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

Sponsor
Takeda
Study ID
NCT03339219
Phase
PHASE2
Status
Completed

Conditions

  • Advanced Renal Cell 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 of cabozantinib measured by Independent Radiology Committee (IRC)-assessed objective response rate (ORR) in Japanese participants with advanced renal cell carcinoma (RCC) that has progressed after prior vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) therapy.

Key Dates

Start date
Dec 13, 2017
Status verified
Aug 2021
Primary completion
Aug 25, 2020
Completion
Aug 25, 2020

Study Design

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

Arms

  • Experimental: Cabozantinib 60 mg
    Cabozantinib 60 mg, tablet, orally, once daily (QD) in the fasted state until unacceptable toxicity or need for subsequent systemic anticancer treatment up to 2.5 years.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: From first dose of study drug up to first documentation of CR or PR (up to 2.5 years) ]

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