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


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Neoplasms

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

1033-011

NCT ID:

NCT00051051

Start Date:

December 2002

Completion Date:

May 2005

Related Keywords:

  • Breast Neoplasms
  • Breast Neoplasms
  • Neoplasms

Name

Location

Pfizer Investigational SiteBirmingham, Alabama  35205
Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteDetroit, Michigan  48201
Pfizer Investigational SiteCincinnait, Ohio  45236
Pfizer Investigational SiteSpringfield, Illinois  62701-1014
Pfizer Investigational SiteBronx, New York  10461
Pfizer Investigational SiteHouston, Texas  77030
Pfizer Investigational SiteFederal Way, Washington  98003
Pfizer Investigational SiteAurora, Colorado  80012
Pfizer Investigational SiteClearwater, Florida  33761
Pfizer Investigational SiteKansas City, Kansas  66112
Pfizer Investigational SiteNorth Adams, Massachusetts  01247
Pfizer Investigational SiteColumbia, Missouri  65201
Pfizer Investigational SiteKingston, Pennsylvania  18704-5535
Pfizer Investigational SiteBristol, Tennessee  37620
Pfizer Investigational SiteSalt Lake City, Utah  84112