A Study to Investigate the Safety and Efficacy of Ricolinostat

Sponsor
Beijing 3E-Regenacy Pharmaceuticals Co., Ltd. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05229042
Collaborator
(none)
57
2
26

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
57 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Double blank
Primary Purpose:
Treatment
Official Title:
An Exploratory Study to Investigate the Safety and Efficacy of Ricolinostat for Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Anticipated Study Start Date :
Feb 28, 2022
Anticipated Primary Completion Date :
Jan 28, 2024
Anticipated Study Completion Date :
Apr 28, 2024

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. TEAT [6 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:

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

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

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

    7. Neuropathy of <Grade 4 using the general guideline of grading scales defined in Common Terminology Criteria for Adverse Events (CTCAE; v5.0) .

    8. 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.

    9. 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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

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

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Beijing 3E-Regenacy Pharmaceuticals Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT05229042
    Other Study ID Numbers:
    • BCRG-CN-101
    First Posted:
    Feb 8, 2022
    Last Update Posted:
    Feb 8, 2022
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 8, 2022