LYT-100 in Healthy Volunteers and BCRL - Clinical trial • Breast Cancer Foundation NZ

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LYT-100 in Healthy Volunteers and BCRL

Recruiting
Updated: June 9, 2021

This study is investigating the safety, tolerability and pharmacokinetic (PK) profile of LYT-100 in healthy volunteers and in those with breast cancer-related lymphoedema (BCRL).

This study is investigating the safety, tolerability and pharmacokinetic (PK) profile of LYT-100 in healthy volunteers and in those with breast cancer-related lymphoedema.

Who is it for?

Healthy volunteers

  • Male or female between 18 and 75 years old (inclusive) at the time of screening.
  • In good general health at screening, free from clinically significant unstable medical, surgical or psychiatric illness, at the discretion of the Investigator.

Patients with breast cancer-related lymphoedema

  • Female or male between 18 and 80 years old (inclusive) at the time of informed consent.
  • At least six 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 three 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 three 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 six months since breast cancer surgery, as determined at screening and baseline.
  • Documented evidence of Stage 1 or 2 lymphoedema.
  • Receiving standard of care compression or agreeable to using care compression, or no compression at all = four weeks prior to screening and throughout the study.

Study details

Part 1 is a multiple ascending dose trial in healthy volunteers (HV) of LYT-100 to determine safety, tolerability, and pharmacokinetic (PK) profile under fed conditions.

Part 2 is a single dose safety, tolerability, and PK trial in HV of LYT-100 under fasted conditions.

Part 3 is a trial of up to six-months duration for safety, tolerability, PK, biomarkers and exploratory clinical assessments in breast cancer patients with secondary lymphoedema.

Full trial information

Australia

Flinders University
University of the Sunshine Coast, Sunshine Coast
Macquarie University Health Sciences Centre, Sydney

Contact:

Michael Chen
Christopher Korth

If you think you might be a candidate for this trial, use the contact details supplied, or talk to your doctor.

Want to access a trial that's not in your area? It's not always possible, but if you're interested, email us at intouch@bcf.org.nz

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