Ketoconazole

Generic Name: Ketoconazole

Brand Names: Extina, Ketodan, Ketoderm, Nizoral, Xolegel, Ketoconazole HRA

Drug Type: Small Molecule

Chemical Formula: C_₂₆H_₂₈Cl_₂N_₄O_₄

CAS Number: 65277-42-1

Unique Ingredient Identifier: R9400W927I

Background: Ketoconazole is an imidazole antifungal agent used in the prevention and treatment of a variety of fungal infections. It functions by preventing the synthesis of ergosterol, the fungal equivalent of cholesterol, thereby increasing membrane fluidity and preventing growth of the fungus. Ketoconazole was first approved in an oral formulation for systemic use by...

Indication: Ketoconazole is used in the treatment or prevention of fungal infections including blastomycosis, candidiasis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis. In Europe, it is also used in the treatment of endogenous Cushing's syndrome.

Associated Conditions: Bacterial Vaginosis (BV), Blastomycosis, Candidiasis, Systemic, Chromoblastomycosis, Chronic Mucocutaneous Candidiasis (CMC), Coccidioidomycosis, Dandruff, Endogenous Cushing's Syndrome, Fungal Infections, Histoplasmosis, Paracoccidioidomycosis, Seborrheic Dermatitis, Tinea Corporis caused by Epidermophyton floccosumin, Tinea Corporis caused by Trichophyton mentagrophytes, Tinea Corporis caused by Trichophyton rubrum, Tinea Cruris caused by Epidermophyton floccosumin, Tinea Cruris caused by Trichophyton mentagrophytes, Tinea Cruris caused by Trichophyton rubrum, Tinea Pedis caused by Epidermophyton floccosumin, Tinea Pedis caused by Trichophyton mentagrophytes, Tinea Pedis caused by Trichophyton rubrum, Vaginal Candidiasis, Vulvovaginal Candidiasis, Cutaneous candidiasis, Recalcitrant Dermatophytosis, Tinea versicolor caused by Malassezia infection

Associated Therapies: -

Clinical Trials

Carboxyamidotriazole and Ketoconazole in Treating Patients With Advanced Cancers

Phase 1

Completed

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Interventions: Drug: carboxyamidotriazole
Drug: chemotherapy
Drug: ketoconazole

First Posted Date: 2004-06-03

Last Posted Date: 2013-02-07

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 30

Registration Number: NCT00003249

Locations: 🇺🇸
University of Chicago Cancer Research Center, Chicago, Illinois, United States

Combination Chemotherapy With Ketoconazole in Treating Patients With Prostate Cancer

Phase 2

Completed

Conditions: Prostate Cancer

Interventions: Drug: Estramustine phosphate sodium
Drug: Doxorubicin Hydrochloride
Drug: Etoposide
Drug: Paclitaxel
Drug: Ketoconazole
Drug: Vinblastine

First Posted Date: 2004-05-24

Last Posted Date: 2012-07-30

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 75

Registration Number: NCT00003084

Locations: 🇺🇸
University of Texas - MD Anderson Cancer Center, Houston, Texas, United States

A Phase II Trial of Early Medical Adrenalectomy for "D0.5" Prostate Cancer

Phase 2

Terminated

Conditions: Prostate Cancer

Interventions: Drug: aminoglutethimide
Drug: ketoconazole
Drug: therapeutic hydrocortisone

First Posted Date: 2004-04-02

Last Posted Date: 2012-09-27

Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Target Recruit Count: 2

Registration Number: NCT00006371

Locations: 🇺🇸
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States

Combination Chemotherapy Plus Warfarin in Treating Patients With Prostate Cancer

Phase 2

Completed

Conditions: Prostate Cancer
Thromboembolism

First Posted Date: 2003-11-13

Last Posted Date: 2013-01-16

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Registration Number: NCT00014352

Locations: 🇺🇸
Memorial Sloan-Kettering Cancer Center, New York, New York, United States

Hormone Therapy Plus Chemotherapy in Treating Patients With Prostate Cancer

Phase 3

Completed

Conditions: Prostate Cancer

Interventions: Drug: bicalutamide
Drug: docetaxel
Drug: doxorubicin hydrochloride
Drug: estramustine phosphate sodium
Drug: flutamide
Drug: ketoconazole
Drug: paclitaxel
Drug: releasing hormone agonist therapy
Drug: vinblastine sulfate

