omacetaxine mepesuccinate

DRUG11 trials

Sponsors

National Cancer Institute (NCI), M.D. Anderson Cancer Center, Teva Branded Pharmaceutical Products R&D, Inc., Roswell Park Cancer Institute, University of Illinois at Chicago

Conditions

Acute Myeloid LeukemiaAcute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic SyndromeAdult Acute Megakaryoblastic Leukemia (M7)Adult Acute Minimally Differentiated Myeloid Leukemia (M0)Adult Acute Monoblastic Leukemia (M5a)Adult Acute Monocytic Leukemia (M5b)Adult Acute Myeloblastic Leukemia With Maturation (M2)Adult Acute Myeloblastic Leukemia Without Maturation (M1)

Phase 1

An Open-Label Study to Investigate the Pharmacokinetics of Omacetaxine Mepesuccinate

CompletedNCT01844869

Teva Branded Pharmaceutical Products R&D, Inc.Hematologic Malignancies, Solid Tumors

Start: 2013-07-31End: 2015-01-31Updated: 2015-01-30

A Study to Evaluate the Pharmacokinetics, Safety,and Efficacy of Omacetaxine Given Subcutaneously as a Fixed Dose in Patients With Chronic Phase (CP) or Accelerated Phase (AP) Chronic Myeloid Leukemia (CML) (Referred to as the SYNSINCT Study)

TerminatedNCT02078960

Teva Branded Pharmaceutical Products R&D, Inc.Chronic Myeloid Leukemia

Start: 2014-10-09End: 2017-11-27Updated: 2021-11-09

AML-02: Omacetaxine With Standard-of-Care Induction With Cytarabine & Idarubicin in Newly-Diagnosed AML Patients

TerminatedNCT02440568

University of Illinois at ChicagoAcute Myeloid Leukemia

Start: 2015-06-05End: 2018-11-30Updated: 2021-07-06

Omacetaxine and Venetoclax for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome Harboring Mutant RUNX1

TerminatedNCT04874194

M.D. Anderson Cancer CenterHematopoietic and Lymphoid Cell Neoplasm, Recurrent Acute Biphenotypic Leukemia, Recurrent Acute Myeloid Leukemia +4

Start: 2021-12-17End: 2024-09-16Updated: 2025-11-03

Phase 2

Homoharringtonine in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia

CompletedNCT00006364

National Cancer Institute (NCI)Childhood Chronic Myelogenous Leukemia, Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Chronic Phase Chronic Myelogenous Leukemia +1

Start: 1999-11-30Updated: 2013-01-23

Homoharringtonine Plus Low-Dose Cytarabine in Treating Patients With Newly Diagnosed Chronic Myelogenous Leukemia in Chronic Phase

CompletedNCT00003694

National Cancer Institute (NCI)Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Chronic Phase Chronic Myelogenous Leukemia

Start: 1999-03-31Updated: 2013-06-05

Chemotherapy and Biological Therapy in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia

CompletedNCT00003239

M.D. Anderson Cancer CenterLeukemia

Start: 1998-03-31End: 2001-10-31Updated: 2012-07-30

Homoharringtonine and Interferon Alfa in Treating Patients With Chronic Myelogenous Leukemia

CompletedNCT00002574

National Cancer Institute (NCI)Leukemia

Start: 1994-09-30Updated: 2013-02-05

Homoharringtonine (Omacetaxine Mepesuccinate) in Treating Patients With Chronic Myeloid Leukemia (CML) With the T315I BCR-ABL Gene Mutation

CompletedNCT00375219

Teva Branded Pharmaceutical Products R&D, Inc.Chronic Myeloid Leukemia

Start: 2006-09-20End: 2013-06-28Updated: 2021-11-15

Open Label Study of Subcutaneous Homoharringtonine (Omacetaxine Mepesuccinate) in Patients With Advanced CML

CompletedNCT00462943

Teva Branded Pharmaceutical Products R&D, Inc.Chronic Myeloid Leukemia

Start: 2007-03-07End: 2013-06-27Updated: 2021-12-28

Omacetaxine Mepesuccinate, Cytarabine, and Decitabine in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia

TerminatedNCT02029417

Roswell Park Cancer InstituteAcute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome, Adult Acute Megakaryoblastic Leukemia (M7), Adult Acute Minimally Differentiated Myeloid Leukemia (M0) +14

Start: 2014-07-31End: 2015-12-31Updated: 2016-05-09

Related Papers

Omacetaxine and venetoclax in relapsed/refractory acute myeloid leukemia or myelodysplastic syndrome with mutant RUNX1.

2025-07-25

Safety and Efficacy of the Addition of the Protein Translation Inhibitor Omacetaxine to Induction with Cytarabine and Idarubicin in Newly Diagnosed AML

Blood2022-11-15

A Safety Study of the Addition of Omacetaxine to the Standard-of-Care Induction Regimen of Cytarabine and Idarubicin in Newly-Diagnosed AML Patients

Blood2018-11-29

Landmark analysis of overall survival (OS) in patients with chronic (CP) or accelerated (AP) phase chronic myeloid leukemia (CML) treated with omacetaxine mepesuccinate.

Journal of Clinical Oncology2014-05-20

Phase 2 study of subcutaneous omacetaxine mepesuccinate after TKI failure in patients with chronic-phase CML with T315I mutation.

2012-08-1599 citations