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of MK0822 in Prolonging Time to First Bone Metastasis in Men With Castration-Resistant Prostate Cancer (0822-030)(WITHDRAWN)

This study has been withdrawn prior to enrollment.
(Withdrawn for administrative reasons)
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00691899
First received: June 4, 2008
Last updated: November 22, 2013
Last verified: November 2013

June 4, 2008
November 22, 2013
Not Provided
August 2008   (final data collection date for primary outcome measure)
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 [ Time Frame: Approximately 36 months (event-driven study) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00691899 on ClinicalTrials.gov Archive Site
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 36 months (event-driven study) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study to Assess the Effects of MK0822 in Prolonging Time to First Bone Metastasis in Men With Castration-Resistant Prostate Cancer (0822-030)(WITHDRAWN)
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

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.

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Prostate Cancer
  • Drug: odanacatib
    odanacatib; 5mg oral, once daily for Approximately 36 months.
    Other Name: MK0822
  • Drug: placebo (unspecified)
    placebo; oral, once daily for Approximately 36 months
  • Experimental: 1
    Intervention: Drug: odanacatib
  • Placebo Comparator: 2
    Intervention: Drug: placebo (unspecified)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
August 2008
August 2008   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00691899
0822-030, 2006_533, MK-0822-030
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
November 2013

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