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Generated: March 24, 2019

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CLINICAL TRIALS PROFILE FOR ZILEUTON

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Clinical Trials for Zileuton

Trial ID Title Status Sponsor Phase Summary
NCT00056004 Zileuton in Preventing Lung Cancer in Patients With Bronchial Dysplasia Completed National Cancer Institute (NCI) Phase 2 RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of zileuton may be an effective way to prevent lung cancer in patients who have bronchial dysplasia. PURPOSE: Randomized phase II trial to study the effectiveness of zileuton in preventing lung cancer in patients who have bronchial dysplasia.
NCT00056004 Zileuton in Preventing Lung Cancer in Patients With Bronchial Dysplasia Completed Barbara Ann Karmanos Cancer Institute Phase 2 RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of zileuton may be an effective way to prevent lung cancer in patients who have bronchial dysplasia. PURPOSE: Randomized phase II trial to study the effectiveness of zileuton in preventing lung cancer in patients who have bronchial dysplasia.
NCT00070486 Carboplatin and Gemcitabine Combined With Celecoxib and/or Zileuton in Treating Patients With Advanced Non-Small Cell Lung Cancer Completed National Cancer Institute (NCI) Phase 2 RATIONALE: Drugs used in chemotherapy, such as carboplatin and gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Celecoxib and zileuton may stop the growth of tumor cells by stopping blood flow to the tumor and may block the enzymes necessary for tumor cell growth. Combining chemotherapy with celecoxib and/or zileuton may kill more tumor cells. PURPOSE: Randomized phase II trial to study the effectiveness of combining celecoxib and/or zileuton with carboplatin and gemcitabine in treating patients who have advanced non-small cell lung cancer.
NCT00070486 Carboplatin and Gemcitabine Combined With Celecoxib and/or Zileuton in Treating Patients With Advanced Non-Small Cell Lung Cancer Completed Alliance for Clinical Trials in Oncology Phase 2 RATIONALE: Drugs used in chemotherapy, such as carboplatin and gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Celecoxib and zileuton may stop the growth of tumor cells by stopping blood flow to the tumor and may block the enzymes necessary for tumor cell growth. Combining chemotherapy with celecoxib and/or zileuton may kill more tumor cells. PURPOSE: Randomized phase II trial to study the effectiveness of combining celecoxib and/or zileuton with carboplatin and gemcitabine in treating patients who have advanced non-small cell lung cancer.
NCT00098358 Study of Oral Zileuton in the Treatment of Moderate to Severe Facial Acne Vulgaris Unknown status Critical Therapeutics Phase 2 Tissue inflammation is a major component of the acne disease process. Leukotriene B4 (LTB4) is thought to be a major player in the development of tissue inflammation. Synthesis of LTB4 is controlled by the enzyme 5-lipoxygenase. Zileuton blocks the activity of 5-lipoxygenase. This study will test the safety and efficacy of zileuton in the treatment of facial acne.
NCT00262405 Zileuton for the Treatment of Idiopathic Pulmonary Fibrosis Completed National Institutes of Health (NIH) Phase 2 Open label trial of zileuton compared to azathioprine/prednisone for patients with idiopathic pulmonary fibrosis. Study subjects will undergo a detailed clinical, radiographic, and physiologic assessment at baseline. Subjects will be monitored off treatment for three months for changes in symptoms and physiology. Subjects will then be randomized to six months of treatment with zileuton or azathioprine/prednisone. The primary endpoint of this trial is change in LTB4 levels in bronchoalveolar lavage fluid following six months of treatment. Secondary endpoints are progression free survival, change in dyspnea, change in quality of life, and change in physiology.
NCT00262405 Zileuton for the Treatment of Idiopathic Pulmonary Fibrosis Completed University of Michigan Phase 2 Open label trial of zileuton compared to azathioprine/prednisone for patients with idiopathic pulmonary fibrosis. Study subjects will undergo a detailed clinical, radiographic, and physiologic assessment at baseline. Subjects will be monitored off treatment for three months for changes in symptoms and physiology. Subjects will then be randomized to six months of treatment with zileuton or azathioprine/prednisone. The primary endpoint of this trial is change in LTB4 levels in bronchoalveolar lavage fluid following six months of treatment. Secondary endpoints are progression free survival, change in dyspnea, change in quality of life, and change in physiology.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Zileuton

Condition Name

Condition Name for Zileuton
Intervention Trials
Asthma 6
Tobacco Use Disorder 2
Chronic Myelogenous Leukemia 2
Lung Cancer 2
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Condition MeSH

Condition MeSH for Zileuton
Intervention Trials
Asthma 5
Fibrosis 2
Leukemia, Myeloid 2
Leukemia, Myelogenous, Chronic, BCR-ABL Positive 2
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Clinical Trial Locations for Zileuton

Trials by Country

Trials by Country for Zileuton
Location Trials
United States 75
Brazil 1
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Trials by US State

Trials by US State for Zileuton
Location Trials
Massachusetts 9
California 6
Michigan 5
Minnesota 4
Maryland 4
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Clinical Trial Progress for Zileuton

Clinical Trial Phase

Clinical Trial Phase for Zileuton
Clinical Trial Phase Trials
Phase 4 4
Phase 3 2
Phase 2 7
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Clinical Trial Status

Clinical Trial Status for Zileuton
Clinical Trial Phase Trials
Completed 12
Terminated 5
Recruiting 2
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Clinical Trial Sponsors for Zileuton

Sponsor Name

Sponsor Name for Zileuton
Sponsor Trials
Critical Therapeutics 4
National Cancer Institute (NCI) 4
University of Massachusetts, Worcester 2
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Sponsor Type

Sponsor Type for Zileuton
Sponsor Trials
Other 13
Industry 8
NIH 7
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