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Bioequivalence of Ped-TMZ vs Temodal in CNS Malignancies
NCT04467346Phase 1Completed
- Sponsor
- ORPHELIA Pharma
- Start
- Sep 2020
- Primary completion
- Dec 2021
- Modality
- Small Molecules
- Countries
- 1
01
Overview
Phase 1, randomised, open-label trial of temozolomide in glioblastoma (GBM) and malignant glioma (2 arms), sponsored by ORPHELIA Pharma. Primary endpoints: Maximum Plasma Concentration at Day 2 and Area Under the Curve from time 0 to last measurable concentration at Day 2. Started Sep 2020; status: completed.
02
Drugs
temozolomide
03
Conditions
glioblastoma (GBM)malignant glioma
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