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

NCT00399802 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: 0822-0162006_533MK-0822-016
• Study Type: interventional
• Target: 43
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer; Metastatic Bone Disease

Outcome Measures

Primary Outcomes (3)

• 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.

  Baseline and Week 4

• 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.

  Up to 6 weeks

• 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.

  Up to 4 weeks

Secondary Outcomes (1)

• Percentage Change From Baseline in Urinary Deoxypyridinoline (u-DPD) at Week 4

  Baseline and Week 4

Study Arms (2)

Single IV infusion of ZA 4 mg

ACTIVE COMPARATOR

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; Drug: Odanacatib matching placebo

Odanacatib 5 mg

EXPERIMENTAL

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; Drug: ZA matching placebo

Interventions

ZA DRUG

Single ZA 4 mg IV infusion at the start of treatment

Also known as: Zometa®

Single IV infusion of ZA 4 mg

Odanacatib DRUG

Once-daily odanacatib 5 mg tablet for 4 weeks

Also known as: MK-0822

Odanacatib 5 mg

Odanacatib matching placebo DRUG

Once-daily odanacatib matching placebo for 4 weeks

Single IV infusion of ZA 4 mg

ZA matching placebo DRUG

Single IV infusion of ZA matching placebo given at the start of treatment

Odanacatib 5 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has histologically or cytologically-confirmed breast cancer
• Patient has documented skeletal metastases

You may not qualify if:

• Patient is undergoing current oral bisphosphonate therapy, or has a history of oral bisphosphonate use within 6 months of entry into study

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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.

  PMID: 21147688 RESULT

MeSH Terms

Conditions

Breast Neoplasms; Bone Diseases

Interventions

Zoledronic Acid; odanacatib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2006
• First Posted: November 15, 2006
• Study Start: November 16, 2006
• Primary Completion: December 5, 2007
• Study Completion: December 5, 2007
• Last Updated: August 16, 2018
• Results First Posted: February 1, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share