gastro intestinal stromal tumour

Gastrointestinal Stromal Tumour Trials and Regorafenib Access Program

This information was prepared for AGITG members by Professor Desmond Yip and Professor John Zalcberg.

There are now a number of treatment options available for patients with metastatic or locally advanced gastrointestinal stromal tumour who have progressed on imatinib and sunitinib:

Clinical Trials

1. Blueprint VOYAGER study: Phase III trial of BLU-285 (avapritinib) versus regorafenib in patients with locally advanced unresectable or metastatic gastrointestinal stromal tumour.

Study details: https://clinicaltrials.gov/ct2/show/NCT03465722

This trial is of a potent oral kinase inhibitor that targets KIT/PDGFR activation loop mutations in patients who have failed 2 or 3 lines of therapy including imatinib and sunitinib (but not regorafenib). Cross over of the regorafenib arm patients to BLU285 is allowed on progression. Wild type GIST patients are excluded.

This trial has opened at the Monash Medical Centre

(PI: Eva Segelov: eva.segelov@monash.edu)

Upcoming additional centres will be Flinders Medical Centre (PI Amitesh Roy: Amitesh.Roy@sa.gov.au) and The Canberra Hospital (PI  Desmond Yip: desmond.yip@act.gov.au)

Patients may be initially enrolled at Monash and transfer to the other centres subsequently.

 

2. Deciphera INVICTUS study: Phase III study of DCC 2618 vs placebo in advanced GIST patients who have been treated with prior anticancer therapies (must include imatinib, sunitinib and regorafenib).

Study details: https://clinicaltrials.gov/ct2/show/NCT03353753

This is a fourth line clinical trial of an oral kinase switch control inhibitor against resistant KIT and PDGFR mutations. Wild type or mutation status unknown GIST patients are eligible.

This trial is open at the Alfred Hospital

(PI John Zalcberg: john.zalcberg@monash.edu)

 

Notes:

  • Travel expenses for regional and interstate patients are covered in both of the above studies.
  • A phase III trial of DCC 2618 versus sunitinib in second-line therapy of GIST is planned to open at sites around Australia later this year. Progressing patients on imatinib should be considered for dose escalation to 800 mg on Novartis access program below while waiting for study to open.

 

Compassionate Access

3. Novartis Glivec Access Program for gastrointestinal stromal tumours

Patients who progress on frontline imatinib can be dose escalated to 600 mg daily on the PBS. Novartis provide an extra 200mg daily through this program to top up dose to 800 mg daily.

Contact: access-onc.aus@novartis.com or phone 02 9805 3555

 

4. Bayer GAIN Stivarga (regorafenib) GIST Access Program.

Thanks to successful lobbying of Bayer led by John Zalcberg through MOGA, a free compassionate access program for regorafenib is available for patients who have failed imatinib and sunitinib.

Consideration should be made of enrolment of patients onto VOYAGER study first.

Contact: medaffairs.anz@bayer.com or Mian Zhang (Patient Engagement Associate, Bayer): 02 9391 6181

 

 

 

 

 

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