A phase I/II, open-label, dose-escalating study to evaluate the safety, tolerability and pharmacokinetics of twice daily oral midostaurin and to evaluate the preliminary clinical and pharmacodynamic response in pediatric patients with relapsed or refractory leukemia - N/A

ovartis Pharma Services AG0 sites22 target enrollmentJuly 8, 2009

Overview

No summary available.

Registry

who.int

Start Date

July 8, 2009

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Patients must have a documented diagnosis of one of the following leukemias:
•MLL\-rearranged ALL, refractory to standard induction treatment or in first or subsequent relapse
•FLT3\-mutated AML refractory to standard induction (after failure of at least 2 different induction chemotherapy regimens) or refractory to reinduction at 1st relapse (after failure of the first re\-induction course), or in second or greater relapse
•2\. Patients must be less than 18 years of age and \=3 months of age.
•3\. Patients must have a Lansky/Karnofsky performance status \= 60\.
•4\. Patients must have the following laboratory values reflecting
•appropriate organ function:
•AST and ALT \= 5x Upper Limit of Normal (ULN),
•Serum Bilirubin \= 1\.5 x ULN,
•Serum Creatinine \= 2 x ULN.

•1\. Patients with symptomatic leukemic CNS involvement.
•2\. Patients with isolated extramedullary leukemia.
•3\. Patients must have recovered from prior cytotoxic chemotherapy, with a minimum wash\-out time of previous chemotherapy of 72 hours. For intrathecal chemotherapy, the minimum wash\-out time is 48 hours (other exceptions for intrathecal chemotherapy are noted in Section 6\.6\.5\)
•4\. Patients who had prior allogeneic, syngeneic or autologous bone
•marrow or stem cell transplant less than 2 months from Day 1
•5\. Patients who have received any investigational agent within 30 days or 5 half\-lives, whichever is greater, prior to Day 1\. An investigational agent is an agent with no approved medical uses in adults or pediatrics.
•6\. Patients who have had prior treatment with a FLT3 inhibiting drug or investigational agent; except for sorafenib.
•7\. Use of CYP3A4/5 enzyme inducing or inhibiting drugs or CYP3A4/5 enzyme inducing or inhibiting herbal supplements while on study treatment
•8\. The use of corticosteroids while on study drug (exceptions are noted in Section 6\.6\.5\)
•9\. Patients who have had any surgical procedure, excluding central