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A Study to Assess the Effects of MK0822 in Prolonging Time to First Bone Metastasis in Men With Castration-Resistant Prostate Cancer (0822-030)

Sponsor
Merck Sharp & Dohme LLC (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT00691899
Collaborator
(none)
0
Enrollment
2
Arms

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate the effects of MK0822 in prolonging the time to first bone metastasis in men with castration-resistant prostate cancer.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

Merck Duration of Treatment : odanacatib; approximately 36 months (even driven study) - Comparator Duration of Treatment : placebo (unspecified); approximately 36 months (event driven study)

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
A Phase III Study to Assess the Safety, Tolerability, and Efficacy of MK0822 (Odanacatib) in Prolonging Time to First Bone Metastasis in Men With Castration-Resistant Prostate Cancer
Study Start Date :
Sep 1, 2008
Anticipated Primary Completion Date :
Sep 1, 2008
Anticipated Study Completion Date :
Sep 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Drug: odanacatib
odanacatib; 5mg oral, once daily for Approximately 36 months.
Other Names:
  • MK0822

    		•
    Placebo Comparator: 2

    Drug: placebo (unspecified)
    placebo; oral, once daily for Approximately 36 months

    Outcome Measures

    Primary Outcome Measures

    1. To assess the effect of treatment with MK0822 5 mg once daily on bone metastasis-free survival (i.e., the risk of developing a first bone metastasis or dying from any cause) compared to placebo [Approximately 36 months (event-driven study)]

    Secondary Outcome Measures

    1. To assess the effect of treatment with MK0822 5 mg once daily on the risk of developing a first bone metastasis compared to placebo [Approximately 36 months (event-driven study)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Castration-resistant prostate cancer; increased risk for prostate cancer progression

    • Patient underwent bilateral orchiectomy 6 months or more (i.e., =180 days) prior to Visit 1, or is receiving androgen-deprivation therapy and is on a stable regimen for at least 3 months (i.e., =90 days) prior to Visit 1. Androgen-deprivation therapy may include gonadotropin-releasing hormone agonists such as leuprolide, goserelin, or triptorelin

    Exclusion Criteria:

    • Bone metastases or history of bone metastases

    • Patient has other distant metastases (e.g., visceral, including brain, or soft-tissue). Patients with regional lymph nodal metastases are eligible

    • Patient has ANY of the following:

    1. currently is 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 received chemotherapy within the 2 years prior to Visit 1 (for example, doxorubicin, cytoxan, estramustine, paclitaxel, docetaxel, etoposide, vinblastine, 5-fluorouracil, interferon, mitoxantrone). This exclusion criterion does not include androgen-deprivation therapy (e.g., gonadotropin-releasing hormone agonists such as leuprolide, goserelin, or triptorelin)

    • Patient has a history of any malignancy other than prostate cancer <5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer. Melanoma, leukemia, lymphoma, and myeloproliferative disorders of any duration are excluded

    • Patient is currently participating in, 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 prostate cancer study with a registered medication (i.e., approved by the regulatory agency in which he resides) being tested for the treatment of prostate cancer (an unapproved indication)

    • Patient is currently using a systemically administered azole antifungal (for example, ketoconazole, fluconazole, itraconazole, miconazole, posaconazole, ravuconazole, and voriconazole). Patients taking these medications must discontinue their use at least one week prior to starting blinded study medication

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Merck Sharp & Dohme LLC

    Investigators

    • Study Director: Medical Monitor, Merck Sharp & Dohme LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Merck Sharp & Dohme LLC
    ClinicalTrials.gov Identifier:
    NCT00691899
    Other Study ID Numbers:
    • 0822-030
    • 2006_533
    • MK-0822-030
    First Posted:
    Jun 6, 2008
    Last Update Posted:
    Aug 12, 2016
    Last Verified:
    Nov 1, 2015
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of Aug 12, 2016