EUCTR2015-004469-10-ES进行中（未招募）1 期
Open label phase II clinical trial of enzalutamide in metastatic or advanced non-resectable granulosa cell ovarian tumors. GreKo III study. - GREKO III
Grupo Español de Tumores Huérfanos e Infrecuentes (GETHI)0 个研究点目标入组 35 人开始时间: 2017年12月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 35
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •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
排除标准
- •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.
研究者
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