NCT02216578

Ph II CABOGIST in GIST

Phase II Study of Cabozantinib in Patients With Gastrointestinal Stromal Tumor (GIST) Who Progressed During Neoadjuvant, Adjuvant or Palliative Therapy With Imatinib and Sunitinib

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Metastatic Gastrointestinal Stromal Tumor

Interventions

Type	Name	Description
DRUG	cabozantinib	Oral

Timeline

• Start date: 2017-02-02
• Primary completion: 2019-05-20
• Completion: 2021-02-23
• First posted: 2014-08-15
• Last updated: 2021-07-15

Locations

11 sites across 6 countries: Belgium, Czechia, France, Germany, Hungary, United Kingdom