Enzalutamide in Metastatic or Advanced Non-resectable Granulosa Cell Ovarian Tumors: GREKO III Study (NCT03464201) | Clinical Trial Compass
CompletedPhase 2
Enzalutamide in Metastatic or Advanced Non-resectable Granulosa Cell Ovarian Tumors: GREKO III Study
Spain16 participantsStarted 2018-04-13
Plain-language summary
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".
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria:
* Patients who have given written informed consent
* Women aged 18 years or over
* Eastern Cooperative Oncology Group (ECOG) ≤ 1
* Diagnosis of histologically confirmed ovarian granulose carcinoma
* Availability of sufficient biopsy material for confirmation of the diagnosis by a centralized pathologist and determination of the mutation FOXL2402C→ G(C134W). If this material is not available, principal investigator of the study will confirm eligibility of the patient.
* Metastatic or unresectable disease
* Radiologically measurable disease. In case you there is not measurable disease, principal investigator of the study will confirm eligibility of the patient. - - Life expectancy ≥ 12 weeks
* Patients with adequate hepatic function, defined by: Aspartate transaminase (AST) and alanine aminotransferase (ALT) serum values ≤ 3 x upper limit of normal (except in the presence of metastasis in which case values ≤ 5 x upper limit of normal will be allowed), Total bilirubin values ≤ 1,5 x upper limit of normal
* Patients with adequate bone marrow function, defined by: Absolute neutrophil count ≥ 1.5 x 109 / L, Platelets ≥100 x 109/L, Hemoglobin ≥ 9 g/dL
* Patients with adequate renal function: serum creatinine ≤ 1,5 x upper limit of normal
* Absence of any disability to follow the study protocol
* Women childbearing potential who are sexually active, not undergoing hysterectomy or double adnexectomy, should follow the following contraceptive indications: Negative …