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LYT-100 in Patients With BCRL

NCT04243837 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-04-23

Study results available
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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

Conditions

  • Breast Cancer Related Lymphoedema
  • Lymphoedema

Interventions

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

Sponsors & Collaborators

  • Novotech (Australia) Pty Limited

    collaborator INDUSTRY

  • PureTech

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-03-01
Primary Completion
2022-09-09
Completion
2022-09-09
FDA Drug
Yes

Countries

  • United States
  • Australia

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04243837 on ClinicalTrials.gov