A Phase II Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Study the Efficacy and Safety of Bicalutamide With or Without Deforolimus in Men With Asymptomatic, Metastatic Castrate-Resistant Prostate Cancer

• Conditions: Men with asymptomatic,metastatic castrate-resistant prostate cancer.; MedDRA version: 14.1Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2008-000422-39-IT
• Lead Sponsor: MERCK & CO., INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-06
• Last Update Posted: 7 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 156

Inclusion Criteria

Patient has histologically confirmed adenocarcinomas of the prostate. Archival pathological material is available for submission to central laboratory. Patient has evidence of metastatic disease at protocol entry or at the time of prior hormonal manipulation, determined radiographically by the presence of at least 2 bone scan lesions consistent with metastases or abdominal/pelvic lymph nodes ≥2 cm on longest axial measurement. Solitary or ambiguous bone lesions should be confirmed with plain radiographs or magnetic resonance imaging (MRI). Patient has evidence of disease progression despite castrate levels of testosterone (<50 ng/dl) following orchiectomy or during therapy with a luteinizing hormone releasing hormone (LHRH) agonist or antagonist (with or without an anti-androgen). Patient has a PSA ≥10 ng/ml. A minimum of four weeks has elapsed between prior surgery or radiotherapy (limited to no more than 25 percent of the bone marrow) and enrollment. Patient maintains therapy with a LHRH agonist or antagonist for the duration of the study, or has undergone bilateral orchiectomy. Patient has performance status ≤1 on Eastern Cooperative Oncology Group (ECOG) Performance Scale. Patient voluntarily agreed to participate by giving written informed consent. Patient is ≥18 years of age on day of signing informed consent.. Patients who are not surgically sterile are required to use a reliable method of contraception from time of screening until 30 days after the last dose of study drug. Patient has adequate organ function
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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

Exclusion Criteria

Patient has received bicalutamide, flutamide, or nilutamide within the past 12 months. Patient has received prior chemotherapy for metastatic prostate cancer. Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of initial dosing with study drug. Patient has previously received rapamycin or rapamycin analogs, including deforolimus, temsirolimus, or everolimus. Patient is receiving corticosteroids administered at doses greater than those used for normal replacement therapy. . Patient is receiving an opioid or narcotic analgesic prescribed for pain due to prostate cancer. In the opinion of the investigator, the patient has pain related to metastatic prostate cancer that warrants the initiation of chemotherapy. Patient has a history of prior malignancy including primary central nervous system tumor, with the following exceptions: basal cell carcinoma of the skin; or any patient who has undergone potentially curative therapy with no evidence of that disease for five years, or who is deemed at low risk for recurrence by his treating physician. Patient has any visceral metastatic disease including 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 progression are eligible for study entry. Patient has known hypersensitivity to macrolide antibiotics (i.e.: clarithomycin, erythromycin, or azythromycin); or bicalutamide. Patient has New York Heart Association (NYHA) Class III or IV congestive heart failure or any other significant history of cardiac disease including: myocardial infarction within the last 6 months; ventricular arrhythmia or acute congestive heart failure within the last 3 months; uncontrolled angina or uncontrolled hypertension. Patient has newly diagnosed (within 3 months before enrollment) or poorly controlled Type 1 or 2 diabetes. Patient has an active infection requiring prescribed intervention. Patient is known to be human immunodeficiency virus (HIV) positive. Patient has a known history of Hepatitis B or C. Patient has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. Patient is, at the time of signing informed consent, a regular user (including ''recreational use'') of any illicit drugs or has a recent history (within the last year) or drug or alcohol use. Patient has not adequately recovered from any prior surgical procedure or has undergone any major surgical procedure within 2 weeks prior to the first dose of study drug (patients having undergone recent placement of a central venous access port will be considered eligible if they have fully recovered). Patient has a history or current evidence of any condition, therapy, or lab abnormality that might confound the results of the study or interfere with the patient's participation for the full duration of the study, or it is not in the best interest of the patient to participate. Patient has a requirement for concurrent treatment with medications that are strong inducers or inhibitors of cytochrome P450 (CYP3A). Patients should be off these medications for at least 2 weeks prior to the first dose of deforolimus. Concomitant medications that are metabolized by CYP3A are allowed (e.g., simvastatin or atorvastatin).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified