Managed Access Programs for PKC412, Midostaurin

NCT05219266 | Unknown

• 1 other identifier: CPKC412A2407I
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this registration is to list Managed Access Programs (MAPs) related to PKC4, Midostaurin.

Conditions

FMS-Like Tyrosine Kinase 3 (FLT3)-Mutated Acute Myeloid Leukemia; Acute Myeloid Leukemia; Aggressive Systemic Mastocytosis; Mast Cell Leukemia; Systemic Mastocytosis With an Associated Hematologic Neoplasm

Keywords

FLT3-mutated AML; AML; Aggressive systemic mastocytosis; Mast cell leukemia; Systemic mastocytosis with an associated hematologic neoplasm; MAP; Manage access program; PKC412; Midostaurin

Interventions

midostaurin DRUG

Patients receive midostaurin

Also known as: PKC412

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• An independent request should be received from a licensed physician (in some instances from Health Authorities, Institutions or Governments).
• The patient has a serious or life-threatening disease or condition and no comparable or satisfactory alternative therapy is available for diagnosis, monitoring or treatment; patient is not medically eligible for available treatment alternatives or has exhausted all available treatment options.
• The patient is not eligible or able to enroll in a Novartis clinical trial or continue participation in a Novartis clinical trial.
• There is a potential patient benefit to justify the potential risk of the treatment use, and the potential risk is not unreasonable in the context of the disease or condition to be treated.
• The patient must meet any other medical criteria established by the medical experts responsible for the product or by the Health Authority in a country (as applicable).
• Provision of the product will not interfere with the initiation, conduct or completion of a Novartis clinical trial or overall development program.
• Managed access provision is allowed per local laws/regulations.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Mastocytosis, Systemic; Leukemia, Mast-Cell

Interventions

midostaurin

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Mastocytosis; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Mast Cell Activation Disorders; Immune System Diseases

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: February 2, 2022
• Last Updated: June 28, 2024

Record last verified: 2024-06