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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.

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Metastatic Bone Disease Drug: ZA Drug: Odanacatib Drug: Odanacatib matching placebo Drug: ZA matching placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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)
Actual Study Start Date : November 16, 2006
Actual Primary Completion Date : December 5, 2007
Actual Study Completion Date : December 5, 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/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.
Drug: ZA
Single ZA 4 mg IV infusion at the start of treatment
Other Name: Zometa®
Drug: Odanacatib matching placebo
Once-daily odanacatib matching placebo for 4 weeks
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.
Drug: Odanacatib
Once-daily odanacatib 5 mg tablet for 4 weeks
Other Name: MK-0822
Drug: ZA matching placebo
Single IV infusion of ZA matching placebo given at the start of treatment



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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 bisphosphonate use within 6 months of entry into study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00399802


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

Publications of Results:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00399802     History of Changes
Other Study ID Numbers: 0822-016
2006_533 ( Other Identifier: Merck Registration Number )
MK-0822-016 ( Other Identifier: Merck Protocol Number )
First Posted: November 15, 2006    Key Record Dates
Results First Posted: February 1, 2018
Last Update Posted: March 1, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Breast Neoplasms
Bone Diseases
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Musculoskeletal Diseases