None listed
Conditions
Interventions
Group 1 Type of group
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.
Group name:Group 3 Type of group
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.
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Sex/Gender
Male
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: • The patient has histologically confirmed adenocarcinomas of the prostate. • Pathological archival material is available for delivery to the central laboratory. • The patient presents evidence of metastatic disease upon entering the protocol or at the time of the previous hormonal treatment, determined radiographically through the presence of at least 2 bone examination lesions consistent with metastases or abdominal / pelvic lymph nodes> 2 cm in the longest axial measurement. Unique or ambiguous bone lesions should be confirmed with simple radiographs or magnetic resonance imaging (MRJ). • The patient presents evidence of disease progression despite levels of castration of testosterone ( 10 ng / ml. • A minimum of four weeks has elapsed between previous surgery or radiotherapy (limited to no more than 25 percent of the bone marrow) and enrollment. • The patient maintains therapy with an LHRH agonist or antagonist throughout the study, or has undergone a bilateral orchiectomy. • The patient has a general status 18 years of age on the day of signing the informed consent. • Patients who are not surgically sterile should use a reliable contraceptive method from the time of selection until 30 days after the last dose of the study drug. • The patient has an adequate organic function as indicated by laboratory values
Exclusion criteria
Exclusion criteria: • The patient has received bicalutamide, flutamide or nilutamide within the last 12 months. • The patient has previously received chemotherapy for metastatic prostate cancer. • The patient is currently participating or has participated in a study with a compound or device under investigation within 30 days of the initial dose administration of the study drug. • The patient has previously received rapamycin or rapamycin analogues, such as deforolimus, temsirolimus or everolimus. • The patient is receiving corticosteroids administered at higher doses than those used for normal replacement therapy. • The patient is receiving a narcotic opioid or analgesic prescribed for pain due to prostate cancer. • In the opinion of the researcher, the patient suffers from pain related to metastatic prostate cancer that justifies the beginning of chemotherapy. • The patient has a history of anterior malignancy as a primary tumor of the central nervous system, with the following exception: cutaneous basal cell carcinoma; or any patient who has undergone a potentially curative therapy without evidence of said disease for five years, or who is considered by their attending physician to have a low risk of recurrence. • The patient has some metastatic visceral disease such as malignant pleural effusions or ascites, current or previously treated epidural disease, active or treated CNS metastases, and / or carcinomatous meningitis. Exception: patients with treated epidural lesions and no other epidural evolution are eligible to enter the study. • The patient has known hypersensitivity to macrolide antibiotics (ie: clarithromycin, erythromycin or azithromycin); or bicalutamide. • The patient has Class III or IV congestive heart failure according to the New York Heart Association or any other significant history of heart disease such as: myocardial infarction within the last 6 months ; ventricular arrhythmia or acute congestive heart failure within the last 3 months; uncontrolled angina or uncontrolled hypertension. • The patient has recently diagnosed Type 1 or 2 diabetes (within 3 months prior to enrollment) or poorly controlled. • The patient has an active infection that requires prescription intervention. • The patient is known to be positive for the human immunodeficiency virus (HIV). • The patient has a known history of Hepatitis B or C. • The patient has known psychiatric or substance abuse disorders that could interfere with the cooperation with the test requirements. • The patient is, at the time of signing the informed consent, a regular user (including recreational use) of any illicit drug or has a recent history (within the last year) of drug addiction or alcoholism. • The patient has not adequately recovered from any previous surgical procedure or has undergone a major surgical procedure within 2 weeks prior to the first dose of the study drug (patients who have undergone the recent placement of a central venous access path will be considered eligible if they have been fully recovered.) • The patient has a current history or evidence of any laboratory condition, therapy or abnormality that could confuse the results of the study or interfere with the patient´s participation throughout the study, or it is not convenient for the patient to participate. • The patient requires concurrent treatment with drugs that are strong inducers or inhibitors of cytochrome P450 (CYP3A). P
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Defined as a decrease of PSA> 30% with respect to baseline within the first 12 weeks of the study treatment. The decrease is determined through the minimum postbasal value of the PSA within the first 12 weeks. Measure:PSA decrease of 30% within 12 weeks Timepoints:12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:It is defined as a decrease of PSA> 50% with respect to baseline, confirmed by a second value at least 4 weeks later. Measure:PSA response Timepoints:12 weeks ; Outcome name:It is defined as the time from randomization to the date of the evolution of the PSA defined below. Patients without PSA evolution at the time of analysis will be censored on the date of the last follow-up. Measure:Time to PSA Evolution Timepoints:12 weeks ; Outcome name:Defined as follows 1. Patients with a decrease in PSA with respect to baseline (the definition of the PSA response is not required): the date on which an increase of 25% or greater is documented and an absolute increase of 2 ng / ml or more with respect to the minimum level, which is confirmed by a second value obtained 3 or more weeks later. 2. Patients without any decrease in PSA with respect to baseline: the date on which an increase of 25% or greater is documented and an absolute increase of 2 ng / ml or more with respect to baseline after 12 weeks of treatment. No confirmation is required. Measure:PSA evolution Timepoints:12 weeks ; Outcome name:Defined as the time from randomization to any of the following events (whichever occurs first): Evolution of PSA, Evolution of bone exploration, Evolution of quantifiable disease, Bone events, including the incidence of a pathological fracture or the need for orthopedic intervention for a bone metastasis during the intake of the study drug, the need to start radiotherapy for any reason during the study, death from any cause Measure:Survival without evolution (PFS) Timepoints:Week 12 | — |
Countries
Belgium, Colombia, Denmark, Finland, Italy, Netherlands, Peru, Poland, Spain, Sweden, United Kindgdom, United States
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed