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

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00691899

Purpose

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	Intervention	Phase
Prostate Cancer	Drug: odanacatib Drug: placebo (unspecified)	Phase III

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

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

Further study details as provided by Merck:

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 ]

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 ]

Estimated Enrollment:	1550
Estimated Study Completion Date:	August 2008

Arms	Assigned Interventions
1: Experimental	Drug: odanacatib odanacatib; 5mg oral, once daily for Approximately 36 months.
2: Placebo Comparator	Drug: placebo (unspecified) placebo; oral, once daily for Approximately 36 months

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)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00691899

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2008_527, MK0822-030
Study First Received:	June 4, 2008
Last Updated:	December 17, 2008
ClinicalTrials.gov Identifier:	NCT00691899
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Neoplasm Metastasis

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplastic Processes
Neoplasms by Site
Pathologic Processes

ClinicalTrials.gov processed this record on January 15, 2009