NCT04243837

LYT-100 in Patients With BCRL

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: PureTech · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Breast Cancer Related Lymphoedema
• Lymphoedema

Interventions

Type	Name	Description
DRUG	LYT-100 BCRL	BCRL patients will receive LYT-100 BID for 6 months
DRUG	Placebo BCRL	BCRL patients will receive Placebo BID for 6 months

Timeline

• Start date: 2020-03-01
• Primary completion: 2022-09-09
• Completion: 2022-09-09
• First posted: 2020-01-28
• Last updated: 2024-04-23
• Results posted: 2024-04-23

Locations

8 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study