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AMG 102 in advanced malignant glioma
NCT00427440Phase 2
Key facts
- Status
- Completed
- Start
- Nov 2006
- Primary completion
- Dec 2008
- Sponsor
- Amgen
- Modality
- Antibody Conjugates, Recombinant Proteins and Enzymes, Engineered Antibody Formats
- Drugs
- rilotumumab
- Conditions
- malignant glioma
01
Overview
Phase 2, open-label trial of rilotumumab in malignant glioma (2 arms), sponsored by Amgen. Primary endpoint: Objective Response Rate at 9 weeks. Started Nov 2006; status: completed.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
10 mg/kg Arm
AMG 102 at 10 mg/kg IV every 2 weeks
20 mg/kg Arm
AMG 102 at 20 mg/kg IV every 2 weeks
03
Who it enrols
Adults with histologically confirmed recurrent grade 4 advanced malignant glioma, measurable disease, and adequate organ function, excluding those with recent CNS bleeding or prior c-Met/HGF targeted therapy.
04
Endpoints
Primary
Objective Response Rate
Secondary
Safety Profile
Overall Survival
Progression-Free Survival
Duration of Response
Time to Response
Pharmacokinetics
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