drugset / Trial / NCT01768897
CPI-613, Cytarabine, and Mitoxantrone Hydrochloride in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
Phase 1
Completed
67 enrolled
Wake Forest University Health Sciences
National Cancer Institute (NCI) · collab
NaSingle-groupOpen-labelTreatment
Summary
This phase I trial studies the side effects and best dose of CPI-613 when given together with cytarabine and mitoxantrone hydrochloride in treating patients with relapsed or refractory acute myeloid leukemia. Drugs used in chemotherapy, such as CPI-613, cytarabine and mitoxantrone hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. CPI-613 may help cytarabine and mitoxantrone hydrochloride work better by making cancer cells more sensitive to the drugs
Timeline
- Start
- 2013-01
- Primary completion
- 2016-01
- Completion
- 2016-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CPI-613 | Small molecule | — | Intravenous |
| Background | Cytarabine | Small molecule | — | Intravenous |
| Background | Mitoxantrone | Small molecule | — | Intravenous |
Indications
acute myeloid leukemia with 11q23 abnormalities
acute myeloid leukemia with abnormal bone marrow eosinophils inv(16)(p13q22) or t(16;16)(p13;q22)
acute myeloid leukemia with t(8;21)(q22;q22) translocation
acute myeloid leukemia, del(5q31-q32)
acute myeloid leukemia, t(16;16)(p13.1;q22)
acute promyelocytic leukemia