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

NCT00051051

Last updated date
Study Location
Pfizer Investigational Site
Montgomery, Alabama, 36106, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Neoplasms
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Phase II Study of CI-1033 in Treating Patients With Metastatic (Stage IV) Breast Cancer
Official Title  ICMJE A Phase II, Randomized, Open-Label Study of Single Agent CI-1033 in Patients With Metastatic Breast Cancer
Brief 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Neoplasms
Intervention  ICMJE Drug: CI-1033
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June 23, 2005)
168
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Canada,   France,   Ireland,   Italy,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00051051
Other Study ID Numbers  ICMJE 1033-011
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP