Estramustine

Overview

A nitrogen mustard linked to estradiol, usually as phosphate; used to treat prostatic neoplasms; also has radiation protective properties.

Background

A nitrogen mustard linked to estradiol, usually as phosphate; used to treat prostatic neoplasms; also has radiation protective properties.

Indication

For the palliative treatment of patients with metastatic and/or progressive carcinoma of the prostate

Associated Conditions

Metastatic Prostate Cancer

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Evaluation of the Efficacy of Estramustine in Patient With Breast Cancer Progression After Treatment With Aromatase Inhibitor.	2016/08/15	NCT02866955	Phase 2	Completed	Institut de Cancérologie de Lorraine
Efficacy and Safety of Estracyt® in Metastatic Breast Cancer	2016/08/02	NCT02853071	Phase 2	Withdrawn	Centre Hospitalier Universitaire de Besancon
Hormone Therapy Plus Chemotherapy as Initial Treatment for Local Failures or Advanced Prostate Cancer	2015/09/25	NCT02560051	Phase 2	Terminated	The University of Texas Health Science Center, Houston
Hormonal Therapy and Chemotherapy Followed by Prostatectomy in Patients With Prostate Cancer	2015/07/10	NCT02494713	Phase 2	Terminated	The University of Texas Health Science Center, Houston
Docetaxel Followed by Radical Prostatectomy in Patients With High Risk Localized Prostate Cancer	2010/12/01	NCT01250717	Phase 2	Completed	Beth Israel Deaconess Medical Center
Safety and Efficacy Study of of Docetaxel vs Docetaxel Estramustine in Hormone Refractory Prostatic Cancer	2007/10/10	NCT00541281	Phase 2	Completed	Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Adjuvant Docetaxel and Estramustine Phosphate for High Risk Localized Prostate Cancer	2005/09/19	NCT00193271	Phase 2	Completed	SCRI Development Innovations, LLC
Weekly Paclitaxel, Low-Dose Estramustine, and Carboplatin in the Treatment of Hormone Refractory Prostate Carcinoma	2005/09/19	NCT00193193	Phase 2	Completed	SCRI Development Innovations, LLC
Estramustine, Docetaxel, and Carboplatin for Patients With Hormone Refractory Prostate Cancer Progressing After Mitoxantrone-Based Chemotherapy.	2005/09/16	NCT00183924	Phase 2	Completed	University of Southern California
Isotretinoin, Interferon Alfa-2b, Docetaxel, and Estramustine in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy	2005/09/15	NCT00176527	Phase 2	Terminated	University of Medicine and Dentistry of New Jersey

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Emcyt	Pfizer Laboratories Div Pfizer Inc	0013-0132	ORAL	140 mg in 1 1	2/22/2024

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
Estramustine Phosphate Capsules	Pfizer Italia S.R.L.	国药准字HJ20170266	化学药品	胶囊剂	3/21/2022

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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