Trial Condition(s):

Castration-Resistant Prostate Cancer

Study to investigate the availability of the study drug ODM-201 in the body of patients with prostate cancer, as affected by food and drug formulations (ARAFOR)

Bayer Identifier:

17830

ClinicalTrials.gov Identifier:

NCT01784757

EudraCT Number:

2012-002279-32

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). The alteration of the study drug as affected by food and drug formulation is also investigated. The study medication ODM-201 is an androgen receptor inhibitor tested in men with metastatic castration-resistant prostate cancer (mCRPC).

Inclusion Criteria
- Male subjects aged 18 years or older with histologically confirmed adenocarcinoma of prostate
                - Metastatic disease defined as documented metastasis on bone scan and/or computed tomography (CT) or magnetic resonance imaging (MRI)
                - Progressive disease as defined by any one of the following criteria: a) Rising PSA levels: two consecutive increases in PSA levels documented over a previous reference value obtained at least one week apart with the lowest value being ≥ 2 ng/ml. If the third PSA level is less than the second, an additional fourth test to confirm a rising PSA (i.e., the fourth value is ≥ the second value and is ≥ 2 ng/ml) is acceptable; b) Radiographic disease progression based on RECIST 1.1 criteria in subjects with soft-tissue lesions or appearance of 2 or more new lesions on bone scan in subjects with bone disease.
                - Life expectancy at least 6 months
                - Asymptomatic or mildly symptomatic prostate cancer
                - Prior surgical castration or concurrent use of an agent for medical castration (e.g., LHRH analog) with serum testosterone at screening < 50 ng/dl or < 1.7 nmol/l
Exclusion Criteria
- Previous chemotherapy for prostate cancer
                - History of other malignancy within the previous 5 years, except for basal cell carcinoma of skin
                - Prior or concomitant use of any investigational or approved androgen receptor antagonist except for flutamide, bicalutamide or nilutamide
                - Prior or concomitant use of any CYP17 inhibitor (e.g. Abiraterone, TAK-700 or TOK-001), ketoconazole or sipuleucel-T within 4 weeks of start of study treatment

Trial Summary

Enrollment Goal
30
Trial Dates
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Phase
1
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

Helsinki University Central Hospital

Helsinki, Finland, 00029

Status
Completed
 
Locations

Tampere University Hospital

Tampere, Finland, 33521

Status
Completed
 
Locations

Institut Gustave Roussy

Villejuif, France, 94805

Status
Completed
 
Locations

Curie Institute

Paris, France, 75248

Status
Completed
 
Locations

CHD La Roche Sur Yon

La Roche sur Yon, France, 85925

Status
Completed
 
Locations

Center Eugene Marquis

Rennes, France, 35042

Status
Completed
 
Locations

P. Stradins Clinical University Hospital

Riga, Latvia, 1002

Status
Completed
 
Locations

Vidzemes Hospital

Valmiera, Latvia, 4201

Status
Completed
 
Locations

Riga East University Hospital

Riga, Latvia, 1038

Status
Completed
 

Trial Design