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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-004469-10 | EudraCT Number |
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| Name | Class |
|---|---|
| Astellas Pharma Inc | INDUSTRY |
| Apices Soluciones S.L. | INDUSTRY |
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The good tolerability profile of enzalutamide, the fact that the administration of steroids is not necessary and the impressive results achieved in prostate cancer, make this drug an ideal candidate to be tested in ovarian granulosa cancer, a tumor that could somehow be considered as "female prostate cancer".
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enzalutamide | Experimental | Enzalutamide 160 mg daily p.o. (4 capsules 40mg per day) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enzalutamide 40 MG | Drug | Enzalutamide 160 mg p.o. every day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | Number of responses according to RECIST 1.1 criteria | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical benefit rate | Stabilization of disease plus the sum of partial and complete responses according to RECIST 1.1 criteria. | Up to 6 months |
| Progression-free survival (PFS) | Number of progression of the disease according to RECIST 1.1 criteria or death of the patient for any cause |
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Inclusion Criteria:
Exclusion Criteria:
Due to kind of disease only female patients are acceptable for the trial
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| Name | Affiliation | Role |
|---|---|---|
| Garcia-Donas, MD | CIOCC (Hospital Universitario HM Sanchinarro) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Mar | Barcelona | Spain | ||||
| Hospital Reina Sofia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39454227 | Derived | Garcia-Donas J, Redondo A, Santaballa A, Garrigos L, Rubio MJ, Lainez N, Gonzalez MI, Cueva JF, Barquin A, Grazioso TP, Hurtado A, Sevillano E, Grande E, Rodriguez-Moreno JF, Navarro P. Phase II clinical trial assessing the efficacy of enzalutamide in advanced non-resectable granulosa cell ovarian tumors: The GREKO III study (GETHI2016-01). Gynecol Oncol. 2024 Dec;191:233-239. doi: 10.1016/j.ygyno.2024.10.019. Epub 2024 Oct 24. |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| C540278 | enzalutamide |
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| Up to 6 months |
| Overall survival (OS) | Number of deaths for any cause. | Up to 6 months |
| Incidence of Treatment-Emergent Adverse Events | Number of Adverse Events per patient | Up to 6 months |
| Córdoba |
| Spain |
| Hospital Madrid Sanchinarro (CIOCC) | Madrid | Spain |
| Hospital Universitario La Paz | Madrid | Spain |
| Hospital Son Llatzer | Palma de Mallorca | Spain |
| Hospital de Navarra | Pamplona | Spain |
| Complejo Hospitalario Universitario de Santiago | Santiago de Compostela | Spain |
| Hospital La Fe | Valencia | Spain |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |