Recurrent/Refractory Glioblastoma Clinical Trial
Official title:
Phase II Study of Single-agent Crenolanib in Recurrent/Refractory Glioblastoma With PDGFRA Gene Amplification
This is a proof of concept, single-arm study to investigate crenolanib monotherapy in patients with recurrent/refractory glioblastoma with PDGFRA gene amplification by assessing the progression-free survival (PFS) at 6 months. Crenolanib will be given orally starting at 100 mg TID continuously until disease progression, unacceptable toxicity, or consent withdrawal.
This is a proof of concept, single-arm study to investigate crenolanib monotherapy in
patients with recurrent/refractory glioblastoma with PDGFRA gene amplification. Eligible
patients include those with recurrent/refractory glioblastoma after prior therapy including
surgery, radiation, and temozolomide. The trial is designed to assess the anti-tumor activity
of crenolanib in recurrent/refractory glioblastoma with PDGFRA gene amplification based on
the estimation of progression-free survival (PFS) at 6 months. Symptom burden will be
evaluated using the M.D. Anderson Symptom Inventory-Brain Tumor (MDASI-BT).
Crenolanib will be administered orally continuously at 100 mg TID on a 28-day cycle basis .
Patients are allowed to receive crenolanib for a maximum of 26 cycles if clinical benefit has
been observed.
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