MedTrace Logo

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

NCT01553656 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2015-08-20

No results posted yet for this study

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.

Conditions

Interventions

DRUG

cabozantinib capsules

cabozantinib capsules administered as 25-mg and 100-mg strengths once-daily until disease progression

DRUG

cabozantinib tablets

cabozantinib tablets administered as 20-mg and 60-mg strengths once-daily until disease progression

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2015-05-31
Completion
2015-07-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01553656 on ClinicalTrials.gov