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

NCT06538272 | Completed Phase 2

• 1 other identifier: ONO-2910-03
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 30

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.

Conditions

CIPN - Chemotherapy-Induced Peripheral Neuropathy

Outcome Measures

Primary Outcomes (18)

• 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

• 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

Study Arms (2)

ONO-2910

EXPERIMENTAL

Drug: ONO-2910

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ONO-2910 DRUG

ONO-2910 Tablet will be orally administered once daily.

ONO-2910

Placebo DRUG

Placebo Tablet will be orally administered once daily.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ono Pharmaceutical Co. Ltd: lead

Study Sites (30)

Fujita Health University Hospital

Aichi, Japan

Location

Nagoya City University Hospital

Aichi, Japan

Location

Nagoya University Hospital

Aichi, Japan

Location

Funabashi Municipal Medical Center

Chiba, Japan

Location

Medical Corporation Tesshokai Kameda Medical Center

Chiba, Japan

Location

National Cancer Center Hospital East

Chiba, Japan

Location

Kitakyushu City Hospital Organization Kitakyushu Municipal Medical Center

Fukuoka, Japan

Location

Gunma Prefectural Cancer Center

Gunma, Japan

Location

University of Tsukuba Hospital

Ibaraki, Japan

Location

Social Medical Corporation Hakuaikai Sagara Hospital

Kagoshima, Japan

Location

Nippon Medical School Musashikosugi Hospital

Kanagawa, Japan

Location

Tokai University Hospital

Kanagawa, Japan

Location

Kumamoto Shinto General Hospital

Kumamoto, Japan

Location

Kumamoto University Hospital

Kumamoto, Japan

Location

Okayama University Hospital

Okayama, Japan

Location

Nahanishi Clinic

Okinawa, Japan

Location

Osaka Breast Clinic

Osaka, Japan

Location

Osaka Prefectural Hospital Organization Osaka International Cancer Institute

Osaka, Japan

Location

Osaka Rosai Hospital

Osaka, Japan

Location

Osaka University Hospital

Osaka, Japan

Location

Yodogawa Christian Hospital

Osaka, Japan

Location

Japanese Saitama Red Cross Hospital

Saitama, Japan

Location

Saitama Medical University International Medical Center

Saitama, Japan

Location

Shizuoka General Hospital

Shizuoka, Japan

Location

Center Hospital of the National Center for Global Health and Medicine

Tokyo, Japan

Location

National Cancer Center Hospital

Tokyo, Japan

Location

Nippon Medical School Hospital

Tokyo, Japan

Location

St. Luke's International Hospital

Tokyo, Japan

Location

Tokyo Metropolitan Komagome Hospital

Tokyo, Japan

Location

Toranomon Hospital

Tokyo, Japan

Location

Study Officials

• Project Leader

  Ono Pharmaceutical Co. Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: August 5, 2024
• Study Start: August 31, 2023
• Primary Completion: September 19, 2024
• Study Completion: September 19, 2024
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

JP (30)