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

Completed · Phase 2

Conditions studied: Prostate Cancer

In brief

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

Key facts

Study ID

NCT01549951

Run by

Millennium Pharmaceuticals, Inc.

People needed

50

Starts

2012-05-01

Expected to finish

2015-01-01

Last updated by the study team

2016-06-01

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Pinnacle Oncology — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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