drugset / Trial / NCT02773524
A Study of Regorafenib in Refractory Advanced Gastro-Oesophageal Cancer
Phase 3
Unknown
250 enrolled
Australasian Gastro-Intestinal Trials Group
Academic and Community Cancer Research United · collabCanadian Cancer Trials Group · collabNational Health and Medical Research Council, Australia · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
A randomised phase III, double-blind, placebo-controlled trial with 2:1 (regorafenib : placebo)
Timeline
- Start
- 2016-11
- Primary completion
- 2022-01
- Completion
- 2022-12
Outcome
Met primary endpoint
paper Pooled OS analysis hazard ratio (HR) was 0.70 (95% CI, 0.56 to 0.87; P = .001; 361 events). PMID 39365958 ↗
paper INTEGRATE IIa alone OS HR was 0.68 (95% CI, 0.52 to 0.90; P = .006; 238 events), PMID 39365958 ↗
paper Regorafenib improves survival compared with placebo in refractory AGOC. PMID 39365958 ↗
Publications
- Soon YY, Sjoquist K, Marschner IC, Schou IM, Pavlakis N, Goldstein D, Shitara K, Stockler MR, Simes J, Martin AJ. INTEGRATE pooled phase 2/3 results are robust to postprogression switching and the winner's curse. JNCI Cancer Spectr. 2025 Jul 1;9(4):pkaf053. doi: 10.1093/jncics/pkaf053.
- Pavlakis N, Shitara K, Sjoquist K, Martin A, Jaworski A, Tebbutt N, Bang YJ, Alcindor T, O'Callaghan C, Strickland A, Rha SY, Lee KW, Kim JS, Bai LY, Hara H, Oh DY, Yip S, Zalcberg J, Price T, Simes J, Goldstein D. INTEGRATE IIa Phase III Study: Regorafenib for Refractory Advanced Gastric Cancer. J Clin Oncol. 2025 Feb;43(4):453-463. doi: 10.1200/JCO.24.00055. Epub 2024 Oct 4.
- Lam LL, Pavlakis N, Shitara K, Sjoquist KM, Martin AJ, Yip S, Kang YK, Bang YJ, Chen LT, Moehler M, Bekaii-Saab T, Alcindor T, O'Callaghan CJ, Tebbutt NC, Hague W, Chan H, Rha SY, Lee KW, Gebski V, Jaworski A, Zalcberg J, Price T, Simes J, Goldstein D. INTEGRATE II: randomised phase III controlled trials of regorafenib containing regimens versus standard of care in refractory Advanced Gastro-Oesophageal Cancer (AGOC): a study by the Australasian Gastro-Intestinal Trials Group (AGITG). BMC Cancer. 2023 Feb 22;23(1):180. doi: 10.1186/s12885-023-10642-7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Regorafenib | Small molecule | 160 mg | Oral |