NCT00399802

A Study to Examine the Effects of an Experimental Drug on Women With Breast Cancer and Metastatic Bone Disease (MBD)(0822-016)(COMPLETED)

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a 4-week study to examine the effects of a new experimental medication on women with breast cancer and established bone metastases. This study will enroll approximately 45 women. The primary hypotheses are: (1) odanacatib will result in a substantial suppression of urinary N-telopeptide of type I collagen (u-NTx) similar to that achieved with an intravenous (IV) infusion of zoledronic acid (ZA) over 4 weeks of treatment; and (2) odanacatib (MK-0822) will be safe and well tolerated during 4 weeks of treatment.

Conditions

• Breast Cancer
• Metastatic Bone Disease

Interventions

Type	Name	Description
DRUG	ZA	Single ZA 4 mg IV infusion at the start of treatment
DRUG	Odanacatib	Once-daily odanacatib 5 mg tablet for 4 weeks
DRUG	Odanacatib matching placebo	Once-daily odanacatib matching placebo for 4 weeks
DRUG	ZA matching placebo	Single IV infusion of ZA matching placebo given at the start of treatment

Timeline

• Start date: 2006-11-16
• Primary completion: 2007-12-05
• Completion: 2007-12-05
• First posted: 2006-11-15
• Last updated: 2018-08-16
• Results posted: 2018-02-01

Regulatory

• FDA-regulated drug study