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

May 3, 2007 updated by: Pfizer

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

168

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1070
        • Pfizer Investigational Site
      • Brussels, Belgium, 1000
        • Pfizer Investigational Site
      • Leuven, Belgium, 3000
        • Pfizer Investigational Site
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Pfizer Investigational Site
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Pfizer Investigational Site
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 5H6
        • Pfizer Investigational Site
      • Montreal, Quebec, Canada, H2L 4M1
        • Pfizer Investigational Site
  • France
      • Avignon Cedex 2, France, 84082
        • Pfizer Investigational Site
      • Paris Cedex 05, France, 75248
        • Pfizer Investigational Site
      • Paris Cedex 13, France, 75651
        • Pfizer Investigational Site
  • Ireland
      • Dublin 8, Ireland
        • Pfizer Investigational Site
      • Galway, Ireland
        • Pfizer Investigational Site
  • Italy
      • Bologna, Italy, 40139
        • Pfizer Investigational Site
      • Forli', Italy, 47100
        • Pfizer Investigational Site
      • Modena, Italy, 41100
        • Pfizer Investigational Site
      • Roma, Italy, 00144
        • Pfizer Investigational Site
  • Spain
      • Madrid, Spain, 28041
        • Pfizer Investigational Site
      • Madrid, Spain, 28040
        • Pfizer Investigational Site
  • Sweden
      • Stockholm, Sweden, 118 83
        • Pfizer Investigational Site
      • Stockholm, Sweden, 17176
        • Pfizer Investigational Site
  • United Kingdom
      • Glasgow, United Kingdom, G11 6NT
        • Pfizer Investigational Site
      • London, United Kingdom, SE1 9RT
        • Pfizer Investigational Site
      • London, United Kingdom, SW3 6JJ
        • Pfizer Investigational Site
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • Pfizer Investigational Site
  • United States
    • Alabama
      • Montgomery, Alabama, United States, 36106
        • Pfizer Investigational Site
    • California
      • Arroyo Grande, California, United States, 93420
        • Pfizer Investigational Site
      • Montebello, California, United States, 90640
        • Pfizer Investigational Site
      • San Francisco, California, United States, 94115
        • Pfizer Investigational Site
    • Colorado
      • Aurora, Colorado, United States, 80010
        • Pfizer Investigational Site
    • Florida
      • Aventura, Florida, United States, 33180
        • Pfizer Investigational Site
      • Miami Beach, Florida, United States, 33140
        • Pfizer Investigational Site
      • Plantation, Florida, United States, 33324
        • Pfizer Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60637-1470
        • Pfizer Investigational Site
      • Maywood, Illinois, United States, 60153
        • Pfizer Investigational Site
    • Kansas
      • Kansas City, Kansas, United States, 66112
        • Pfizer Investigational Site
      • Lenexa, Kansas, United States, 66214
        • Pfizer Investigational Site
      • Overland Park, Kansas, United States, 66210
        • Pfizer Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Pfizer Investigational Site
      • Boston, Massachusetts, United States, 02115
        • Pfizer Investigational Site
      • Boston, Massachusetts, United States, 02215
        • Pfizer Investigational Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-0922
        • Pfizer Investigational Site
      • Brownstown, Michigan, United States, 48183
        • Pfizer Investigational Site
      • Dearborn, Michigan, United States, 48126
        • Pfizer Investigational Site
      • Detroit, Michigan, United States, 48202
        • Pfizer Investigational Site
      • West Bloomfield, Michigan, United States, 48322
        • Pfizer Investigational Site
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Pfizer Investigational Site
      • Kansas City, Missouri, United States, 64131
        • Pfizer Investigational Site
      • Kansas City, Missouri, United States, 64154
        • Pfizer Investigational Site
      • Lee's Summit, Missouri, United States, 64064
        • Pfizer Investigational Site
    • New York
      • Bronx, New York, United States, 10461
        • Pfizer Investigational Site
      • Bronx, New York, United States, 10467
        • Pfizer Investigational Site
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Pfizer Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Pfizer Investigational Site
    • Tennessee
      • Gallatin, Tennessee, United States, 37066
        • Pfizer Investigational Site
      • Hermitage, Tennessee, United States, 37076
        • Pfizer Investigational Site
      • Lebanon, Tennessee, United States, 37087
        • Pfizer Investigational Site
      • Murfreesboro, Tennessee, United States, 37130
        • Pfizer Investigational Site
      • Nashville, Tennessee, United States, 37203
        • Pfizer Investigational Site
      • Nashville, Tennessee, United States, 37205
        • Pfizer Investigational Site
      • Nashville, Tennessee, United States, 37207
        • Pfizer Investigational Site
      • Nashville, Tennessee, United States, 37211
        • Pfizer Investigational Site
    • Texas
      • Dallas, Texas, United States, 75246
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77030
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78229
        • Pfizer Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Pfizer Investigational Site
    • Washington
      • Walla Walla, Washington, United States, 99362
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2002

Study Completion (Actual)

May 1, 2005

Study Registration Dates

First Submitted

January 2, 2003

First Submitted That Met QC Criteria

January 2, 2003

First Posted (Estimate)

January 3, 2003

Study Record Updates

Last Update Posted (Estimate)

May 4, 2007

Last Update Submitted That Met QC Criteria

May 3, 2007

Last Verified

September 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1033-011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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