A Single Arm, Phase 2, Open-Label Study to Determine the Efficacy of Twice Daily Oral Dosing of PKC412 Administered to Patients With Aggressive Systemic Mastocytosis (ASM) and Mast Cell Leukemia (MCL).
Phase of Trial: Phase II
Latest Information Update: 21 Sep 2018
At a glance
- Drugs Midostaurin (Primary)
- Indications Leukaemia; Mastocytosis
- Focus Therapeutic Use
- 28 Apr 2018 Status changed from active, no longer recruiting to completed.
- 28 Apr 2017 According to a Novartis media release, based on this and another single-arm open-label multicenter trial (profile 38826), the US Food and Drug Administration (FDA) has approved Rydapt to treat adults with advanced systemic mastocytosis (SM), which includes aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN) and mast cell leukemia.
- 08 Jul 2015 Planned End Date changed from 1 Jan 2015 to 1 Dec 2017 as reported by ClinicalTrials.gov record.