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

Pfizer

Status and phase

Completed

Phase 2

Conditions

Breast Neoplasms

Treatments

Drug: CI-1033

Study type

Interventional

Funder types

Industry

Identifiers

NCT00051051

1033-011

Details and patient eligibility

About

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).

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.