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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01549951
• Other study ID #: C21012
• Secondary ID: 2012-000136-26
• Status: Completed
• Phase: Phase 2
• First received: March 7, 2012
• Last updated: July 1, 2013
• Start date: May 2012
• Est. completion date: March 2013

Study information

• Verified date: July 2013
• Source: Millennium Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationEuropean Union: European Medicines Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Orteronel+Prednisone
Orteronel 400-mg plus prednisone 5-mg will be administered BID orally continuously throughout the treatment cycle of the study.

Locations

Country	Name	City	State
United States	Pinnacle Oncology	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Millennium Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the change from baseline in QTc, based on the QTc with Fridericia correction (QTcF) method	To evaluate the effect of Orteronel plus prednisone on the QT/QTc interval	Cycle 1, Day 1 through Cycle 2, Day 1(Study Day 29±1) for the primary end point. Responders may continue the treatment.	Yes
Secondary	To determine the changes from baseline in QTc with Bazett correction (QTcB), PR and QRS intervals, and uncorrected QT interval	To evaluate the effect of Orteronel plus prednisone on the QT/QTc interval	Cycle 1, Day 1 through Cycle 2, Day 1(Study Day 29±1)	Yes
Secondary	To determine the changes from baseline in HR	To evaluate the effect of Orteronel plus prednisone on the QT/QTc interval	Cycle 1, Day 1 through Cycle 2, Day 1(Study Day 29±1)	Yes
Secondary	To determine the changes from baseline in ECG morphology	To evaluate the effect of Orteronel plus prednisone on the QT/QTc interval	Cycle 1, Day 1 through Cycle 2, Day 1(Study Day 29±1)	Yes
Secondary	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)	To assess the safety and pharmacokinetics of Orteronel plus prednisone	Cycle 1, Day 1 through Cycle 2, Day 1(Study Day 29±1)	No
Secondary	To determine the correlation between the QTcF change from baseline and plasma concentrations of Orteronel	To evaluate the effect of Orteronel plus prednisone on the QT/QTc interval	Cycle 1, Day 1 through Cycle 2, Day 1(Study Day 29±1)	Yes
Secondary	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	Determination of adverse events	From signing of the informed consent form through 30 days after the last dose of study drug	Yes