EUCTR2009-011925-14-AT
Active, not recruiting
Phase 1
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
ConditionsHistologically or cytologically confirmed hepatocellular carcinoma not amenable to local therapy with adequate renal, hematological and liver paramenters with Child-Pugh score 5-6, in 1st line systemic therapy.Therapeutic area: Diseases [C] - Cancer [C04]
DrugsNexavar
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Histologically or cytologically confirmed hepatocellular carcinoma not amenable to local therapy with adequate renal, hematological and liver paramenters with Child-Pugh score 5-6, in 1st line systemic therapy.
- Sponsor
- Boehringer Ingelheim RCV GmbH & Co. KG
- Enrollment
- 132
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
- •8\. Written informed consent consistent with ICH\-GCP and local legislation
- •Are the trial subjects under 18? no
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
- •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
Outcomes
Primary Outcomes
Not specified
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