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
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Metastatic Bone Disease
Drug: Odanacatib
Drug: Comparator: zoledronic acid
Drug: Comparator: Placebo (unspecified)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • suppression of urinary N-telopeptide / safety and tolerability [ Time Frame: 4 Weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • urinary deoxypyridinoline [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: November 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Arm 1: odanacatib 50 mg tablet once weekly; one time zoledronic acid 4 mg IV infusion.
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®
2
Arm 2: odanacatib 50 mg tablet once weekly; one time zoledronic acid Pbo IV infusion.
Drug: Odanacatib
odanacatib 50 mg tablet once weekly, 4 week treatment period.
Other Name: MK0822
Drug: Comparator: Placebo (unspecified)
zoledronic acid Pbo IV infusion, 4 week treatment period.
3
Arm 3: odanacatib Pbo tablet once weekly; one time zoledronic acid 4 mg IV infusion.
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.
4
Arm 4: odanacatib Pbo tablet once weekly; one time zoledronic acid Pbo IV infusion.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 or bisphosphonate use within 6 months of entry into study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00399802

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00399802     History of Changes
Other Study ID Numbers: 0822-016, 2006_533, MK-0822-016
Study First Received: November 14, 2006
Last Updated: March 13, 2014
Health Authority: Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Bone Diseases
Breast Neoplasms
Musculoskeletal Diseases
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014