ALT GIST


ALT GIST

The ALT-GIST compares imatinib with an alternating regime of imatinib and regorafenib in patients with confirmed, metastatic GIST without previous therapy. The trial is currently open for participation in several countries.

Agents: Imatinib alternating with Regorafenib vs. Imatinib alone
Phase II
Status  Open, recruiting
Sponsor The Australasian Gastro-Intestinal Trials Group in collaboration with EORTC

Further information: https://clinicaltrials.gov/ct2/show/study/NCT02365441?show_locs=Y#locn

WHO is the trial for?

  • Adult patients with histologically confirmed gastrointestinal stromal tumours (GIST) - if CD-117-negative: DOG-1 must be positive or a KIT/PDGFRA mutation must be present
  • Inoperatable tumour with metastatis
  • No prior tyrosine kinase inhibitor (TKI) for metastatic disease.
    Exception:
    • Patients who have had up to 21 days of uninterrupted treatment of standard dose imatinib (400mg daily)
    • Imatinib therapy given as an adjuvant treatment and completed at least 3 months prior to entry into this trial is permitted.
  • Overall health status of the patient has to be good (ECOG performance status 0-2)
  • Adequate function of bone marrow, liver and kidneys
 

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

The study tries to answer the question if alternating imatinib and regorafenib is comparable or even superior to a treatment with imatinib alone in patients with metastatic GIST who had no other previous treatment (first-line).

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.

WHEN will the trial be open?

 The study is open/recruiting.

WHERE is the trial available?

 

The trial is available in 25 study centers in Australia, Finland, France, The Netherlands, Norway, Singapore, Slovakia, Spain, Sweden and the United Kingdom.
For a complete list of trial locations, please see here: https://clinicaltrials.gov/ct2/show/study/NCT02365441?show_locs=Y#locn

Study coordinator:
Contact: NHMRC CTC (National Health and Medical Research Center - Clinical Trials Centre)
Phone: +02 9562 5000
E-Mail: This email address is being protected from spambots. You need JavaScript enabled to view it.

STUDY DESIGN: What does the study look like?

There will be 2 study arms (groups): all participating patients will be randomly divided (by a computer) in two groups.
Patients in one group will be assigned to imatinib alone. Patients in the other group will receive imatinib alternating with regorafenib.

SHARE your experience

  
You want to share your experience on this trial?
Send us an e-mail to: This email address is being protected from spambots. You need JavaScript enabled to view it.
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.

Merken