NCT01666600

NOA-12: BIBF1120 and R-RT in Glioblastoma

A Phase I/II, Randomized, Open-label, Multi-centre Study of BIBF1120 + Reirradiation (R-RT) Versus Reirradiation in the Treatment of Patients With First or Second Progression of Glioblastoma

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Prof. Dr. Wolfgang Wick · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients with glioblastoma at first or second progression who have failed standard treatment that must have included radiochemotherapy with temozolomide and who are a candidate for a reirradiation can be included into the trial. In the phase I part the minimal tolerated dose (MTD)of BIBF 1120 in combination with radiotherapy will be investigated. Subjects in phase II will be randomised to receive reirradiation alone or reirradiation + 2 x MTD BIBF1120.

Conditions

• Glioblastoma Multiforme

Interventions

Type	Name	Description
DRUG	BIBF 1120	BIBF 1120 is given as 2 x minimal tolerated dose per day as long as as a clinical benefit is considered by the treating physician.
RADIATION	radiotherapy	36 Gy, 2 Gy / fraction, 18 fractions

Timeline

• Start date: 2012-08-01
• Primary completion: 2017-03-01
• Completion: 2017-09-01
• First posted: 2012-08-16
• Last updated: 2017-11-01

Locations

2 sites across 1 country: Germany