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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00399802
First received: November 14, 2006
Last updated: March 13, 2014
Last verified: March 2014

November 14, 2006
March 13, 2014
November 2006
December 2007   (final data collection date for primary outcome measure)
suppression of urinary N-telopeptide / safety and tolerability [ Time Frame: 4 Weeks ] [ Designated as safety issue: Yes ]
Proprietary Information - Exploratory (Non-Confirmatory) Trial
Complete list of historical versions of study NCT00399802 on ClinicalTrials.gov Archive Site
urinary deoxypyridinoline [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Breast Cancer
  • Metastatic Bone Disease
  • Drug: Odanacatib
    odanacatib 50 mg tablet once weekly, 4 week treatment period.
    Other Name: MK0822
  • Drug: Comparator: zoledronic acid
    one time zoledronic acid 4 mg IV infusion.
    Other Name: Zometa®
  • Drug: Comparator: Placebo (unspecified)
    odanacatib Pbo tablet once weekly, 4 week treatment period.
  • Drug: Comparator: Placebo (unspecified)
    zoledronic acid Pbo IV infusion, 4 week treatment period.
  • 1
    Arm 1: odanacatib 50 mg tablet once weekly; one time zoledronic acid 4 mg IV infusion.
    Interventions:
    • Drug: Odanacatib
    • Drug: Comparator: zoledronic acid
  • 2
    Arm 2: odanacatib 50 mg tablet once weekly; one time zoledronic acid Pbo IV infusion.
    Interventions:
    • Drug: Odanacatib
    • Drug: Comparator: Placebo (unspecified)
  • 3
    Arm 3: odanacatib Pbo tablet once weekly; one time zoledronic acid 4 mg IV infusion.
    Interventions:
    • Drug: Comparator: zoledronic acid
    • Drug: Comparator: Placebo (unspecified)
  • 4
    Arm 4: odanacatib Pbo tablet once weekly; one time zoledronic acid Pbo IV infusion.
    Interventions:
    • Drug: Comparator: Placebo (unspecified)
    • Drug: Comparator: Placebo (unspecified)
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
45
December 2007
December 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 or bisphosphonate use within 6 months of entry into study
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00399802
0822-016, 2006_533, MK-0822-016
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
March 2014

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