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

Sponsor
Exelixis
Study ID
NCT01553656
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • cabozantinib capsules — DRUG
    cabozantinib capsules administered as 25-mg and 100-mg strengths once-daily until disease progression
  • cabozantinib tablets — DRUG
    cabozantinib tablets administered as 20-mg and 60-mg strengths once-daily until disease progression

Study Details

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.

Key Dates

Start date
Feb 28, 2011
Status verified
Aug 2015
Primary completion
May 31, 2015
Completion
Jul 31, 2015

Study Design

Enrollment
85 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cabozantinib capsules and tablets
    Subjects will be enrolled in cohorts at different dose levels in order to determine the maximum tolerated dose of cabozantinib. Initially, subjects enrolled will receive the capsule formulation; other subjects will receive the tablet formulation.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose [ Time Frame: Assessed in the clinic on Days 1 through 29 ]

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