Glioblastoma multiforme grade IV
Conditions
Interventions
Product Name: Theraloc
Product Code: OSAG 101
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Nimotuzumab
CAS Number: N/A
Current Sponsor code: HR3
Other descriptive na
Sponsors
Oncoscience AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Each study patient must meet all of the following conditions: • Investigator verifies patient's mental capacity to consent. • Patient signed informed consent • Histologically verified diagnosis of glioblastoma multiforme grade IV • Age 18-70 • Karnofsky-Index >70 • 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 (e.g. birth-control-pill, condom). • Treatment in a study center • Adequate haematological, renal and hepatic function according to the following definitions: • Leucocytes >2.0x10 9/l • Platelets = 50 x 10 9/l • Hb > 10g/dl • Billirubin total =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: None of the following conditions are permitted for a study patient: • If investigator has any concerns regarding patient's mental condition or if patient is under disability, patient must not be randomized • Previous participation in this study • Prior chemotherapy or X-ray therapy or other experimental treatments during this study • Participation in another therapeutic study involving the basic condition • Females of childbearing age with insufficient or inadequately assured contraception • Pregnancy or lactation • Other existing serious conditions that could adversely affect the patient's therapy in accordance with the protocol • Any other condition or therapy which in the opinion of the attending physician could represent a risk for the patient or interfere with study objectives • Known contraindications against antibodies (e.g., prior treatment with recombinant/monoclonal antibodies) • Missing or incomplete statement of consent • Patients with evidence of second malignancy • MRI not feasible
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Effectiveness of a humanized EGFR antibody for newly diagnosed histologically confirmed Glioblastoma multiforme grade IV ;Secondary Objective: ;Primary end point(s): - Progression-free survival determined by MRI | — |
Countries
Germany
Outcome results
None listed