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Generated: February 22, 2019

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CLINICAL TRIALS PROFILE FOR THALIDOMIDE

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Clinical Trials for Thalidomide

Trial ID Title Status Sponsor Phase Summary
NCT00000790 Thalidomide for Treatment of Oral and Esophageal Aphthous Ulcers and HIV Viremia in Patients With HIV Infection Completed Andrulis Pharmaceuticals Phase 2 PRIMARY: To evaluate the effectiveness and safety of thalidomide for treatment of oral and esophageal aphthous ulcers (those unrelated to a known infection or malignancy) in patients with advanced HIV disease. To evaluate the effect of thalidomide on HIV load in this patient population. Per 06/28/94 amendment, to evaluate the effectiveness of thalidomide in preventing recurrences in patients whose aphthae completely heal at the end of acute treatment. SECONDARY: To evaluate the effect of thalidomide on blood tumor necrosis factor (TNF) levels and to obtain pharmacokinetic data on the drug. Per 06/28/94 amendment, to evaluate the safety of thalidomide. Per 05/10/95 amendment, to explore in a substudy the effects of thalidomide on idiopathic genital aphthous ulcers in HIV-infected women. Aphthous ulcers of the mouth or esophagus can interfere with eating, resulting in malnutrition and wasting. Thalidomide has been proposed as an effective therapy for severe forms of aphthous ulceration in AIDS patients.
NCT00000790 Thalidomide for Treatment of Oral and Esophageal Aphthous Ulcers and HIV Viremia in Patients With HIV Infection Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 PRIMARY: To evaluate the effectiveness and safety of thalidomide for treatment of oral and esophageal aphthous ulcers (those unrelated to a known infection or malignancy) in patients with advanced HIV disease. To evaluate the effect of thalidomide on HIV load in this patient population. Per 06/28/94 amendment, to evaluate the effectiveness of thalidomide in preventing recurrences in patients whose aphthae completely heal at the end of acute treatment. SECONDARY: To evaluate the effect of thalidomide on blood tumor necrosis factor (TNF) levels and to obtain pharmacokinetic data on the drug. Per 06/28/94 amendment, to evaluate the safety of thalidomide. Per 05/10/95 amendment, to explore in a substudy the effects of thalidomide on idiopathic genital aphthous ulcers in HIV-infected women. Aphthous ulcers of the mouth or esophagus can interfere with eating, resulting in malnutrition and wasting. Thalidomide has been proposed as an effective therapy for severe forms of aphthous ulceration in AIDS patients.
NCT00000812 A Phase I, Placebo-Controlled, Dose-Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Thalidomide in Subjects With HIV-1 Infection Completed Celgene Corporation Phase 1 PRIMARY: To evaluate the safety, tolerability, and pharmacokinetics of daily oral thalidomide. SECONDARY: To examine the effect of thalidomide on antiviral activity and tumor necrosis factor-alpha (TNF-alpha) production, and the correlation between TNF-alpha inhibition and viral burden. A protein in the blood called tumor necrosis factor (TNF-alpha) is abnormally elevated in patients with HIV infection and may cause the body to produce more virus. In vitro studies have demonstrated that thalidomide reduces TNF-alpha levels and inhibits production of HIV. However, more information on the pharmacological and immunological aspects of thalidomide is needed.
NCT00000812 A Phase I, Placebo-Controlled, Dose-Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Thalidomide in Subjects With HIV-1 Infection Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 1 PRIMARY: To evaluate the safety, tolerability, and pharmacokinetics of daily oral thalidomide. SECONDARY: To examine the effect of thalidomide on antiviral activity and tumor necrosis factor-alpha (TNF-alpha) production, and the correlation between TNF-alpha inhibition and viral burden. A protein in the blood called tumor necrosis factor (TNF-alpha) is abnormally elevated in patients with HIV infection and may cause the body to produce more virus. In vitro studies have demonstrated that thalidomide reduces TNF-alpha levels and inhibits production of HIV. However, more information on the pharmacological and immunological aspects of thalidomide is needed.
NCT00001446 A Randomized Phase II Study of Oral Thalidomide in Patients With Hormone-Refractory Prostate Cancer Completed National Cancer Institute (NCI) Phase 2 This is a phase II study designed to evaluate the potential clinical efficacy of thalidomide in patients with hormone-refractory prostate cancer. An important aspect of this study is to characterize the pharmacokinetics of thalidomide, as well as make correlations between the degree of angiogenesis occurring in a patient and the activity of thalidomide.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Thalidomide

Condition Name

Condition Name for Thalidomide
Intervention Trials
Multiple Myeloma 139
Multiple Myeloma and Plasma Cell Neoplasm 19
Myeloma 9
Leukemia 9
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Condition MeSH

Condition MeSH for Thalidomide
Intervention Trials
Multiple Myeloma 180
Neoplasms, Plasma Cell 172
Lymphoma 27
Plasmacytoma 22
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Clinical Trial Locations for Thalidomide

Trials by Country

Trials by Country for Thalidomide
Location Trials
United States 877
China 58
Canada 46
United Kingdom 39
Italy 37
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Trials by US State

Trials by US State for Thalidomide
Location Trials
New York 75
California 41
Arkansas 41
Ohio 40
Texas 40
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Clinical Trial Progress for Thalidomide

Clinical Trial Phase

Clinical Trial Phase for Thalidomide
Clinical Trial Phase Trials
Phase 4 19
Phase 3 77
Phase 2/Phase 3 11
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Clinical Trial Status

Clinical Trial Status for Thalidomide
Clinical Trial Phase Trials
Completed 222
Recruiting 64
Unknown status 51
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Clinical Trial Sponsors for Thalidomide

Sponsor Name

Sponsor Name for Thalidomide
Sponsor Trials
National Cancer Institute (NCI) 98
Celgene Corporation 75
University of Arkansas 30
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Sponsor Type

Sponsor Type for Thalidomide
Sponsor Trials
Other 539
Industry 158
NIH 119
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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Federal Trade Commission
Fuji
Medtronic
Cantor Fitzgerald
Boehringer Ingelheim
Express Scripts
Johnson and Johnson
Deloitte

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