Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00233454
Status:
COMPLETED
Last Update Posted:
2018-09-20
First Post:
2005-10-03
Brief Title:
Phase 2 Midostaurin in Aggressive Systemic Mastocytosis and Mast Cell Leukemia
Sponsor:
Jason Robert Gotlib
Organization:
Stanford University
Study Overview
Official Title:
A Single Arm Phase 2 Open-Label Study to Determine the Efficacy of Twice Daily Oral Dosing of PKC412 Midostaurin Administered to Patients With Aggressive Systemic Mastocytosis ASM and Mast Cell Leukemia MCL
Status:
COMPLETED
Status Verified Date:
2018-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The safety and efficacy of midostaurin PKC412 a novel investigational drug will be evaluated on the basis of response rate when administered to patients with aggressive systemic mastocytosis ASM or mast cell leukemia MCL
Detailed Description:
This study assesses the activity and safety profile of twice-daily oral doses of midostaurin in patients with aggressive systemic mastocytosis ASM or mast cell leukemia MCL with or without associated clonal hematological non-mast cell lineage disease AHNMD
Aggressive systemic mastocytosis ASM and mast cell leukemia MCL are characterized by excessive bone marrow production of mast cells which can can infiltrate tissues and release harmful substances resulting in organ damage These diseases have very limited treatment options and poor prognosis Existing treatments for in advanced mast cell disease eg interferon-alpha corticosteroids andor cladribine exhibit low response rates that are usually partial in nature
Aggressive systemic mastocytosis ASM and mast cell leukemia MCL are characterized by excessive bone marrow production of mast cells which can can infiltrate tissues and release harmful substances resulting in organ damage These diseases have very limited treatment options and poor prognosis Existing treatments for in advanced mast cell disease eg interferon-alpha corticosteroids andor cladribine exhibit low response rates that are usually partial in nature
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2213 | OTHER | Novartis Inc | None |
| 95242 | OTHER | None | None |
| HEMMPD0003 | OTHER | None | None |
| CPKC412D2201 | OTHER | None | None |