A Phase III Study to Assess the Safety, Tolerability, and Efficacy of MK-0822 (Odanacatib) in Prolonging Bone Metastasis-Free Survival in Men with Castration-Resistant Prostate Cancer - MK-0822 (Odanacatib) in Men with Hormone-Refractory Prostate Cancer
- Conditions
- Prevention of bone metastases in men with prostate cancerMedDRA version: 9.1Level: LLTClassification code 10005993Term: Bone metastases
- Registration Number
- EUCTR2008-002120-29-GB
- Lead Sponsor
- Merck&Co.,Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 1550
• 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 <50 ng/dL at screening.
• Patient is at increased risk for prostate cancer progression defined as either an elevated PSA of =8 ng/mL obtained at the screening visit as measured by the central laboratory, or a PSA doubling time (PSADT) of =10 months (defined as = 300 days).
• Patient underwent bilateral orchiectomy 3 months or more (i.e., =90 days) prior to Visit 1, or is receiving androgen-deprivation therapy (ADT) and is on a stable GnRH agonist regimen for at least 3 months (i.e., =90 days) prior to Visit 1. ADT cannot be modified between Visit 1 and Visit 2 (the randomization visit). Androgen-deprivation therapy may include gonadotropin-releasing hormone agonists (GnRH) such as leuprolide, goserelin, or triptorelin. Patients receiving anti-androgen (e.g., flutamide, bicalutamide, nilutamide) monotherapy are not eligible, however, patients receiving an anti-androgen in combination with androgen deprivation (with a GnRH agonist or bilateral orchiectomy) are eligible, and in this case these therapies cannot be modified between Visit 1 and Visit 2. Patients who have failed anti-androgen monotherapy in the past, and are now failing androgen deprivation (with a GnRH agonist or bilateral orchiectomy) are also eligible.
• Patient has not undergone radiotherapy, OR if patient has undergone radiotherapy he has recovered and is at least 4 weeks from the previous radiotherapy at the time of screening (Visit 1).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
• 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method