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Ph II CABOGIST in GIST

NCT02216578 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2021-07-15

No results posted yet for this study

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

DRUG

cabozantinib

Oral

Sponsors & Collaborators

  • European Organisation for Research and Treatment of Cancer - EORTC

    lead NETWORK

Principal Investigators

  • Patrick Schöffski, MD · U.Z. Leuven -Campus Gasthuisberg, Leuven, Belgium

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-02
Primary Completion
2019-05-20
Completion
2021-02-23

Countries

  • Belgium
  • Czechia
  • France
  • Germany
  • Hungary
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT02216578 on ClinicalTrials.gov