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Orteronel Maintenance Therapy in Patients With mCRPC Previously Treated With Novel Hormonal Agents

NCT02053311 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2018-07-30

No results posted yet for this study

Summary

The main object of this multicenter, randomized, double-blind, placebo-controlled phase III trial is to assess impact of maintenance of orteronel on disease progression and hence on quality of life of patients with metastatic castration resistant prostate cancer pretreated with novel hormonal agents who have non-progressive disease after chemotherapy with a taxane.

Conditions

Interventions

DRUG

Orteronel

300mg orteronel

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Swiss Cancer Institute

    lead OTHER

Principal Investigators

  • Richard Cathomas, MD · Kantonsspital Graubünden

  • Silke Gillessen, Prof · Cantonal Hospital of St. Gallen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-19
Primary Completion
2014-08-19
Completion
2034-08-19

Countries

  • Switzerland

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02053311 on ClinicalTrials.gov