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Managed Access Programs for PKC412, Midostaurin

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ClinicalTrials.gov Identifier: NCT05219266
Expanded Access Status : Available
First Posted : February 2, 2022
Last Update Posted : April 4, 2024
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief Summary:
The purpose of this registration is to list Managed Access Programs (MAPs) related to PKC4, Midostaurin.

Condition or disease Intervention/treatment
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 Drug: 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 - 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 - 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 Design
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Study Type : Expanded Access
Expanded Access Type : Intermediate-size Population
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: Managed Access Programs for PKC412, Midostaurin

Resource links provided by the National Library of Medicine

Drug Information available for: Midostaurin

Interventions
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Intervention Details:
  • Drug: midostaurin
    Patients receive midostaurin
    Other Name: PKC412
Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05219266


Contacts
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Contact: MAP requests are initiated by a treating physician.https:// www.novart is.com/healthcare-professionals/managed-access-programs. 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals

Sponsors and Collaborators
Novartis Pharmaceuticals
More Information
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT05219266    
Other Study ID Numbers: CPKC412A2407I
First Posted: February 2, 2022    Key Record Dates
Last Update Posted: April 4, 2024
Last Verified: April 2024
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
FLT3-mutated AML
AML
Aggressive systemic mastocytosis
Mast cell leukemia
Systemic mastocytosis with an associated hematologic neoplasm
 MAP
Manage access program
PKC412
Midostaurin
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Mastocytosis
Mastocytosis, Systemic
Hematologic Neoplasms
Leukemia, Mast-Cell
Aggression
Neoplasms by Histologic Type
Neoplasms
Hematologic Diseases
Aberrant Motor Behavior in Dementia
 Behavioral Symptoms
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Mast Cell Activation Disorders
Immune System Diseases
Neoplasms by Site
Midostaurin
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action