TRIAL DETAIL

Ph II CABOGIST in GIST

Drug:
Trial Name:
Ph II CABOGIST in GIST
NCT#:
Conditions:
Gastrointestinal Stromal Tumor
Status:
Active, not recruiting
Phase:
2
Start Date 02/02/2017
Age of Trial (yrs) 7.3
Treatment Phase:
Gleevec-resistant
Drug Category:
KIT/PDGFRA inhibitor + MET/VEGF inhibitor
Strategy:
Block KIT + Block related tumor signal paths
Trial Type:
Specifically GIST and only GIST
Other Protocol IDs:
EORTC-1317, 2014-000501-13
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Patient Contact:
Sents +3227741533 ward.sents@eortc.be
Contact email:
Contact Phone:
Randomized:
IV or Oral:
Oral
Trial Notes:
The study is a multi-center, multi-national, open label, single arm Phase II study of single-agent cabozantinib. The objective of the study is to assess the safety and activity of cabozantinib in patients with metastatic GIST who have previously progressed on imatinib and sunitinib and have not been exposed yet to other KIT- or PDGFR-directed tyrosine kinase inhibitors.

Patient will receive cabozantinib until they experience no further benefit from the treatment, becoming intolerant to the drug or wishing to discontinue the treatment. Treatment beyond RECIST 1.1 progression is allowed in patients deriving clinical benefit upon investigator's discretion, provided no other criteria for treatment withdrawal are met.

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
Herestraat 49
Leuven
Belgium
229 Cours Argonne
Bordeaux
Gironde
33076
France
28 rue Laennec
Lyon
Rhone
69373
France
Villejuif
Val de Narne
94805
France
London
NW1 2PG
UK
550 Wilmslow Rd
Manchester
Lancashire
M20 4BX
UK
197 Fulham Rd.
London
SW3 6JJ
UK
Prague
Czechia
Mannheim
Germany
Budapest
Hungary
Bebington
UK