Therapy Detail
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| Therapy Name | Darolutamide |
| Synonyms | |
| Therapy Description |
Nubeqa (darolutamide) is an androgen receptor antagonist that binds to and prevents nuclear translocation of the androgen receptor, thereby inhibiting expression of genes downstream of androgen receptor signaling that regulate proliferation of prostate cancer cells (PMID: 28490267). Nubeqa (darolutamide) is FDA approved for use in patients with non-metastatic castration-resistant prostate cancer (FDA.gov). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Darolutamide | Nubeqa | BAY1841788|ODM-201 | Hormone - Anti-androgens 29 | Nubeqa (darolutamide) is an androgen receptor antagonist that binds to and prevents nuclear translocation of the androgen receptor, thereby inhibiting expression of genes downstream of androgen receptor signaling that regulate proliferation of prostate cancer cells (PMID: 28490267). Nubeqa (darolutamide) is FDA approved for use in patients with non-metastatic castration-resistant prostate cancer (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| Unknown unknown | prostate cancer | not applicable | Darolutamide | FDA approved | Actionable | In a Phase III trial (ARAMIS) that supported FDA approval, treatment with Nubeqa (darolutamide) resulted in improved median metastasis-free survival (40.4 vs 18.4 months, HR=0.41, p<0.001), overall survival (HR=0.71, 95% CI, 0.5-0.99, p=0.045), and time to pain progression (40.3 vs 25.4 months, HR=0.65, p<0.001) compared to placebo in non-metastatic castration-resistant prostate cancer patients (PMID: 30763142; NCT02200614). | detail... 30763142 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT04157088 | Phase II | Enzalutamide Darolutamide | Study to Compare the Effects of Drug Darolutamide and Drug Enzalutamide on Physical Function, Including Balance and Daily Activity, in Patients With Castration-resistant Prostate Cancer (CRPC) (DaroAcT) | Recruiting | USA | 0 |
| NCT04237584 | Phase III | Darolutamide Darolutamide + Radium Ra 223 dichloride Enzalutamide Enzalutamide + Radium Ra 223 dichloride | A Study Comparing ARB With Radium-223 vs ARB Therapy With Placebo and the Effect Upon Survival for mCRPC Patients (ESCALATE) | Recruiting | USA | 0 |
| NCT03004534 | Phase 0 | Darolutamide | A Study to Evaluate Changes in Human Breast Cancer Tissue Following Short-Term Use of ODM-201 | Completed | USA | CAN | 1 |
| NCT04736199 | Phase III | Darolutamide | Darolutamide in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer (ARANOTE) | Not yet recruiting | CAN | 15 |
| NCT04070209 | Phase II | Darolutamide | Management of Oligoprogressive Castration Resistant Prostate Cancer (PCS X) | Recruiting | CAN | 0 |
| NCT04464226 | Phase III | Darolutamide | Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer | Recruiting | USA | CAN | 32 |
| NCT04335682 | Phase II | Darolutamide Enzalutamide | Androgen Receptor Directed Therapy on Cognitive Function in Patients Treated With Darolutamide or Enzalutamide | Not yet recruiting | USA | 0 |
| NCT02200614 | Phase III | Darolutamide | Efficacy and Safety Study of ODM-201 in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer | Active, not recruiting | USA | CAN | 34 |
| NCT04025372 | Phase II | Bicalutamide Darolutamide | INTREPId (INTermediate Risk Erection PreservatIon Trial) | Recruiting | USA | 0 |
| NCT02799602 | Phase III | Darolutamide Darolutamide + Docetaxel | ODM-201 in Addition to Standard ADT and Docetaxel in Metastatic Castration Sensitive Prostate Cancer (ARASENS) | Active, not recruiting | USA | CAN | 21 |
| NCT03385655 | Phase II | Savolitinib Darolutamide Adavosertib | Prostate Cancer Biomarker Enrichment and Treatment Selection | Recruiting | CAN | 0 |
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