Prevention of bone metastases in men with prostate cancer MedDRA version: 9.1 Level: LLT Classification code 10005993 Term: Bone metastases
Conditions
Interventions
Product Name: MK-0822
Product Code: MK-0822
Pharmaceutical Form: Tablet
Current Sponsor code: MK0822
Other descriptive name: Odanacatib
Concentration unit: mg milligram(s)
Concentration type: equal
Co
Sponsors
Merck&Co.,Inc
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: • Patient is a man =18 years of age on the day of signing the informed consent. • Patient has hormone-refractory (androgen-independent) prostate cancer, defined as 3 rising, consecutive, historical PSA values following bilateral orchiectomy, or while receiving continuous (not intermittent) androgen-deprivation therapy. The second and third historical PSA tests (i.e., values obtained prior to the screening visit) must be separated from the previous test by at least 2 weeks, and the second and third values must each be = 1.0 ng/mL. • Patient has a serum testosterone =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Patient has bone metastases, or has a history of bone metastases: patient must have a negative bone scan obtained during the screening period, or within 1 month prior to the screening visit (Visit 1). All bone scans and associated imaging studies used for eligibility purposes must be adjudicated by the central radiologist before the patient may be randomized at Visit 2. • 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: a) is currently receiving a bisphosphonate (e.g., etidronate, clodronate, tiludronate, pamidronate, alendronate, ibandronate, risedronate, olpadronate, neridronate, zoledronate), or other drug therapy for osteoporosis; b) has been treated with an oral bisphosphonate within the 6 months prior to Visit 1; c) 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, cyclophosphamide, estramustine, paclitaxel, docetaxel, etoposide, vinblastine, 5-fluorouracil, interferon, mitoxantrone). Patients may not start chemotherapy between Visit 1 and Visit 2. This exclusion criterion does not include androgen-deprivation therapy, which is permitted and expected in patients entering this study (e.g., gonadotropin-releasing hormone agonists such as leuprolide, goserelin, or triptorelin). • Patient is using any of the following potent inhibitors of CYP3A4 within 2 weeks prior to starting blinded study medication: (a) systemically administered azole antifungals such as ketoconazole, fluconazole, itraconazole, miconazole, posaconozole, ravuconazole, and voriconazole; (b) nefazodone; (c) the macrolide antibiotics clarithromycin, dirithromycin, erythromycin, and troleandomycin, however, azithromycin, is permitted. The use of any other macrolide antibiotic requires approval by the SPONSOR’s clinical representative. Patients who discontinue these medications at least two weeks prior to starting blinded study medication are eligible.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To assess the effect of treatment with MK-0822 5 mg once daily on bone metastasis-free survival (defined as time to first bone metastasis or death from any cause) compared to placebo. • To assess the effect of treatment with MK-0822 5 mg once daily in a subset of 300 patients on lumbar spine, total hip, femoral neck, trochanter and total body bone mineral density (BMD) compared to placebo. • To assess the tolerability of treatment with MK-0822 5 mg once daily compared to placebo.;Secondary Objective: • To assess the effect of treatment with MK-0822 5 mg once daily on the risk of developing bone metastases compared to placebo. • To assess the effect of treatment with MK-0822 5 mg once daily on the risk of death from any cause compared to placebo. • To assess the effect of treatment with MK-0822 5 mg daily on biochemical markers of bone turnover compared to placebo.;Primary end point(s): Time to First Bone Metastases Death | — |
Countries
United Kingdom
Outcome results
None listed