A Study to Assess the Effects of MK0822 in Prolonging Time to First Bone Metastasis in Men With Castration-Resistant Prostate Cancer - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

June 4, 2008

Last Updated Date

December 17, 2008

Start Date ^†

Current Primary Outcome Measures ^†

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 ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00691899 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

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 ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

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

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.

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 Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Prostate Cancer

Intervention ^†

Drug: odanacatib
Drug: placebo (unspecified)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Withdrawn

Estimated Enrollment ^†

1550

Completion Date

August 2008

Primary Completion Date

Eligibility Criteria ^†

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

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00691899

Responsible Party

Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.

Secondary IDs ^††

MK0822-030

Study Sponsor ^†

Merck

Collaborators ^††

Investigators ^†

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

December 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.