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

Study Overview
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Brief Summary
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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).

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

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Drug: CI-1033


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: CI-1033|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective is to assess the antitumor activity of CI 1033 in patients with metastatic breast cancer. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  |