A Study to Investigate the Safety and Efficacy of Ricolinostat

An Exploratory Study to Investigate the Safety and Efficacy of Ricolinostat for Chemotherapy-Induced Peripheral Neuropathy (CIPN)

This is a double-blind, placebo-controlled study during which patients will receive ricolinostat or placebo.

Study Overview

• Status: Completed
• Conditions: Peripheral Nervous System Diseases
• Intervention / Treatment: Drug: Ricolinostat

Detailed Description

This is a double-blind, placebo-controlled study during which patients will receive ricolinostat or placebo.

Prior to randomization, patients will participate in the Screening and Baseline assessment period to ensure that they meet study inclusion/exclusion criteria.

Following the Screening and Baseline assessment period, patients who meet entry criteria will be randomized in a 2:1 ratio to receive either ricolinostat or placebo.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing3ERegenacy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 <Grade 4 using the general guideline of grading scales defined in Common 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active arm; Subjects received ricolinostat	Drug: Ricolinostat; Oral; Other Names: Placebo
Placebo Comparator: Placebo arm; Subjects received placebo	Drug: Ricolinostat; Oral; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TEAT	The primary endpoint is the incidence of treatment-emergent adverse events (TEAEs) during the Treatment period.	6 months

Collaborators and Investigators

• Sponsor: Beijing 3E-Regenacy Pharmaceuticals Co., Ltd.
• Investigators: Principal Investigator: Binhe Xue, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): November 10, 2023
• Study Completion (Actual): November 10, 2023

Study Registration Dates

• First Submitted: January 19, 2022
• First Submitted That Met QC Criteria: February 6, 2022
• First Posted (Actual): February 8, 2022

Study Record Updates

• Last Update Posted (Estimated): December 4, 2023
• Last Update Submitted That Met QC Criteria: December 1, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neuromuscular Diseases; Peripheral Nervous System Diseases; Nervous System Diseases; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Histone Deacetylase Inhibitors; Ricolinostat
• Other Study ID Numbers: BCRG-CN-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No