Clinical trial conducted in two parts: the first (phase I) to find out the safe dose of BIBF 1120 in the treatment of patients with liver cancer and the second part (phase II) to compare this dose of BIBF 1120 with Sorafenib in the treatment of hepatocellular carcinoma (liver cancer)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 132

Inclusion Criteria

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 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
treatment
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 52
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

Exclusion Criteria

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
phase I)
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
per day)
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
25. Symptomatic CNS metastasis
26. Life expectancy less than 12 weeks
27. Patient unable to take oral medication
28. Gastrointestinal disorders or abnormalities that would interfere with absorption
of the study drug
29. Pregnancy or breast feeding
30. Patient unable to comply with the protocol
31. Other malignancy within the past three years other than basal cell skin cancer,
or carcinoma in situ of the cervix
32. Hypersensitivity to active substance or to any of the excipients of both BIBF
1120 or sorafenib

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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