A Randomized, Double-blind, Placebo Controlled Phase III Study of ODM-201 Versus Placebo in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Patients With Metastatic Hormone Sensitive Prostate Cancer. NCT02799602, Bayer 1777.

  • STATUS
    Recruiting
Updated on 2 September 2021

Summary

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.

Description

For more information contact Cheryl Zinar, Director of Clinical Research, Urologic Consultants of Southeastern PA, 610-667-0458, Czinar@ucsepa.com.

Details
Condition Metastatic Hormone Sensitive Prostate Cancer
Clinical Study IdentifierTX196747
Last Modified on2 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Histologically or cytologically confirmed cancer of prostate
Metastatic disease
Candidates for ADT and docetaxel. Started ADT with or without first generation anti androgen, but no longer than 12 weeks before randomization
An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Adequate bone marrow, liver and renal function

Exclusion Criteria

Prior treatment with: LHRH agonist/antagonists; second generation androgen receptor (AR) inhibitors such as enzalutamide, ARN-509, ODM-201; other investigational AR inhibitors; CYP17 enzyme inhibitor such as abiraterone acetate or oral ketoconazole as antineoplastic treatment for prostate cancer, chemotherapy or immunotherapy for prostate cancer prior to randomization
Treatment with radiotherapy/radiopharmaceuticals within 2 weeks before randomization
Had any of the following within 6 months before randomization: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, congestive heart failure (New York Heart Association Class III or IV)
Had a prior malignancy. Adequately treated basal cell or squamous cell carcinoma of skin or superficial bladder cancer that has not spread behind the connective tissue layer (i.e., pTis, pTa, and pT1) is allowed, as well as any other cancer for which treatment has been completed 5 years before randomization and from which the subject has been disease-free
Gastrointestinal disorder or procedure which is expected to interfere significantly with absorption of study treatment
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