A Study of DSP-2033 (Alvocidib) in Patients With Acute Myeloid Leukemia

Phase 1 Completed 10 enrolled Sumitomo Pharma Co., Ltd.

Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is an open label, multi-center, phase 1 study of DSP-2033 (Alvocidib) in combination with cytarabine/mitoxantrone (ACM regimen) or cytarabine/daunorubicin (A+7+3 regimen) in patients with acute myeloid leukemia (AML).

Timeline

Start: 2018-05-15
Primary completion: 2020-03-31
Completion: 2020-03-31

Publications

Ikezoe T, Ando K, Onozawa M, Yamane T, Hosono N, Morita Y, Kiguchi T, Iwasaki H, Miyamoto T, Matsubara K, Sugimoto S, Miyazaki Y, Kizaki M, Akashi K. Phase I study of alvocidib plus cytarabine/mitoxantrone or cytarabine/daunorubicin for acute myeloid leukemia in Japan. Cancer Sci. 2022 Dec;113(12):4258-4266. doi: 10.1111/cas.15458. Epub 2022 Oct 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cytarabine	Small molecule	100 mg/m2	Intravenous
Subject	Cytarabine	Small molecule	300 mg/m2	Intravenous
Subject	Cytarabine	Small molecule	667 mg/m2	Intravenous
Subject	Mitoxantrone	Small molecule	14 mg/m2	Intravenous
Subject	Mitoxantrone	Small molecule	40 mg/m2	Intravenous
Subject	alvocidib	Small molecule	60 mg/m2	Intravenous
Background	Daunorubicin	Small molecule	60 mg/m2	Intravenous

A Study of DSP-2033 (Alvocidib) in Patients With Acute Myeloid Leukemia

Summary

Timeline

Publications

Drugs

Indications