Crenolanib in Combination With Sorafenib in Patients With Refractory or Relapsed Hematologic Malignancies
Summary
PRIMARY OBJECTIVE: This is a pilot study to characterize the toxicity profile, to determine the maximum tolerated dose of the combination of crenolanib and sorafenib, and to determine the feasibility of administering these drugs in patients with relapsed or refractory hematologic malignancies, including acute myeloid leukemia (AML), AML with prior myelodysplastic syndrome (MDS), and myeloperoxidase (MPO)-positive mixed phenotype acute leukemia with FLT3-internal tandem duplication (ITD) and tyrosine kinase domain (TKD) mutations. The study will include two phases: * The dose-escalation phase will characterize the dose-limiting toxicities (DLTs) and determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of crenolanib when given in combination with sorafenib. * The dose-expansion cohort will further assess the safety and explore the efficacy of this combination.
Timeline
- Start
- 2015-04-02
- Primary completion
- 2016-10-17
- Completion
- 2016-10-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Crenolanib | Small molecule | — | — |
| Subject | Sorafenib | Small molecule | — | Oral |
| Background | Cytarabine | Small molecule | — | Intrathecal |
| Background | Hydrocortisone | Other / unclassified | — | Intrathecal |
| Background | Leucovorin | Small molecule | — | — |
| Background | Methotrexate | Small molecule | — | Intrathecal |