Clinical trial · Expanded Access
Managed Access Programs for PKC412, Midostaurin
NCT05219266CI-TRIAL-00078375no longer availableClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this registration is to list Managed Access Programs (MAPs) related to PKC4, Midostaurin.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Aggressive Systemic Mastocytosis | Aggressive Systemic Mastocytosis | ONTOLOGY_EXACT | 0.98 |
| FMS-Like Tyrosine Kinase 3 (FLT3)-Mutated Acute Myeloid Leukemia | — | UNRESOLVED | — |
| Mast Cell Leukemia | Mast Cell Leukemia | ONTOLOGY_EXACT | 0.98 |
| Systemic Mastocytosis With an Associated Hematologic Neoplasm | Systemic Mastocytosis with an Associated Myeloid Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| midostaurin | Drug | Midostaurin | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.