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: July 6, 2020

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.

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.

For full trial information

Australia

Nucleus Network, Melbourne

Contact:

LuAnn Sabounjian

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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