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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


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To determine the change from baseline in QTc, based on the QTc with Fridericia correction (QTcF) method

Outcome Description:

To evaluate the effect of Orteronel plus prednisone on the QT/QTc interval

Outcome 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.

Safety Issue:

Yes

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Millennium Pharmaceuticals, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

C21012

NCT ID:

NCT01549951

Start Date:

May 2012

Completion Date:

September 2014

Related Keywords:

  • Prostate Cancer
  • Metastatic castrate resistant prostate cancer, mCRPC, orteronel, TAK-700, Phase 2, QT, QTc
  • Prostatic Neoplasms

Name

Location

Pinnacle OncologyScottsdale, Arizona  85258