LYT-100 in Patients With BCRL

NCT04243837 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: LYT-100-2020-US-02
• Study Type: interventional
• Target: 50
• Locations: 2 countries
• Sites: 8

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

Conditions

Breast Cancer Related Lymphoedema; Lymphoedema

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

LYT-100 in patients with BCRL

EXPERIMENTAL

LYT-100 BID for 6 months

Drug: LYT-100 BCRL

Placebo in patients with BCRL

PLACEBO COMPARATOR

Placebo BID for 6 months

Drug: Placebo BCRL

Interventions

LYT-100 BCRL DRUG

BCRL patients will receive LYT-100 BID for 6 months

Also known as: Deupirfenidone

LYT-100 in patients with BCRL

Placebo BCRL DRUG

BCRL patients will receive Placebo BID for 6 months

Also known as: Placebo

Placebo in patients with BCRL

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female or male between 18 and 80 years old (inclusive) at the time of informed consent.
• 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.
• 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.
• 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.
• 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.
• Documented evidence of Stage 1 or 2 lymphedema.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• PureTech: lead
• Novotech (Australia) Pty Limited: collaborator

Study Sites (8)

City of Hope National Medical Center

Duarte, California, 91010, United States

Location

MACRO Trials

Los Angeles, California, 91105, United States

Location

Accel Research Network

Maitland, Florida, 32751, United States

Location

Accel Research Network

Atlanta, Georgia, 30342, United States

Location

University of the Sunshine Coast

Sippy Downs, Queensland, Australia

Location

Ballarat Health Services

Ballarat, Victoria, Australia

Location

Flinders University

Adelaide, Australia

Location

Macquarie University Health Sciences Centre

Sydney, Australia

Location

Related Publications (1)

• 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.

  PMID: 34779583 DERIVED

MeSH Terms

Conditions

Lymphedema

Interventions

pirfenidone

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: PureTech Health, Inc

ckorth@puretechhealth.com

6034982261

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Consists of 1 cohort with 2 arms: active treatment or placebo patients

Study Record Dates

• First Submitted: January 21, 2020
• First Posted: January 28, 2020
• Study Start: March 1, 2020
• Primary Completion: September 9, 2022
• Study Completion: September 9, 2022
• Last Updated: April 23, 2024
• Results First Posted: April 23, 2024

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (4); US (4)