Safety Study of Enzalutamide (MDV3100) in Patients With Incurable Breast Cancer
NCT01597193
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Histologically confirmed breast cancer with accompanying pathology report;
- Submit unstained representative tumor specimen, either as a paraffin block (preferred) or ≥ 10 unstained slides
- Received at least 2 lines of systemic therapy in the advanced setting (for enzalutamide alone arm only);
- Eastern Cooperative Oncology Group performance (ECOG) status of 0 or 1;
- Estimated life expectancy of at least 3 months
- Severe concurrent disease, infection, or comorbidity that, in the judgment of the
Investigator, would make the patient inappropriate for enrollment;
- Pregnant or lactating;
- Known or suspected brain metastasis or leptomeningeal disease;
- History of another malignancy within the previous 5 years other than curatively
treated in situ carcinomas;
- For patients who are enrolled to receive enzalutamide plus anastrozole or exemestane
or fulvestrant must not have received tamoxifen or any medication known to be a potent
CYP3A4 inducer or inhibitor.
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Descriptive Information | |||||
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Brief Title ICMJE | Safety Study of Enzalutamide (MDV3100) in Patients With Incurable Breast Cancer | ||||
Official Title ICMJE | A PHASE 1 OPEN-LABEL, DOSE ESCALATION STUDY EVALUATING THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF ENZALUTAMIDE (FORMERLY MDV3100) IN PATIENTS WITH INCURABLE BREAST CANCER | ||||
Brief Summary | The purpose of this study is to determine the safety, tolerability and pharmacokinetics of enzalutamide alone and in combination with anastrozole, or exemestane, or fulvestrant in patients with incurable breast cancer. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: Non-Randomized Masking: None (Open Label) Primary Purpose: Treatment | ||||
Condition ICMJE | Breast Cancer | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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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 | ||||
Actual Enrollment ICMJE | 101 | ||||
Original Estimated Enrollment ICMJE | 27 | ||||
Actual Study Completion Date ICMJE | January 22, 2018 | ||||
Actual Primary Completion Date | December 15, 2015 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT01597193 | ||||
Other Study ID Numbers ICMJE | MDV3100-08 C3431006 ( Other Identifier: Alias Study Number ) | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||
Study Sponsor ICMJE | Pfizer | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Pfizer | ||||
Verification Date | May 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |