Featured Clinical Trial:

Prostate cancer (product/compound: Orteronel; Prednison)

ClinicAid Locations: Southern California – Fountain Valley, Corona, Riverside

Status:
Open for enrollment (accepting patients). Please contact us and mention Trial ID NCT01193257.

Condition: Prostate Cancer

Product Name/Compound: Orteronel + prednisone

Full Study Title: A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel Plus Prednisone With Placebo Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer That Has Progressed During or Following Docetaxel-based Therapy

Study Summary: This is a randomized, double-blind, multicenter, phase 3 study evaluating orteronel plus prednisone compared with placebo plus prednisone in men with metastatic, castration-resistant prostate cancer (mCRPC) that has progressed following taxane-based therapy

Eligible Participants:

Inclusion (Eligible):

Males >= 18 years of age
Voluntary written consent
Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma
Radiograph-documented metastatic disease
Progressive disease
Prior surgical castration or concurrent use of an agent for medical castration
Must have received a minimum of 6 standard cycles (75 mg/m2/cycle) of docetaxel, or a total of >= 450 mg/m2. Patients who were clearly intolerant to docetaxel before receiving >= 450 mg/m2 are also eligible if they have received at least 3 standard cycles as local standard of care guidelines or >= 225 mg/m2
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
Even if surgically sterilized, patients must Practice effective barrier contraception to one month after the last dose of study drug, OR Abstain from heterosexual intercourse
Meet screening laboratory values as specified in protocol
Stable medical condition
Patients who have had up to 2 prior chemotherapy treatments are eligible to participate

Exclusion (Not Eligible):

Known hypersensitivity to orteronel, prednisone or gonadotropin-releasing hormone (GnRH) analogue
Received prior therapy with orteronel, aminoglutethimide, ketoconazole or abiraterone
Received antiandrogen therapy within 6 weeks for bicalutamide and 4 weeks for all others prior to first dose of study drug
Exposure to radioisotope therapy within 4 weeks of receiving first dose of study drug; exposure to external beam radiation within 2 weeks of receiving first dose of study drug
Documented central nervous system metastases
Treatment with any investigational compound within 30 days prior to first dose of study drug
Diagnosis or treatment of another malignancy within 2 years preceding first dose of study drug except nonmelanoma skin cancer or in situ malignancy completely resected
Uncontrolled cardiovascular condition as specified in study protocol
Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C
Unwilling or unable to comply with protocol
Known gastrointestinal disease or procedure that could interfere with oral absorption or tolerance of orteronel

Study Phase: Phase III (What are Phases?)

To receive information and updates for this trial:
Please contact us and mention the Trial ID below.

Trial ID (ClinicalTrials.gov): NCT01193257

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