Elacytarabine

Overview

Elacytarabine is a fatty acid derivative of cytarabine, an approved cytotoxic cancer drug. Cytarabine has limitations such as minimal uptake in solid tumours and is only used to treat leukaemia. Elacytarabine is designed to overcome this limitation and has shown considerable uptake in solid tumour cells. Elacytarabine is a patented new chemical entity of the nucleoside analog class, with improved biological properties and the potential to treat solid tumours such as non-small cell lung cancer, malignant melanoma and ovarian cancer.

Indication

Investigated for use/treatment in leukemia (unspecified) and melanoma.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
The Pharmacokinetics and Cardiac Properties of Elacytarabine (CP-4055)	2010/12/13	NCT01258816	Phase 1	Completed	Clavis Pharma
Study of Elacytarabine Versus Investigator's Choice in Patients With Late Stage Acute Myeloid Leukaemia (AML)	2010/06/22	NCT01147939	Phase 3	Completed	Clavis Pharma
A Study of Elacytarabine (CP-4055) Plus Idarubicin as Second Course Remission-Induction Therapy in Patients With Acute Myeloid Leukaemia	2009/12/18	NCT01035502	Phase 2	Completed	Clavis Pharma
A Phase I/II Study of CP-4055 in Patients With Platinum Resistant Ovarian Cancer	2009/01/29	NCT00831636	Phase 1	Completed	Clavis Pharma
A Phase II Study of CP-4055 as Second Line Therapy in Patients With Advanced Colorectal Cancer	2007/07/10	NCT00498407	Phase 2	Completed	Clavis Pharma
Multicentre, Dose Finding, Ph II,CP-4055 in Comb. With Sorafenib - Patients With Metastatic Malignant Melanoma	2007/07/10	NCT00498836	Phase 2	Completed	Clavis Pharma
A Phase I/II Study of CP-4055 in Patients With Refractory/Relapsed Hematologic Malignancies	2006/11/30	NCT00405743	Phase 1	Completed	Clavis Pharma

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

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