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A Study to Assess the Effects of MK0822 in Reducing the Risk of Bone Metastasis in Women With Breast Cancer (0822-029)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00692458
Recruitment Status : Withdrawn (Withdrawn for administrative reasons)
First Posted : June 6, 2008
Last Update Posted : August 12, 2016
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE June 4, 2008
First Posted Date  ICMJE June 6, 2008
Last Update Posted Date August 12, 2016
Study Start Date  ICMJE September 2008
Estimated Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2008)
to assess the effect of treatment with MK0822 5 mg once daily on the risk of developing a first bone metastasis compared to placebo [ Time Frame: approximately 60 months (event driven study) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2008)
to assess the effect of treatment with MK0822 5 mg once daily on disease-free survival compared to placebo [ Time Frame: approximately 60 months (event driven study) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess the Effects of MK0822 in Reducing the Risk of Bone Metastasis in Women With Breast Cancer (0822-029)
Official Title  ICMJE A Phase III Study to Assess the Safety, Tolerability, and Efficacy of MK0822 (Odanacatib) in Reducing the Risk of Bone Metastasis in Women With Breast Cancer
Brief Summary The purpose of this study is to test MK0822 on reducing the risk of bone metastasis in women with breast cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: Comparator: odanacatib
    odanacatib; 5mg oral, once daily for approximately 60 months.
  • Drug: Comparator: placebo
    placebo; oral, once daily for approximately 60 months
Study Arms  ICMJE
  • Experimental: 1
    odanacatib
    Intervention: Drug: Comparator: odanacatib
  • Placebo Comparator: 2
    placebo
    Intervention: Drug: Comparator: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: November 22, 2013)
0
Original Estimated Enrollment  ICMJE
 (submitted: June 5, 2008)
4000
Estimated Study Completion Date  ICMJE September 2008
Estimated Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Confirmed primary State II or Stage III breast cancer
  • Patient is not receiving adjuvant chemotherapy (e.g., cyclophosphamide, doxorubicin, carboplatin) at the time of randomization and has not received adjuvant chemotherapy for at least 6 weeks prior to the randomization visit (Visit 2). This inclusion criterion does not include hormone therapy, which is permitted (see inclusion criterion # 7)
  • Patient is not receiving hormonal therapy OR if patient is receiving hormonal therapy (e.g., leuprolide, tamoxifen, anastrozole) she is on a stable regimen for at least 3 months at the time of screening (Visit 1). If patient is HER2-positive and is receiving trastuzumab treatment, she must be on a stable regimen for at least 1 month at the time of Visit 1
  • Patient is not pregnant or breast-feeding. All women of childbearing potential must have a negative urine pregnancy test at screening (Visit 1)

Exclusion Criteria:

  • Bone metastases or history of bone metastases
  • Patient has evidence of other distant metastases (e.g., visceral, soft-tissue, or brain)
  • Patient has had a prior local or regional recurrence of her breast cancer, or a contralateral tumor. DCIS (ductal carcinoma in-situ), and LCIS (local carcinoma in-situ) in either the ipsilateral or contralateral breast are permitted
  • Patient has ANY of the following:

    1. is currently receiving a bisphosphonate or other drug therapy for osteoporosis
    2. has been treated with an oral bisphosphonate for osteoporosis for more than 3 months within the 2 years prior to Visit 1, or for a total of more than 6 months at any time prior to Visit 1
    3. has been treated with an intravenous bisphosphonate within the 12 months prior to Visit 1
  • Patient has a history of malignancy other than breast cancer <5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. Patients with melanoma, leukemia, lymphoma, and myeloproliferative disorders of any duration are exclusionary
  • Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of signing the informed consent
  • Patient is currently participating in or has at any time in the past participated in a breast cancer study with a registered medication (i.e., approved by the regulatory agency in which she resides) being tested for the treatment of breast cancer (an unapproved indication)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Puerto Rico,   United States
 
Administrative Information
NCT Number  ICMJE NCT00692458
Other Study ID Numbers  ICMJE 0822-029
2008_526
MK-0822-029
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date November 2015

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