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CompletedNCT06538272Updated Apr 3, 2025

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

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

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Aug 2023, registered Jul 2024).
Phase
Phase 2
Study type
Interventional
Enrollment
210
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • CIPN - Chemotherapy-Induced Peripheral Neuropathy
03

In context

Peripheral Nervous System Diseases

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
210 participants (actual)

Study arms

  • Experimental
    ONO-2910

    Drug: ONO-2910

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugONO-2910

    ONO-2910 Tablet will be orally administered once daily.

  • DrugPlacebo

    Placebo Tablet will be orally administered once daily.

06

What researchers measure

Primary outcomes

  1. 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

  2. Number of Participants with AE

    Time frame: Up to 101 days

  3. Weight

    Time frame: Up to 87 days

  4. body temperature

    Time frame: Up to 87 days

  5. pulse rate

    Time frame: Up to 87 days

  6. blood pressure

    Time frame: Up to 87 days

  7. ECG heart rate

    Time frame: Up to 87 days

  8. ECG RR interval

    Time frame: Up to 87 days

  9. ECG PR interval

    Time frame: Up to 87 days

  10. ECG QRS complex

    Time frame: Up to 87 days

  11. ECG QT interval

    Time frame: Up to 87 days

  12. ECG QTcF

    Time frame: Up to 87 days

  13. Hematology

    Time frame: Up to 87 days

  14. Clinical chemistry

    Time frame: Up to 87 days

  15. Blood coagulation

    Time frame: Up to 87 days

  16. Urinalysis

    Time frame: Up to 87 days

  17. Pregnancy test

    Time frame: Up to 101 days

  18. Viral test

    Time frame: baseline

07

Study locations

30 sites
  • Fujita Health University Hospital
    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
  • 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
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06538272
Lead sponsor
Ono Pharmaceutical Co. Ltd
Responsible party
Sponsor
First posted
Aug 5, 2024
Start date
Aug 31, 2023
Primary completion
Sep 19, 2024
Completion
Sep 19, 2024
Last update
Apr 3, 2025

Study contacts

Project Leader
study director · Ono Pharmaceutical Co. Ltd

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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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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