Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/EUCTR2020-000775-20-DE
EUCTR2020-000775-20-DEActive, not recruitingPhase 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 enrollmentStarted: April 27, 2020Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Enrollment
40
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

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.
  • •Male patients, even if surgically sterilized (i.e. status post-vasectomy) must agree to practice effective barrier contraception (e.g. condom) and to refrain from sperm donation during the entire study treatment period and through at least 4 months after the last dose of study drug or agree to completely abstain from heterosexual intercourse.
  • •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 20
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 20

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.
  • •11.Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia.
  • •12.Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications.
  • •13.Treatment with investigational systemic therapy within 28 days
  • •or five times the elimination half-life of the investigational product, whichever is longer, prior to initiation of study treatment.
  • •14.Prior cabozantinib use.
  • •15.Known or suspected hypersensitivity to cabozantinib or any other excipients of the IMP.
  • •16. Rare hereditary galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.
  • •17. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
  • •18.Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities § 40 Abs. 1 S. 3 Nr. 4 AMG.
  • •19.Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts [§ 40 Abs. 1 S. 3 Nr. 3a AMG].

Investigators

Sponsor
Frankfurter Institut für Klinische Krebsforschung IKF GmbH am Krankenhaus Nordwest

Similar Trials

Recruiting
Not Applicable
A phase II study of the dose reduction and shortening of duration of immunosuppressant after HLA-haploidentical transplantation with post-transplantation cyclophosphamide following reduced-intensity conditioninghematologic malignancies
JPRN-UMIN000026002JSCT55
Recruiting
Not Applicable
A phase II study of the dose reduction and shortening of duration of immunosuppressant after HLA-haploloidentical transplantation with post-transplantation cyclophosphamide following myeloablative conditioninghematologic malignancies
JPRN-UMIN000026001JSCT42
Recruiting
Phase 1
A phase 1/2, dose and schedule evaluation study to investigate the safety and clinical activity of belantamab mafodotin administered in combination with lenalidomide, dexamethasone and nirogacestat in patients with transplant ineligible newly diagnosed multiple myelomaewly diagnosed patients with multiple myelomaMedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864
EUCTR2022-001942-39-GRHellenic Society of Hematology (EAE)36
Active, not recruiting
Phase 1
Belantamab Mafodotin in combination with Lenalidomide and Dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who transplant ineligible.
EUCTR2020-005826-27-GRHellenic Society of Hematology (EAE)66
Active, not recruiting
Phase 1
Belantamab Mafodotin in combination with Daratumumab, Lenalidomide and Dexamethasone for the treatment of patients with newly diagnosed multiple myeloma transplant ineligible.newly diagnosed multiple myelomaMedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864
EUCTR2021-006792-42-GRHellenic Society of Hematology (EAE)36