A Phase II Study of CI-1033 in Treating Patients With Metastatic (Stage IV) Breast Cancer

NCT00051051 | Completed Phase 2

• 1 other identifier: 1033-011
• Study Type: interventional
• Target: 168
• Locations: 9 countries
• Sites: 66

Brief Summary

CI-1033 is an experimental drug that acts as an inhibitor of erbB (EGFR) receptors, which may be involved in tumor growth. The primary objective of this study is to assess the antitumor activity of CI-1033 in patients with metastatic breast cancer. Patients with histologically confirmed metastatic (Stage IV) breast cancer and who have received no more than 2 prior cytotoxic chemotherapy regimens are eligible for this study. CI-1033 is administered orally. Patients are required to have blood tests periodically while receiving treatment and will be closely monitored throughout the study for possible side effects and response to treatment. Patients may not have received any prior treatment with other agents that target erbB receptors, including Herceptin (trastuzumab) or Iressa (gefitinib).

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

• The primary objective is to assess the antitumor activity of CI 1033 in patients with metastatic breast cancer.

Secondary Outcomes (4)

• Secondary objectives include an assessment of safety and patient reported outcomes (eg, quality of life [QOL])

• correlations between erbB expression and efficacy

• exploratory analyses of soluble erbB-2 or other biomarkers

• exploratory questions to measure the patient-reported impact of diarrhea and skin reactions will also be assessed

Interventions

CI-1033 DRUG

Eligibility Criteria

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

You may qualify if:

• Female, at least 18 years of age
• Histologically confirmed diagnosis of breast cancer
• Metastatic (Stage IV) disease
• Progressive or recurrent disease following the most recent therapy
• No more than 2 different, prior cytotoxic chemotherapy regimens for metastatic disease
• At least one measurable target lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) that has not been irradiated
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, determined within 2 weeks prior to randomization
• Estimated life expectancy of \> 12 weeks
• Capable of giving written informed consent
• Capable of swallowing intact CI-1033 capsules
• Capable of understanding and adhering to the protocol requirements
• No prior exposure to CI-1033 or other agents that target the erbB receptor family (such as Herceptin, Iressa, Tarceva, IMC-C225, and EKB-569)
• No known hypersensitivity reaction to tyrosine kinase inhibitors
• Adequate liver, renal, or bone marrow function determined within 2 weeks prior to randomization
• No cytotoxic chemotherapy within 3 weeks prior to baseline disease assessments (6 weeks for nitrosoureas or mitomycin)

You may not qualify if:

• Prior exposure to CI-1033 or other agents that target the erbB receptor family; cytotoxic chemotherapy within 3 weeks prior to baseline disease assessments (6 weeks for nitrosoureas or mitomycin); immunotherapy (including Herceptin) or other biologic therapy within 2 weeks prior to baseline disease assessments; hormone therapy (including hormone replacement therapy) within 4 weeks prior to baseline disease assessments; 6 weeks for megestrol acetate (to exclude the possibility of a hormone-withdrawal response); patients with untreated brain metastases.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (66)

Pfizer Investigational Site

Montgomery, Alabama, 36106, United States

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Arroyo Grande, California, 93420, United States

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Montebello, California, 90640, United States

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San Francisco, California, 94115, United States

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Aurora, Colorado, 80010, United States

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Aventura, Florida, 33180, United States

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Miami Beach, Florida, 33140, United States

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Plantation, Florida, 33324, United States

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Chicago, Illinois, 60637-1470, United States

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Maywood, Illinois, 60153, United States

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Kansas City, Kansas, 66112, United States

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Lenexa, Kansas, 66214, United States

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Overland Park, Kansas, 66210, United States

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Boston, Massachusetts, 02114, United States

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Pfizer Investigational Site

Boston, Massachusetts, 02115, United States

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Boston, Massachusetts, 02215, United States

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Ann Arbor, Michigan, 48109-0922, United States

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Brownstown, Michigan, 48183, United States

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Dearborn, Michigan, 48126, United States

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Detroit, Michigan, 48202, United States

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West Bloomfield, Michigan, 48322, United States

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Kansas City, Missouri, 64111, United States

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Kansas City, Missouri, 64131, United States

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Kansas City, Missouri, 64154, United States

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Lee's Summit, Missouri, 64064, United States

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The Bronx, New York, 10461, United States

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The Bronx, New York, 10467, United States

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Cleveland, Ohio, 44106, United States

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Philadelphia, Pennsylvania, 19104, United States

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Gallatin, Tennessee, 37066, United States

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Hermitage, Tennessee, 37076, United States

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Lebanon, Tennessee, 37087, United States

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Murfreesboro, Tennessee, 37130, United States

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Nashville, Tennessee, 37203, United States

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Nashville, Tennessee, 37205, United States

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Nashville, Tennessee, 37207, United States

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Nashville, Tennessee, 37211, United States

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Dallas, Texas, 75246, United States

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Houston, Texas, 77030, United States

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San Antonio, Texas, 78229, United States

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Salt Lake City, Utah, 84112, United States

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Walla Walla, Washington, 99362, United States

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Brussels, 1000, Belgium

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Brussels, 1070, Belgium

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Leuven, 3000, Belgium

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Vancouver, British Columbia, V5Z 4E6, Canada

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Hamilton, Ontario, L8V 5C2, Canada

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Chicoutimi, Quebec, G7H 5H6, Canada

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Montreal, Quebec, H2L 4M1, Canada

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Avignon, 84082, France

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Paris, 75248, France

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Paris, 75651, France

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Dublin, Ireland

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Galway, Ireland

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Bologna, 40139, Italy

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Forlì, 47100, Italy

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Modena, 41100, Italy

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Roma, 00144, Italy

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Madrid, Madrid, 28040, Spain

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Pfizer Investigational Site

Madrid, Madrid, 28041, Spain

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Stockholm, 118 83, Sweden

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Stockholm, 17176, Sweden

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Pfizer Investigational Site

Sutton, Surrey, SM2 5PT, United Kingdom

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Glasgow, G11 6NT, United Kingdom

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Pfizer Investigational Site

London, SE1 9RT, United Kingdom

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Pfizer Investigational Site

London, SW3 6JJ, United Kingdom

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Canertinib

Condition Hierarchy (Ancestors)

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

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 2, 2003
• First Posted: January 3, 2003
• Study Start: December 1, 2002
• Study Completion: May 1, 2005
• Last Updated: May 4, 2007

Record last verified: 2006-09

Locations

SE (2); FR (3); GB (4); BE (3); CA (4); ES (2); IE (2); IT (4); US (42)