EUCTR2009-011925-14-GB进行中（未招募）1 期
A multicenter, open label, phase I / II study to evaluate safety, pharmacokinetics and efficacy of BIBF 1120 in comparison with oral sorafenib for advanced hepatocellular carcinoma patients. - BIBF 1120 in HCC
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
- 170
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
入选标准
- •1. HCC, either histologically/cytologically confirmed diagnosis or clinically diagnosis by
- •AASLD criteria, which is not amenable to local therapy (RFA, PEI, RT, TACE)
- •2. Age 18 years or older
- •3. ECOG performance score of 2 or less
- •4. Child-Pugh score A (score 5-6)
- •5. At least one measurable lesion according to RECIST 1.0 (this criterion is limited to
- •phase II only)
- •6. In case a measurable lesion was previously treated by loco-regional therapy (RFA, PEI, TACE, or RT), this lesion must
- •have to be documented as progression according to RECIST 1.0 by CT or MRI (this criterion
- •is limited to phase II only)
- •7. Time interval from last local therapy more than 4 weeks prior to start of study
- •8. Written informed consent consistent with ICH-GCP and local legislation
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Prior systemic therapy for metastatic/unresectable HCC (for phase II)
- •2. More then one line of prior systemic therapy for metastatic/unresectable HCC (for
- •3. Fibrolamellar HCC
- •4. Uncontrolled or refractory ascites by adequate medical therapy
- •5. Bilirubin greater than 1.5 times ULN
- •6. AST or ALT greater than 2 times ULN
- •7. Hepatic encephalopathy more than grade 1 according to Child-Pugh criteria
- •8. Prothrombin time international normalized ratio greater than 2.3, or prothrombin
- •time more than 6 seconds prolonged than control
- •9. Absolute neutrophil count less than 1000/µL
- •10. Platelet count less than 60000/µL
- •11. Hemoglobin less than 9 g/dL
- •12. Serum creatinine greater than 1.5 times ULN
- •13. Proteinuria of CTCAE grade 2 or greater
- •14. Variceal bleeding within 6 months prior to start of study treatment
- •15. History of major thrombotic (except portal vein thrombosis) or clinically relevant
- •major bleeding event in the past 6 months
- •16. Known inherited predisposition to bleeding or thrombosis
- •17. Significant cardiovascular diseases (i.e. hypertension not controlled by medical
- •therapy (blood pressure > 150/90 mmHg), unstable angina, history of myocardial
- •infarction within the past 6 months, congestive heart failure > NYHA II, serious
- •cardiac arrhythmia, pericardial effusion)
- •18. Therapeutic anticoagulation (except low dose heparin and/or heparin flush as
- •needed for maintenance of an indwelling intravenous device) or antiplatelet
- •therapy (except for chronic low-dose therapy with acetylsalicylic acid = 325mg
- •19. Last administration of systemic treatment for HCC within 4 weeks prior to start
- •of study treatment or no recovery from any treatment related toxicity
- •20. Major surgery within 4 weeks prior to start of study treatment
- •21. Treatment with other investigational drugs concomitantly with this trial (except
- •for present trial drug)
- •22. Serious illness or concomitant non-oncological disease such as neurologic,
- •psychiatric, infectious disease or active ulcers (gastro-intestinal tract, skin) or
- •laboratory abnormality that may increase the risk associated with study
- •participation or study drug administration and in the judgment of the
- •investigator would make the patient inappropriate for entry into the study
- •23. Patients who are sexually active and unwilling to use a medically acceptable
- •method of contraception (e.g. such as implants, injectables, combined oral
- •contraceptives, some intrauterine devices or vasectomized partner for
- •participating females, condomes for participating males) during the trial and for
- •at least twelve months after end of active therapy
- •24. Current alcohol abuse or drug abuse that would limit patient ability to comply
- •with protocol
研究者
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