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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Breast Cancer, Metastatic Bone Disease

Intervention / Treatment
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* Drug: ZA
* Drug: Odanacatib
* Drug: Odanacatib matching placebo
* Drug: ZA matching placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Single IV infusion of ZA 4 mg<br>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. | Drug: ZA<br>* Single ZA 4 mg IV infusion at the start of treatment<br>* Other names: Zometa®;Drug: Odanacatib matching placebo<br>* Once-daily odanacatib matching placebo for 4 weeks<br>|
| Experimental: Odanacatib 5 mg<br>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. | Drug: Odanacatib<br>* Once-daily odanacatib 5 mg tablet for 4 weeks<br>* Other names: MK-0822;Drug: ZA matching placebo<br>* Single IV infusion of ZA matching placebo given at the start of treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |