drugset / Trial / NCT01553656

Dose-Finding Study of Cabozantinib (XL184) in Japanese Subjects With Advanced Cancer

NCT01553656

Phase 1 Completed 85 enrolled Exelixis
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the safety profile, tolerability, pharmacokinetics (PK), pharmacodynamics, pharmacogenomic (PGX) and preliminary efficacy following daily oral doses of cabozantinib (XL184) in Japanese patients with advanced or metastatic solid tumors. Also, the effect of XL184 in the treatment of non-small cell lung cancer (NSCLC) patients with various activating mutations will be evaluated at the recommended Phase 2 dose.

Timeline

Start
2011-02
Primary completion
2015-05
Completion
2015-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Cabozantinib Small molecule 20 mg Oral
Subject Cabozantinib Small molecule 25 mg Oral
Subject Cabozantinib Small molecule 60 mg Oral
Subject Cabozantinib Small molecule 100 mg Oral