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

NCT ID: NCT06538272

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-31
• Study Completion Date: 2024-09-19

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

ONO-2910

Group Type: EXPERIMENTAL

ONO-2910

Intervention Type: DRUG

ONO-2910 Tablet will be orally administered once daily.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo Tablet will be orally administered once daily.

Interventions

ONO-2910

ONO-2910 Tablet will be orally administered once daily.

Intervention Type: DRUG

Placebo

Placebo Tablet will be orally administered once daily.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients with ECOG Performance Status 0 or 1

2. Patients scheduled to receive 12 consecutive weekly doses of PTX (80 mg/m2, intravenous infusion) as a perioperative treatment of clinical stage I-III breast cancer (concomitant use of trastuzumab and pertuzumab is allowed)

3. Patients who meet the following organ functions according to the laboratory test results at the time of treatment registration.However, blood transfusions and measurements within 7 days after administration of granulocyte colony-stimulating factor (G-CSF) are excluded.

Neutrophil count >= 1,500/mm3, Platelet count >= 75,000/mm3, Hemoglobin >= 10.0 g/dL or >= 6.2 mmol/L, Serum creatinine <= 2.0 mg/dL, Total bilirubin <= 3.0 mg/dL, ALT and AST <= 100 IU/L or less than 2.5 times the facility's upper limit of clinical laboratory test values

Exclusion Criteria

1. Patients with grade 1 or higher peripheral sensory neuropathy, peripheral motor neuropathy, or extremity edema in the upper or lower extremities.

2. Patients with pain or numbness in the upper or lower extremities due to a history/complication, such as stroke, diabetic neuropathy, alcoholic neuropathy, carpal tunnel syndrome, tarsal tunnel syndrome, chronic inflammatory demyelinating polyradiculoneuropathy, Guillain-Barre syndrome, Fisher syndrome, knee osteoarthritis, hernia, cervical spondylosis, lumbar spondylosis, spinal canal stenosis, peripheral circulatory disorders, hand-foot syndrome,etc.

3. Patients who have difficulty in evaluating limb symptoms due to trauma/defects in the upper or lower limbs, or complications such as infectious or inflammatory diseases on the skin of the upper or lower limbs.

4. Patients with concurrent multiple cancers.

5. Patients who have not recovered from toxicity (Grade 1 or less) from prior treatment.

6. Patients who have been administered platinum agents, bortezomib, vinca alkaloids, and taxanes including PTX in the past, and patients who are scheduled to be administered these drugs other than PTX during the study period.

7. Prior treatment other than trastuzumab or pertuzumab (chemotherapy, molecular targeted drug therapy, antibody therapy, hormone therapy, immunotherapy, radiation therapy, etc.) within 7 days before the start of the treatment period (Visit 2) (including the start date of the treatment period) ) was performed.

8. At the beginning of the treatment phase (Visit 2), Patients using peripheral neuropathic pain medications such as pregabalin, mirogabalin, duloxetine, tricyclic and tetracyclic antidepressants, gabapentin, analgesics such as loxoprofen and acetaminophen, vitamin B12 such as mecobalamin, chinese herbal medicines indicated for pain such as goshajinkigan, and opioids such as oxycodone.

9. Patients who plan to receive preventive compression therapy (surgical gloves, elastic stockings, etc.) or preventive cooling therapy for chemotherapy-induced limb adverse events during the study period

10. Patients scheduled for surgery during the study period

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ono Pharmaceutical Co. Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Project Leader

Role: STUDY_DIRECTOR

Ono Pharmaceutical Co. Ltd

Locations

Fujita Health University Hospital

Aichi, , Japan

Nagoya City University Hospital

Aichi, , Japan

Nagoya University Hospital

Aichi, , Japan

Funabashi Municipal Medical Center

Chiba, , Japan

Medical Corporation Tesshokai Kameda Medical Center

Chiba, , Japan

National Cancer Center Hospital East

Chiba, , Japan

Kitakyushu City Hospital Organization Kitakyushu Municipal Medical Center

Fukuoka, , Japan

Gunma Prefectural Cancer Center

Gunma, , Japan

University of Tsukuba Hospital

Ibaraki, , Japan

Social Medical Corporation Hakuaikai Sagara Hospital

Kagoshima, , Japan

Nippon Medical School Musashikosugi Hospital

Kanagawa, , Japan

Tokai University Hospital

Kanagawa, , Japan

Kumamoto Shinto General Hospital

Kumamoto, , Japan

Kumamoto University Hospital

Kumamoto, , Japan

Okayama University Hospital

Okayama, , Japan

Nahanishi Clinic

Okinawa, , Japan

Osaka Breast Clinic

Osaka, , Japan

Osaka Prefectural Hospital Organization Osaka International Cancer Institute

Osaka, , Japan

Osaka Rosai Hospital

Osaka, , Japan

Osaka University Hospital

Osaka, , Japan

Yodogawa Christian Hospital

Osaka, , Japan

Japanese Saitama Red Cross Hospital

Saitama, , Japan

Saitama Medical University International Medical Center

Saitama, , Japan

Shizuoka General Hospital

Shizuoka, , Japan

Center Hospital of the National Center for Global Health and Medicine

Tokyo, , Japan

National Cancer Center Hospital

Tokyo, , Japan

Nippon Medical School Hospital

Tokyo, , Japan

St. Luke's International Hospital

Tokyo, , Japan

Tokyo Metropolitan Komagome Hospital

Tokyo, , Japan

Toranomon Hospital

Tokyo, , Japan

Countries

Japan

Other Identifiers

ONO-2910-03

Identifier Type: -

Identifier Source: org_study_id