Advanced ovarian granulosa unresectable or metastatic tumor MedDRA version: 20.0 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Xtandi
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: ENZALUTAMIDE
CAS Number: 915087-33-1
Current Sponsor code: ENZALUTAMIDE
Other descriptive name: ENZALUTAMIDE
Concentration un
Sponsors
Grupo Español de Tumores Huérfanos e Infrecuentes (GETHI)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who have given written informed consent 2. Women aged 18 years or over 3. ECOG = 1 4. Diagnosis of histologically confirmed ovarian granulosa carcinoma. 5. 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. 6. Metastatic or unresectable disease 7. Radiologically measurable disease. In case you there is not measurable disease, principal investigator of the study will confirm eligibility of the patient. 8. Life expectancy = 12 weeks. 9. Patients with adequate hepatic function, defined by: - AST and ALT serum values ??= 3 x ULN (except in the presence of metastasis in which case values ??= 5 x ULN will be allowed) - Total bilirubin values ??=1,5 ??x ULN 10. Patients with adequate bone marrow function, defined by: - Absolute neutrophil count =1.5 x 109 / L - Platetets =100 x 109/L, - Hemoglobine =9 g/dL. 11. Patients with adequate renal function: serum creatinine =1,5 x LSN 12. Absence of any disability to follow the study protocol. 13. Women childbearing potential who are sexually active, not undergoing hysterectomy or double adnexectomy, should follow the following contraceptive indications: - Negative Pregnancy Test in serum or urine in the 72 hours before the start of treatment. - Use of a medically accepted method of contraception during: 2 months prior to the start of study treatment, during the study and up to 3 months after the last dose of treatment. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 34 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1
Exclusion criteria
Exclusion criteria: 1. Patients with another primary tumor 2 years before beginning the drug under study, with the exception of adequetely treated or totally surgically removed cervical carcinoma in-situ or basaliome or superficial bladder carcinoma. 2. Patients who have received radical radiotherapy = 4 weeks prior to the start of study treatment or who have not recovered from toxicities of radiotherapy. Palliative radiation therapy for painful bone lesions bone is allowed up to 14 days prior to the beginning of the study treatment 3. History of seizures or any conditions that may predispose to suffer them. 4. Current or previously treated brain metastases or disease leptomeningea. 5. Patients with cardiac insufficiency or heart disease clinically significant ncluding any of the following: - History or presence of uncontrolled severe ventricular arrhythmias. - Clinically significant resting bradycardia. - Any of the following diseases within 6 months prior to the start of the study drug Myocardial infarction (MI), severe or unstable angina, coronary revascularization, congestive cardiac insufficiency (CCI), cerebrovascular accident (CVA), transient ischemic accident (TIA) 6. Patients with altered gastrointestinal function or with gstric disease that significantly alters the absorption of enzalutamide, such as for example: severe ulcer diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, extensive resection (> 1m) of the small bowel or inability to swallow oral medication. The previous partial or total gastrectomy is not an exclusion criterion. 7. Diagnosis of human immunodeficiency virus (HIV) infection. 8. Pregnant or lactating women. 9. Women of childbearing potential not using an effective contraceptive method. 10. Patients who do not want or can follow the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of enzalutamide in advanced ovarian granulosa unresectable or metastatic tumor by the overall response rate (ORR), defined as the percentage of patients achieving partial or complete response according to RECIST 1.1 criteria, by means of radiological evaluation.;Secondary Objective: - To evaluate the clinical benefit rate, defined as the stabilization of disease for at least 6 months, plus the sum of partial and complete responses according to RECIST 1.1 criteria, by means of radiological evaluation. - To evaluate progression-free survival (PFS), defined as time from the administration of the first dose of treatment to the progression of the disease according to RECIST 1.1 criteria or death of the patient for any cause. - To evaluate overall survival (OS), defined as the time since the administration of the first dose of treatment until the death of the patient for any cause. - To determine the toxicity profile of enzalutamide in the population of the study.;Primary end point(s): Overall Rate Response (ORR);Timepoint(s) of evaluation of this end point: Achivement of partial or complete response according to RECIST 1.1 criteria, by means of radiological evaluation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Clinical Benefit Rate - Progression Free Survival (PFS) - Overall Survival (OS) - Toxicity to Enzalutamide ;Timepoint(s) of evaluation of this end point: - Clinical Benefit Rate, achivement of stabilization of the disease during at least 6 months and achievement of both partial and complete responses - Progression Free Survival (PFS), achivement of progression diseases since first administration of the study drug - Overall Survival (OS), achivement of the death of the patient for any cause since first administration of the study drug - Toxicity to Enzalutamide, since first administration of the study drug until the end of the study treatment. | — |
Countries
Spain
Contacts
Public ContactClinical Operations Department
APICES SOLUCIONES S.L.
Outcome results
None listed