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Clinical Trials List

Protocol NumberBAY 1841788/17777

2016-11-01 - 2022-10-28

Phase III

Recruiting6

ICD-10C61

Malignant neoplasm of prostate

ICD-9185

Malignant neoplasm of prostate

A Randomized, Double-blind, Placebo Controlled Phase III Study of Darolutamide (ODM-201) Versus Placebo in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Patients With Metastatic Hormone Sensitive Prostate Cancer

  • Trial Applicant

    COVANCE TAIWAN SERVICES LIMITED

  • Sponsor

    Bayer AG.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Hsi-Chin Wu Division of Hematology & Oncology

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator CHUNG-HSIN CHEN

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Audit

None

Principal Investigator Yi-Hsiu Huang

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

10 Recruiting

Audit

None

Principal Investigator 江博暉 未分科

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Hsi-Chin Wu 未分科

Co-Principal Investigator

Audit

None

Principal Investigator See-Tong Pang
Linkou Chang Gung Medical Foundation

Taiwan National PI

馮思中

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

7 Recruiting

Audit

None

Principal Investigator Shu-Pin Huang 未分科

Co-Principal Investigator

Audit

CRO

Principal Investigator Shu-Pin Huang

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

metastatic hormone-sensitive prostate cancer

Objectives

The purpose of the study is to assess the efficacy and safety of BAY1841788 (darolutamide (ODM-201)) in combination with standard androgen deprivation therapy (ADT) and docetaxel in patients with metastatic hormone sensitive prostate cancer.

Test Drug

BAY 1841788/ODM-201(Darlutamide)

Active Ingredient

Darlutamide (ODM-201)

Dosage Form

Dosage

300

Endpoints

A

Inclution Criteria

A

Exclusion Criteria

A

The Estimated Number of Participants

  • Taiwan

    48 participants

  • Global

    1300 participants