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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ONO-2910 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ONO-2910 | Drug | ONO-2910 Tablet will be orally administered once daily. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Number of Participants with AE | Up to 101 days | |
| Weight | Up to 87 days | |
| body temperature | Up to 87 days | |
| pulse rate | Up to 87 days | |
| blood pressure | Up to 87 days | |
| ECG heart rate | Up to 87 days | |
| ECG RR interval | Up to 87 days | |
| ECG PR interval | Up to 87 days | |
| ECG QRS complex | Up to 87 days | |
| ECG QT interval | Up to 87 days | |
| ECG QTcF | Up to 87 days |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Project Leader | Ono Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujita Health University Hospital | Aichi | Japan | ||||
| Nagoya City University Hospital |
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| Placebo |
| Drug |
Placebo Tablet will be orally administered once daily. |
|
| Hematology | Up to 87 days |
| Clinical chemistry | Up to 87 days |
| Blood coagulation | Up to 87 days |
| Urinalysis | Up to 87 days |
| Pregnancy test | Up to 101 days |
| Viral test | baseline |
| 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 |