Dose Escalation Study of Cabozantinib for Advanced HCC Patients With Preserved Liver Function

Sponsor
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Study ID
NCT04522908
Phase
PHASE2
Status
Completed

Conditions

  • Hepatocellular Carcinoma (HCC)
  • Second Line Treatment

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cabozantinib Oral Tablet — DRUG
    Cabozantinib starting dose of 40 mg, oral, once daily for 4 weeks followed by Cabozantinib escalated dose of 60 mg, oral, once daily from week 5 onwards

Study Details

Open-label, single arm, multicenter phase II trial assessing the tolerability of a reduced starting dose of 40 mg cabozantinib for 4 weeks and subsequent dose escalation to 60 mg cabozantinib until disease progression or intolerable toxicities.

Key Dates

Start date
Oct 12, 2020
Status verified
Jan 2025
Primary completion
Oct 4, 2024
Completion
Oct 4, 2024

Study Design

Enrollment
40 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cabozantinib - Single Arm
    Single Arm with Cabozantinib starting dose 40 mg for 4 weeks and dose escalation to 60 mg afterwards.

Primary Outcome Measure

Treatment discontinuation rate due to treatment-related adverse events [ Time Frame: 27 months ]

Related Studies