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Last Updated: December 1, 2020

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CLINICAL TRIALS PROFILE FOR PTI-428

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Clinical Trials for PTI-428

Trial ID Title Status Sponsor Phase Summary
NCT00399113 Safety Study of 188Re-PTI-6D2 in Patients With Metastatic Melanoma Completed Pain Therapeutics Phase 1 The purpose of this first-in-man study is to evaluate the safety of 188Re-PTI-6D2 in patients with metastatic melanoma. All patients will receive a tracer dose of 188Re-PTI-6D2 in order to provide information on how the monoclonal antibody is distributed throughout the body and to assess tumor targeting. No therapeutic dose of radiation will be given in the first study.
NCT00491595 Phase I Clinical Study of Soy Isoflavones in Healthy, Post-Menopausal Women Completed National Cancer Institute (NCI) Phase 1 The purpose of this research study is to examine the safety of specific soy components, known as isoflavones, and to find out what effects (good and bad) these components have on tissues that are sensitive to the hormone estrogen in healthy, post-menopausal women. Isoflavones are compounds that occur naturally in soybeans and can be extracted to put in to capsule form or add to foods. The capsule formulation being used in this study is considered an investigational drug. This research is being done because many scientists believe that isoflavones may play a role in the prevention of some kinds of cancer. While isoflavones have been safely consumed in foods for centuries, we need to know if these soy components are safe to take in higher doses when they are extracted from foods and provided in a supplement form. We plan to test the safety and effects of the soy isoflavones known as genistein, daidzein and glycitein.
NCT00491595 Phase I Clinical Study of Soy Isoflavones in Healthy, Post-Menopausal Women Completed University of North Carolina Phase 1 The purpose of this research study is to examine the safety of specific soy components, known as isoflavones, and to find out what effects (good and bad) these components have on tissues that are sensitive to the hormone estrogen in healthy, post-menopausal women. Isoflavones are compounds that occur naturally in soybeans and can be extracted to put in to capsule form or add to foods. The capsule formulation being used in this study is considered an investigational drug. This research is being done because many scientists believe that isoflavones may play a role in the prevention of some kinds of cancer. While isoflavones have been safely consumed in foods for centuries, we need to know if these soy components are safe to take in higher doses when they are extracted from foods and provided in a supplement form. We plan to test the safety and effects of the soy isoflavones known as genistein, daidzein and glycitein.
NCT00734188 Dose Escalation and Safety Study of 188Re-PTI-6D2 in Patients With Metastatic Melanoma Completed Pain Therapeutics Phase 1 This is an open-label, dose-escalation study to determine the safety, maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) of 188Re-PTI-6D2 in patients with metastatic melanoma.
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for PTI-428

Condition Name

Condition Name for
Intervention Trials
Cystic Fibrosis 4
Healthy Volunteer 3
Alzheimer Disease 3
Metastatic Melanoma 2
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Condition MeSH

Condition MeSH for
Intervention Trials
Cystic Fibrosis 4
Fibrosis 4
Alzheimer Disease 3
Melanoma 2
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Clinical Trial Locations for PTI-428

Trials by Country

Trials by Country for
Location Trials
United States 86
Italy 3
Israel 2
Spain 2
United Kingdom 2
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Trials by US State

Trials by US State for
Location Trials
Texas 7
Florida 5
Arizona 4
Michigan 3
Massachusetts 3
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Clinical Trial Progress for PTI-428

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 3 3
Phase 2 6
Phase 1/Phase 2 1
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Recruiting 13
Completed 6
Not yet recruiting 3
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Clinical Trial Sponsors for PTI-428

Sponsor Name

Sponsor Name for
Sponsor Trials
Proteostasis Therapeutics, Inc. 7
Pain Therapeutics 6
National Institute on Aging (NIA) 2
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Sponsor Type

Sponsor Type for
Sponsor Trials
Industry 18
Other 8
NIH 4
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