A Phase I Dose Escalation Study of BKM120 With Radiation Therapy and Temozolomide in Patients With Newly Diagnosed Glioblastoma

Phase 1 Completed 38 enrolled Novartis Pharmaceuticals

Non-randomizedSingle-groupOpen-labelTreatment

Summary

This clinical study will assess the doses of BKM120 appropriate for patients with newly diagnosed glioblastoma when given in combination with radiotherapy and temozolomide.

Timeline

Start: 2011-12-30
Primary completion: 2017-05-17
Completion: 2017-05-17

Publications

Wen PY, Rodon JA, Mason W, Beck JT, DeGroot J, Donnet V, Mills D, El-Hashimy M, Rosenthal M. Phase I, open-label, multicentre study of buparlisib in combination with temozolomide or with concomitant radiation therapy and temozolomide in patients with newly diagnosed glioblastoma. ESMO Open. 2020 Jul;5(4):e000673. doi: 10.1136/esmoopen-2020-000673.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Buparlisib	Small molecule	40 mg	Oral
Subject	Buparlisib	Small molecule	60 mg	Oral
Subject	Buparlisib	Small molecule	80 mg	Oral
Subject	Buparlisib	Small molecule	100 mg	Oral
Background	Temozolomide	Small molecule	200 mg/m2	Oral

A Phase I Dose Escalation Study of BKM120 With Radiation Therapy and Temozolomide in Patients With Newly Diagnosed Glioblastoma

Summary

Timeline

Publications

Drugs

Indications