A Multinational, Randomised, Double-blind, Placebo-controlled, Phase III Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer

CompletadoFase 3ClinicalTrials.gov

ID: NCT02200614Tipo: INTERVENTIONALInicio: 12 de sept de 2014Fin estimado: 14 de jun de 2021

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to assess the safety and efficacy of BAY1841788 (ODM-201) in patients with non-metastatic castration-resistant prostate cancer.

Elegibilidad

Edad mínima: 18 YearsSexo: MALE

Criterios de inclusión

Histologically or cytologically confirmed adenocarcinoma of prostate without neuroendocrine differentiation or small cell features.
Castration-resistant prostate cancer (CRPC) with castrate level of serum testosterone.
Prostate-specific Antigen (PSA) doubling time of ≤ 10 months and PSA \> 2ng/ml.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Blood counts at screening: haemoglobin ≥ 9.0 g/dl,absolute neutrophil count ≥ 1500/µl, platelet count ≥ 100,000/µl.
Screening values of serum alanine aminotransferase (ALT) and/or aspartate transaminase (AST) ≤ 2.5 x upper limit of normal (ULN), total bilirubin ≤ 1.5 x ULN, creatinine ≤ 2.0 x ULN.
Sexually active patients, unless surgically sterile, must agree to use condoms as an effective barrier method and refrain from sperm donation during the study treatment and for 3 months after the end of the study treatment.

Criterios de exclusión

History of metastatic disease at any time or presence of detectable metastases.
Acute toxicities of prior treatments and procedures not resolved to grade ≤ 1 or baseline before randomisation.
Prior treatment with: second generation androgen receptor (AR) inhibitors, other investigational AR inhibitors, or CYP17 enzyme inhibitor.
Use of estrogens or 5-α reductase inhibitors or AR inhibitors.
Prior chemotherapy or immunotherapy for prostate cancer.
Use of systemic corticosteroid.
Radiation therapy within 12 weeks before randomisation.
Severe or uncontrolled concurrent disease, infection or co-morbidity.
Treatment with bisphosphonate or denosumab within 12 weeks before randomisation.
Known hypersensitivity to the study treatment or any of its ingredients.
Major surgery within 28 days before randomisation.
Any of the following within 6 months before randomisation: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft; congestive heart failure New York Heart Association (NYHA) Class III or IV.
Uncontrolled hypertension.
Prior malignancy.
Gastrointestinal disorder or procedure which expects to interfere significantly with absorption of study treatment.
Active viral hepatitis, active human immunodeficiency virus (HIV) or chronic liver disease.
Treatment with any investigational drug within 28 days before randomisation.
Any condition that in the opinion of the investigator would impair the patients' ability to comply with the study procedures.

Intervenciones

drug

Darolutamide (Nubeqa, BAY1841788)

Darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg.

drug

Placebo

Matching placebo 2 tablets twice daily with food.

Ubicaciones

Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina

Santa Fé, Santa Fe Province, Argentina

San Miguel de Tucumán, Tucumán Province, Argentina

Córdoba, Argentina

La Rioja, Argentina

Patrocinadores

PrincipalBayer

ColaboradorOrion Corporation, Orion Pharma

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