Clinical trial NCT01549951: Study to Investigate the Effects of Orteronel on the QT/QTc Interval in Patients With Metastatic Castration-Resistant Prostate Cancer
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Metastatic castrate resistant prostate cancer, mCRPC, orteronel, TAK-700, Phase 2, QT, QTc
Lead sponsor: Millennium Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2012-03-09
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Maximum Change From Baseline in QTc Interval Based on the Fridericia Correction (QTcF) Method
timeFrame: Cycle 1 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose; Cycle 2 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose
Secondary outcomes:
measure: Maximum Change From Baseline in QTc Based on the Bazett Correction (QTcB) Method, PR, QRS and Uncorrected QT Interval
timeFrame: Cycle 1 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose; Cycle 2 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose
measure: Changes From Baseline in Heart Rate
timeFrame: Cycle 1 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose; Cycle 2 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose
measure: Number of Participants Reporting Change From Baseline in ECG Morphology
timeFrame: Cycle 1 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose; Cycle 2 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose
measure: Correlation Between the QTcF Change From Baseline and Plasma Concentrations of Orteronel
timeFrame: Cycle 1 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose; Cycle 2 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose
measure: AUC(0-6): Area Under the Plasma Concentration-Time Curve From Time 0 to 6 Hours Postdose for Orteronel and M-I Metabolite
timeFrame: Cycle 1 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose; Cycle 2 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose
measure: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Orteronel and M-I Metabolite
timeFrame: Cycle 1 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose; Cycle 2 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose
measure: Cmax: Maximum Observed Plasma Concentration for Orteronel and M-I Metabolite
timeFrame: Cycle 1 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose; Cycle 2 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose
measure: Number of Participants Reporting One or More Treatment-emergent Adverse Events
timeFrame: Baseline up to 30 days after last dose of study drug (Day 86)
measure: Number of Participants Reporting Clinically Significant Abnormalities in Laboratory Values
timeFrame: Baseline up to 30 days after last dose of study drug (Day 86)
measure: Number of Participants Reporting Clinically Significant Abnormalities in Vital Signs
timeFrame: Baseline up to 30 days after last dose of study drug (Day 86)
measure: Number of Participants Reporting Clinically Significant Abnormalities in Physical Findings
timeFrame: Baseline up to 30 days after last dose of study drug (Day 86)
measure: Number of Participants Reporting Clinically Significant Abnormalities in ECG
timeFrame: Baseline up to 30 days after last dose of study drug (Day 86)
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Pinnacle Oncology
state: Arizona
Study officials:
affiliation: Millennium Pharmaceuticals, Inc.
name: Medical Monitor
role: STUDY_DIRECTOR
References: