Efficacy and Safety of Cabozantinib in Patients With Hepatocellular Carcinoma

Sponsor
Istituto Clinico Humanitas
Study ID
NCT04435977
Phase
PHASE2
Status
Unknown

Conditions

  • Hepatocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Cabozantinib 60 MG — DRUG
    • The assigned dose for study treatment is 60 mg qd. Two dose reductions will be permitted (Table 2): * 60 mg qd to 40 mg qd (level 1) * 40 mg qd to 20 mg qd (level 2)

Study Details

This is an open-label, single-center, Phase II trial designed to estimate in terms of PFS the efficacy of cabozantinib, given as second- or third- line treatment in HCC patients that progress on or are intolerant to immune checkpoint inhibitors, including anti-PD-1 and anti-PD-L1 antibodies.

Key Dates

Start date
Jan 30, 2020
Status verified
Jun 2020
Primary completion
Jun 30, 2023
Completion
Sep 30, 2023

Study Design

Enrollment
46 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cabozantinib
    Drug: Cabozantinib Subjects who meet all study eligibility criteria will take tablets containing 60 mg of cabozantinib once daily orally. Required dose reductions will be in decrements of 20 mg cabozantinib (maximum two dose reductions).

Primary Outcome Measure

PFS [ Time Frame: through study completion, an average of 1 year ]

Central Contacts