A Study to Investigate the Safety and Efficacy of Ricolinostat

NCT05229042 | Completed Phase 1 FDA Drug

• 1 other identifier: BCRG-CN-101
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Peripheral Nervous System Diseases

Outcome Measures

Primary Outcomes (1)

• TEAT

  The primary endpoint is the incidence of treatment-emergent adverse events (TEAEs) during the Treatment period.

  6 months

Study Arms (2)

Active arm

ACTIVE COMPARATOR

Subjects received ricolinostat

Drug: Ricolinostat

Placebo arm

PLACEBO COMPARATOR

Subjects received placebo

Drug: Ricolinostat

Interventions

Ricolinostat DRUG

Oral

Also known as: Placebo

Active arm; Placebo arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to understand the study's purpose and requirements, and able to voluntarily provide informed consent to participate.
• Age ≥ 18 years and \< 70 years at the time of signing the informed consent form (ICF).
• Female patients diagnosed with breast cancer:
• Who have been treated with either docetaxel or paclitaxel.
• Who have a Karnofsky performance status of 70 or more at Screening.
• Who have completed their chemotherapy at least 1 month prior to randomization.
• Neuropathy of \<Grade 4 using the general guideline of grading scales defined in Common Terminology Criteria for Adverse Events (CTCAE; v5.0) .
• 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.
• Able to adhere to the study visit schedule and other protocol requirements.

You may not qualify if:

• Women who are pregnant or lactating.
• Extremely overweight, defined as body mass index (BMI) \> 40 kg/m2.
• Presence of any neuropathy other than CIPN.
• 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.
• Presence of skin conditions in the affected dermatome that, in the judgement of the Investigator, could interfere with evaluation of the neuropathic pain condition.
• Presence of non-CIPN pain that may interfere with study assessments and/or self-evaluation of peripheral neuropathic pain.
• History of alcoholism or drug/chemical abuse within 1 year prior to randomization as judged by the Investigator based on clinical history.
• Opioid use at a dose of ≥ 30 morphine milligram equivalents on 3 or more days a week during the month at Screening.
• The use of cannabidiol (CBD) during the 1 month at Screening.

Sponsors & Collaborators

• Beijing 3E-Regenacy Pharmaceuticals Co., Ltd.: lead

Study Sites (1)

Beijing3ERegenacy

Beijing, China

Location

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Interventions

ricolinostat

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Binhe Xue

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blank
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2022
• First Posted: February 8, 2022
• Study Start: January 1, 2022
• Primary Completion: November 10, 2023
• Study Completion: November 10, 2023
• Last Updated: December 4, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)