A Study to Assess the Effects of MK0822 in Prolonging Time to First Bone Metastasis in Men With Castration-Resistant Prostate Cancer (0822-030)
Primary Purpose
Prostate Cancer
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
odanacatib
placebo (unspecified)
Sponsored by
About this trial
This is an interventional prevention trial for Prostate Cancer
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:
- currently is receiving a bisphosphonate or other drug therapy for osteoporosis
- 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
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00691899
Brief Title
A Study to Assess the Effects of MK0822 in Prolonging Time to First Bone Metastasis in Men With Castration-Resistant Prostate Cancer (0822-030)
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 Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Withdrawn for administrative reasons
Study Start Date
September 2008 (undefined)
Primary Completion Date
September 2008 (Anticipated)
Study Completion Date
September 2008 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. 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.
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
odanacatib
Other Intervention Name(s)
MK0822
Intervention Description
odanacatib; 5mg oral, once daily for Approximately 36 months.
Intervention Type
Drug
Intervention Name(s)
placebo (unspecified)
Intervention Description
placebo; oral, once daily for Approximately 36 months
Primary Outcome Measure Information:
Title
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)
Secondary Outcome Measure Information:
Title
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)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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:
currently is receiving a bisphosphonate or other drug therapy for osteoporosis
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Study to Assess the Effects of MK0822 in Prolonging Time to First Bone Metastasis in Men With Castration-Resistant Prostate Cancer (0822-030)
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