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

Phase 2

Completed

• Conditions: Breast Cancer; Metastatic Bone Disease
• Interventions: Drug: ZA; Drug: Odanacatib; Drug: Odanacatib matching placebo; Drug: ZA matching placebo

• Registration Number: NCT00399802
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-11-14
• Study First Submitted QC: 2006-11-14
• Study First Posted: 2006-11-15
• Study Start: 2006-11-16
• Primary Completion: 2007-12-05
• Study Completion: 2007-12-05
• Results First Submitted: 2017-04-05
• Results First Submitted QC: 2017-07-12
• Results First Posted: 2018-02-01
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-18
• Last Update Posted: 2018-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 43

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single IV infusion of ZA 4 mg	Odanacatib matching placebo	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.
Single IV infusion of ZA 4 mg	ZA	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.
Odanacatib 5 mg	ZA matching placebo	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.
Odanacatib 5 mg	Odanacatib	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.

Primary Outcome Measures

Name	Time	Method
Percentage Change From Baseline in Urinary N-telopeptide of Type I Collagen (u-NTx) at Week 4	Baseline and 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.
Number of Participants Who Experienced an Adverse Event (AE)	Up to 6 weeks	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.
Number of Participants Who Discontinued Treatment Due to an AE	Up to 4 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Percentage Change From Baseline in Urinary Deoxypyridinoline (u-DPD) at Week 4	Baseline and 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.