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

Millennium Pharmaceuticals

Status and phase

Completed

Phase 3

Conditions

Prostate Cancer

Treatments

Drug: Prednisone

Drug: Placebo

Drug: Orteronel

Study type

Interventional

Funder types

Industry

Identifiers

NCT01193244

2010-018661-35 (EudraCT Number)

U1111-1181-0387 (Registry Identifier)

0991413276 (Other Identifier)

10/H0406/75 (Registry Identifier)

C21004

Details and patient eligibility

About

This is a randomized, double-blind, multicenter, phase 3 study evaluating orteronel (TAK-700) plus prednisone compared with placebo plus prednisone in the treatment of men with progressive, chemotherapy-naive, metastatic, castration-resistant prostate cancer (mCRPC)

Enrollment

1,560 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Each patient must meet all of the following inclusion criteria:

Voluntary written consent
Male patients 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
Either absence of pain or pain not requiring use of any opioid or narcotic analgesia in the 2 weeks prior to study entry
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Even if surgically sterilized, patients must practice effective barrier contraception during the entire study treatment and for 4 months after the last dose of study drug, OR abstain from heterosexual intercourse
Meet screening laboratory values as specified in protocol
Stable medical condition

Exclusion criteria

Patients 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
Received antiandrogen therapy within 6 weeks for bicalutamide and 4 weeks for all others prior to first dose of study drug
Continuous daily use of oral prednisone or oral dexamethasone for more than 14 days within 3 months prior to study
Received prior chemotherapy for prostate cancer with exception of neoadjuvant/adjuvant therapy as part of initial primary treatment for local disease that was completed 2 or more years prior to screening
Exposure to radioisotope therapy within 4 weeks of receiving first dose of study drug; exposure to external beam radiation within 2 weeks of start of screening until receiving the 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
Current spinal cord compression, bilateral hydronephrosis or current bladder neck outlet obstruction
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
Uncontrolled nausea, vomiting or diarrhea
Known gastrointestinal disease or procedure that could interfere with oral absorption or tolerance of orteronel