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ODM-201

DRUG5 trials

Sponsors

Orion Corporation, Orion Pharma, Swiss Cancer Institute, European Organisation for Research and Treatment of Cancer - EORTC, Gustave Roussy, Cancer Campus, Grand Paris

Conditions

Metastatic Castrate-resistant Prostate (CRPC) CancerProstate CancerProstate Cancer Metastatic

Phase 1

Safety and Pharmacokinetics Study of ODM-201 in Castrate Resistant Prostate Cancer
CompletedNCT01317641
Orion Corporation, Orion PharmaProstate Cancer
Start: 2011-03-31End: 2013-07-31Updated: 2017-03-29

Phase 2

Safety and Tolerability of ODM-201 in Castrate Resistant Prostate Cancer; Extension Study to Study 3104001
CompletedNCT01429064
Orion Corporation, Orion PharmaProstate Cancer
Start: 2011-06-30End: 2015-11-30Updated: 2017-02-20
ODM-201 Maintenance Therapy in Patients With mCRPC Previously Treated With Novel Hormonal Agents.
TerminatedNCT02933801
Swiss Cancer InstituteProstate Cancer, Prostate Cancer Metastatic
Start: 2017-03-31End: 2023-11-15Updated: 2024-03-13
ODM-201 vs Androgen Deprivation Therapy in Hormone naïve Prostate Cancer
Active, not recruitingNCT02972060
European Organisation for Research and Treatment of Cancer - EORTCProstate Cancer
Start: 2017-12-01End: 2036-12-31Updated: 2025-09-19
A Study of Patient Preference Between ODM-201 and Enzalutamide in Men With Metastatic Castrate-resistant Prostate Cancer
CompletedNCT03314324
Gustave Roussy, Cancer Campus, Grand ParisMetastatic Castrate-resistant Prostate (CRPC) Cancer
Start: 2017-11-29End: 2024-09-25Updated: 2026-08-17

Related Papers

Comparative efficacy and safety of talazoparib plus enzalutamide and other first-line treatments for metastatic castration-resistant prostate cancer.
2025-03-014 citations
A phase 2 randomized open-label study of oral darolutamide monotherapy vs. androgen deprivation therapy in men with hormone-naive prostate cancer (EORTC-GUCG 1532).
Journal of Clinical Oncology2023-02-201 citations
Long-term safety of darolutamide in patients with metastatic castration-resistant prostate cancer.
Journal of Clinical Oncology2022-02-161 citations
Clinical Pharmacokinetics of the Androgen Receptor Inhibitor Darolutamide in Healthy Subjects and Patients with Hepatic or Renal Impairment
Clinical Pharmacokinetics2021-12-0613 citations
ODENZA: A French prospective, randomized, open-label, multicenter, cross-over phase II trial of preference between darolutamide and enzalutamide in men with asymptomatic or mildly symptomatic metastatic castrate-resistant prostate cancer (CRPC).
Journal of Clinical Oncology2021-05-202 citations
ODENZA: A study of patient preference between ODM-201 (darolutamide) and enzalutamide in men with metastatic castrate-resistant prostate cancer (mCRPC).
Journal of Clinical Oncology2019-03-01
ODENZA: A study of patient preference between ODM-201 (darolutamide) and enzalutamide in men with metastatic castrate-resistant prostate cancer (mCRPC).
Journal of Clinical Oncology2018-05-202 citations
A phase 2 trial of darolutamide maintenance therapy in patients with metastatic castration resistant prostate cancer (mCRPC) previously treated with AR targeting agents and non-progressive on a subsequent taxane (SAKK 08/16).
Journal of Clinical Oncology2018-05-20
A phase 2 trial of ODM-201 maintenance therapy in patients with metastatic castration resistant prostate cancer (mCRPC) previously treated with a AR targeting agent and non-progressive on a second line taxane (SAKK 08/16).
Journal of Clinical Oncology2018-02-203 citations
Intergroup study EORTC-1532-gucg: A phase 2 randomized open-label study of oral darolutamide (ODM-201) vs. androgen deprivation therapy (ADT) with LHRH agonists or antagonist in men with hormone naive prostate cancer (PCa).
Journal of Clinical Oncology2018-02-202 citations
Safety and Antitumour Activity of ODM-201 (BAY-1841788) in Castration-resistant, CYP17 Inhibitor-naïve Prostate Cancer: Results from Extended Follow-up of the ARADES Trial
European Urology Focus2017-02-2720 citations
Safety and Antitumour Activity of ODM-201 (BAY-1841788) in Chemotherapy-naïve and CYP17 Inhibitor-naïve Patients: Follow-up from the ARADES and ARAFOR Trials.
2017-02-1425 citations
PD32-08 SYNERGISTIC ANTICANCER EFFECT OF COMBINATION TREATMENT WITH MEK INHIBITOR AND PI3K /MTOR DUAL INHIBITOR IN CASTRATION-RESISTANT PROSTATE CANCER IN VIVO AND EX VIVO
The Journal of Urology2016-03-282 citations
PD32-06 LONG-TERM SAFETY AND ANTITUMOR ACTIVITY OF ODM-201 IN CHEMOTHERAPY AND CYP17-INHIBITOR NAÏVE PATIENTS FROM THE ARADES AND THE ARAFOR TRIALS
The Journal of Urology2016-03-28
Activity and safety of ODM-201 in patients with progressive metastatic castration-resistant prostate cancer (ARADES): an open-label phase 1 dose-escalation and randomised phase 2 dose expansion trial.
2014-06-25143 citations
Bone and soft tissue response from a phase I/II study with ODM-201 in metastatic castration-resistant prostate cancer (mCRPC).
Journal of Clinical Oncology2014-02-016 citations