontinuation from study treatment, assessed every 9 weeks up to 129 weeks	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 \[PD\]).

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Objective Response (OR) for Phase 2 (Double-blind)	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	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.
Percentage of Participants With Objective Response (OR) for Phase 2 (Open-label)	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	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.
Duration of Response (DR) for Phase 2 (Double-blind)	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	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.
Duration of Response (DR) for Phase 2 (Open-label)	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	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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇬🇧 Sheffield, Yorkshire, United Kingdom