Clinical trial · Interventional
Nimotuzumab in Adults With Glioblastoma Multiforma
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
NCT00753246CI-TRIAL-00008572completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Determination of efficiency of nimotuzumab in adults with glioblastoma multiforma
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adults With Glioblastoma Multiforma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| nimotuzumab | Drug | Nimotuzumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Arm B
- description
- adults with TMZ, RT
- interventionNames
- Drug: nimotuzumab
- type
- EXPERIMENTAL
- label
- Arm A
- description
- adults with TMZ, RT, nimotuzumab
- interventionNames
- Drug: nimotuzumab
Primary outcomes (1)
- measure
- Progression-free interval determined by MRI
- timeFrame
- week 12, 24, 36, 52
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.