A Phase 2 interventional study of ONO-2910 and Placebo in CIPN - Chemotherapy-Induced Peripheral Neuropathy, sponsored by Ono Pharmaceutical Co. Ltd. Completed at 30 sites in Japan. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-04-03.
Sponsored by Ono Pharmaceutical Co. Ltd · Phase 2, Interventional, and Prevention
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.
1,003 studies on the registry are indexed under Peripheral Nervous System Diseases; 177 are open to participants now.
This study's enrollment of 210 is above the median of 60 across 768 interventional studies indexed under Peripheral Nervous System Diseases.
Browse Peripheral Nervous System Diseases studies →Ono Pharmaceutical Co. Ltd is the lead sponsor of 66 studies on the registry; 3 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
Drug: ONO-2910
Drug: Placebo
ONO-2910 Tablet will be orally administered once daily.
Placebo Tablet will be orally administered once daily.
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
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
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Peripheral Nervous System Diseases→
Ono Pharmaceutical Co. Ltd