Clinical trial · Interventional
PKC412, Daunorubicin, and Cytarabine in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
A Phase IB, Open-Label Study to Determine the Safety and Pharmacokinetics of Twice Daily Oral Dosing of PKC412 Administered in Combinations Sequentially and Concomitantly With Daunorubicin and Cytarabine for Standard Induction Therapy, and High Dose Cytarabine for Consolidation in Patients With Acute Myeloid Leukemia (AML)
- 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)
RATIONALE: PKC412 may stop the growth of cancer cells by blocking the enzymes necessary for their growth. It may also increase the effectiveness of daunorubicin and cytarabine by making cancer cells more sensitive to the drugs. Drugs used in chemotherapy, such as daunorubicin and cytarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining PKC412 with chemotherapy may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best way to give PKC412 when given either after or together with daunorubicin and cytarabine in treating patients with newly diagnosed acute myeloid leukemia.
Conditions
Conditions (1)
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 (AML) | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cytarabine | Drug | Cytarabine | ALIAS |
| daunorubicin hydrochloride | Drug | Daunorubicin | ALIAS |
| midostaurin | Drug | Midostaurin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PKC412 administered sequentially
- description
- twice daily oral dosing of PKC412 administered sequentially
- interventionNames
- Drug: midostaurin
- type
- EXPERIMENTAL
- label
- PKC412 administered concomitantly
- description
- PKC412 administered concomitantly with standard induction daunorubicin and cytarabine therapy followed by high-dose consolidation therapy with cytarabine
- interventionNames
- Drug: cytarabine
- Drug: daunorubicin hydrochloride
- Drug: midostaurin
Primary outcomes (1)
- measure
- Complete Response (CR) rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed acute myeloid leukemia (AML) * Newly diagnosed disease * No history of or newly diagnosed myelodysplastic syndromes, history of myeloproliferative disease, or secondary AML * No CNS malignancy PATIENT CHARACTERISTICS: Age * 18 to 60 Performance status * Karnofsky 70-100% Life expectancy * Not specified Hematopoietic * Not specified Hepatic * AST and ALT ≤ 1.5 times upper limit of normal (ULN) * Bilirubin ≤ 1.5 times ULN * No active viral hepatitis Renal * Creatinine ≤ 1.5 times ULN * No chronic renal disease Cardiovascular * Ejection fraction ≥ 50% by MUGA or echocardiogram * No congestive heart failure * No myocardial infarction within the past 6 months * No poorly controlled hypertension * No other cardiovascular disease Pulmonary * No pulmonary infiltrate, including those suspected to be infectious * Patients with pulmonary infection whose clinical symptoms have resolved are eligible provided there are no residual pulmonary infiltrates on chest x-ray Other * No gastrointestinal impairment or disease that would preclude absorption of study drugs * No uncontrolled diabetes * No active uncontrolled infection * No other disease, except carcinoma in situ, that would preclude study participation * No other severe or uncontrolled medical condition that would preclude study participation * HIV negative * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception during and for 3 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy * At least 5 days since prior growth factors * No concurrent biological response modifiers Chemotherapy * No prior chemotherapy * No other concurrent chemotherapy Endocrine therapy * Not specified Radiotherapy * No prior radiotherapy except radiation castration * No concurrent radiotherapy Surgery * More than 14 days since prior surgical procedure except central venous catheter placement or other minor procedure (e.g., skin biopsy) Other * More than 30 days since prior investigational agents * No other concurrent anticancer agents * No other concurrent investigational drugs
References
Publications (1)
- RESULTStone RM, Fischer T, Paquette R, Schiller G, Schiffer CA, Ehninger G, Cortes J, Kantarjian HM, DeAngelo DJ, Huntsman-Labed A, Dutreix C, del Corral A, Giles F. Phase IB study of the FLT3 kinase inhibitor midostaurin with chemotherapy in younger newly diagnosed adult patients with acute myeloid leukemia. Leukemia. 2012 Sep;26(9):2061-8. doi: 10.1038/leu.2012.115. Epub 2012 Apr 27. PMID 22627678