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.

• Register: EUCTR
• Last refreshed on: 10 July 2015
• Main ID: EUCTR2012-000136-26-GR
• Date of registration: 02/04/2012
• Prospective Registration: Yes
• Primary sponsor: Millennium Pharmaceuticals, Inc.
• Public title: 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.
• Scientific title: A Phase 2, Open-Label, Single-Arm, Multidose Study to Investigate the Effects of Orteronel on the QT/QTc Interval in Patients With Metastatic Castration-Resistant Prostate Cancer
• Date of first enrolment: 07/05/2012
• Target sample size: 40
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-000136-26
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1

Countries of recruitment

Canada, France, Greece, Ireland, Romania, United States

Contacts

• Name: Drug Information Call Center
• Affiliation: Millennium, Drug Information Call Center

• Name: Drug Information Call Center
• Affiliation: Millennium, Drug Information Call Center

Key inclusion & exclusion criteria

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>480ms, 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



Age minimum:
Age maximum:
Gender:
Female: no
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Cancer [C04]

metastatic castration-resistant prostate cancer (mCRPC)
MedDRA version: 14.1 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Intervention(s)

Product Name: Recommended INN-Orteronel
Product Code: TAK-700
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Recommended INN = orterone
CAS Number: 566939-85-3
Current Sponsor code: TAK-700
Other descriptive name: 6-[(7S)-7-hydroxy-6,7-dihydro-5H-pyrrolo[1,2-c]imidazol-7-yl]-N-methyl-2-naphthamide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-

Trade Name: Decortin
Product Name: Decortin
Product Code: Prednisone
Pharmaceutical Form: Tablet
INN or Proposed INN: PREDNISONE
CAS Number: 53-03-2
Current Sponsor code: EMD 15216
Other descriptive name: Decortin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-

Primary Outcome(s)

Secondary Objective: To continue to assess the safety and pharmacokinetics of orteronel, when administered with prednisone, in patients with mCRPC

Primary end point(s): The primary endpoint is the change from baseline in QTc, based on the QTc with Fridericia correction (QTcF) method

Main Objective: To evaluate the effects of orteronel, when administered with prednisone, on the QT/QTc interval in patients with metastatic castration-resistant prostate cancer (mCRPC)

Timepoint(s) of evaluation of this end point: Cycle 1 Day 1 through Cycle 2 Day 1 [study Day 29 +/- 1 day]

Secondary Outcome(s)

Secondary end point(s): The secondary endpoints include:
- Change from baseline in QTc with Bazett correction (QTcB), PR and QRS intervals, and uncorrected QT interval
-Change from baseline in HR
-Change from baseline in ECG morphology
-PK parameters for orteronel, including AUC from 0 to 6 hours (AUC0-6hr), Cmax, and first time to maximum plasma concentration (Tmax)
-Correlation between the QTcF change from baseline and plasma concentrations of orteronel
-Rates of AEs and serious adverse events (SAEs), changes in clinical laboratory values, vital sign measurements, physical examination findings, and ECG results

Timepoint(s) of evaluation of this end point: Cycle 1 Day 1 through Cycle 2 Day 1 [study Day 29 +/- 1 day]

Secondary ID(s)

C21012

Source(s) of Monetary Support

Millennium Pharmaceuticals, Inc.