NCT02365441 (ALT GIST) is a Phase 2 clinical trial of Regorafenib in Gastrointestinal Stromal Tumour, sponsored by Australasian Gastro-Intestinal Trials Group.

Who is sponsoring NCT02365441?

NCT02365441 is sponsored by Australasian Gastro-Intestinal Trials Group.

What drugs are being tested in NCT02365441?

Interventions in NCT02365441: Regorafenib, imatinib.

What condition does NCT02365441 study?

NCT02365441 studies Gastrointestinal Stromal Tumour.

Is NCT02365441 still recruiting?

NCT02365441 is currently status unknown. Last updated 7 July 2023.

Last reviewed 2023-07-07 · How we verify

NCT02365441: ALT GIST

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Status unknown Phase 2 Last updated 7 July 2023

What this trial tests

Phase 2 trial testing Regorafenib in Gastrointestinal Stromal Tumour in 78 participants. Status unknown.

Timeline

30 June 2015

Primary endpoint
31 December 2023

31 December 2023

Quick facts

Lead sponsor	Australasian Gastro-Intestinal Trials Group
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	78
Start date	30 June 2015
Primary completion	31 December 2023
Estimated completion	31 December 2023
Sites	25 locations across France, Finland, Netherlands, Slovakia, Sweden, United Kingdom, Norway, Australia

Drugs / interventions tested

Regorafenib — full drug profile →
imatinib — full drug profile →

Conditions studied

Gastrointestinal Stromal Tumour — all drugs for Gastrointestinal Stromal Tumour →

Sponsor

Australasian Gastro-Intestinal Trials Group — full company profile →

Who can join

18 and older, any sex, with Gastrointestinal Stromal Tumour. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

Gastrointestinal Stromal Tumors (GISTs): Novel Therapeutic Strategies with Immunotherapy and Small Molecules.
Vallilas C, Sarantis P, Kyriazoglou A, Koustas E, et al · · 2021 · cited 41× · PMID 33419029 · DOI 10.3390/ijms22020493
Advances and Challenges on Management of Gastrointestinal Stromal Tumors.
Mei L, Du W, Idowu M, von Mehren M, et al · · 2018 · cited 35× · PMID 29868467 · DOI 10.3389/fonc.2018.00135
PDGF/PDGFR effects in osteosarcoma and the "add-on" strategy.
Xu J, Xie L, Guo W. · · 2018 · cited 30× · PMID 30083310 · DOI 10.1186/s13569-018-0102-1
Regorafenib regresses an imatinib-resistant recurrent gastrointestinal stromal tumor (GIST) with a mutation in exons 11 and 17 of c-kit in a patient-derived orthotopic xenograft (PDOX) nude mouse model.
Miyake K, Kawaguchi K, Kiyuna T, Miyake M, et al · · 2018 · cited 6× · PMID 29334307 · DOI 10.1080/15384101.2017.1423223
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.
Yip D, Zalcberg J, Blay JY, Eriksson M, et al · · 2025 · cited 2× · PMID 40133509 · DOI 10.1038/s41416-025-02983-w
Micromanagement of drug-resistant advanced gastrointestinal stromal tumors: regorafenib-new ammunition in battling exon 17 mutations.
Eckardt AJ, Klein O. · · 2018 · cited 1× · PMID 29552663 · DOI 10.21037/tgh.2018.02.01

Verify or expand the search:

Other trials of Regorafenib

Trials testing the same drug.

NCT06902246 — Regorafenib and Yttrium-90 Radioembolization for Unresectable Hepatocellular Carcinoma · Phase 2 · recruiting
NCT07392866 — A Clinical Study of SH006 Injection in Combination Therapy Versus Regorafenib in the Treatment of Advanced Hepatocellula · Phase 2, PHASE3 · not yet recruiting
NCT06820957 — Testing a New Combination of Anti-cancer Drugs in Patients Newly Diagnosed With Ewing Sarcoma Who Have Cancer That Has S · Phase 2, PHASE3 · active not recruiting
NCT07223567 — A Trial of Regorafenib Plus Lorigerlimab in Patients With Locally Recurrent or Regrowing pMMR/MSS Localized Rectal Cance · Phase 2 · withdrawn
NCT07134205 — The Study of JMT101 Combined With Irinotecan as a ≥3rd-Line Treatment in Metastatic Colorectal Cancer · Phase 3 · not yet recruiting

Other recruiting trials for Gastrointestinal Stromal Tumour

Currently open trials in the same condition.

NCT07124000 — DESTINY-PANTUMOUR04 · recruiting

Other Australasian Gastro-Intestinal Trials Group trials

Trials by the same sponsor.

NCT05042128 — The ASCEND Study: Gemcitabine and Nab-Paclitaxel With LSTA1 (Certepetide) or Placebo in Patients With Untreated Metastat · Phase 2 · active not recruiting
NCT05862051 — RESOLUTE Trial Aims to Investigate the Value of Adding Local Ablative Treatment to Standard Systemic Treatment for Unres · NA · unknown
NCT06290505 — A Trial of Palliative Chemotherapy, Radiation and Immune Treatment for Oesophageal Cancer: PALEO Study · Phase 2 · recruiting
NCT04879368 — RegoNivo vs Standard of Care Chemotherapy in AGOC · Phase 3 · active not recruiting
NCT03647839 — Modulation Of The Tumour Microenvironment Using Either Vascular Disrupting Agents or STAT3 Inhibition in Order to Synerg · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02365441 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Australasian Gastro-Intestinal Trials Group
Last refreshed: 7 July 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02365441.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing