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Bicalutamide

Generic Name
Bicalutamide
Brand Names
Casodex
Drug Type
Small Molecule
Chemical Formula
C18H14F4N2O4S
CAS Number
90357-06-5
Unique Ingredient Identifier
A0Z3NAU9DP
Background

Bicalutamide is an oral non-steroidal anti-androgen for prostate cancer. It is comprised of a racemic mixture that is a 50:50 composition of the (R)-bicalutamide and (S)-bicalutamide enantionmers. Bicalutamide binds to the androgen receptor.

Indication

Bicalutamide is indicated in combination with a luteinizing hormone-releasing hormone (LHRH) agonist for the treatment of Stage D2 metastatic carcinoma of the prostate.

Associated Conditions
Metastatic stage D2 Prostatic carcinoma
Associated Therapies
-

TAK-700 in Castration Resistant Prostate Cancer

Phase 2
Withdrawn
Conditions
Prostate Cancer
Interventions
First Posted Date
2012-08-07
Last Posted Date
2016-06-10
Lead Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Registration Number
NCT01658527
Locations
🇧🇪

Cliniques Universitaires Saint-Luc, Brussels, Belgium

🇧🇪

Onze Lieve Vrouw Ziekenhuis, Aals, Belgium

🇧🇪

AZ Groeninge Kortrijk - Campus Vercruysselaan, Kortrijck, Belgium

and more 1 locations

Feasibility of Hormones and Radiation for Intermediate or High Risk Prostate Cancer

Not Applicable
Active, not recruiting
Conditions
Prostate Cancer
Interventions
First Posted Date
2011-04-27
Last Posted Date
2024-05-24
Lead Sponsor
University of Chicago
Target Recruit Count
74
Registration Number
NCT01342367
Locations
🇺🇸

University of Chicago, Chicago, Illinois, United States

A Study of Enzalutamide Versus Bicalutamide in Castrate Men With Metastatic Prostate Cancer

Phase 2
Completed
Conditions
Prostatic Neoplasms
Interventions
First Posted Date
2011-02-03
Last Posted Date
2024-12-06
Lead Sponsor
Astellas Pharma Inc
Target Recruit Count
375
Registration Number
NCT01288911
Locations
🇷🇴

Site RO3042, Bucharest, RO, Romania

🇷🇴

Site RO3039, Bucharest, RO, Romania

🇷🇴

Site RO3035, Bucharest, Romania

and more 85 locations

Bicalutamide With or Without Akt Inhibitor MK2206 in Treating Patients With Previously Treated Prostate Cancer

Phase 2
Active, not recruiting
Conditions
Stage IIA Prostate Cancer AJCC v7
Recurrent Prostate Carcinoma
Stage I Prostate Cancer AJCC v7
Stage IIB Prostate Cancer AJCC v7
Stage III Prostate Cancer AJCC v7
Interventions
Drug: Akt Inhibitor MK2206
Drug: Bicalutamide
Other: Clinical Observation
Other: Laboratory Biomarker Analysis
First Posted Date
2010-12-02
Last Posted Date
2025-01-03
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
108
Registration Number
NCT01251861
Locations
🇺🇸

Bixby Medical Center, Adrian, Michigan, United States

🇺🇸

Hickman Cancer Center, Adrian, Michigan, United States

🇺🇸

Michigan Cancer Research Consortium NCORP, Ann Arbor, Michigan, United States

and more 195 locations

Docetaxel Followed by Radical Prostatectomy in Patients With High Risk Localized Prostate Cancer

Phase 2
Completed
Conditions
Prostate Cancer
Interventions
First Posted Date
2010-12-01
Last Posted Date
2014-02-04
Lead Sponsor
Beth Israel Deaconess Medical Center
Target Recruit Count
28
Registration Number
NCT01250717
Locations
🇺🇸

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

Bicalutamide and RO4929097 in Treating Patients With Previously Treated Prostate Cancer

Phase 2
Terminated
Conditions
Recurrent Prostate Cancer
Stage IV Prostate Cancer
Adenocarcinoma of the Prostate
Interventions
Other: placebo
Drug: gamma-secretase/Notch signalling pathway inhibitor RO4929097
Drug: bicalutamide
First Posted Date
2010-09-14
Last Posted Date
2017-12-02
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
10
Registration Number
NCT01200810
Locations
🇺🇸

Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States

Bicalutamide and Goserelin or Leuprolide Acetate With or Without Cixutumumab in Treating Patients With Newly Diagnosed Metastatic Prostate Cancer

Phase 2
Completed
Conditions
Recurrent Prostate Carcinoma
Stage IV Prostate Cancer
Prostate Adenocarcinoma
Interventions
Drug: Bicalutamide
Biological: Cixutumumab
Drug: Goserelin Acetate
Other: Laboratory Biomarker Analysis
Drug: Leuprolide Acetate
Other: Pharmacological Study
First Posted Date
2010-05-10
Last Posted Date
2018-02-26
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
211
Registration Number
NCT01120236
Locations
🇺🇸

Fairbanks Memorial Hospital, Fairbanks, Alaska, United States

🇺🇸

University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States

🇺🇸

Highlands Oncology Group-Rogers, Rogers, Arkansas, United States

and more 167 locations

Bicalutamide and Raloxifene in Treating Patients With Metastatic or Hormone-Refractory Prostate Cancer

Early Phase 1
Completed
Conditions
Stage IV Prostate Cancer
Prostate Cancer
Hormone-resistant Prostate Cancer
Adenocarcinoma of the Prostate
Interventions
Drug: bicalutamide
Drug: raloxifene
Procedure: quality-of-life assessment
First Posted Date
2010-01-15
Last Posted Date
2017-03-23
Lead Sponsor
Mayo Clinic
Target Recruit Count
18
Registration Number
NCT01050842
Locations
🇺🇸

Mayo Clinic In Arizona, Scottsdale, Arizona, United States

Bioequivalence Study of Bicalutamide 50 mg Tablet and Casodex® 50 mg Tablet in Healthy Subjects Under Fed Conditions

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2010-01-08
Last Posted Date
2010-03-02
Lead Sponsor
Kremers Urban Development Company
Target Recruit Count
60
Registration Number
NCT01044706
Locations
🇨🇦

SFBC Anapharm, sainte-Foy, Quebec, Canada

Study of Bicalutamide 1 x 50 mg Tablet in Healthy Subjects Under Fasting Conditions

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2009-09-09
Last Posted Date
2009-09-09
Lead Sponsor
Teva Pharmaceuticals USA
Target Recruit Count
60
Registration Number
NCT00973050
Locations
🇨🇦

Anapharm Inc., Sainte-Foy, Quebec, Canada

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