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Safety and Pharmacokinetics Study of ODM-201 in Castrate Resistant Prostate Cancer

NCT01317641 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2017-03-29

Study results available
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Summary

The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of ODM-201 in patients with castrate resistant prostate cancer.

Conditions

Interventions

DRUG

ODM-201

ODM-201 administered orally daily

Sponsors & Collaborators

  • Endo Pharmaceuticals

    collaborator INDUSTRY

  • Orion Corporation, Orion Pharma

    lead INDUSTRY

Principal Investigators

  • Karim Fizazi · Gustave Roussy, Cancer Campus, Grand Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • United States
  • Czechia
  • Estonia
  • Finland
  • France
  • United Kingdom

Study Locations

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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 NCT01317641 on ClinicalTrials.gov