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

NCT ID: NCT00399802

Last Updated: 2018-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-16
• Study Completion Date: 2007-12-05

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Single IV infusion of ZA 4 mg

Participants will receive a single IV infusion of ZA 4 mg at the start of treatment and a once-daily odanacatib matching placebo tablet for 4 weeks.

Group Type: ACTIVE_COMPARATOR

ZA

Intervention Type: DRUG

Single ZA 4 mg IV infusion at the start of treatment

Odanacatib matching placebo

Intervention Type: DRUG

Once-daily odanacatib matching placebo for 4 weeks

Odanacatib 5 mg

Participants will receive a once-daily odanacatib 5 mg tablet for 4 weeks and a single IV infusion of ZA matching placebo at the start of treatment.

Group Type: EXPERIMENTAL

Odanacatib

Intervention Type: DRUG

Once-daily odanacatib 5 mg tablet for 4 weeks

ZA matching placebo

Intervention Type: DRUG

Single IV infusion of ZA matching placebo given at the start of treatment

Interventions

ZA

Single ZA 4 mg IV infusion at the start of treatment

Intervention Type: DRUG

Odanacatib

Once-daily odanacatib 5 mg tablet for 4 weeks

Intervention Type: DRUG

Odanacatib matching placebo

Once-daily odanacatib matching placebo for 4 weeks

Intervention Type: DRUG

ZA matching placebo

Single IV infusion of ZA matching placebo given at the start of treatment

Intervention Type: DRUG

Other Intervention Names

Zometa®; MK-0822

Eligibility Criteria

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 bisphosphonate use within 6 months of entry into study

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Jensen AB, Wynne C, Ramirez G, He W, Song Y, Berd Y, Wang H, Mehta A, Lombardi A. The cathepsin K inhibitor odanacatib suppresses bone resorption in women with breast cancer and established bone metastases: results of a 4-week, double-blind, randomized, controlled trial. Clin Breast Cancer. 2010 Dec 1;10(6):452-8. doi: 10.3816/CBC.2010.n.059.

Reference Type: RESULT

PMID: 21147688 (View on PubMed)

Other Identifiers

2006_533

Identifier Type: OTHER

Identifier Source: secondary_id

MK-0822-016

Identifier Type: OTHER

Identifier Source: secondary_id

0822-016

Identifier Type: -

Identifier Source: org_study_id