Overview

A Study to Investigate the Safety and Efficacy of Ricolinostat

Status:
Not yet recruiting
Trial end date:
2024-04-28
Target enrollment:
0
Participant gender:
All
Summary
This is a double-blind, placebo-controlled study during which patients will receive ricolinostat or placebo.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Beijing 3E-Regenacy Pharmaceuticals Co., Ltd.
Treatments:
Ricolinostat
Criteria
Inclusion Criteria:

1. Able to understand the study's purpose and requirements, and able to voluntarily
provide informed consent to participate.

2. Age ≥ 18 years and < 70 years at the time of signing the informed consent form (ICF).

3. Female patients diagnosed with breast cancer:

1. Who have been treated with either docetaxel or paclitaxel.

2. Who have a Karnofsky performance status of 70 or more at Screening.

3. Who have completed their chemotherapy at least 1 month prior to randomization.

4. Neuropathy of Terminology Criteria for Adverse Events (CTCAE; v5.0) .

5. Women of childbearing potential (WOCBP) must agree to use reliable contraceptive
methods for the duration of the study and for at least 3 months after completing
treatment with study drug. For the purposes of this study, reliable methods of
contraception include abstinence, oral contraceptives, hormonal contraceptive implants
such as Nexplanon, hormonal vaginal ring such as NuvaRing, intrauterine devices in
place for at least 3 months, or barrier methods used in conjunction with spermicide.
To be considered post-menopausal and of non childbearing potential, women less than 60
years with less than 2 years since their last period must have follicle-stimulating
hormone (FSH) > 40 IU/L and estradiol < 20 pg/mL unless on hormone replacement.

6. Able to adhere to the study visit schedule and other protocol requirements.

Exclusion Criteria:

1. Women who are pregnant or lactating.

2. Extremely overweight, defined as body mass index (BMI) > 40 kg/m2.

3. Presence of any neuropathy other than CIPN.

4. Presence of a clinical condition commonly associated with neuropathy that could better
account for the presence of the patient's neuropathy, such as diabetes or a risk
factor for marked B12 deficiency (malabsorption syndrome, atrophic gastritis, strict
vegan diet, etc.), or a megaloblastic (macrocytic) anemia consistent with B12
deficiency.

5. Presence of skin conditions in the affected dermatome that, in the judgement of the
Investigator, could interfere with evaluation of the neuropathic pain condition.

6. Presence of non-CIPN pain that may interfere with study assessments and/or
self-evaluation of peripheral neuropathic pain.

7. History of alcoholism or drug/chemical abuse within 1 year prior to randomization as
judged by the Investigator based on clinical history.

8. Opioid use at a dose of ≥ 30 morphine milligram equivalents on 3 or more days a week
during the month at Screening.

9. The use of cannabidiol (CBD) during the 1 month at Screening.