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

Breast Cancer Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00399802
• Other study ID #: 0822-016
• Secondary ID: 2006_533MK-0822-
• Status: Completed
• Phase: Phase 2
• Start date: November 16, 2006
• Est. completion date: December 5, 2007

Study information

• Verified date: July 2018
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: December 5, 2007
• Est. primary completion date: December 5, 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Diseases
• Breast Cancer
• Breast Neoplasms
• Metastatic Bone Disease

Intervention

Drug:
• ZA
Single ZA 4 mg IV infusion at the start of treatment
• Odanacatib
Once-daily odanacatib 5 mg tablet for 4 weeks
• Odanacatib matching placebo
Once-daily odanacatib matching placebo for 4 weeks
• ZA matching placebo
Single IV infusion of ZA matching placebo given at the start of treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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, c — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage Change From Baseline in Urinary N-telopeptide of Type I Collagen (u-NTx) at Week 4	u-NTx is a biochemical index of bone resorption. Participants provided urine specimens on Day 1 (baseline) and at Week 4 for measurement of u-NTx.	Baseline and Week 4
Primary	Number of Participants Who Experienced an Adverse Event (AE)	An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.	Up to 6 weeks
Primary	Number of Participants Who Discontinued Treatment Due to an AE	An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.	Up to 4 weeks
Secondary	Percentage Change From Baseline in Urinary Deoxypyridinoline (u-DPD) at Week 4	u-DPD is a biochemical marker of bone resorption. Participants provided urine specimens on Day 1 (baseline) and Week 4 for measurement of u-DPD.	Baseline and Week 4