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

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Montgomery, Alabama, 36106 United States
Contact
1-800-718-1021
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.

NCT00051051
Pfizer
Completed
A Phase II Study of CI-1033 in Treating Patients With Metastatic (Stage IV) Breast Cancer

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Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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A Phase II Study of CI-1033 in Treating Patients With Metastatic (Stage IV) Breast Cancer
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).
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Neoplasms
Drug: CI-1033
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
168
May 2005
Not Provided

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.

Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Canada,   France,   Ireland,   Italy,   Spain,   Sweden,   United Kingdom,   United States
 
 
NCT00051051
1033-011
Not Provided
Not Provided
Not Provided
Not Provided
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2006

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]



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