Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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30 March 2015 |
Main ID: |
EUCTR2012-000136-26-IE |
Date of registration:
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10/04/2012 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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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.
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Scientific title:
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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:
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14/08/2012 |
Target sample size:
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40 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-000136-26 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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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
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Phase:
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Countries of recruitment
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Canada
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France
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Greece
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Ireland
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Romania
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United States
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Contacts
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Name:
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Drug Information Call Center
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Address:
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40 Landsdowne Street
MA 02139
Cambridge, Masachussetts
United States |
Telephone:
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+1510740 2412 |
Email:
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medical@mlnm.com |
Affiliation:
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Millennium, Drug Information Call Center |
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Name:
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Drug Information Call Center
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Address:
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40 Landsdowne Street
MA 02139
Cambridge, Masachussetts
United States |
Telephone:
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+1510740 2412 |
Email:
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medical@mlnm.com |
Affiliation:
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Millennium, Drug Information Call Center |
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Key inclusion & exclusion criteria
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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
Age minimum:
Age maximum:
Gender:
Female: no Male: yes
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Health Condition(s) or Problem(s) studied
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metastatic castration-resistant prostate cancer (mCRPC) MedDRA version: 16.1
Level: PT
Classification code 10036909
Term: Prostate cancer metastatic
System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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Therapeutic area: Diseases [C] - Cancer [C04]
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Intervention(s)
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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-
Trade Name: Prednison acis Product Name: Prednison acis 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-
Trade Name: Prednison-ratiopharm Product Name: Prednison-ratiopharm 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-
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Primary Outcome(s)
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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)
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Primary end point(s): The primary endpoint is the change from baseline in QTc, based on the QTc with Fridericia correction (QTcF) method
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Secondary Objective: To continue to assess the safety and pharmacokinetics of orteronel, when administered with prednisone, in patients with mCRPC
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Timepoint(s) of evaluation of this end point: Cycle 1 Day 1 through Cycle 2 Day 1 [study Day 29 +/- 1 day]
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: Cycle 1 Day 1 through Cycle 2 Day 1 [study Day 29 +/- 1 day]
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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
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Secondary ID(s)
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C21012
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2012-000136-26-GR
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Source(s) of Monetary Support
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Millennium Pharmaceuticals, Inc.
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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