glioblastoma MedDRA version: 18.1 Level: PT Classification code 10018337 Term: Glioblastoma multiforme System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 18.1 Level: PT Classification code 10018336 Term: Glioblastoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: BIBF 1120
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: Nintedanib
Current Sponsor code: BIBF 1120
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration n
Sponsors
Ruprecht-Karls-University Heidelberg, Medical Faculty
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male and female patients with a recurrence / progression of glioblastoma either not being eligible for tumour resection or having macroscopic residual tumor after resection of the recurrence - Diagnosis of glioblastoma must be proven histologically and progress must be documented by MRI. MRI images must not be older than 2 weeks before first dosing/start of RT - Not more than two prior therapy regimens including one or two resections, one or two chemotherapies (one temozolomidecontaining concomitant to radiotherapy) and one radiotherapy (RT) for the brain tumor - Previous irradiation therapy of the primary tumor with a maximal dose of 60 Gy; at least 8 months since the end of preirradiation - Candidate for reirradiation with recurrent tumor visible on MRIT1 (Gd) and with the largest diameter measuring 1 cm to 5 cm - Informed consent - Age = 18 years, smoking or non-smoking, of any ethnic origin - Karnofsky performance index (KPI) = 60% - Neutrophile counts > 1500/µl / Platelet counts > 80.000/µl / Haemoglobin > 10 g/dl / Serum creatinine =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - More than one RT of brain, prior first radiotherapy with more than 60 Gy - Cumulative total dose on the optical chiasm >54 Gy for 2 Gy/fraction, a/ß=2 - Prior treatment with bevacizumab, iodine seeds and/or brachytherapy - Unable to undergo contrast-enhanced MRI - Past medical history of diseases with poor prognosis according to the judgement of the Investigator, e.g. severe coronary heart disease, severe diabetes, immune deficiency, residual deficits after stroke, severe mental retardation - HIV or hepatitis infection - Pregnancy or breast feeding - Treatment within any other clinical trial parallel to the treatment phase of the current study or within 30 days before inclusion - Known coronary artery disease, significant cardiac arrhythmias or severe congestive heart failure (NYHA class III – IV)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Phase I - Maximal tolerated dose of BIBF1120 in combination reirradiation - Safety and tolerability of BIBF1120 in conjunction with radiotherapy - Pharmacokinetic studies in plasma and cerebrospinal fluid Phase II Primary objective: - 6 months rate of progression-free survival (PFS6) ;Secondary Objective: Secondary objectives: - Safety and tolerability of BIBF1120 Phase II Secondary objectives: - Safety and tolerability of BIBF1120 - Progression-free survival - Objective response rates (OR) - Duration of response (DR) in responders - Overall survival - Quality of life as determined by EORTC QLQ-C15-PAL and the EORTC brain module QLQ-BN 20 - Cognitive function determined by MMSE/NeuroCoq Fx ;Primary end point(s): Phase I: Maximal tolerated dose of BIBF1120 in combination with reirradiation Phase II: Progression free survival;Timepoint(s) of evaluation of this end point: Phase I: Daily evaluation of dose limiting toxicities Phase II: every 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Phase I: safety and tolerability Phase II: response rates, overall survival, quality of life;Timepoint(s) of evaluation of this end point: Phase I: weekly evaluation Phase II: every 6 weeks / 6 months after randomization | — |
Countries
Germany
Outcome results
None listed