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NOA-12: BIBF1120 and R-RT in Glioblastoma

Primary Purpose

Glioblastoma Multiforme

Status

Terminated

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

BIBF 1120

radiotherapy

About this trial

This is an interventional treatment trial for Glioblastoma Multiforme

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male and female patients with a recurrence / progression of glioblastoma either not being eligible for tumour resection or having macroscopic residual tumour 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 temozolomide containing concomitant to radiotherapy) and one radiotherapy (RT) for the brain tumour
Previous irradiation therapy of the primary tumour with a maximal dose of 60 Gy; at least 8 months since the end of preirradiation
Candidate for reirradiation with recurrent tumour 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 < 1.5-fold upper normal range / Bilirubin, AST or ALT < 2,5-fold upper normal range unless attributed to anticonvulsants / Alkaline phosphatase < 2,5-fold upper normal range
Adequate contraception
If on steroids, stable or decreasing treatment with steroids within 5 days before treatment start

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, α/β=2
Prior treatment with bevacizumab, iodine seeds and/or brachytherapy
Unable to undergo 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)

Sites / Locations

University Hospital Heidelberg, Department of Neurooncology
University Hospital Heidelberg, Department of Pharmacology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BIBF 1120 + reirradiation

reirradiation alone

Arm Description

2 x minimal tolerated dose BIBF 1120 per day in combination with radiotherapy (2 Gy / fraction; 36 Gy in total)

radiotherapy (2 Gy / fraction; 36 Gy in total)

Outcomes

Primary Outcome Measures

Maximal tolerated dose of BIBF 1120 in combination with reirradiation (Phase I)

Secondary Outcome Measures

Number of participants with adverse events as a measure of safety and tolerability of BIBF1120

Progression-free survival

Objective response rates (OR)

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

Full Information

NCT ID

NCT01666600

First Posted

July 12, 2012

Last Updated

October 30, 2017

Sponsor

Prof. Dr. Wolfgang Wick

1. Study Identification

Unique Protocol Identification Number

NCT01666600

Brief Title

NOA-12: BIBF1120 and R-RT in Glioblastoma

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Terminated

Why Stopped

Interim Analysis for Feasibility

Study Start Date

August 2012 (undefined)

Primary Completion Date

March 2017 (Actual)

Study Completion Date

September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Prof. Dr. Wolfgang Wick

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glioblastoma Multiforme

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

63 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BIBF 1120 + reirradiation

Arm Type

Experimental

Arm Description

2 x minimal tolerated dose BIBF 1120 per day in combination with radiotherapy (2 Gy / fraction; 36 Gy in total)

Arm Title

reirradiation alone

Arm Type

Active Comparator

Arm Description

radiotherapy (2 Gy / fraction; 36 Gy in total)

Intervention Type

Drug

Intervention Name(s)

BIBF 1120

Intervention Description

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.

Intervention Type

Radiation

Intervention Name(s)

radiotherapy

Intervention Description

36 Gy, 2 Gy / fraction, 18 fractions

Primary Outcome Measure Information:

Title

Maximal tolerated dose of BIBF 1120 in combination with reirradiation (Phase I)

Time Frame

day 0, 8, 15 and 17 post-dose during phase I

Secondary Outcome Measure Information:

Title

Number of participants with adverse events as a measure of safety and tolerability of BIBF1120

Time Frame

Up to 90 days follow-up

Title

Progression-free survival

Time Frame

Time from randomization until death or disease progression

Title

Objective response rates (OR)

Time Frame

Time from randomization until response

Title

Overall survival

Time Frame

Time from randomization until death

Title

Quality of life as determined by EORTC QLQ-C15 PAL and the EORTC brain module QLQ-BN 20

Time Frame

Screening and 6-weekly after radiotherapy

Title

Cognitive function determined by MMSE

Time Frame

Screening and 6-weekly after end of radiotherapy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male and female patients with a recurrence / progression of glioblastoma either not being eligible for tumour resection or having macroscopic residual tumour 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 temozolomide containing concomitant to radiotherapy) and one radiotherapy (RT) for the brain tumour Previous irradiation therapy of the primary tumour with a maximal dose of 60 Gy; at least 8 months since the end of preirradiation Candidate for reirradiation with recurrent tumour 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 < 1.5-fold upper normal range / Bilirubin, AST or ALT < 2,5-fold upper normal range unless attributed to anticonvulsants / Alkaline phosphatase < 2,5-fold upper normal range Adequate contraception If on steroids, stable or decreasing treatment with steroids within 5 days before treatment start 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, α/β=2 Prior treatment with bevacizumab, iodine seeds and/or brachytherapy Unable to undergo 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)

Facility Information:

Facility Name

University Hospital Heidelberg, Department of Neurooncology

City

Heidelberg

State/Province

Baden-Württemberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

University Hospital Heidelberg, Department of Pharmacology

City

Heidelberg

State/Province

Baden-Württemberg

ZIP/Postal Code

69120

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

NOA-12: BIBF1120 and R-RT in Glioblastoma

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