Phase I/II comparison of efficacy and safety of BBF 1120 and sorafenib in patients with advanced hepatocellular carcinoma

Phase 1

• Conditions: Histologically or cytologically confirmed hepatocellular carcinoma not amenable to local therapy with adequate renal, hematological and liver paramenters with Child-Pugh score 7 or less, in 1st line systemic therapy. Note for phase II only liver function group I patients with Child Pugh A will be enrolled; Therapeutic area: Diseases [C] - Cancer [C04]; MedDRA version: 16.1 Level: LLT Classification code 10049010 Term: Carcinoma hepatocellular System Organ Class: 100000004864

• Registration Number: EUCTR2009-011925-14-GB
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-07-23
• Study Completion: 2016-10-12
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 170

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified