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
- Conditions
- CIPN - Chemotherapy-Induced Peripheral Neuropathy
- Interventions
- Drug: Placebo
- Registration Number
- NCT06538272
- Lead Sponsor
- Ono Pharmaceutical Co. Ltd
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 210
- Patients with ECOG Performance Status 0 or 1
- 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)
- 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
- Patients with grade 1 or higher peripheral sensory neuropathy, peripheral motor neuropathy, or extremity edema in the upper or lower extremities.
- 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.
- 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.
- Patients with concurrent multiple cancers.
- Patients who have not recovered from toxicity (Grade 1 or less) from prior treatment.
- 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.
- 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.
- 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.
- 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
- Patients scheduled for surgery during the study period
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ONO-2910 ONO-2910 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method ECG QTcF Up to 87 days Pregnancy test Up to 101 days body temperature Up to 87 days Efficacy evaluation：Proportion of participants with peripheral sensory neuropathy (NP)# of Grade 2 or higher by 12 weeks after the start of intervention 12 week Weight Up to 87 days pulse rate Up to 87 days ECG RR interval Up to 87 days Number of Participants with AE Up to 101 days ECG PR interval Up to 87 days Hematology Up to 87 days Urinalysis Up to 87 days ECG QRS complex Up to 87 days ECG heart rate Up to 87 days Clinical chemistry Up to 87 days blood pressure Up to 87 days ECG QT interval Up to 87 days Blood coagulation Up to 87 days Viral test baseline
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (30)
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
Social Medical Corporation Hakuaikai Sagara Hospital
🇯🇵Kagoshima, Japan
Nippon Medical School Musashikosugi Hospital
🇯🇵Kanagawa, Japan
Kumamoto Shinto General Hospital
🇯🇵Kumamoto, Japan
Okayama University Hospital
🇯🇵Okayama, Japan
Nahanishi Clinic
🇯🇵Okinawa, Japan
Osaka Rosai Hospital
🇯🇵Osaka, Japan
Osaka University Hospital
🇯🇵Osaka, Japan
Japanese Saitama Red Cross Hospital
🇯🇵Saitama, Japan
Yodogawa Christian Hospital
🇯🇵Osaka, 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
Saitama Medical University International Medical Center
🇯🇵Saitama, Japan
Nippon Medical School Hospital
🇯🇵Tokyo, Japan
St. Luke's International Hospital
🇯🇵Tokyo, Japan
Toranomon Hospital
🇯🇵Tokyo, Japan
Osaka Breast Clinic
🇯🇵Osaka, Japan
Osaka Prefectural Hospital Organization Osaka International Cancer Institute
🇯🇵Osaka, Japan
Tokyo Metropolitan Komagome Hospital
🇯🇵Tokyo, Japan
Kumamoto University Hospital
🇯🇵Kumamoto, Japan
Tokai University Hospital
🇯🇵Kanagawa, Japan
Fujita Health University Hospital
🇯🇵Aichi, Japan
University of Tsukuba Hospital
🇯🇵Ibaraki, Japan