EUCTR2014-004283-37-ES进行中（未招募）1 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Studyto Assess the Efficacy and Safety of Enzalutamide in Subjectswith Advanced Hepatocellular Carcinoma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 165
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
- All
入选标准
- •Waivers to the inclusion and exclusion criteria will NOT be allowed.
- •1. Subject has consented and signed an Institutional Review Board (IRB)/Independent Ethics
- •Committee (IEC) approved written Informed Consent and privacy language as per national
- •regulations (e.g., Health Insurance Portability and Accountability Act [HIPAA] for U.S. sites)
- •prior to any study-related procedures (including withdrawal of prohibited medication, if
- •applicable).
- •2. Subject is ? 18 years of age.
- •3. Subject has histological diagnosis of advanced HCC of any etiology. Clinical diagnosis by the
- •European Association for the Study of the Liver (EASL) criteria is acceptable. For subjects
- •without cirrhosis, histological confirmation is required (archive samples are acceptable).
- •4. Subject has BCLC stage B or C.
- •5. Subject?s lesions are not amenable to local therapies which may be beneficial, such as
- •transarterial chemoembolization (TACE), radiofrequency ablation, etc., and the subject is not a
- •candidate for any curative treatments such as resection or liver transplant.
- •6. Subject has hepatic function status of Child Pugh Class A at Screening.
- •7. Subject received prior systemic treatment for HCC with sorafenib or other anti-VEGF therapy
- •and had confirmed disease progression or discontinued treatment due to a drug-related toxicity.
- •Subject may have received 1 line of systemic investigational therapy after sorafenib/anti-VEGF
- •8. Subject has adequately recovered from toxicities due to prior HCC therapy to ? grade 1.
- •9. Subject has an ECOG performance status ? 1 at Screening and on Day 1.
- •10. Subject has available formalin-fixed, paraffin-embedded tumor specimen that enabled the
- •diagnosis of HCC with adequate viable tumor cells in a tissue block (preferred) or ? 10
- •(20 preferred) unstained serial slides accompanied by an associated pathology report is required
- •prior to enrollment. Archival or fresh biopsy tissue is acceptable.
- •11. Subject has an estimated life expectancy of at least 3 months on Day 1, in the opinion of the
- •investigator
- •12. Female subject is either:
- •? Not of childbearing potential:
- •-postmenopausal (defined as no spontaneous menses for at least 12 consecutive months prior to Screening with follicle-stimulating hormone [FSH] > 40 IU/L for women < 55 years of age at Screening), or
- •-documented to be surgically sterile or status posthysterectomy (at least 1 month prior to
- •Screening).
- •? Or, if of childbearing potential:
- •- must have a negative urine pregnancy test at Screening and on Day 1 before the first dose of study drug is administered, and
- •- must use 2 acceptable methods of birth control* from Screening through 3 months after the last dose of study drug.
- •13. Male subject and his female partner who is of childbearing potential must use 2 acceptable
- •methods of birth control from Screening through 3 months after the last dose of study drug.
- •*Two acceptable methods of birth control are as follows:
- •? Condom (barrier method of contraception);
- •? One of the following is required:
- •- Placement of an intrauterine device (IUD) or intrauterine system (IUS) by the female subject or female partner of a male subject;
- •- Additional barrier method: contraceptive sponge or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository by the female subject or female partner of a male subject.
- •- For male subject or male partner of female subject, vasectomy or other procedure resulting in infertility (e.g., bilateral orchiectomy)
排除标准
- •1. Subject has a severe concurrent disease, infection or comorbidity that, in the judgment of the
- •investigator, would make the subject inappropriate for enrollment.
- •2. Subject has fibrolamellar variant of HCC.
- •3. Subject has status of Child-Pugh Class B or C at Screening.
- •4. Subject has a history of organ allograft including liver transplant.
- •5. Subject has uncontrolled symptomatic ascites.
- •6. Subject has known or suspected brain metastasis or active leptomeningeal disease.
- •7. Subject has a history of a non-HCC malignancy with the following exceptions:
- •-The subject with a previous history of a noninvasive carcinoma is eligible if in the opinion of
- •the investigator he/she has had successful curative treatment any time prior to Screening and
- •requires no further therapy for the malignancy.
- •-For all other malignancies, the subject is eligible if he/she has undergone potentially curative
- •therapy and has been considered disease free for at least 3 years prior to Screening.
- •8. Subject has inadequate marrow, hepatic, and/or renal function at the Screening Visit defined as:
- •-Absolute neutrophil count < 1.5 x109/L (< 1500 cells/mm3)
- •-Platelet count < 50 x109/L (< 50,000 cells/mm3)
- •-Hemoglobin < 8.5 g/dL (< 5.3 mmol/L)
- •-International normalized ratio > 1.7
- •-Albumin < 2.8 g/dL (< 28 g/L)
- •-Total bilirubin > 2 x ULN
- •-AST or ALT > 5 x ULN
- •-Creatinine > 1.5 x ULN
- •9. Subject has a history of seizure or any condition that may predispose to seizure (e.g., prior
- •cortical stroke, significant brain trauma, encephalopathy within 3 months of Day 1).
- •10. Subject has a history of esophageal varices within 3 months before the Day 1 visit.
- •11. Subject has a history of loss of consciousness or transient ischemic attack within 12 months
- •before the Day 1 visit.
- •12. Subject has clinically significant cardiovascular disease including:
- •-Myocardial infarction within 6 months before the Day 1 visit.
- •-Uncontrolled angina within 6 months before the Day 1 visit.
- •-Congestive heart failure New York Heart Association (NYHA) Class III or IV or history of
- •congestive heart failure NYHA Class III or IV in the past, unless a Screening echocardiogram
- •or multi-gated acquisition scan performed within 3 months before the Day 1 visit reveals a
- •left ventricular ejection fraction that is ? 45%.
- •- History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, Torsade de Pointes).
- •-History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place.
- •- Hypotension as indicated by systolic blood pressure < 86 mmHg on 2 consecutive measurements at the Screening visit.
- •-Bradycardia (in the presence of known cardiovascular disease) as indicated by a heart rate of
- •< 50 beats per minute on the Screening electrocardiogram (ECG) recording.
- •-Uncontrolled hypertension as indicated by systolic blood pressure > 170 mmHg or diastolic blood pressure > 105 mmHg on 2 consecutive measurements at the Screening visit.
- •13. Subject has a gastrointestinal disorder affecting absorption.
- •14. Subject had previous local therapy (e.g., surgery, radiation therapy, hepatic arterial therapy,
- •chemoembolization, radiofrequency ablation, percutaneous ethanol injection or cryoablation)
- •within 14 days prior to Day 1, has not recovered from toxicities from prior local therapy or may
- •require major surgical procedure during the course of the study.
- •15. Subject has received chemotherapy, immunotherapy or any other systemic anticancer therapy
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