Study to Investigate the Effects of Orteronel on the QT/QTc Interval in Patients With Metastatic Castration-Resistant Prostate Cancer

Millennium Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Prostate Cancer

Treatments

Drug: Orteronel+Prednisone

Study type

Interventional

Funder types

Industry

Identifiers

NCT01549951

C21012

2012-000136-26 (EudraCT Number)

U1111-1179-5656 (Registry Identifier)

Details and patient eligibility

About

The purpose of this phase 2, open-label, single-arm, multidose, multicenter study is to investigate the effects of Orteronel plus Prednisone on the QT/QTc interval in patients with Metastatic Castration-Resistant Prostrate Cancer

Enrollment

50 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Voluntary written consent
Screening PSA ≥ 2ng/ml
Patients must have a diagnosis of mCRPC
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
Prior surgical or medical castration with testosterone at screening < 50 ng/dL

Exclusion criteria

Prior chemotherapy for prostate cancer within 6 months prior to screening. (Any prior therapy with cabazitaxel, mitoxantrone, or anthracyclines is exclusionary.)
Documented central nervous system metastases
Clinically significant heart disease
Patients who have an abnormal 12-lead ECG result at screening including one or more of the following: QRS>110 ms, QTcF>480ms, PR interval>200 ms
Patients who have a history of risk factors for TdP including unexplained syncope, known long QT syndrome, heart failure, angina, or clinically significant abnormal laboratory assessments

Please note that there are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.

Site personnel will explain the trial in detail and answer any question you may have if you do qualify for the study. You can then decide whether or not you wish to participate. If you do not qualify for the trial, site personnel will explain the reasons