jRCT2031230173已完成不适用
ONO-2910-03: 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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 210
- 主要终点
- Proportion of subjects with Grade 2 or higher peripheral sensory neuropathy
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Prevention Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 75age old not（—）
- 性别
- All
入选标准
- •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
排除标准
- •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.
- •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.
- •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
结局指标
主要结局
Proportion of subjects with Grade 2 or higher peripheral sensory neuropathy
时间窗: 12 weeks after starting administration
Proportion of subjects with Grade 2 or higher peripheral sensory neuropathy by 12 weeks after starting administration.
次要结局
未报告次要终点
研究者
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