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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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ClinicalTrials.gov Identifier: NCT00399802
Recruitment Status : Completed
First Posted : November 15, 2006
Results First Posted : February 1, 2018
Last Update Posted : March 1, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

November 14, 2006
November 15, 2006
April 5, 2017
February 1, 2018
March 1, 2018
November 16, 2006
December 5, 2007   (Final data collection date for primary outcome measure)
  • 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.
Proprietary Information - Exploratory (Non-Confirmatory) Trial
Complete list of historical versions of study NCT00399802 on ClinicalTrials.gov Archive Site
Percentage Change From Baseline in Urinary Deoxypyridinoline (u-DPD) at Week 4 [ Time Frame: 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.
Proprietary Information - Exploratory (Non-Confirmatory) Trial
Not Provided
Not Provided
 
A Study to Examine the Effects of an Experimental Drug on Women With Breast Cancer and Metastatic Bone Disease (MBD)(0822-016)(COMPLETED)
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)
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Breast Cancer
  • Metastatic Bone Disease
  • Drug: ZA
    Single ZA 4 mg IV infusion at the start of treatment
    Other Name: Zometa®
  • Drug: Odanacatib
    Once-daily odanacatib 5 mg tablet for 4 weeks
    Other Name: MK-0822
  • Drug: Odanacatib matching placebo
    Once-daily odanacatib matching placebo for 4 weeks
  • Drug: ZA matching placebo
    Single IV infusion of ZA matching placebo given at the start of treatment
  • Active Comparator: 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.
    Interventions:
    • Drug: ZA
    • Drug: Odanacatib matching placebo
  • Experimental: 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.
    Interventions:
    • Drug: Odanacatib
    • Drug: ZA matching placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
Not Provided
December 5, 2007
December 5, 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Australia,   Colombia,   Denmark,   Ecuador,   Germany,   Israel,   Italy,   Mexico,   New Zealand,   Norway
 
NCT00399802
0822-016
2006_533 ( Other Identifier: Merck Registration Number )
MK-0822-016 ( Other Identifier: Merck Protocol Number )
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP