drugset / Trial / NCT01393912
PDGFR Inhibitor Crenolanib in Children/Young Adults With Diffuse Intrinsic Pontine Glioma or Recurrent High-Grade Glioma
Phase 1
Completed
55 enrolled
St. Jude Children's Research Hospital
Arog Pharmaceuticals, Inc. · collabThe V Foundation for Cancer Research · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a Phase I clinical trial evaluating crenolanib (CP-868,596), an inhibitor of Platelet Derived Growth Factor Receptor (PDGFR)-kinase in children and young adults with newly diagnosed diffuse intrinsic pontine glioma (DIPG) (Stratum A) or in recurrent, progressive or refractory High Grade Glioma (HGG) including DIPG (Stratum B). This study drug targets the most commonly amplified region of genome found in DIPG and pediatric high grade glioma (HGG) which encodes for the PDGF receptor kinase. An oral investigational agent crenolanib will be administered daily during and after local radiation therapy (RT) in Diffuse Intrinsic Pontine Glioma DIPG (Stratum A), or daily for children with recurrent/refractory HGG (Stratum B).
Timeline
- Start
- 2011-07
- Primary completion
- 2014-09
- Completion
- 2016-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Crenolanib | Small molecule | 170 mg/m2 | Oral |
| Subject | Crenolanib | Small molecule | 220 mg/m2 | Oral |