Back to resultsA Study to Examine the Effects of an Experimental Drug on Women With Breast Cancer and Metastatic Bone Disease (MBD)(0822-016)(COMPLETED)
Primary Purpose
Breast Cancer, Metastatic Bone Disease
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
ZA
Odanacatib
Odanacatib matching placebo
ZA matching placebo
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Single IV infusion of ZA 4 mg
Odanacatib 5 mg
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT00399802
First Posted
November 14, 2006
Last Updated
July 18, 2018
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00399802
Brief Title
A Study to Examine the Effects of an Experimental Drug on Women With Breast Cancer and Metastatic Bone Disease (MBD)(0822-016)(COMPLETED)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
November 16, 2006 (Actual)
Primary Completion Date
December 5, 2007 (Actual)
Study Completion Date
December 5, 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Metastatic Bone Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single IV infusion of ZA 4 mg
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Odanacatib 5 mg
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
ZA
Other Intervention Name(s)
Zometa®
Intervention Description
Single ZA 4 mg IV infusion at the start of treatment
Intervention Type
Drug
Intervention Name(s)
Odanacatib
Other Intervention Name(s)
MK-0822
Intervention Description
Once-daily odanacatib 5 mg tablet for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Odanacatib matching placebo
Intervention Description
Once-daily odanacatib matching placebo for 4 weeks
Intervention Type
Drug
Intervention Name(s)
ZA matching placebo
Intervention Description
Single IV infusion of ZA matching placebo given at the start of treatment
Primary Outcome Measure Information:
Title
Percentage Change From Baseline in Urinary N-telopeptide of Type I Collagen (u-NTx) at Week 4
Description
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.
Time Frame
Baseline and Week 4
Title
Number of Participants Who Experienced an Adverse Event (AE)
Description
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.
Time Frame
Up to 6 weeks
Title
Number of Participants Who Discontinued Treatment Due to an AE
Description
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.
Time Frame
Up to 4 weeks
Secondary Outcome Measure Information:
Title
Percentage Change From Baseline in Urinary Deoxypyridinoline (u-DPD) at Week 4
Description
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.
Time Frame
Baseline and Week 4
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
21147688
Citation
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, controlled trial. Clin Breast Cancer. 2010 Dec 1;10(6):452-8. doi: 10.3816/CBC.2010.n.059.
Results Reference
result
Learn more about this trial
A Study to Examine the Effects of an Experimental Drug on Women With Breast Cancer and Metastatic Bone Disease (MBD)(0822-016)(COMPLETED)
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