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Omacetaxine

Phase 1

Hematologic Tumors | Small molecule | Oncology |Teva Pharmaceutical Industries Limited|Last Updated: May 12, 2014

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

Omacetaxine · 1 trial · 1 indication

Phase 1 1
NCT00675350Pharmacokinetic (PK) Study of Homoharringtonine (Omacetaxine Mepesuccinate) Administered Subcutaneously to Patients With Advanced Solid and Hematologic TumorsHematologic Tumors
COMPLETED12 Analytics
PHASE1COMPLETED
Pharmacokinetic (PK) Study of Homoharringtonine (Omacetaxine Mepesuccinate) Administered Subcutaneously to Patients With Advanced Solid and Hematologic Tumors
Hematologic TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Pharmacokinetic Evaluation
28 days
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP

Treatment Arms

ArmTypeDescription
HomoharringtonineEXPERIMENTAL -

Interventions

NameTypeDescription
OmacetaxineDRUG1.25 mg/m2 subcutaneous twice daily for 14 days
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Be ≥18 years old. * Be diagnosed with relapsed or refractory leukemia including chronic myelogenous leukemia (CML), acute promyelocytic leukemia (APL), acute myelogenous leukemia (AML), or myelodysplastic syndrome (MDS) * Relapsed defined as reappearance of leukemic blasts ...

Countries:United States
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Frequently asked questions about Omacetaxine

What is Omacetaxine used for?

Omacetaxine is an investigational small molecule being studied for the treatment of hematologic tumors, which are cancers of the blood and bone marrow. It is currently in Phase 1 clinical development and has not been approved by the FDA.

Who makes Omacetaxine?

Omacetaxine is being developed by Teva Pharmaceutical Industries Limited, a company traded on the New York Stock Exchange under the ticker symbol TEVA. The drug is currently in Phase 1 clinical development for hematologic tumors.

What phase is Omacetaxine in?

Omacetaxine is in Phase 1 clinical development. It is an investigational drug being studied for hematologic tumors and has not been approved by the FDA. One Phase 1 trial has been completed.

What clinical trials is Omacetaxine in?

Omacetaxine has one completed clinical trial, NCT00675350, a Phase 1 pharmacokinetic study of homoharringtonine (omacetaxine mepesuccinate) administered subcutaneously to patients with advanced solid and hematologic tumors. The trial enrolled 12 participants in the United States.

Is Omacetaxine the same as Homoharringtonine?

Yes, Omacetaxine is also known as homoharringtonine and omacetaxine mepesuccinate. The clinical trial NCT00675350 refers to the drug as homoharringtonine (omacetaxine mepesuccinate), confirming these names refer to the same investigational drug.