Regorafenib in metastatic/unresectable KIT/PDGFR Wild Type GIST (REGISTRI)

This study evaluates the treatment with regorafenib in patients with metastatic and/or unresectable KIT/PDGFR wild type GIST in the first line setting.

Trial name REGISTRI
Agents: Regorafenib
Phase II
Status Open, recruiting
Sponsor Grupo Espanol de Investigacion en Sarcomas (Collaborator: Bayer)

Single Agent Regorafenib in First-line for Metastatic/Unresectable KIT/PDGFR Wild Type GIST (REGISTRI)

Further information:

WHO is the trial for?

  • Adult patients with histologically confirmed KIT/PDGFR wild-type, unresectable or metastatic GIST, mutational screening done in exon 11, 9, 13 and 17 in KIT gene and in 12 and 18 exons of PDGFR gene
  • No prior tyrosine kinase inhibitor (TKI) for metastatic disease. Exception: Imatinib therapy given as an adjuvant treatment and relapse after a minimum of 2 years from treatment with imatinib
  • Overall health status of the patient has to be good (ECOG performance status 0 or 1)
  • Adequate function of bone marrow, liver and kidneys

WHAT is the key question that this trial is attempting to answer?

Previous data suggest that Regorafenib might be effective as upfront treatment of metastatic or unresectable locally advanced KIT/PDGFR Wild Type GIST. This study tries to evaluate this in the clinical setting.

WHY patients might want to participate?

This clinical trial offers patients an opportunity to access a new therapy strategy. This trial will further support the research in GIST and potentially help other patients with this disease. The trial might or might not have benefit in your individual case. For more about the importance and benefits of joining clinical trials, please click here.

WHEN will the trial be open?

The study is open (recruiting)

WHERE is the trial available?

The trial is available in several study centers in Italy and Spain, further study sites are planned to open in France soon.

For a complete list of trial locations, please see here.

Study contacts:

STUDY DESIGN: What does the study look like?

There will be only one study arm (group): all participating patients will be receiving regorafenib.
It will be given at a dose of 160mg once a day, 3 weeks on / 1 week off.

HOW do I get more information?

Patient organisations supporting GIST and/or sarcoma patients in your country may offer additional information about the trial, current recruitment status, and key contacts. Click here for a list of patient organisations serving GIST and/or sarcoma patients. If there are no such organisation in your country, please email us for more information:

SHARE your experience

You want to share your experience on this trial?
Send us an e-mail to:
Note that your experience would be helpful for other patients and patient organisations.

RESULTS of the study

No results are available at this time. Future results will be linked here.

Disclaimer: This is a patient-friendly summary of the clinical trial which has been provided for informational purposes only. Patients should consult their physician about any clinical trial opportunity.


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