Study to Investigate the Effects of Orteronel on the QT/QTc Interval in Patients With Metastatic Castration-Resistant Prostate Cancer
NCT ID: NCT01549951
Last Updated: 2016-06-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
50 participants
INTERVENTIONAL
2012-05-31
2015-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Orteronel+Prednisone
Orteronel+Prednisone
Orteronel 400-mg plus prednisone 5-mg will be administered BID orally continuously throughout the treatment cycle of the study.
Interventions
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Orteronel+Prednisone
Orteronel 400-mg plus prednisone 5-mg will be administered BID orally continuously throughout the treatment cycle of the study.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
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
18 Years
MALE
No
Sponsors
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Millennium Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Millennium Pharmaceuticals, Inc.
Locations
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Pinnacle Oncology
Scottsdale, Arizona, United States
Countries
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Other Identifiers
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2012-000136-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1179-5656
Identifier Type: REGISTRY
Identifier Source: secondary_id
C21012
Identifier Type: -
Identifier Source: org_study_id
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