Adults With Glioblastoma MultiformaPhase 3NCT00753246
Nimotuzumab in Adults With Glioblastoma Multiforma
A Phase 3 study testing nimotuzumab in people with Adults With Glioblastoma Multiforma, run by Oncoscience AG at 1 site in Germany.
Trial summary
Determination of efficiency of nimotuzumab in adults with glioblastoma multiforma Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Adults With Glioblastoma Multiforma
- What is being tested?
- nimotuzumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2007to Jan 2012
- Phase
- Phase 3
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient signed informed consent
- Newly diagnosed, histologically confirmed glioblastoma multiforme grade IV
- Condition is measurable by MRI in at least one dimension
- Age 18-70
- Karnofsky-Index > 40
- Treatment in a study center
Show all 13Show fewer
- Female patients with a childbearing potential must have a negative pregnancy test within one week before inclusion in the trial. Those female and male patients admitted in the study must use a reliable method of contraception.
- Adequate haematological, renal and hepatic function:
- Leucocytes >2.0x10^9/l
- Hb> 10g/dl
- Billirubin total < 2.5x upper limit of normal (ULN)
- Creatinin i.S. < 1.5x ULN
- AST (GOT)/ALT (GPT) < 5x ULN
Who cannot join
- Patients with history of anaphylactic reaction to murine or humanized antibody
- Patients with evidence second malignancy
- Patients who are pregnant or patients who refused adequate contraceptive precaution (female and male) during the trial
- Pregnancy and lactation
- Other conditions considered by investigators as sound reasons for disqualification from enrolment into the study such as: potential non compliance with protocol requirement
- No MRI for tumour evaluation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase-III Study of Standard Radiotherapy Plus Concomitant and Adjuvant OSAG 101 (Theraloc®) Plus Temozolomide vs. Standard Radiotherapy Plus Concomitant and Adjuvant Temozolomide in Patient With Newly Diagnosed, Histologically Confirmed Glioblastoma Multiforme Grade IV
Determination of efficiency of nimotuzumab in adults with glioblastoma multiforma
Read the detailed description
The objective of the present study is a comparison of treatment of patients with newly diagnosed glioblastoma multiforme grade IV. Patients will be randomized in one of two arms when included. Patients randomly assigned to arm A will receive Nimotuzumab (OSAG 101) plus Temozolomide concomitant with standard radiotherapy. Patients randomised in arm B will receive standard radiotherapy plus Temozolomide treatment.
- Conditions
- Adults With Glioblastoma Multiforma
- Being tested
- nimotuzumab
- Keywords
- glioblastoma multiforma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nimotuzumabDrug
monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| Arm B | Placebo comparator | adults with TMZ, RT Receives: Drug: nimotuzumab |
| Arm A | Experimental | adults with TMZ, RT, nimotuzumab Receives: Drug: nimotuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free interval determined by MRI
Measured: week 12, 24, 36, 52
Secondary outcomes (1)
Overall survival Time to reintervention Response rate according to RECIST criteria Toxicity according to CTC criteria Symptom control Quality of life
Measured: week 12, 24, 36, 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2008 (estimated)
- Study startAug 2007
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adults With Glioblastoma MultiformaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oncoscience AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Neurological Clinic, Knappschaftskrankenhaus Bochum-Langendreer, Bochum, Germany, University of Bonn, Dep. of Neurosurgery and Policlinic, University Hospital, Dresden, Germany, Heinrich-Heine University, Duesseldorf, Johann Wolfgang Goethe University Hospital, University of Giessen, Universitätsklinikum Hamburg-Eppendorf, University of Kiel, Dr. von Haunersches Children's Medical Hospital, University of Munich, Germany, Universität Tübingen
- Investigators
- Manfred Westphal, Prof. MD, Principal investigator, University Hamburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00753246
- Sponsor's protocol ID
- OSAG101-BSA05
- Status last verified
- Nov 2012
- First submitted
- 20 Nov 2007
- Last updated
- 3 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase-III Study of Standard Radiotherapy Plus Concomitant and Adjuvant OSAG 101 (Theraloc®) Plus Temozolomide vs. Standard Radiotherapy Plus Concomitant and Adjuvant Temozolomide in Patient With Newly Diagnosed, Histologically Confirmed Glioblastoma Multiforme Grade IV
- ClinicalTrials.gov ID
- NCT00753246
- Acronym / sponsor ID
- OSAG101-BSA05
- Conditions
- Adults With Glioblastoma Multiforma
- Keywords
- glioblastoma multiforma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Oncoscience AGIndustry (pharma, biotech, devices)
- Collaborators
- Neurological Clinic, Knappschaftskrankenhaus Bochum-Langendreer, Bochum, Germany, University of Bonn, Dep. of Neurosurgery and Policlinic, University Hospital, Dresden, Germany, Heinrich-Heine University, Duesseldorf, Johann Wolfgang Goethe University Hospital, University of Giessen, Universitätsklinikum Hamburg-Eppendorf, University of Kiel, Dr. von Haunersches Children's Medical Hospital, University of Munich, Germany, Universität Tübingen
- Study start
- Aug 2007
- Study completion
- Jan 2012 (actual)
- First posted
- 16 Sep 2008 (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.
Determination of efficiency of nimotuzumab in adults with glioblastoma multiforma
Detailed description
The objective of the present study is a comparison of treatment of patients with newly diagnosed glioblastoma multiforme grade IV. Patients will be randomized in one of two arms when included. Patients randomly assigned to arm A will receive Nimotuzumab (OSAG 101) plus Temozolomide concomitant with standard radiotherapy. Patients randomised in arm B will receive standard radiotherapy plus Temozolomide treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm B | Placebo comparator | Drug: nimotuzumabadults with TMZ, RT |
| Arm A | Experimental | Drug: nimotuzumabadults with TMZ, RT, nimotuzumab |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patient signed informed consent
- Newly diagnosed, histologically confirmed glioblastoma multiforme grade IV
- Condition is measurable by MRI in at least one dimension
- Age 18-70
- Karnofsky-Index > 40
Key exclusion criteria (6 listed)
- Patients with history of anaphylactic reaction to murine or humanized antibody
- Patients with evidence second malignancy
- Patients who are pregnant or patients who refused adequate contraceptive precaution (female and male) during the trial
- Pregnancy and lactation
- Other conditions considered by investigators as sound reasons for disqualification from enrolment into the study such as: potential non compliance with protocol requirement
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 |
|---|---|---|
| nimotuzumabmonoclonal antibody | Drug | Arm A, Arm B |
Primary outcome
Progression-free interval determined by MRI
Time frame: week 12, 24, 36, 52
1 secondary outcome
Overall survival Time to reintervention Response rate according to RECIST criteria Toxicity according to CTC criteria Symptom control Quality of life
Time frame: week 12, 24, 36, 52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2012.
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.
Manfred Westphal, Prof. MD principal investigator
University Hamburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing nimotuzumab in people with Adults With Glioblastoma Multiforma, run by Oncoscience AG at 1 site 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 13 inclusion and 6 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: finished, as of the sponsor's last update on 3 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Progression-free interval determined by MRI (time frame: week 12, 24, 36, 52). 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 3 Dec 2012; AzTrials last refreshed its copy on 7 Nov 2026.