Trial Condition(s):

Castration-Resistant Prostate Cancer

Study to test how patients with prostate cancer respond to and tolerate the treatment with ODM-201, how the human body absorbs, distributes and excretes the drug, and to find the optimal dose for patients (ARADES)

Bayer Identifier:

17829

ClinicalTrials.gov Identifier:

NCT01317641

EudraCT Number:

2010-022802-41

EU CT Number:

Not Available

Study Completed

Trial Purpose

The purpose of the study is to test how well patients with prostate cancer that keeps growing and has spread to other parts of the body respond to treatment with ODM-201 (Nubeqa, Darolutamide, BAY1841788). In addition, researchers want to find the optimal dose of ODM-201 for patients and investigate how the drug is tolerated, absorbed, distributed and excreted in/from the human body. The study medication ODM-201 is an androgen receptor inhibitor tested in men with metastatic castration-resistant prostate cancer (mCRPC).

Inclusion Criteria
- Histologically confirmed adenocarcinoma of the prostate
                - Ongoing androgen deprivation therapy (ADT) with a LHRH analogue or antagonist or bilateral orchiectomy and serum testosterone level <50 ng/dL (<0.5 ng/mL, <1.7 nmol/L) at screening
                - Progressive metastatic disease during the androgen deprivation and after the treatment with antiandrogen and antiandrogen withdrawal
                - The patient had received 1 or 2 chemotherapy treatments, OR was ineligible for chemotherapy, OR was intolerant of chemotherapy, OR had declined chemotherapy, OR had no need for chemotherapy yet.
                - The patient had an ECOG performance status of 0-1 at screening.
                - The patient had screening liver, renal and albumin values of: Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal (ULN), Total bilirubin ≤ 2 x ULN, Creatinine ≤1.5 x ULN and Albumin > 3.0 g/dL.
                - Prior treatment with antiandrogen. Discontinuation of bicalutamide or nilutamide at least 6 weeks and other antiandrogens at least 4 weeks prior to the start of the study treatment.
                - Life expectancy of at least 3 months
Exclusion Criteria
- Patients who received prior therapy with MDV3100 or any investigational androgen receptor antagonist
                - Patients who received chemotherapy, radiotherapy or any experimental therapy within 4 weeks (within 6 weeks for nitrosoureas and mitomycin C) of the start of study treatment or had not recovered to Grade ≤1 or returned to baseline from any acute treatment-related toxicities of the previous therapy except for alopecia and Grade 2 neuropathy
                - Therapy with oral ketoconazole or CYP17 inhibitor within 30 days prior to the start of study treatment

Trial Summary

Enrollment Goal
136
Trial Dates
black-arrow
Phase
1/2
Could I receive a placebo?
No
Products
Nubeqa (Darolutamide, BAY1841788)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Queen Elizabeth Hospital

Birmingham, United Kingdom, B15 2TH

Status
Completed
Locations

University Hospital Olomouc

Olomouc, Czech Republic, 775 20

Status
Completed
Locations

Cardiff University And Velindre Cancer Centre

Cardiff, United Kingdom, CF14 2TL

Status
Completed
Locations

Christie Hospital NHS Foundation Trust

Manchester, United Kingdom, M204BX

Status
Completed
Locations

Hospital Znojmo

Znojmo, Czech Republic, 669 02

Status
Completed
Locations

Faculty Hospital Hradec Králové

Hradec Králové, Czech Republic, 500 05

Status
Completed
Locations

East Tallinn Central Hospital

Tallinn, Estonia, 10138

Status
Completed
Locations

Helsinki University Central Hospital

Helsinki, Finland, 00029

Status
Completed
Locations

Tampere University Hospital

Tampere, Finland, 33521

Status
Completed
Locations

Kuopio University Hospital

Kuopio, Finland, 70211

Status
Completed
Locations

Oulu University Hospital

Oulu, Finland, 90029

Status
Completed
Locations

Turku University Hospital

Turku, Finland, 20521

Status
Completed
Locations

Institut Gustave Roussy

Villejuif, France, 94805

Status
Completed
Locations

Hôpital Saint Louis

Paris, France, 75745

Status
Completed
Locations

Churchill Hospital

Oxford, United Kingdom, OX3 7LJ

Status
Completed
Locations

Delaware Valley Urology

Voorhees, United States, 08043

Status
Completed
Locations

Cleveland Clinic

Cleveland, United States, 44195

Status
Completed
Locations

Urology Center Colorado

Wheat Ridge, United States, 80211

Status
Completed
Locations

Carolina Urologic Research Center

Myrtle Beach, United States, 29572

Status
Completed
Locations

Eastern CT Hematology And Oncology

Norwich, United States, 06360

Status
Completed
Locations

Brooklyn Urology Research Group

New York, United States, 11215

Status
Completed
Locations

Urology Health Team PLLC

Ocala, United States, 34474

Status
Completed
Locations

Chesapeake Urology Research Associates

Baltimore, United States, 21327

Status
Completed

Trial Design