A Phase II Study to Assess the Safety, Tolerability, and Efficacy of MK-0822 (Cathepsin-K Inhibitor) in the Treatment of Women With Breast Cancer and Established Bone Metastases (MBD)
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer, Metastatic Bone Disease
Female
Breast Cancer, Metastatic Bone Disease
Trial Information
A Phase II Study to Assess the Safety, Tolerability, and Efficacy of MK-0822 (Cathepsin-K Inhibitor) in the Treatment of Women With Breast Cancer and Established Bone Metastases (MBD)
Inclusion Criteria:
- Patient has histologically or cytologically-confirmed breast cancer
- Patient has documented skeletal metastases
Exclusion Criteria:
- Patient is undergoing current oral bisphosphonate therapy, or has a history of oral
or bisphosphonate use within 6 months of entry into study
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
suppression of urinary N-telopeptide / safety and tolerability
Outcome Time Frame:
4 Weeks
Safety Issue:
Yes
Principal Investigator
Medical Monitor
Investigator Role:
Study Director
Investigator Affiliation:
Merck
Authority:
Denmark: Danish Medicines Agency
Study ID:
2006_533
NCT ID:
NCT00399802
Start Date:
November 2006
Completion Date:
December 2007
Related Keywords:
- Breast Cancer
- Metastatic Bone Disease
- Bone Diseases
- Breast Neoplasms
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