A phase IB, open-label study to determine the safety and pharmacokinetics of twice daily oral dosing of PKC412 [midostaurin]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).
Phase of Trial: Phase I
Latest Information Update: 23 Mar 2015
At a glance
- Drugs Midostaurin (Primary) ; Cytarabine; Daunorubicin
- Indications Acute myeloid leukaemia
- Focus Pharmacokinetics; Therapeutic Use
- 10 Jun 2017 Biomarkers information updated
- 05 Jun 2013 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
- 24 Dec 2009 Planned number of patients changed from 52 to 70 as reported by M.D. Anderson Cancer Center.