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)
Overview
- Phase
- Phase 2
- Intervention
- ZA
- Conditions
- Breast Cancer
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 43
- Primary Endpoint
- Percentage Change From Baseline in Urinary N-telopeptide of Type I Collagen (u-NTx) at Week 4
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
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
Arms & Interventions
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.
Intervention: ZA
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.
Intervention: Odanacatib matching placebo
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.
Intervention: Odanacatib
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.
Intervention: ZA matching placebo
Outcomes
Primary Outcomes
Percentage Change From Baseline in Urinary N-telopeptide of Type I Collagen (u-NTx) at Week 4
Time Frame: 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)
Time Frame: 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
Time Frame: 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 Outcomes
- Percentage Change From Baseline in Urinary Deoxypyridinoline (u-DPD) at Week 4(Baseline and Week 4)