Efficacy and Safety of RAD001 in Treating Plexiform Neurofibromas (PN) Associated With Neurofibromatosis (NF1)
Status:
Terminated
Trial end date:
2015-04-01
Target enrollment:
Participant gender:
Summary
This study was to evaluate the antitumor activity and safety of RAD001 in patients with
Plexiform neurofibromas (PN) associated with Neurofibromatosis Type 1 (NF1).
The aim of the study was to :
1. determine whether RAD001, administrated orally daily on a continuous dosing schedule
might:
1. Increases time to disease progression (TTP) based on volumetric MRI measurements in
children and adults with NF1 in inoperable documented progressive PN (stratum 1).
2. Results in objective radiographic responses based on volumetric MRI measurements in
children and adults with NF1 and inoperable PN in the absence of documented
radiographic progression at the trail entry (stratum
2. To evaluate the tolerability and toxicity of chronic RAD001 administration in this
patient population as assessed by the NCI Common Toxicity Criteria, version 4.0.