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Clinical Trials/EUCTR2020-000775-20-DE
EUCTR2020-000775-20-DE
Active, not recruiting
Phase 1

A phase II study evaluating reduced starting dose and dose escalation of Cabozantinib as second-line therapy for advanced HCC in patients with preserved liver function

Frankfurter Institut für Klinische Krebsforschung IKF GmbH am Krankenhaus Nordwest0 sites40 target enrollmentApril 27, 2020
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ConditionsAdvanced stage hepatocellular carcinoma (HCC) patients with preserved liver function in second line therapyTherapeutic area: Diseases [C] - Cancer [C04]
DrugsCabometyx

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Advanced stage hepatocellular carcinoma (HCC) patients with preserved liver function in second line therapy
Sponsor
Frankfurter Institut für Klinische Krebsforschung IKF GmbH am Krankenhaus Nordwest
Enrollment
40
Status
Active, not recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 27, 2020
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Frankfurter Institut für Klinische Krebsforschung IKF GmbH am Krankenhaus Nordwest

Eligibility Criteria

Inclusion Criteria

  • •1\.Fully\-informed written consent.
  • •2\.Males and females \= 18 years of age.
  • •\*There are no data that indicate special gender distribution. Therefore, patients will be enrolled in the study gender\-independently.
  • •3\.Patients with HCC who have been previously treated with any first line therapy.
  • •4\.Locally advanced or metastatic and/or unresectable HCC with preserved liver function (Child\-Pugh A only, if liver cirrhosis is present) with diagnosis confirmed by histology/cytology or clinically by guideline criteria.
  • •5\.Disease that is not amenable to curative surgical and/or locoregional therapies, or progressive disease after surgical and/or locoregional therapies.
  • •6\. Resolution of any acute, clinically significant treatment\-related toxicity from prior therapy to Grade 1 prior to study entry, with the exception of alopecia.
  • •7\. ECOG performance status \= 2\.
  • •8\.Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of study treatment.
  • •9\.For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods from the time of signing the informed consent through at least 4 months after the last dose of study drug, or agree to completely abstain from heterosexual intercourse.

Exclusion Criteria

  • •1\.Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within at least 4 months.
  • •2\.Significant portal hypertension (moderate or severe ascites). Significant hypertension, defined as blood pressure \= 140 mmHg (systolic) or \= 90 mmHg (diastolic) in repeated measurements.
  • •3\.Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
  • •4\.Patients with impaired liver function defined as Child\-Pugh B or C, if liver cirrhosis is present.
  • •5\.Severely impaired kindey function (defined as creatinine \> 2mg/dl and/or creatinine clearance \< 45 ml/min).
  • •6\. Elevations of AST/ALT \> 5 x ULN at baseline.
  • •7\.Presence of encephalopathy in past 12 months.
  • •8\.Significant cardiovascular disease (such as NYHA Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina.
  • •9\.Baseline QTcF \> 500 ms.
  • •10\.Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study.

Outcomes

Primary Outcomes

Not specified

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