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
  Purpose

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


Condition Intervention Phase
Prostate Cancer
Drug: Orteronel+Prednisone
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Millennium Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 50
Study Start Date: May 2012
Study Completion Date: March 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Orteronel+Prednisone 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01549951

Locations
United States, Arizona
Pinnacle Oncology
Scottsdale, Arizona, United States, 85258
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Investigators
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01549951     History of Changes
Other Study ID Numbers: C21012, 2012-000136-26
Study First Received: March 7, 2012
Last Updated: July 1, 2013
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency

Keywords provided by Millennium Pharmaceuticals, Inc.:
Metastatic castrate resistant prostate cancer, mCRPC, orteronel, TAK-700, Phase 2, QT, QTc

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Prednisone
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014