Study to Investigate the Effects of Orteronel on the QT/QTc Interval in Patients With Metastatic Castration-Resistant Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01549951
First received: March 7, 2012
Last updated: July 1, 2013
Last verified: July 2013

March 7, 2012
July 1, 2013
May 2012
December 2012   (final data collection date for primary outcome measure)
To determine the change from baseline in QTc, based on the QTc with Fridericia correction (QTcF) method [ Time Frame: Cycle 1, Day 1 through Cycle 2, Day 1(Study Day 29±1) for the primary end point. Responders may continue the treatment. ] [ Designated as safety issue: Yes ]
To evaluate the effect of Orteronel plus prednisone on the QT/QTc interval
Same as current
Complete list of historical versions of study NCT01549951 on ClinicalTrials.gov Archive Site
  • To determine the changes from baseline in QTc with Bazett correction (QTcB), PR and QRS intervals, and uncorrected QT interval [ Time Frame: Cycle 1, Day 1 through Cycle 2, Day 1(Study Day 29±1) ] [ Designated as safety issue: Yes ]
    To evaluate the effect of Orteronel plus prednisone on the QT/QTc interval
  • To determine the changes from baseline in HR [ Time Frame: Cycle 1, Day 1 through Cycle 2, Day 1(Study Day 29±1) ] [ Designated as safety issue: Yes ]
    To evaluate the effect of Orteronel plus prednisone on the QT/QTc interval
  • To determine the changes from baseline in ECG morphology [ Time Frame: Cycle 1, Day 1 through Cycle 2, Day 1(Study Day 29±1) ] [ Designated as safety issue: Yes ]
    To evaluate the effect of Orteronel plus prednisone on the QT/QTc interval
  • To determine the PK parameters for Orteronel, including AUC from 0 to 6 hours (AUC0-6hr), Cmax, and first time to maximum plasma concentration (Tmax) [ Time Frame: Cycle 1, Day 1 through Cycle 2, Day 1(Study Day 29±1) ] [ Designated as safety issue: No ]
    To assess the safety and pharmacokinetics of Orteronel plus prednisone
  • To determine the correlation between the QTcF change from baseline and plasma concentrations of Orteronel [ Time Frame: Cycle 1, Day 1 through Cycle 2, Day 1(Study Day 29±1) ] [ Designated as safety issue: Yes ]
    To evaluate the effect of Orteronel plus prednisone on the QT/QTc interval
  • To determine the rates of AEs and serious adverse events (SAEs), changes in clinical laboratory values, vital sign measurement, physical examination findings, and ECG results [ Time Frame: From signing of the informed consent form through 30 days after the last dose of study drug ] [ Designated as safety issue: Yes ]
    Determination of adverse events
Same as current
Not Provided
Not Provided
 
Study to Investigate the Effects of Orteronel on the QT/QTc Interval in Patients With Metastatic Castration-Resistant Prostate Cancer
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

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

Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
Drug: Orteronel+Prednisone
Orteronel 400-mg plus prednisone 5-mg will be administered BID orally continuously throughout the treatment cycle of the study.
Other Name: TAK-700
Experimental: Orteronel+Prednisone
Intervention: Drug: Orteronel+Prednisone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
March 2013
December 2012   (final data collection date for primary outcome measure)

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

Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01549951
C21012, 2012-000136-26
No
Millennium Pharmaceuticals, Inc.
Millennium Pharmaceuticals, Inc.
Not Provided
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
Millennium Pharmaceuticals, Inc.
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP