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ODM-201 Maintenance Therapy in Patients With mCRPC Previously Treated With Novel Hormonal Agents.

NCT02933801 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2024-03-13

No results posted yet for this study

Summary

The main objective of the trial is to assess impact of maintenance therapy with ODM-201 on radiographic progression-free survival (rPFS) of patients with mCRPC pretreated with novel hormonal agents who have non-progressive disease after chemotherapy with a taxane.

Conditions

Interventions

DRUG

ODM-201

ODM-201 will be given at a dose of 600 mg BID orally on a continuous basis.

OTHER

Placebo

Placebo will be given at a dose of 600 mg BID orally on a continuous basis.

Sponsors & Collaborators

  • Swiss Cancer Institute

    lead OTHER

Principal Investigators

  • 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
2017-03-31
Primary Completion
2021-06-28
Completion
2023-11-15

Countries

  • France
  • Italy
  • Spain
  • Switzerland

Study Locations

More Related Trials

Entities

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 NCT02933801 on ClinicalTrials.gov