First Posted Date: 2003-01-27

Last Posted Date: 2020-10-22

Lead Sponsor: Radiation Therapy Oncology Group

Target Recruit Count: 21

Registration Number: NCT00030654

Locations: 🇺🇸
Veterans Affairs Outpatient Clinic - Martinez, Martinez, California, United States
🇺🇸
Penrose Cancer Center at Penrose Hospital, Colorado Springs, Colorado, United States
🇺🇸
Hope Cancer Care Center at Longmont United Hospital, Longmont, Colorado, United States

and more 75 locations

Chemotherapy With or Without Strontium-89 in Treating Patients With Prostate Cancer

Phase 3

Terminated

Conditions: Prostate Cancer

Interventions: Drug: Doxorubicin hydrochloride
Drug: Docetaxel
Radiation: Strontium chloride Sr 89
Drug: Estramustine phosphate sodium
Drug: Prednisone
Drug: Ketoconazole
Drug: Dexamethasone
Drug: Vinblastine

First Posted Date: 2003-01-27

Last Posted Date: 2016-03-22

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 265

Registration Number: NCT00024167

Locations: 🇺🇸
Siouxland Hematology-Oncology Associates, LLP, Sioux City, Iowa, United States
🇺🇸
St. Luke's Regional Medical Center, Sioux City, Iowa, United States
🇺🇸
University of Mississippi Cancer Clinic, Jackson, Mississippi, United States

and more 36 locations

Hormone Therapy Compared With Combination Chemotherapy in Treating Patients With Prostate Cancer

Phase 3

Completed

Conditions: Prostate Cancer

First Posted Date: 2003-01-27

Last Posted Date: 2023-06-15

Lead Sponsor: Eastern Cooperative Oncology Group

Registration Number: NCT00027859

Locations: 🇺🇸
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center, Los Angeles, California, United States
🇺🇸
Veterans Affairs Outpatient Clinic - Martinez, Martinez, California, United States
🇺🇸
Abramson Cancer Center at the University of Pennsylvania, Philadelphia, Pennsylvania, United States

and more 95 locations

Chemotherapy Plus Hormone Therapy Versus Androgen Suppression in Treating Patients With Metastatic or Unresectable Prostate Cancer

Phase 3

Completed

Conditions: Prostate Cancer

Interventions: Drug: Bicalutamide
Drug: Doxorubicin hydrochloride
Drug: Estramustine Phosphate Sodium
Drug: Flutamide
Drug: Nilutamide
Drug: Ketoconazole
Procedure: Conventional Surgery
Drug: Therapeutic Hydrocortisone
Drug: Vinblastine

First Posted Date: 2003-01-27

Last Posted Date: 2018-10-31

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 306

Registration Number: NCT00002855

Locations: 🇺🇸
University of Texas - MD Anderson Cancer Center, Houston, Texas, United States

A Comparison of Fluconazole and Ketoconazole in the Treatment of Fungal Infections of the Throat in Patients With Weakened Immune Systems

Not Applicable

Completed

Conditions: Candidiasis, Esophageal
HIV Infections

First Posted Date: 2001-08-31

Last Posted Date: 2005-06-24

Lead Sponsor: Pfizer

Registration Number: NCT00002304

Locations: 🇺🇸
Eisenhower Med Ctr, Rancho Mirage, California, United States
🇺🇸
Univ Hosp, Boston, Massachusetts, United States
🇺🇸
Buckley Braffman Stern Med Associates, Philadelphia, Pennsylvania, United States

and more 39 locations

Acute Respiratory Distress Syndrome Clinical Network (ARDSNet)

Phase 3

Completed

Conditions: Respiratory Distress Syndrome, Adult
Lung Diseases

First Posted Date: 1999-10-28

Last Posted Date: 2016-03-23

Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Registration Number: NCT00000579

Locations: 🇺🇸
Baystate Medical Center, Springfield, Massachusetts, United States
🇺🇸
Duke University, Durham, North Carolina, United States
🇺🇸
Wake Forest University, Winston-Salem, North Carolina, United States

and more 18 locations

Drug Development Updates

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