CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 35 enrolled
Drug / intervention
Cabozantinibdrug
Likely dose
Not stated in record
Key inclusion· 7
  • ✓Japanese male or female participants ≥20 years old
  • ✓Histologically or cytologically confirmed renal cell carcinoma with clear-cell component
  • ✓Measurable disease by RECIST 1.1
  • ✓Prior treatment with at least one VEGFR-targeting TKI (sorafenib, sunitinib, axitinib, pazopanib, or tivozanib)
Key exclusion· 5
  • ✕Prior treatment with everolimus or other mTORC1/PI3K/AKT inhibitor (e.g., temsirolimus)
  • ✕Prior cabozantinib treatment
  • ✕Any kinase inhibitor (including investigational) within 14 days of study start
  • ✕Any anticancer antibody (including investigational) within 28 days of study start

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03339219
NCT03339219Phase 2Completed
CompareCT.gov

A Phase 2, Open-Label, Single-Arm Study of Cabozantinib in Japanese Patients With Advanced Renal Cell Carcinoma That Has Progressed After Prior VEGFR Tyrosine Kinase Inhibitor Therapy

Takeda·interventional·Posted Nov 13, 2017·Updated Sep 20, 2021

In Brief

A Phase 2 clinical trial evaluating Cabozantinib for Advanced Renal Cell Carcinoma. Completed, enrolled 35 participants across 19 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Renal Cell Carcinoma
CountriesJapan
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedNov 13, 2017
Enrollment StartDec 13, 2017
Primary CompletionAug 25, 2020
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 8.6 years ago

Interventions

Cabozantinibdrug

Cabozantinib tablets