LYT-100 in Patients With BCRL

Lymphoedema Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04243837
• Other study ID #: LYT-100-2020-US-02
• Status: Terminated
• Phase: Phase 2
• Start date: March 1, 2020
• Est. completion date: September 9, 2022

Study information

• Verified date: April 2022
• Source: PureTech
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: September 9, 2022
• Est. primary completion date: September 9, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Main 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.

Main 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.

Related Conditions & MeSH terms

• Breast Cancer Lymphedema
• Breast Cancer Related Lymphoedema
• Breast Neoplasms
• Lymphedema
• Lymphoedema

Intervention

Drug:
• LYT-100 BCRL
BCRL patients will receive LYT-100 BID for 6 months
• Placebo BCRL
BCRL patients will receive Placebo BID for 6 months

Locations

Country	Name	City	State
Australia	Flinders University	Adelaide
Australia	Ballarat Health Services	Ballarat	Victoria
Australia	University of the Sunshine Coast	Sippy Downs	Queensland
Australia	Macquarie University Health Sciences Centre	Sydney
United States	Accel Research Network	Atlanta	Georgia
United States	City of Hope National Medical Center	Duarte	California
United States	MACRO Trials	Los Angeles	California
United States	Accel Research Network	Maitland	Florida

Sponsors (2)

Lead Sponsor	Collaborator
PureTech	Novotech (Australia) Pty Limited

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability: Number of Participants With Treatment-emergent Adverse Events (TEAEs)	Evaluate the safety and tolerability of LYT-100 as measured by TEAEs	6 months