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

NCT00076024 | Completed Phase 1 Results DMC

• 1 other identifier: A4061010
• Study Type: interventional
• Target: 174
• Locations: 8 countries
• Sites: 54

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.

Conditions

Breast Neoplasms

Keywords

metastatic breast cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• 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 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

• 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

• 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

Other Outcomes (1)

• Population Pharmacokinetics of Axitinib (AG-013736) for Phase 2 (Double-blind)

  Day 1 (pre-dose), Day 22 and Day 43 and then every 9 weeks up to 129 weeks

Study Arms (2)

Docetaxel + Placebo

OTHER

Docetaxel + Placebo

Drug: Placebo; Drug: Docetaxel

Docetaxel + AG-013736

EXPERIMENTAL

Docetaxel + AG-013736

Drug: AG-013736 (axitinib); Drug: Docetaxel

Interventions

Placebo DRUG

5 mg twice daily \[bid\] continuous dosing

Docetaxel + Placebo

Docetaxel DRUG

Standard of care drug administration

Docetaxel + Placebo

AG-013736 (axitinib) DRUG

5mg twice daily \[bid\] continuous dosing

Docetaxel + AG-013736

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Adjuvant chemotherapy given in the past 12 months
• Uncontrolled brain metastases

Sponsors & Collaborators

• Pfizer: lead

Study Sites (54)

Pfizer Investigational Site

Tucson, Arizona, 85724-5024, United States

Location

Pfizer Investigational Site

Tucson, Arizona, 85724, United States

Location

Pfizer Investigational Site

Berkeley, California, 94704, United States

Location

Pfizer Investigational Site

Montebello, California, 90640, United States

Location

Pfizer Investigational Site

Monterey Park, California, 91754, United States

Location

Pfizer Investigational Site

San Francisco, California, 94115, United States

Location

Pfizer Investigational Site

San Gabriel, California, 91776, United States

Location

Pfizer Investigational Site

Whittier, California, 90602, United States

Location

Pfizer Investigational Site

Jacksonville, Florida, 32204, United States

Location

Pfizer Investigational Site

Jacksonville, Florida, 32207, United States

Location

Pfizer Investigational Site

Jacksonville, Florida, 32223, United States

Location

Pfizer Investigational Site

Jacksonville Beach, Florida, 32250, United States

Location

Pfizer Investigational Site

Melbourne, Florida, 32901, United States

Location

Pfizer Investigational Site

Orange Park, Florida, 32073, United States

Location

Pfizer Investigational Site

Palatka, Florida, 32177, United States

Location

Pfizer Investigational Site

Saint Augustine, Florida, 32086, United States

Location

Pfizer Investigational Site

Chicago, Illinois, 60612, United States

Location

Pfizer Investigational Site

Chicago, Illinois, 60637, United States

Location

Pfizer Investigational Site

Zion, Illinois, 60099, United States

Location

Pfizer Investigational Site

Boston, Massachusetts, 02118, United States

Location

Pfizer Investigational Site

Ann Arbor, Michigan, 48106, United States

Location

Pfizer Investigational Site

Stony Brook, New York, 11794, United States

Location

Pfizer Investigational Site

Cleveland, Ohio, 44195, United States

Location

Pfizer Investigational Site

Corvallis, Oregon, 97330, United States

Location

Pfizer Investigational Site

Edmonton, Alberta, T6G 1Z2, Canada

Location

Pfizer Investigational Site

Ottawa, Ontario, K1H 8L6, Canada

Location

Pfizer Investigational Site

Montreal, Quebec, H2L 4M1, Canada

Location

Pfizer Investigational Site

Nový Jičín, 741 01, Czechia

Location

Pfizer Investigational Site

Prague, 180 00, Czechia

Location

Pfizer Investigational Site

Berlin, 10117, Germany

Location

Pfizer Investigational Site

Essen, 45122, Germany

Location

Pfizer Investigational Site

Frankfurt, 60590, Germany

Location

Pfizer Investigational Site

Freiburg im Breisgau, 79106, Germany

Location

Pfizer Investigational Site

Hamburg, 22081, Germany

Location

Pfizer Investigational Site

Bangalore, Karnataka, 560 034, India

Location

Pfizer Investigational Site

Pune, Maharashtra, 411 004, India

Location

Pfizer Investigational Site

Napoli, 80131, Italy

Location

Pfizer Investigational Site

Roma, 00128, Italy

Location

Pfizer Investigational Site

Roma, 00135, Italy

Location

Pfizer Investigational Site

Roma, 00144, Italy

Location

Pfizer Investigational Site

Rozzano (Mi), 20089, Italy

Location

Pfizer Investigational Site

Taormina, ME, 98039, Italy

Location

Pfizer Investigational Site

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Pfizer Investigational Site

Sabadell, Barcelona, 08208, Spain

Location

Pfizer Investigational Site

Girona, Girona, 17007, Spain

Location

Pfizer Investigational Site

Madrid, Madrid, 28040, Spain

Location

Pfizer Investigational Site

Madrid, Madrid, 28041, Spain

Location

Pfizer Investigational Site

Málaga, Malaga, 29010, Spain

Location

Pfizer Investigational Site

Valencia, Valencia, 46009, Spain

Location

Pfizer Investigational Site

Valencia, Valencia, 46010, Spain

Location

Pfizer Investigational Site

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Pfizer Investigational Site

Rickmansworth, Middlesex, HA5 2RN, United Kingdom

Location

Pfizer Investigational Site

Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

Location

Pfizer Investigational Site

Sheffield, Yorkshire, S10 2SJ, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Docetaxel; Axitinib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Benzamides; Amides; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

Analysis of TTP (Phase 2, Double-blind) was performed with both discontinuation due to lack of efficacy (LOE) considered a progression and not considered a progression event. Latter was considered primary analysis and former a sensitivity analysis.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2004
• First Posted: January 14, 2004
• Study Start: February 1, 2004
• Primary Completion: January 1, 2007
• Study Completion: November 1, 2008
• Last Updated: June 26, 2012
• Results First Posted: March 16, 2012

Record last verified: 2012-06

Locations

IT (6); CZ (2); IN (2); DE (5); ES (8); CA (3); US (24); GB (4)