PKC412

DRUG4 trials

Sponsors

Novartis Pharma AG, Novartis Pharmaceuticals, Richard Stone, MD, M.D. Anderson Cancer Center

Conditions

Acute Myeloid LeukemiaLeukemiaMyelodysplastic SyndromeMyelodysplastic Syndromesuntreated FLT3-mutated Acute Myeloid Leukemia

Phase 1

PKC412 in Participants With Acute Myeloid Leukemia or With Myelodysplastic Syndrome (CPKC412A2104 Core); and PKC412 in Participants With Acute Myeloid Leukemia or With Myelodysplastic Syndrome With Either Wild Type or Mutated FMS-like Tyrosine Kinase 3 (FLT3) (CPKC412A2104E1 and CPKC412A2104E2)

CompletedNCT00045942

Novartis PharmaceuticalsAcute Myeloid Leukemia, Myelodysplastic Syndromes

Start: 2002-01-30End: 2008-03-27Updated: 2017-08-11

RAD001 in Combination With PKC412 in Patients With Relapsed, Refractory or Poor Prognosis AML or MDS

Active, not recruitingNCT00819546

Richard Stone, MDAcute Myeloid Leukemia, Myelodysplastic Syndrome

Start: 2009-01-01End: 2026-12-01Target: 29Updated: 2026-03-25

PKC412 and 5-Azacytidine

CompletedNCT01202877

M.D. Anderson Cancer CenterLeukemia

Start: 2011-03-31End: 2015-07-31Updated: 2018-10-16

Phase 2

A phase II, open-label, single arm study to evaluate the safety, efficacy, and pharmacokinetics of twice daily midostaurin (PKC412) combined with standard chemotherapy and as a single agent post-consolidation therapy in children with untreated FLT3-mutated AML

Active, not recruitingCTIS2023-509834-20-00

Novartis Pharma AGuntreated FLT3-mutated Acute Myeloid Leukemia

Start: 2019-03-13Target: 13Updated: 2025-09-18