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.

Phase 2

Completed

• Conditions: hepatocellular carcinoma; liver cancer; 10019815

• Registration Number: NL-OMON39531
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 1

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

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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint is time to progression.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secundary endpoins are:<br /><br>-safety of BIBF 1120<br /><br>-Dose Limiting Toxicities<br /><br>-Pharmacokinetics<br /><br>-objective RECIST 1.0 tumor response<br /><br>-Overall survival</p><br>