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This is a double-blind, placebo-controlled study during which patients will receive ricolinostat or placebo.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active arm | Active Comparator | Subjects received ricolinostat |
|
| Placebo arm | Placebo Comparator | Subjects received placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ricolinostat | Drug | Oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| TEAT | The primary endpoint is the incidence of treatment-emergent adverse events (TEAEs) during the Treatment period. | 6 months |
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Inclusion Criteria:
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:
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Binhe Xue | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing3ERegenacy | Beijing | China |
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| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C572255 | ricolinostat |
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