drugset / Trial / NCT02177825
Study of Imatinib Mesylate in Neurofibromatosis Type I Patients Aged 2 to 21 With Plexiform Neurofibromas
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Imatinib | Small molecule | 110 mg/m2 | Oral |
| Subject | Imatinib | Small molecule | 440 mg/m2 | Oral |