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

Phase 2 Unknown 78 enrolled Australasian Gastro-Intestinal Trials Group European Organisation for Research and Treatment of Cancer - EORTC · collab Scandinavian Sarcoma Group · collab

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

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

Outcome

Missed primary endpoint

paper Best responses and OTR were similar at 9 months. PMID 40133509 ↗

paper Alternation of imatinib and regorafenib did not impact on 9 months objective response PMID 40133509 ↗

Publications

Yip D, Zalcberg J, Blay JY, Eriksson M, Espinoza D, Price T, Marreaud S, Italiano A, Steeghs N, Boye K, Underhill C, Gebski V, Simes J, Gelderblom H, Joensuu H. Imatinib alternating with regorafenib compared to imatinib alone for the first-line treatment of advanced gastrointestinal stromal tumor: The AGITG ALT-GIST intergroup randomized phase II trial. Br J Cancer. 2025 Jun;132(10):897-904. doi: 10.1038/s41416-025-02983-w. Epub 2025 Mar 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Imatinib	Small molecule	400 mg	Oral
Subject	Regorafenib	Small molecule	160 mg	Oral