LYT-100 in Patients With BCRL

NCT ID: NCT04243837

Last Updated: 2024-04-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2022-09-09

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.

Conditions

Breast Cancer Related Lymphoedema; Lymphoedema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

LYT-100 in patients with BCRL

LYT-100 BID for 6 months

Group Type: EXPERIMENTAL

LYT-100 BCRL

Intervention Type: DRUG

BCRL patients will receive LYT-100 BID for 6 months

Placebo in patients with BCRL

Placebo BID for 6 months

Group Type: PLACEBO_COMPARATOR

Placebo BCRL

Intervention Type: DRUG

BCRL patients will receive Placebo BID for 6 months

Interventions

LYT-100 BCRL

BCRL patients will receive LYT-100 BID for 6 months

Intervention Type: DRUG

Placebo BCRL

BCRL patients will receive Placebo BID for 6 months

Intervention Type: DRUG

Other Intervention Names

Deupirfenidone; Placebo

Eligibility Criteria

Inclusion Criteria

1. Female or male between 18 and 80 years old (inclusive) at the time of informed consent.

2. At least 6 months since any type of breast cancer surgery (excluding fine needle aspiration biopsy [FNA]), at the time of study screening. No intention to have breast reconstructive surgery, nipple reconstruction and/or tattooing during the course of the study.

3. At least 3 months since completion of all types of treatment for breast cancer, including but not limited to neoadjuvant, radiotherapy, chemotherapy and immunotherapy, at the time of study screening.

4. At least 3 months treatment of stable adjuvant treatment with hormonal or anti-HER2 therapy at the time of screening, with no planned changes to this therapy throughout the duration of the study.

5. Diagnosis of primary breast cancer, and without evidence of recurrence of breast cancer and/or metastasis for at least 6 months since breast cancer surgery, as determined at screening and baseline.

6. Documented evidence of Stage 1 or 2 lymphedema.

7. Receiving standard of care compression or agreeable to using care compression, or no compression at all ≥ 4 weeks prior to screening and throughout the study.

Exclusion Criteria

1. Bilateral lymphoedema or history of bilateral axillary lymph node removal (i.e., sentinel lymph node or axillary lymph node dissection), or primary lymphoedema or lymphatic or vascular malformation, determined at screening.

2. Chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs within 3 months prior to study drug administration; corticosteroids are permitted at the discretion of the PI.

3. Recent history (in the 8 weeks prior to screening) of cellulitis, lymphangitis, dermatitis, necrotizing fasciitis, or current open wounds or sores in the affected extremity.

4. Stage III lymphoedema, or history of clinically diagnosed secondary lymphoedema greater than 4 years, determined at screening.

5. Initiated use of compression or manual lymphatic drainage or other lymphoedema therapies at the start of the study within 4 weeks of the screening visit. Rescreening is allowed following a course of stable compression regimen of > 4 weeks.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novotech (Australia) Pty Limited

INDUSTRY

Sponsor Role: collaborator

PureTech

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

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

Countries

United States; Australia

References

Chen MC, Korth CC, Harnett MD, Elenko E, Lickliter JD. A Randomized Phase 1 Evaluation of Deupirfenidone, a Novel Deuterium-Containing Drug Candidate for Interstitial Lung Disease and Other Inflammatory and Fibrotic Diseases. Clin Pharmacol Drug Dev. 2022 Feb;11(2):220-234. doi: 10.1002/cpdd.1040. Epub 2021 Nov 15.

Reference Type: DERIVED

PMID: 34779583 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

LYT-100-2020-US-02

Identifier Type: -

Identifier Source: org_study_id