Trial intelligence / Profile preview

INC280 + Buparlisib in Recurrent Glioblastoma

NCT01870726Phase 2

Key facts

Status: Terminated
Start: Jan 2014
Primary completion: Dec 2016
Countries: 5
Sponsor: Novartis
Modality: Fragment-Derived Small Molecules, Reversible Covalent Inhibitors, Bivalent/Multivalent Binders

Drugs: capmatinib
Conditions: glioblastoma (GBM)

Overview

Phase 2, open-label trial of capmatinib in glioblastoma (GBM) (2 arms), sponsored by Novartis. Primary endpoints: Dose Limiting Toxicities, Progression Free Survival Rate at 6 months and 1 more. Started Jan 2014; status: terminated.

Design

2 arms

Study design: Non-randomizedOpen-label

Phase Ib
INC280 + Buparlisib dose escalation
Phase II
INC280 monotherapy (originally planned as combo)

Who it enrols

Adult patients with recurrent glioblastoma who have received prior radiotherapy and temozolomide. Patients must have PTEN mutations/deletion (Phase Ib) or c-Met amplification/PTEN mutations (Phase II).

Endpoints

Primary

Dose Limiting ToxicitiesCycle 1 (28 days)
Progression Free Survival Rate6 months
Concentrations of INC280 and Buparlisib in Tumor7 days

Secondary

Adverse Events3 years
Pharmacokinetic Profile of INC280 and Buparlisib6 months
Best Overall Response3 years
Overall Survival3 years

Beyond the preview

Go deeper on NCT01870726.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT01870726.