Phase 2
Completed N=50
Study to Investigate the Effects of Orteronel on the QT/QTc Interval in Patients With Metastatic Castration-Resistant Prostate Cancer
Source: ClinicalTrials.gov NCT01549951 ↗Enrolled (actual)
50
Serious AEs
34.0%
Results posted
Jun 2016
Primary outcomePrimary: Maximum Change From Baseline in QTc Interval Based on the Fridericia Correction (QTcF) Method — -1.4 millisecond (msec)
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Change From Baseline in QTc Interval Based on the Fridericia Correction (QTcF) Method |
-1.4 | — |
| SECONDARY Maximum Change From Baseline in QTc Based on the Bazett Correction (QTcB) Method, PR, QRS and Uncorrected QT Interval |
9.7; -4.2; -1.0; -12.5 | — |
| SECONDARY Changes From Baseline in Heart Rate |
5.7 | — |
| SECONDARY Number of Participants Reporting Change From Baseline in ECG Morphology |
1; 8; 3 | — |
| SECONDARY Correlation Between the QTcF Change From Baseline and Plasma Concentrations of Orteronel |
-0.002603 | — |
| SECONDARY AUC(0-6): Area Under the Plasma Concentration-Time Curve From Time 0 to 6 Hours Postdose for Orteronel and M-I Metabolite |
7570.4; 12971.6 | — |
| SECONDARY Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Orteronel and M-I Metabolite |
2.0; 1.6; 4.5; 3.0 | — |
| SECONDARY Cmax: Maximum Observed Plasma Concentration for Orteronel and M-I Metabolite |
1904.0; 3017.9; 263.5; 597.5 | — |
| SECONDARY Number of Participants Reporting One or More Treatment-emergent Adverse Events |
48 | — |
| SECONDARY Number of Participants Reporting Clinically Significant Abnormalities in Laboratory Values |
5 | — |
| SECONDARY Number of Participants Reporting Clinically Significant Abnormalities in Vital Signs |
— | — |
| SECONDARY Number of Participants Reporting Clinically Significant Abnormalities in Physical Findings |
— | — |
| SECONDARY Number of Participants Reporting Clinically Significant Abnormalities in ECG |
— | — |
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT01549951). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.