A Phase 2 Study of Cabozantinib in Japanese Participants With Advanced Hepatocellular Carcinoma

Sponsor
Takeda
Study ID
NCT03586973
Phase
PHASE2
Status
Completed

Conditions

  • Advanced Hepatocellular Carcinoma

Eligibility Criteria

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

Interventions

Study Details

The purpose of this study is to evaluate the efficacy and safety of cabozantinib in Japanese participants with advanced hepatocellular carcinoma (HCC) who have received prior systemic anticancer therapy.

Key Dates

Start date
Aug 6, 2018
Status verified
Apr 2023
Primary completion
Jul 17, 2019
Completion
Jun 29, 2021

Study Design

Enrollment
34 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A: Cabozantinib 60 mg
    Participants who have received first/second line anticancer therapy with sorafenib were assigned to Cohort A and received cabozantinib 60 milligrams (mg), tablet, orally, once daily in the fasted state, up to approximately 2 years.
  • Experimental: Cohort B: Cabozantinib 60 mg
    Participants who did not receive first/second line anticancer therapy with sorafenib were assigned to Cohort B and received cabozantinib 60 mg, tablet orally, once daily in the fasted state, up to approximately 2 years.

Primary Outcome Measure

24-Week Progression-Free Survival Rate (PFSR) [ Time Frame: Week 25 Day 1 plus 7 days ]

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