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

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:

MedlinePlus related topics: Cancer Prostate Cancer Steroids

Drug Information available for: Prednisone

U.S. FDA Resources

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

Estimated Enrollment:	44
Study Start Date:	May 2012
Estimated Study Completion Date:	September 2014
Estimated Primary Completion Date:	September 2014 (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

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:	January 23, 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 Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Prednisone
Glucocorticoids

Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 16, 2013