Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2008_572 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ariad Pharmaceuticals | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will look to see if the combination of ridaforolimus and bicalutamide works better than placebo and bicalutamide in men with prostate cancer.
Ridaforolimus (MK8669/AP23573) was also known as deforolimus until May 2009.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open Label | Experimental | ridaforolimus (MK8669)+ bicalutamide |
|
| Ridaforolimus | Experimental | ridaforolimus (MK8669)+ bicalutamide |
|
| Placebo | Placebo Comparator | Placebo + bicalutamide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ridaforolimus (MK8669) | Drug | Three 10 mg tablets administered daily for 5 consecutive days each week followed by 2 days without ridaforolimus and one 50 mg tablet of bicalutamide administered once daily for 7 days each week. Treatment will continue until disease progression. |
| Measure | Description | Time Frame |
|---|---|---|
| 30% Prostate specific antigen (PSA) decline within 12 weeks | 12 weeks | |
| Number of dose limiting toxicities (DLTs) | Day 1 to Day 35 |
| Measure | Description | Time Frame |
|---|---|---|
| Prostate specific antigen (PSA) response rate | 12 weeks | |
| Number of patients with progression free survival (PFS) | 12 weeks | |
| Time to prostate specific antigen (PSA) progression |
Not provided
Inclusion Criteria:
Exclusion Criteria :
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23921574 | Result | Meulenbeld HJ, de Bono JS, Tagawa ST, Whang YE, Li X, Heath KH, Zandvliet AS, Ebbinghaus SW, Hudes GR, de Wit R. Tolerability, safety and pharmacokinetics of ridaforolimus in combination with bicalutamide in patients with asymptomatic, metastatic castration-resistant prostate cancer (CRPC). Cancer Chemother Pharmacol. 2013 Oct;72(4):909-16. doi: 10.1007/s00280-013-2250-6. Epub 2013 Aug 7. |
Not provided
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C515074 | ridaforolimus |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Comparator: Placebo | Drug | Three tablets of matching placebo to ridaforolimus administered daily for 5 consecutive days each week followed by 2 days without matching placebo and on 50 mg tablet of bicalutamide administered once daily for 7 days each week. Treatment will continue until disease progression. |
|
| open-label ridaforolimus (MK8669) | Drug | Single dose of three 10 mg tablets ridaforolimus on Day 1, and 50 mg bicalutamide once daily starting on Day 2. On Day 8, patients will begin taking three 10 mg tablets of ridaforolimus daily for 5 consecutive days each week followed by 2 days without ridaforolimus and one 50 mg tablet of bicalutamide once daily for 7 days each week. Treatment will continue until disease progression. |
|
|
| 12 weeks |
| Pharmacokinetics Maximum Concentration (Cmax), Time to Maximum Plasma Concentration (Tmax), Area Under the Concentration Versus Time Curve (AUC) of Ridaforolimus | 30 Minutes to 24 hour postdose |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |