Study Comparing Orteronel Plus Prednisone in Participants With Metastatic Castration-Resistant Prostate Cancer.

Millennium Pharmaceuticals

Status and phase

Completed

Phase 3

Conditions

Prostate Cancer

Treatments

Drug: Prednisone

Drug: Orteronel Placebo

Drug: Orteronel

Study type

Interventional

Funder types

Industry

Identifiers

NCT01193257

2010-018662-23 (EudraCT Number)

CTR20131423 (Registry Identifier)

C21005 (Registry Identifier)

U1111-1181-8040 (Registry Identifier)

0991413212 (Registry Identifier)

Details and patient eligibility

About

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 Docetaxel-based therapy

Enrollment

1,099 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Each participant must meet all of the following inclusion criteria:

Voluntary written consent
Male 18 years or older
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
Progressive disease during or following 1 or 2 regimens of cytotoxic chemotherapy, 1 of which must have included docetaxel. Must have received greater than or equal to (>=) 360 milligram per square meter (mg/m^2) of docetaxel within a 6-month period. Participants who were clearly intolerant to docetaxel or develop progressive disease before receiving >= 360 mg/m^2 are also eligible if they have received at least 225 mg/m^2 of docetaxel within a 6-month period and meet the other study entry criteria.
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
Even if surgically sterilized, participants must practice effective barrier contraception during the entire study treatment period and for 4 months after the last dose of study drug, OR Abstain from heterosexual intercourse
Screening laboratory values as specified in protocol
Stable medical condition
Life expectancy of 6 months or more
Participants who have had up to 2 prior chemotherapy treatments are eligible to participate

Exclusion criteria

Participants meeting any of the following exclusion criteria are not to be enrolled in the study:

Known hypersensitivity to orteronel, prednisone or gonadotropin-releasing hormone (GnRH) analogue
Received prior therapy with orteronel, aminoglutethimide, ketoconazole or abiraterone
Any other therapies for prostate cancer, except for GnRH analogue therapy, must be discontinued 2 weeks before the first dose of study drug
Radioisotope therapy or external beam radiation therapy within 4 weeks of 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 (Participants who are in long-term follow-up following active treatment in other trials are eligible)
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
Uncontrolled nausea, vomiting, or diarrhea despite appropriate medical therapy
Prostate cancer confined to just the prostrate bed or immediate adjacent tissue