Status:
COMPLETED
Phase I/II Study of MK-0752 Followed by Docetaxel in Advanced or Metastatic Breast Cancer
Lead Sponsor:
University of Michigan Rogel Cancer Center
Collaborating Sponsors:
Baylor College of Medicine
Ohio State University
Conditions:
Metastatic Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
New and better therapies for locally advanced and metastatic breast cancer are needed because, even if standard treatment is successful in shrinking the cancer, there is still a high chance that the c...
Detailed Description
Purpose-Accumulating evidence supports the existence of breast cancer stem cells (BCSCs), which are characterized by their capacity to self-renew and divide indefinitely, and resistance to conventiona...
Eligibility Criteria
Inclusion
- Men or women with metastatic (Stage IV) breast cancer, or with locally advanced breast cancer (Stages IIIA \> 10 cm, or Stages IIIB and IIIC) that did not respond to first-line anthracycline-based chemotherapy, for whom docetaxel is a recommended therapy
- Presence of measurable or evaluable disease
- Adequate organ function
- Ability to swallow intact study drug capsules
- Zubrod Performance Status of 0-1 with at least a 3 month life expectancy
- Appropriate time must have elapsed since prior anti-neoplastic therapy with resolution of acute toxicity
Exclusion
- Concurrent treatment with hormonal therapy intended to treat cancer
- Radiotherapy within 7 days prior to first dose
- Symptomatic central nervous system, and/or epidural metastases or symptomatic carcinomatous meningitis or with radiation treatment completed within the past 8 weeks
- Serious comorbid illness which will limit the ability of the patient to safely receive anticancer treatment
- Patients who are pregnant or nursing
- Confounding factors present to provide misinterpretation of data (i.e., concurrent malignancy)
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00645333
Start Date
March 1 2008
End Date
October 1 2012
Last Update
April 4 2014
Active Locations (3)
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1
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
2
University of Michigan Cancer Center
Ann Arbor, Michigan, United States, 48109
3
Baylor College of Medicine
Houston, Texas, United States, 77030