Status:
NO_LONGER_AVAILABLE
Managed Access Programs for PKC412, Midostaurin
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
FMS-Like Tyrosine Kinase 3 (FLT3)-Mutated Acute Myeloid Leukemia
Acute Myeloid Leukemia
Eligibility:
All Genders
18+ years
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 a...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05219266
Last Update
June 28 2024
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