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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
210
Fujita Health University Hospital
Efficacy evaluation:Proportion of participants with peripheral sensory neuropathy (NP)# of Grade 2 or higher by 12 weeks after the start of intervention
Time frame: 12 week
Number of Participants with AE
Time frame: Up to 101 days
Weight
Time frame: Up to 87 days
body temperature
Time frame: Up to 87 days
pulse rate
Time frame: Up to 87 days
blood pressure
Time frame: Up to 87 days
ECG heart rate
Time frame: Up to 87 days
ECG RR interval
Time frame: Up to 87 days
ECG PR interval
Time frame: Up to 87 days
ECG QRS complex
Time frame: Up to 87 days
ECG QT interval
Time frame: Up to 87 days
ECG QTcF
Time frame: Up to 87 days
Hematology
Time frame: Up to 87 days
Clinical chemistry
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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
...and 20 more locations
Time frame: Up to 87 days
Blood coagulation
Time frame: Up to 87 days
Urinalysis
Time frame: Up to 87 days
Pregnancy test
Time frame: Up to 101 days
Viral test
Time frame: baseline