Glioblastoma MultiformePhase 1/2NCT01666600
NOA-12: BIBF1120 and R-RT in Glioblastoma
A Phase 1/2 study testing BIBF 1120 and radiotherapy in people with Glioblastoma Multiforme, run by Prof. Dr. Wolfgang Wick at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma Multiforme
- What is being tested?
- BIBF 1120 and radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 2 sitesGermany
- Study dates
- Aug 2012to Sep 2017
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
University Hospital Heidelberg, Department of Neurooncology
Heidelberg, Baden-Wurttemberg, 69120
University Hospital Heidelberg, Department of Pharmacology
Heidelberg, Baden-Wurttemberg, 69120
About this study
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
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
- Being tested
- BIBF 1120, radiotherapy
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIBF 1120Drug
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.
radiotherapyRadiation
36 Gy, 2 Gy / fraction, 18 fractions
| Study group | Role | What they receive |
|---|---|---|
| BIBF 1120 + reirradiation | Experimental | 2 x minimal tolerated dose BIBF 1120 per day in combination with radiotherapy (2 Gy / fraction; 36 Gy in total) Receives: Drug: BIBF 1120 |
| reirradiation alone | Active comparator | radiotherapy (2 Gy / fraction; 36 Gy in total) Receives: Radiation: radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal tolerated dose of BIBF 1120 in combination with reirradiation (Phase I)
Measured: day 0, 8, 15 and 17 post-dose during phase I
Secondary outcomes (6)
Number of participants with adverse events as a measure of safety and tolerability of BIBF1120
Measured: Up to 90 days follow-up
Progression-free survival
Measured: Time from randomization until death or disease progression
Objective response rates (OR)
Measured: Time from randomization until response
Overall survival
Measured: Time from randomization until death
Quality of life as determined by EORTC QLQ-C15 PAL and the EORTC brain module QLQ-BN 20
Measured: Screening and 6-weekly after radiotherapy
Cognitive function determined by MMSE
Measured: Screening and 6-weekly after end of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionMar 2017
- Study completionSep 2017
Why it stopped: Interim Analysis for Feasibility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma MultiformeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Wolfgang Wick
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Dr. Wolfgang Wick, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01666600
- Sponsor's protocol ID
- NONK-3/NOA-12
- Status last verified
- Oct 2017
- First submitted
- 12 Jul 2012
- Last updated
- 1 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01666600
- Acronym / sponsor ID
- NONK-3/NOA-12
- Conditions
- Glioblastoma Multiforme
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim Analysis for Feasibility
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Prof. Dr. Wolfgang WickUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Mar 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 16 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIBF 1120 + reirradiation | Experimental | Drug: BIBF 11202 x minimal tolerated dose BIBF 1120 per day in combination with radiotherapy (2 Gy / fraction; 36 Gy in total) |
| reirradiation alone | Active comparator | Radiation: radiotherapyradiotherapy (2 Gy / fraction; 36 Gy in total) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIBF 1120BIBF 1120 is given as 2 x minimal tolerated dose per day as long as as a clinical benefit is considered by the treating physician. | Drug | BIBF 1120 + reirradiation |
| radiotherapy36 Gy, 2 Gy / fraction, 18 fractions | Radiation | reirradiation alone |
Primary outcome
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
6 secondary outcomes
Number of participants with adverse events as a measure of safety and tolerability of BIBF1120
Time frame: Up to 90 days follow-up
Progression-free survival
Time frame: Time from randomization until death or disease progression
Objective response rates (OR)
Time frame: Time from randomization until response
Overall survival
Time frame: Time from randomization until death
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
Cognitive function determined by MMSE
Time frame: Screening and 6-weekly after end of radiotherapy
Results and safety
The study was stopped early (reason given: Interim Analysis for Feasibility). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BIBF 1120 and radiotherapy in people with Glioblastoma Multiforme, run by Prof. Dr. Wolfgang Wick at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Interim Analysis for Feasibility). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2017.