Spots Global Cancer Trial Database for LYT-100 in Patients With BCRL
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Trial Identification
Brief Title: LYT-100 in Patients With BCRL
Official Title: A Phase 2a Double-Blind, Placebo-Controlled Study to Determine the Safety, Tolerability, Pharmacokinetics, and Efficacy of Deupirfenidone (LYT-100) in Patients With Breast Cancer-Related Upper Limb Secondary Lymphoedema
Study ID: NCT04243837
Study Description
Brief Summary: This is a trial of up to 6-months duration for safety, tolerability, clinical efficacy assessments, PK and biomarkers analysis in breast carcinoma patients with secondary lymphoedema
Detailed Description: This trial will utilize a randomised, double-blinded, placebo controlled design that will assess the safety, tolerability, and secondarily clinical efficacy of LYT-100 over a period of up to 6-months of dosing in breast carcinoma patients with secondary lymphoedema following sentinel lymph node biopsy and/or axillary node dissection, with or without radiation.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: Yes
Locations
City of Hope National Medical Center, Duarte, California, United States
MACRO Trials, Los Angeles, California, United States
Accel Research Network, Maitland, Florida, United States
Accel Research Network, Atlanta, Georgia, United States
University of the Sunshine Coast, Sippy Downs, Queensland, Australia
Ballarat Health Services, Ballarat, Victoria, Australia
Flinders University, Adelaide, , Australia
Macquarie University Health Sciences Centre, Sydney, , Australia
Contact Details
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