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

June 21, 2012 updated by: Pfizer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

174

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Pfizer Investigational Site
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Pfizer Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H2L 4M1
        • Pfizer Investigational Site
  • Czech Republic
      • Novy Jicin, Czech Republic, 741 01
        • Pfizer Investigational Site
      • Praha 8, Czech Republic, 180 00
        • Pfizer Investigational Site
  • Germany
      • Berlin, Germany, 10117
        • Pfizer Investigational Site
      • Essen, Germany, 45122
        • Pfizer Investigational Site
      • Frankfurt, Germany, 60590
        • Pfizer Investigational Site
      • Freiburg, Germany, 79106
        • Pfizer Investigational Site
      • Hamburg, Germany, 22081
        • Pfizer Investigational Site
  • India
    • Karnataka
      • Bangalore, Karnataka, India, 560 034
        • Pfizer Investigational Site
    • Maharashtra
      • Pune, Maharashtra, India, 411 004
        • Pfizer Investigational Site
  • Italy
      • Napoli, Italy, 80131
        • Pfizer Investigational Site
      • Roma, Italy, 00144
        • Pfizer Investigational Site
      • Roma, Italy, 00128
        • Pfizer Investigational Site
      • Roma, Italy, 00135
        • Pfizer Investigational Site
      • Rozzano (Mi), Italy, 20089
        • Pfizer Investigational Site
      • Taormina, ME, Italy, 98039
        • Pfizer Investigational Site
  • Spain
      • Girona, Spain, 17007
        • Pfizer Investigational Site
      • Madrid, Spain, 28041
        • Pfizer Investigational Site
      • Madrid, Spain, 28040
        • Pfizer Investigational Site
      • Malaga, Spain, 29010
        • Pfizer Investigational Site
      • Valencia, Spain, 46009
        • Pfizer Investigational Site
      • Valencia, Spain, 46010
        • Pfizer Investigational Site
    • Barcelona
      • Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Pfizer Investigational Site
      • Sabadell, Barcelona, Spain, 08208
        • Pfizer Investigational Site
  • United Kingdom
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO16 6YD
        • Pfizer Investigational Site
    • Middlesex
      • Rickmansworth, Middlesex, United Kingdom, HA5 2RN
        • Pfizer Investigational Site
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
        • Pfizer Investigational Site
    • Yorkshire
      • Sheffield, Yorkshire, United Kingdom, S10 2SJ
        • Pfizer Investigational Site
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • Pfizer Investigational Site
      • Tucson, Arizona, United States, 85724-5024
        • Pfizer Investigational Site
    • California
      • Berkeley, California, United States, 94704
        • Pfizer Investigational Site
      • Montebello, California, United States, 90640
        • Pfizer Investigational Site
      • Monterey Park, California, United States, 91754
        • Pfizer Investigational Site
      • San Francisco, California, United States, 94115
        • Pfizer Investigational Site
      • San Gabriel, California, United States, 91776
        • Pfizer Investigational Site
      • Whittier, California, United States, 90602
        • Pfizer Investigational Site
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Pfizer Investigational Site
      • Jacksonville, Florida, United States, 32204
        • Pfizer Investigational Site
      • Jacksonville, Florida, United States, 32223
        • Pfizer Investigational Site
      • Jacksonville Beach, Florida, United States, 32250
        • Pfizer Investigational Site
      • Melbourne, Florida, United States, 32901
        • Pfizer Investigational Site
      • Orange Park, Florida, United States, 32073
        • Pfizer Investigational Site
      • Palatka, Florida, United States, 32177
        • Pfizer Investigational Site
      • St. Augustine, Florida, United States, 32086
        • Pfizer Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Pfizer Investigational Site
      • Chicago, Illinois, United States, 60612
        • Pfizer Investigational Site
      • Zion, Illinois, United States, 60099
        • Pfizer Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Pfizer Investigational Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • Pfizer Investigational Site
    • New York
      • Stony Brook, New York, United States, 11794
        • Pfizer Investigational Site
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Pfizer Investigational Site
    • Oregon
      • Corvallis, Oregon, United States, 97330
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Docetaxel + Placebo
Drug: Placebo
5 mg twice daily [bid] continuous dosing
Drug: Docetaxel
Standard of care drug administration
EXPERIMENTAL: Docetaxel + AG-013736
Drug: Docetaxel
Standard of care drug administration
Drug: AG-013736 (axitinib)
5mg twice daily [bid] continuous dosing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Tumor Progression (TTP)
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
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Objective Response (OR) for Phase 2 (Double-blind)
Time Frame: 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.
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 Objective Response (OR) for Phase 2 (Open-label)
Time Frame: 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.
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
Duration of Response (DR) for Phase 2 (Double-blind)
Time Frame: 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.
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
Duration of Response (DR) for Phase 2 (Open-label)
Time Frame: 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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Population Pharmacokinetics of Axitinib (AG-013736) for Phase 2 (Double-blind)
Time Frame: Day 1 (pre-dose), Day 22 and Day 43 and then every 9 weeks up to 129 weeks
Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.
Day 1 (pre-dose), Day 22 and Day 43 and then every 9 weeks up to 129 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Primary Completion (ACTUAL)

January 1, 2007

Study Completion (ACTUAL)

November 1, 2008

Study Registration Dates

First Submitted

January 12, 2004

First Submitted That Met QC Criteria

January 13, 2004

First Posted (ESTIMATE)

January 14, 2004

Study Record Updates

Last Update Posted (ESTIMATE)

June 26, 2012

Last Update Submitted That Met QC Criteria

June 21, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A4061010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Neoplasms

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belarus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe