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

Breast Neoplasms Clinical Trial

Official title:

A Phase II, Randomized, Open-Label Study of Single Agent CI-1033 in Patients With Metastatic Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00051051
• Other study ID #: 1033-011
• Status: Completed
• Phase: Phase 2
• First received: January 2, 2003
• Last updated: May 3, 2007
• Start date: December 2002
• Est. completion date: May 2005

Study information

• Verified date: September 2006
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)

• No immunotherapy (including Herceptin) or other biologic therapy within 2 weeks prior to baseline disease assessments

• No hormone therapy (including hormone replacement therapy) within 4 weeks prior to baseline disease assessments (6 weeks for megestrol acetate)

• Patients must have recovered from the acute effects of any radiation therapy or surgery

• No treatment with any other investigational therapy within 4 weeks prior to baseline disease assessments

• No history of any cancer other than the present condition (except nonmelanoma skin cancer or carcinoma in situ of the cervix) within the last 5 years

• No patients with untreated brain metastases or patients that have not recovered from treatment for brain metastases

• No known malabsorption syndrome or other condition that may impair absorption of study medication

• No comorbidity or condition which compromises compliance with this protocol as judged by the investigator or that would significantly complicate interpretation of the safety profile of CI-1033

• No patients having reproductive potential who are not using a method of birth control or who are pregnant or breastfeeding or have a positive pregnancy test during baseline

Exclusion Criteria:

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• CI-1033

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Brussels
Belgium	Pfizer Investigational Site	Brussels
Belgium	Pfizer Investigational Site	Leuven
Canada	Pfizer Investigational Site	Chicoutimi	Quebec
Canada	Pfizer Investigational Site	Hamilton	Ontario
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Vancouver	British Columbia
France	Pfizer Investigational Site	Avignon Cedex 2
France	Pfizer Investigational Site	Paris Cedex 05
France	Pfizer Investigational Site	Paris Cedex 13
Ireland	Pfizer Investigational Site	Dublin 8
Ireland	Pfizer Investigational Site	Galway
Italy	Pfizer Investigational Site	Bologna
Italy	Pfizer Investigational Site	Forli'
Italy	Pfizer Investigational Site	Modena
Italy	Pfizer Investigational Site	Roma
Spain	Pfizer Investigational Site	Madrid
Spain	Pfizer Investigational Site	Madrid
Sweden	Pfizer Investigational Site	Stockholm
Sweden	Pfizer Investigational Site	Stockholm
United Kingdom	Pfizer Investigational Site	Glasgow
United Kingdom	Pfizer Investigational Site	London
United Kingdom	Pfizer Investigational Site	London
United Kingdom	Pfizer Investigational Site	Sutton	Surrey
United States	Pfizer Investigational Site	Ann Arbor	Michigan
United States	Pfizer Investigational Site	Arroyo Grande	California
United States	Pfizer Investigational Site	Aurora	Colorado
United States	Pfizer Investigational Site	Aventura	Florida
United States	Pfizer Investigational Site	Boston	Massachusetts
United States	Pfizer Investigational Site	Boston	Massachusetts
United States	Pfizer Investigational Site	Boston	Massachusetts
United States	Pfizer Investigational Site	Bronx	New York
United States	Pfizer Investigational Site	Bronx	New York
United States	Pfizer Investigational Site	Brownstown	Michigan
United States	Pfizer Investigational Site	Chicago	Illinois
United States	Pfizer Investigational Site	Cleveland	Ohio
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Dearborn	Michigan
United States	Pfizer Investigational Site	Detroit	Michigan
United States	Pfizer Investigational Site	Gallatin	Tennessee
United States	Pfizer Investigational Site	Hermitage	Tennessee
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Kansas City	Missouri
United States	Pfizer Investigational Site	Kansas City	Missouri
United States	Pfizer Investigational Site	Kansas City	Missouri
United States	Pfizer Investigational Site	Kansas City	Kansas
United States	Pfizer Investigational Site	Lebanon	Tennessee
United States	Pfizer Investigational Site	Lee's Summit	Missouri
United States	Pfizer Investigational Site	Lenexa	Kansas
United States	Pfizer Investigational Site	Maywood	Illinois
United States	Pfizer Investigational Site	Miami Beach	Florida
United States	Pfizer Investigational Site	Montebello	California
United States	Pfizer Investigational Site	Montgomery	Alabama
United States	Pfizer Investigational Site	Murfreesboro	Tennessee
United States	Pfizer Investigational Site	Nashville	Tennessee
United States	Pfizer Investigational Site	Nashville	Tennessee
United States	Pfizer Investigational Site	Nashville	Tennessee
United States	Pfizer Investigational Site	Nashville	Tennessee
United States	Pfizer Investigational Site	Overland Park	Kansas
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania
United States	Pfizer Investigational Site	Plantation	Florida
United States	Pfizer Investigational Site	Salt Lake City	Utah
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	San Francisco	California
United States	Pfizer Investigational Site	Walla Walla	Washington
United States	Pfizer Investigational Site	West Bloomfield	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  France,  Ireland,  Italy,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary objective is to assess the antitumor activity of CI 1033 in patients with metastatic breast cancer.
Secondary	Secondary objectives include an assessment of safety and patient reported outcomes (eg, quality of life [QOL])
Secondary	correlations between erbB expression and efficacy
Secondary	exploratory analyses of soluble erbB-2 or other biomarkers
Secondary	exploratory questions to measure the patient-reported impact of diarrhea and skin reactions will also be assessed

External Links

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