A Study of Nilotinib Versus Imatinib in GIST Patients

Phase 3 Completed 644 enrolled Novartis Pharmaceuticals

RandomizedCrossoverOpen-labelTreatment

Summary

This study will evaluate efficacy and safety of nilotinib versus imatinib in adult patients with unresectable or metastatic gastrointestinal stromal tumors (GIST).

Timeline

Start: 2009-03
Primary completion: 2014-10
Completion: 2014-10

Outcome

Missed primary endpoint

paper 2-year progression-free survival was higher in the imatinib group (59·2% [95% CI 50·9-66·5]) than in the nilotinib group (51·6% PMID 25882987 ↗

paper hazard ratio 1·47 [95% CI 1·10-1·95] PMID 25882987 ↗

Publications

Blay JY, Shen L, Kang YK, Rutkowski P, Qin S, Nosov D, Wan D, Trent J, Srimuninnimit V, Papai Z, Le Cesne A, Novick S, Taningco L, Mo S, Green S, Reichardt P, Demetri GD. Nilotinib versus imatinib as first-line therapy for patients with unresectable or metastatic gastrointestinal stromal tumours (ENESTg1): a randomised phase 3 trial. Lancet Oncol. 2015 May;16(5):550-60. doi: 10.1016/S1470-2045(15)70105-1. Epub 2015 Apr 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Imatinib	Small molecule	400 mg	Oral
Subject	Nilotinib	Small molecule	400 mg	Oral