Sagopilone

Overview

Sagopilone has been used in trials studying the treatment of Melanoma, Neoplasms, CNS Disease, Breast Cancer, and Breast Neoplasms, among others. It is a so-called fully synthetic epothilone and is the first such compound to be in clinical development to combat several forms of cancer. Epothilones are 16-member ring macrolides with antimicrotubule activity that share a similar mechanism of action to the taxanes but have demonstrated potent antiproliferative activity in several different multidrug-resistant and paclitaxel-resistant tumor cell lines in vitro and in vivo.

Indication

No indication information available.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Prevention of Sagopilone-induced Neurotoxicity With Acetyl-L-Carnitine (ALC)	2008/09/11	NCT00751205	Phase 2	Completed	Bayer
Phase II Trial Of ZK-EPO (ZK 219477) (Sagopilone) In Metastatic Melanoma	2008/01/22	NCT00598507	Phase 2	Completed	H. Lee Moffitt Cancer Center and Research Institute
ZK219477 (Sagopilone) in Patients With Breast Cancer and Brain Metastases	2007/07/04	NCT00496379	Phase 2	Terminated	Nancy Lin, MD
Investigation of Mass Balance of the Test Drug and Major Metabolites	2007/02/07	NCT00432302	Phase 1	Completed	Bayer
Epothilone ZK-219477 in Treating Patients With Recurrent Glioblastoma	2007/01/18	NCT00424060	Phase 2	Completed	European Organisation for Research and Treatment of Cancer - EORTC
Epothilone in Recurrent Glioblastoma Patients	2006/11/08	NCT00397072	Phase 2	Completed	Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
A Study of a New Chemotherapy Agent in Combination With Cisplatin to Treat Small Cell Lung Cancer	2006/08/02	NCT00359359	Phase 1	Completed	Bayer
ZK-Epo Given With Prednisone in Patients With Metastatic Androgen-independent Prostate Cancer	2006/07/10	NCT00350051	Phase 2	Completed	Bayer
ZK-Epo Given With Carboplatin in Patients With Recurrent Ovarian Cancer	2006/05/12	NCT00325351	Phase 2	Completed	Bayer
Evaluation of a New Agent for Treatment of Advanced Stage Breast Cancer	2006/04/12	NCT00313248	Phase 2	Completed	Bayer

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.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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