Phase 2
N=43
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 · Metastatic Bone Disease
Bottom Line
View on ClinicalTrials.gov: NCT00399802 ↗Enrolled (actual)
43
Serious AEs
14.0%
Results posted
Feb 2018
Primary outcome: Primary: Percentage Change From Baseline in Urinary N-telopeptide of Type I Collagen (u-NTx) at Week 4 — -73; -77 Percentage change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ZA (Drug); Odanacatib (Drug); Odanacatib matching placebo (Drug); ZA matching placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Dec 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change From Baseline in Urinary N-telopeptide of Type I Collagen (u-NTx) at Week 4 |
-73; -77 | — |
| PRIMARY Number of Participants Who Experienced an Adverse Event (AE) |
10; 20 | — |
| PRIMARY Number of Participants Who Discontinued Treatment Due to an AE |
0; 2 | — |
| SECONDARY Percentage Change From Baseline in Urinary Deoxypyridinoline (u-DPD) at Week 4 |
-52; -30 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00399802). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.