Prostate Cancer
Conditions
Brief summary
This study will look to see if the combination of ridaforolimus and bicalutamide works better than placebo and bicalutamide in men with prostate cancer.
Detailed description
Ridaforolimus (MK8669/AP23573) was also known as deforolimus until May 2009.
Interventions
DRUGridaforolimus (MK8669)
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.
DRUGComparator: Placebo
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.
DRUGopen-label ridaforolimus (MK8669)
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.
Sponsors
Ariad Pharmaceuticals
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed adenocarcinomas of the prostate. * Evidence of metastatic disease * Evidence of disease progression including one of the following: increasing levels of PSA, progressive lymph node disease, or worsening bone scan * PSA level is greater or equal to 7 ng/ml. * ECOG performance status less than or equal to 1
Exclusion criteria
: * Previously received bicalutamide, flutamide, or nilutamide within the past 12 months (except for a period of use less than 30 days long). * Prior chemotherapy for prostate cancer * Prior rapamycin or rapamycin analogs, including ridaforolimus, everolimus, or temsirolimus. * Patient is receiving an opioid or narcotic analgesic for pain due to prostate cancer * Patient has pain related to prostate cancer that warrants the initiation of chemotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 30% Prostate specific antigen (PSA) decline within 12 weeks | 12 weeks |
| Number of dose limiting toxicities (DLTs) | Day 1 to Day 35 |
Secondary
| Measure | 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 | 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 |
Outcome results
None listed