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A Randomised Trial of Imatinib Alternating With Regorafenib Compared to Imatinib Alone for the First Line Treatment of Advanced Gastrointestinal Stromal Tumour (GIST)

NCT02365441 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2023-07-07

No results posted yet for this study

Summary

An open label randomised trial for adults with histologically confirmed measurable metastatic GIST who have received no other treatment for metastatic disease. The study aims to determine if an alternating regimen of imatinib and regorafenib has sufficient activity and safety in comparison to imatinib alone to warrant further evaluation as a first line treatment for metastatic GIST.

Conditions

  • Gastrointestinal Stromal Tumour

Interventions

DRUG

Regorafenib

DRUG

imatinib

Sponsors & Collaborators

  • European Organisation for Research and Treatment of Cancer - EORTC

    collaborator NETWORK

  • Scandinavian Sarcoma Group

    collaborator OTHER

  • Australasian Gastro-Intestinal Trials Group

    lead NETWORK

Principal Investigators

  • Heikki Joensuu, Professor · SSG

  • Desmond Yip, A/Professor · AGITG

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Australia
  • Finland
  • France
  • Netherlands
  • Norway
  • Singapore
  • Slovakia
  • Spain
  • Sweden
  • 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 NCT02365441 on ClinicalTrials.gov