Clinical trial NCT06538272: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: CIPN - Chemotherapy-Induced Peripheral Neuropathy
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2024-08-05
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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:

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

Primary outcomes:
measure: Efficacy evaluation：Proportion of participants with peripheral sensory neuropathy (NP)# of Grade 2 or higher by 12 weeks after the start of intervention
timeFrame: 12 week
measure: Number of Participants with AE
timeFrame: Up to 101 days
measure: Weight
timeFrame: Up to 87 days
measure: body temperature
timeFrame: Up to 87 days
measure: pulse rate
timeFrame: Up to 87 days
measure: blood pressure
timeFrame: Up to 87 days
measure: ECG heart rate
timeFrame: Up to 87 days
measure: ECG RR interval
timeFrame: Up to 87 days
measure: ECG PR interval
timeFrame: Up to 87 days
measure: ECG QRS complex
timeFrame: Up to 87 days
measure: ECG QT interval
timeFrame: Up to 87 days
measure: ECG QTcF
timeFrame: Up to 87 days
measure: Hematology
timeFrame: Up to 87 days
measure: Clinical chemistry
timeFrame: Up to 87 days
measure: Blood coagulation
timeFrame: Up to 87 days
measure: Urinalysis
timeFrame: Up to 87 days
measure: Pregnancy test
timeFrame: Up to 101 days
measure: Viral test
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Fujita Health University Hospital
city: Aichi
country: Japan
facility: Nagoya City University Hospital
city: Aichi
country: Japan
facility: Nagoya University Hospital
city: Chiba
country: Japan
facility: Funabashi Municipal Medical Center
city: Chiba
country: Japan
facility: Medical Corporation Tesshokai Kameda Medical Center
city: Chiba
country: Japan
facility: National Cancer Center Hospital East
city: Fukuoka
country: Japan
facility: Kitakyushu City Hospital Organization Kitakyushu Municipal Medical Center
city: Gunma
country: Japan
facility: Gunma Prefectural Cancer Center
city: Ibaraki
country: Japan
facility: University of Tsukuba Hospital
city: Kagoshima
country: Japan
facility: Social Medical Corporation Hakuaikai Sagara Hospital
city: Kanagawa
country: Japan
facility: Nippon Medical School Musashikosugi Hospital
city: Kanagawa
country: Japan
facility: Tokai University Hospital
city: Kumamoto
country: Japan
facility: Kumamoto Shinto General Hospital
city: Kumamoto
country: Japan
facility: Kumamoto University Hospital
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Okinawa
country: Japan
facility: Nahanishi Clinic
city: Osaka
country: Japan
facility: Osaka Breast Clinic
city: Osaka
country: Japan
facility: Osaka Prefectural Hospital Organization Osaka International Cancer Institute
city: Osaka
country: Japan
facility: Osaka Rosai Hospital
city: Osaka
country: Japan
facility: Osaka University Hospital
city: Osaka
country: Japan
facility: Yodogawa Christian Hospital
city: Saitama
country: Japan
facility: Japanese Saitama Red Cross Hospital
city: Saitama
country: Japan
facility: Saitama Medical University International Medical Center
city: Shizuoka
country: Japan
facility: Shizuoka General Hospital
city: Tokyo
country: Japan
facility: Center Hospital of the National Center for Global Health and Medicine
city: Tokyo
country: Japan
facility: National Cancer Center Hospital
city: Tokyo
country: Japan
facility: Nippon Medical School Hospital
city: Tokyo
country: Japan
facility: St. Luke's International Hospital
city: Tokyo
country: Japan
facility: Tokyo Metropolitan Komagome Hospital
city: Tokyo
country: Japan
facility: Toranomon Hospital
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Project Leader
role: STUDY_DIRECTOR
References: