CIPN - Chemotherapy-Induced Peripheral NeuropathyPhase 2NCT06538272
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 study testing ONO-2910 in people with CIPN - Chemotherapy-Induced Peripheral Neuropathy, run by Ono Pharmaceutical Co., Ltd. at 30 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- CIPN - Chemotherapy-Induced Peripheral Neuropathy
- What is being tested?
- ONO-2910
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 30 sitesJapan
- Study dates
- 31 Aug 2023to 19 Sep 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
Japan30 sites
Fujita Health University Hospital
Aichi
Nagoya City University Hospital
Aichi
Nagoya University Hospital
Aichi
Funabashi Municipal Medical Center
Chiba
Medical Corporation Tesshokai Kameda Medical Center
Chiba
National Cancer Center Hospital East
Chiba
Kitakyushu City Hospital Organization Kitakyushu Municipal Medical Center
Fukuoka
Gunma Prefectural Cancer Center
Gunma
University of Tsukuba Hospital
Ibaraki
Social Medical Corporation Hakuaikai Sagara Hospital
Kagoshima
Nippon Medical School Musashikosugi Hospital
Kanagawa
Tokai University Hospital
Kanagawa
Kumamoto Shinto General Hospital
Kumamoto
Kumamoto University Hospital
Kumamoto
Okayama University Hospital
Okayama
Nahanishi Clinic
Okinawa
Osaka Breast Clinic
Osaka
Osaka Prefectural Hospital Organization Osaka International Cancer Institute
Osaka
Osaka Rosai Hospital
Osaka
Osaka University Hospital
Osaka
Yodogawa Christian Hospital
Osaka
Japanese Saitama Red Cross Hospital
Saitama
Saitama Medical University International Medical Center
Saitama
Shizuoka General Hospital
Shizuoka
Center Hospital of the National Center for Global Health and Medicine
Tokyo
National Cancer Center Hospital
Tokyo
Nippon Medical School Hospital
Tokyo
St. Luke's International Hospital
Tokyo
Tokyo Metropolitan Komagome Hospital
Tokyo
Toranomon Hospital
Tokyo
About this study
Official title: An Early Phase II, Multicenter, Placebo-Controlled, Randomized, Double-Blind, Parallel-Group, Comparison 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
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.
- Being tested
- ONO-2910, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONO-2910Drug
ONO-2910 Tablet will be orally administered once daily.
PlaceboDrug
Placebo Tablet will be orally administered once daily.
| Study group | Role | What they receive |
|---|---|---|
| ONO-2910 | Experimental | Not described Receives: Drug: ONO-2910 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy evaluation：Proportion of participants with peripheral sensory neuropathy (NP)# of Grade 2 or higher by 12 weeks after the start of intervention
Measured: 12 week
Number of Participants with AE
Measured: Up to 101 days
Weight
Measured: Up to 87 days
body temperature
Measured: Up to 87 days
pulse rate
Measured: Up to 87 days
blood pressure
Measured: Up to 87 days
ECG heart rate
Measured: Up to 87 days
ECG RR interval
Measured: Up to 87 days
ECG PR interval
Measured: Up to 87 days
ECG QRS complex
Measured: Up to 87 days
ECG QT interval
Measured: Up to 87 days
ECG QTcF
Measured: Up to 87 days
Hematology
Measured: Up to 87 days
Clinical chemistry
Measured: Up to 87 days
Blood coagulation
Measured: Up to 87 days
Urinalysis
Measured: Up to 87 days
Pregnancy test
Measured: Up to 101 days
Viral test
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start31 Aug 2023
- Primary completion19 Sep 2024
- Study completion19 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CIPN - Chemotherapy-Induced Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by Ono Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Project Leader, Study director, Ono Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06538272
- Sponsor's protocol ID
- ONO-2910-03
- Status last verified
- Mar 2025
- First submitted
- 24 Jul 2024
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Early Phase II, Multicenter, Placebo-Controlled, Randomized, Double-Blind, Parallel-Group, Comparison 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
- ClinicalTrials.gov ID
- NCT06538272
- Acronym / sponsor ID
- ONO-2910-03
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Aug 2023 (actual)
- Primary completion
- 19 Sep 2024 (actual)
- Study completion
- 19 Sep 2024 (actual)
- First posted
- 5 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ONO-2910 | Experimental | Drug: ONO-2910 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ONO-2910ONO-2910 Tablet will be orally administered once daily. | Drug | ONO-2910 |
| PlaceboPlacebo Tablet will be orally administered once daily. | Drug | Placebo |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Project Leader study director
Ono Pharmaceutical Co., Ltd.
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ONO-2910 in people with CIPN - Chemotherapy-Induced Peripheral Neuropathy, run by Ono Pharmaceutical Co., Ltd. at 30 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.