Ignite Creation Date:
2024-05-06 @ 5:10 PM
Last Modification Date:
2024-10-26 @ 2:23 PM
Study NCT ID:
NCT05219266
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2024-06-28
First Post:
2021-10-05
Brief Title:
Managed Access Programs for PKC412 Midostaurin
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
Managed Access Programs for PKC412 Midostaurin
Status:
NO_LONGER_AVAILABLE
Status Verified Date:
2024-06
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 purpose of this registration is to list Managed Access Programs MAPs related to PKC4 Midostaurin
Detailed Description:
CPKC412A2001X - No longer available- An open-labeled multi-center Expanded Treatment Protocol ETP of midostaurin PKC412 in patients 18 years of age or older with newly-diagnosed FLT3-mutated acute myeloid leukemia AML who are eligible for standard induction and consolidation chemotherapy
CPKC412AUS56X - No longer available - An open-label multi-center Expanded Treatment Protocol of Midostaurin PKC412 in adult patients with newly diagnosed Fms-like tyrosine kinase receptor FLT3 mutated Acute Myeloid Leukemia AML who are eligible for standard induction and consolidation chemotherapy
CPKC412A2407I - No longer available- Managed Access Program MAP Cohort Treatment Plan CPKC412A2407I to provide access to midostaurin PKC412 for patients 18 years of age and older with newly-diagnosed FLT3-mutated AML and eligible for induction and consolidation chemotherapy
CPKC412D2001M - No longer available- Managed Access Program MAP to provide access to Midostaurin PKC412 for an individual patient with aggressive systemic mastocytosis ASM mast cell leukemia MCL or mast cell sarcoma MCS
CPKC412AUS56X - No longer available - An open-label multi-center Expanded Treatment Protocol of Midostaurin PKC412 in adult patients with newly diagnosed Fms-like tyrosine kinase receptor FLT3 mutated Acute Myeloid Leukemia AML who are eligible for standard induction and consolidation chemotherapy
CPKC412A2407I - No longer available- Managed Access Program MAP Cohort Treatment Plan CPKC412A2407I to provide access to midostaurin PKC412 for patients 18 years of age and older with newly-diagnosed FLT3-mutated AML and eligible for induction and consolidation chemotherapy
CPKC412D2001M - No longer available- Managed Access Program MAP to provide access to Midostaurin PKC412 for an individual patient with aggressive systemic mastocytosis ASM mast cell leukemia MCL or mast cell sarcoma MCS
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