Cositecan

Overview

Cositecan is the novel camptothecin derivative which is also known as Karenitecin. It has been developed for superior oral bioavailability and increased lactone stability. It is used to treat cancer.

Background

Cositecan is the novel camptothecin derivative which is also known as Karenitecin. It has been developed for superior oral bioavailability and increased lactone stability. It is used to treat cancer.

Indication

Investigated for use/treatment in brain cancer, lung cancer, and melanoma.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Karenitecin Versus Topotecan in Patients With Advanced Epithelial Ovarian Cancer	2007/05/23	NCT00477282	Phase 3	Completed	BioNumerik Pharmaceuticals, Inc.
Phase I/II Trial of Valproic Acid and Karenitecin for Melanoma	2006/07/31	NCT00358319	Phase 1	Terminated	H. Lee Moffitt Cancer Center and Research Institute
Trial of Oral Karenitecin in Patients With Solid Tumors and Lung Cancer	2004/12/02	NCT00097903	Phase 1	Completed	BioNumerik Pharmaceuticals, Inc.
Study of Karenitecin (BNP1350) to Treat Malignant Melanoma	2003/06/12	NCT00062491	Phase 2	Completed	BioNumerik Pharmaceuticals, Inc.
Study of Karenitecin (BNP1350) in Patients With Brain Tumors	2003/06/12	NCT00062478	Phase 2	Completed	BioNumerik Pharmaceuticals, Inc.
Karenitecin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer	2003/02/06	NCT00054119	Phase 2	Completed	Gynecologic Oncology Group
Karenitecin in Treating Patients With Relapsed or Refractory Non-Small Cell Lung Cancer	2003/01/27	NCT00010218	Phase 2	Completed	Alliance for Clinical Trials in Oncology
Karenitecin in Treating Patients With Recurrent Malignant Glioma	2003/01/27	NCT00014521	Phase 1	Completed	National Cancer Institute (NCI)

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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