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临床试验/EUCTR2014-004283-37-ES
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

Astellas Pharma Global Development, Inc.0 个研究点目标入组 165 人开始时间: 2015年10月22日最近更新:
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试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
165
研究概览入排标准研究者记录与标识符相似试验

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

研究者

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