Clinical trial NCT04243837: 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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Cancer Related Lymphoedema
Lymphoedema
Lead sponsor: PureTech
Sponsor class: INDUSTRY
Collaborators: name: Novotech (Australia) Pty Limited
First posted: 2020-01-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Consists of 1 cohort with 2 arms: active treatment or placebo patients
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Safety and Tolerability: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Los Angeles
country: United States
facility: MACRO Trials
state: California
city: Maitland
country: United States
facility: Accel Research Network
state: Florida
city: Atlanta
country: United States
facility: Accel Research Network
state: Georgia
city: Sippy Downs
country: Australia
facility: University of the Sunshine Coast
state: Queensland
city: Ballarat
country: Australia
facility: Ballarat Health Services
state: Victoria
city: Adelaide
country: Australia
facility: Flinders University
city: Sydney
country: Australia
facility: Macquarie University Health Sciences Centre
Study officials:
References:
citation: 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.