Study to Investigate the Chemotherapy-Induced Peripheral Neuropathy (CIPN) Onset-Suppressing Effect and Safety of ONO-2910 in Patients With Breast Cancer Receiving Weekly Paclitaxel
NCT06538272 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 210
Last updated 2025-04-03
Summary
To investigate the safety and CIPN onset-suppressing effect of ONO-2910 in participants receiving paclitaxel (PTX) weekly as chemotherapy for breast cancer in Japan.
Conditions
- CIPN - Chemotherapy-Induced Peripheral Neuropathy
Interventions
- DRUG
-
ONO-2910
ONO-2910 Tablet will be orally administered once daily.
- DRUG
-
Placebo Tablet will be orally administered once daily.
Sponsors & Collaborators
-
Ono Pharmaceutical Co. Ltd
lead INDUSTRY
Principal Investigators
-
Project Leader · Ono Pharmaceutical Co. Ltd
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-08-31
- Primary Completion
- 2024-09-19
- Completion
- 2024-09-19
Countries
- Japan
Study Locations
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