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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
85
cabozantinib capsules administered as 25-mg and 100-mg strengths once-daily until disease progression
cabozantinib tablets administered as 20-mg and 60-mg strengths once-daily until disease progression
The Cancer Institute Hospital of the Japanese Foundation for Cancer Research (JFCR)
Ariake, Koto, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose
To establish the MTD and recommended Phase 2 dose (or dose range as appropriate) of XL184 when administered orally on a once daily schedule in subjects with advanced or metastatic solid tumors.
Time frame: Assessed in the clinic on Days 1 through 29
Safety and tolerability of XL184
Safety and tolerability of multiple doses of XL184 administered orally on a daily basis. Assessed from informed consent until at least 30 days after discontinuation.
Time frame: From study start to October 2014
Plasma Pharmacokinetics
Assess plasma pharmacokinetics of daily oral administration of XL184 from Treatment Day 1 to Day 29.
Time frame: Assessed in the clinic from Day 1 through Day 29
Tumor response (preliminary anti-tumor activity)
Assess tumor response after repeated administration of XL184 from screening until discontinuation. Assessed as best overall response by cohort by radiological response defined by RECIST criteria.
Time frame: Study start to October 2014
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