NOA-12 / NONK-3
A phase I/II, randomized, open-label, multi-center study of BIBF1120 + reirradiation (R-RT) versus re-irradiation in the treatment of patients with first or second progression of glioblastoma
Randomized phase I/II study
EudraCT Number: 2011-000921-61
Phase: I (completed); Phase: II (terminated early)
Patients recruited: 26/83
The NOA-12 / NONK-03 trial investigated whether a combination regimen of BIBF1120 (inhibitor of VEGFR2, FGFR, and PDGFR) and re-irradiation with 18 x 2.4 Gy for patients with first or second progression of glioblastoma provides a favorable signal for freedom from progression at six months. In the control arm, re-irradiation with 18 x 2.4 Gy alone was performed. In the planned interim analysis after observation of 19 patients in the experimental arm over a period of six months, there was no signal for an improvement in PFS6 compared to the control arm, so enrollment in the study was terminated early in February 2017 on the recommendation of the DSMB. Analysis and publication are awaited.