Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04243837




Registration number
NCT04243837
Ethics application status
Date submitted
21/01/2020
Date registered
28/01/2020
Date last updated
23/04/2024

Titles & IDs
Public title
LYT-100 in Patients With BCRL
Scientific 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
Secondary ID [1] 0 0
LYT-100-2020-US-02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer Related Lymphoedema 0 0
Lymphoedema 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LYT-100 BCRL
Treatment: Drugs - Placebo BCRL

Experimental: LYT-100 in patients with BCRL - LYT-100 BID for 6 months

Placebo Comparator: Placebo in patients with BCRL - Placebo BID for 6 months


Treatment: Drugs: LYT-100 BCRL
BCRL patients will receive LYT-100 BID for 6 months

Treatment: Drugs: Placebo BCRL
BCRL patients will receive Placebo BID for 6 months
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and Tolerability: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
6 months

Eligibility
Key inclusion criteria
Main

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
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/09/2022
Sample size
Target
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
University of the Sunshine Coast - Sippy Downs
Recruitment hospital [2] 0 0
Ballarat Health Services - Ballarat
Recruitment hospital [3] 0 0
Flinders University - Adelaide
Recruitment hospital [4] 0 0
Macquarie University Health Sciences Centre - Sydney
Recruitment postcode(s) [1] 0 0
- Sippy Downs
Recruitment postcode(s) [2] 0 0
- Ballarat
Recruitment postcode(s) [3] 0 0
- Adelaide
Recruitment postcode(s) [4] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
PureTech
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Novotech (Australia) Pty Limited
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/ct2/show/NCT04243837
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04243837