drugset / Trial / NCT02177825

Study of Imatinib Mesylate in Neurofibromatosis Type I Patients Aged 2 to 21 With Plexiform Neurofibromas

NCT02177825 ↗

Phase 2 Terminated 5 enrolled St. Justine's Hospital
NaSingle-groupOpen-labelTreatment

Summary

This phase II trial will test the hypothesis that inhibition of c-kit signalling pathways in pediatric patients with Neurofibromatosis Type I(NF-1) and progressing plexiform neurofibroma will result in objective reduction and/or inhibition of plexiform neurofibromas progression. This will be a Phase II study of imatinib mesylate given orally. Patients with stable or responding disease may receive the drug for a period not exceeding one year.

Timeline

Start
2014-06
Primary completion
2019-03-01
Completion
2019-03-01

Outcome

Outcome not reported

Stopped (Enrollment): “Slow accrual 5 patients out of 25 expected. Primary objectives could not be met without recruiting more patients.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Imatinib Small molecule 110 mg/m2 Oral
Subject Imatinib Small molecule 440 mg/m2 Oral