TRIAL DETAIL

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

Drug:
Trial Name:
Dose-Finding Study of Cabozantinib (XL184) in Japanese Subjects With Advanced Cancer
NCT#:
Conditions:
Solid Tumors
Status:
Ongoing, but not recruiting
Phase:
1
Start Date 02/01/2011
Age of Trial (yrs) 10.9
Treatment Phase:
Gleevec-resistant
Drug Category:
KIT/PDGFRA inhibitor + MET/VEGF inhibitor
Strategy:
Block KIT + Block related tumor signal paths
Trial Type:
GIST not specified. GIST patients known to be enrolled.
Other Protocol IDs:
XL184-014
Sponsor:
Exelixis
Patient Contact:
Elelixis Clinical Trials 1-800-393-5494 Backup or International 1+650-837-7400
Contact email:
Contact Phone:
Randomized:
IV or Oral:
Oral
Trial Notes:
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.

Trial Links

Trial Results

 

Drug Information

XL-184, a MET, VEGFR-2 and RET kinase inhibitor for the treatment of thyroid cancer, glioblastoma multiforme and NSCLC
 
FDA news release - FDA approves Cometriq to treat rare type of thyroid cancer
 
Full prescribing information (you must click "Full Prescribing Information" button at the top of this page)
 
Pharmacological inhibition of KIT activates MET signaling in gastrointestinal stromal tumors. (full text PDF available)
 
Phase 1 results in Japanese patients - A PHASE 1 STUDY OF CABOZANTINIB IN JAPANESE PATIENTS WITH ADVANCED SOLID TUMORS: ANTI-TUMOR ACTIVITY IN NSCLC AND GIST
 
Clinical use of cabozantinib in the treatment of advanced kidney cancer: efficacy, safety, and patient selection
 
A novel tyrosine kinase switch is a mechanism of imatinib resistance in gastrointestinal stromal tumors
 
Cabozantinib is active against human GIST xenografts carrying different KIT mutations.
 
Repurposing cabozantinib to GISTs: Overcoming multiple imatinib-resistant cKIT mutations including gatekeeper and activation loop mutants in GISTs preclinical models
 

Trial Sites

Name
Address
City
State
Zip
Country
Chuo-ku
Tokyo
104-0045
Japan
Ariake
Koto
135-8550
Japan