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Trial Title: 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

Condition: CIPN - Chemotherapy-Induced Peripheral Neuropathy

Conditions: Official terms:
Peripheral Nervous System Diseases

Study type: Interventional

Study phase: Phase 2

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Intervention:

Intervention type: Drug
Intervention name: ONO-2910
Description: ONO-2910 Tablet will be orally administered once daily.
Arm group label: ONO-2910

Intervention type: Drug
Intervention name: Placebo
Description: Placebo Tablet will be orally administered once daily.
Arm group label: Placebo

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Fujita Health University Hospital

Address:
City: Aichi
Country: Japan

Facility:
Name: Nagoya City University Hospital

Address:
City: Aichi
Country: Japan

Facility:
Name: Nagoya University Hospital

Address:
City: Aichi
Country: Japan

Facility:
Name: Funabashi Municipal Medical Center

Address:
City: Chiba
Country: Japan

Facility:
Name: Medical Corporation Tesshokai Kameda Medical Center

Address:
City: Chiba
Country: Japan

Facility:
Name: National Cancer Center Hospital East

Address:
City: Chiba
Country: Japan

Facility:
Name: Kitakyushu City Hospital Organization Kitakyushu Municipal Medical Center

Address:
City: Fukuoka
Country: Japan

Facility:
Name: Gunma Prefectural Cancer Center

Address:
City: Gunma
Country: Japan

Facility:
Name: University of Tsukuba Hospital

Address:
City: Ibaraki
Country: Japan

Facility:
Name: Social Medical Corporation Hakuaikai Sagara Hospital

Address:
City: Kagoshima
Country: Japan

Facility:
Name: Nippon Medical School Musashikosugi Hospital

Address:
City: Kanagawa
Country: Japan

Facility:
Name: Tokai University Hospital

Address:
City: Kanagawa
Country: Japan

Facility:
Name: Kumamoto Shinto General Hospital

Address:
City: Kumamoto
Country: Japan

Facility:
Name: Kumamoto University Hospital

Address:
City: Kumamoto
Country: Japan

Facility:
Name: Okayama University Hospital

Address:
City: Okayama
Country: Japan

Facility:
Name: Nahanishi Clinic

Address:
City: Okinawa
Country: Japan

Facility:
Name: Osaka Breast Clinic

Address:
City: Osaka
Country: Japan

Facility:
Name: Osaka Prefectural Hospital Organization Osaka International Cancer Institute

Address:
City: Osaka
Country: Japan

Facility:
Name: Osaka Rosai Hospital

Address:
City: Osaka
Country: Japan

Facility:
Name: Osaka University Hospital

Address:
City: Osaka
Country: Japan

Facility:
Name: Yodogawa Christian Hospital

Address:
City: Osaka
Country: Japan

Facility:
Name: Japanese Saitama Red Cross Hospital

Address:
City: Saitama
Country: Japan

Facility:
Name: Saitama Medical University International Medical Center

Address:
City: Saitama
Country: Japan

Facility:
Name: Shizuoka General Hospital

Address:
City: Shizuoka
Country: Japan

Facility:
Name: Center Hospital of the National Center for Global Health and Medicine