Study to find out whether treatment with orteronel plus prednisone has any potential effects on the heart, by looking at certain heart waves, called QT waves, using an electrocardiogram (ECG) machine.

• Conditions: metastatic castration-resistant prostate cancer (mCRPC); MedDRA version: 16.1Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-000136-26-IE
• Lead Sponsor: Millennium Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-10
• Last Update Posted: 30 March 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

1. Voluntary written consent.

2. Patients must have a diagnosis of mCRPC.

3. Screening PSA = 2 ng/mL.

4. Prior surgical or medical castration with testosterone at screening < 50 ng/dL.

5. Eastern Cooperative Oncology Group performance status of 0 or 1.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1. Prior chemotherapy for prostate cancer within 6 months prior to screening. (Any prior therapy with cabazitaxel, mitoxantrone, or anthracyclines is exclusionary.).

2. Documented central nervous system metastases.

3. Clinically significant heart disease.

4. Patients who have an abnormal 12-lead ECG result at screening including one or more of the following: QRS>110 ms, QTcF>450ms, PR interval>200 ms

5. 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified