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

• Status: Completed
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Millennium Pharmaceuticals, Inc.
• Treatments: Prednisone

Criteria

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