Managed Access Programs for PKC412, Midostaurin

Novartis Pharmaceuticals0 个研究点开始时间: 2022年2月2日最近更新: 2024年6月28日

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

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)

•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.

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