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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00051051
First received: January 2, 2003
Last updated: May 3, 2007
Last verified: September 2006
  Purpose

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).


Condition Intervention Phase
Breast Neoplasms
Drug: CI-1033
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II, Randomized, Open-Label Study of Single Agent CI-1033 in Patients With Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Pfizer:

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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 168
Study Start Date: December 2002
Study Completion Date: May 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00051051

  Hide Study Locations
Locations
United States, Alabama
Pfizer Investigational Site
Montgomery, Alabama, United States, 36106
United States, California
Pfizer Investigational Site
Arroyo Grande, California, United States, 93420
Pfizer Investigational Site
Montebello, California, United States, 90640
Pfizer Investigational Site
San Francisco, California, United States, 94115
United States, Colorado
Pfizer Investigational Site
Aurora, Colorado, United States, 80010
United States, Florida
Pfizer Investigational Site
Aventura, Florida, United States, 33180
Pfizer Investigational Site
Miami Beach, Florida, United States, 33140
Pfizer Investigational Site
Plantation, Florida, United States, 33324
United States, Illinois
Pfizer Investigational Site
Chicago, Illinois, United States, 60637-1470
Pfizer Investigational Site
Maywood, Illinois, United States, 60153
United States, Kansas
Pfizer Investigational Site
Kansas City, Kansas, United States, 66112
Pfizer Investigational Site
Lenexa, Kansas, United States, 66214
Pfizer Investigational Site
Overland Park, Kansas, United States, 66210
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02215
Pfizer Investigational Site
Boston, Massachusetts, United States, 02115
Pfizer Investigational Site
Boston, Massachusetts, United States, 02114
United States, Michigan
Pfizer Investigational Site
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
United States, Missouri
Pfizer Investigational Site
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
United States, New York
Pfizer Investigational Site
Bronx, New York, United States, 10467
Pfizer Investigational Site
Bronx, New York, United States, 10461
United States, Ohio
Pfizer Investigational Site
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Pfizer Investigational Site
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, 37211
Pfizer Investigational Site
Nashville, Tennessee, United States, 37205
Pfizer Investigational Site
Nashville, Tennessee, United States, 37207
Pfizer Investigational Site
Nashville, Tennessee, United States, 37203
United States, Texas
Pfizer Investigational Site
Dallas, Texas, United States, 75246
Pfizer Investigational Site
Houston, Texas, United States, 77030
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
United States, Utah
Pfizer Investigational Site
Salt Lake City, Utah, United States, 84112
United States, Washington
Pfizer Investigational Site
Walla Walla, Washington, United States, 99362
Belgium
Pfizer Investigational Site
Brussels, Belgium, 1000
Pfizer Investigational Site
Brussels, Belgium, 1070
Pfizer Investigational Site
Leuven, Belgium, 3000
Canada, British Columbia
Pfizer Investigational Site
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
Pfizer Investigational Site
Hamilton, Ontario, Canada, L8V 5C2
Canada, Quebec
Pfizer Investigational Site
Chicoutimi, Quebec, Canada, G7H 5H6
Pfizer Investigational Site
Montreal, Quebec, Canada, H2L 4M1
France
Pfizer Investigational Site
Avignon Cedex 2, France, 84082
Pfizer Investigational Site
Paris Cedex 05, France, 75248
Pfizer Investigational Site
Paris Cedex 13, France, 75651
Ireland
Pfizer Investigational Site
Dublin 8, Ireland
Pfizer Investigational Site
Galway, Ireland
Italy
Pfizer Investigational Site
Bologna, Italy, 40139
Pfizer Investigational Site
Forli', Italy, 47100
Pfizer Investigational Site
Modena, Italy, 41100
Pfizer Investigational Site
Roma, Italy, 00144
Spain
Pfizer Investigational Site
Madrid, Spain, 28041
Pfizer Investigational Site
Madrid, Spain, 28040
Sweden
Pfizer Investigational Site
Stockholm, Sweden, 17176
Pfizer Investigational Site
Stockholm, Sweden, 118 83
United Kingdom
Pfizer Investigational Site
Sutton, Surrey, United Kingdom, SM2 5PT
Pfizer Investigational Site
Glasgow, United Kingdom, G11 6NT
Pfizer Investigational Site
London, United Kingdom, SE1 9RT
Pfizer Investigational Site
London, United Kingdom, SW3 6JJ
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00051051     History of Changes
Other Study ID Numbers: 1033-011
Study First Received: January 2, 2003
Last Updated: May 3, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Canertinib dihydrochloride
Anesthetics
Anesthetics, Local
Antineoplastic Agents
Cardiotonic Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014