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A Phase 1 Study of AZD6244 in Children with Recurrent

or Refractory Low Grade Gliomas: A Pediatric Brain

Tumor Consortium Report

.

Anuradha Banerjee, Regina Jakacki, Arzu Onar-Thomas, Shengjie Wu, Theodore Nicolaides, David C. Turner, Stacye Richardson, Tina Young-Poussaint, Joanna

Phillips, Michael Prados, Roger Packer, Ibrahim Qaddoumi, Sridharan Gururangan, Stewart Goldman, Ian Pollack, Austin Doyle, Clinton F. Stewart, James

Boyett, Larry Kun, Maryam Fouladi

Age > 3 and < 21 years with recurrent or refractory low grade glioma

that has failed prior chemo or radiotherapy

Drug administered by mouth, daily, BID continuously

One course=28 days, up to 26 courses of treatment allowed

Dose limiting toxicity (DLT) observation period is end of 1

st

28 day cycle

3 dosage levels (DL) investigated

DL0, 25 mg/m2/dose, BID

DL1, 33 mg/m2/dose, BID

DL2, 43 mg/m2/dose, BID