NCT00603577终止3 期
A Multi-center, Randomized, Double Blind, Placebo Controlled Phase III Study to Assess the Efficacy of Xaliproden in Patients With Oxaliplatin-induced Peripheral Sensory Neuropathy (PSN) Following Adjuvant Chemotherapy for Colon Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Neurological sensory assessment using the National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE, Version 3.0)
研究概览
简要总结
Primary objective:
To assess the effect of xaliproden hydrochloride (xaliproden) 1 mg per oral daily on the rate of complete resolution of peripheral sensory neuropathy (PSN) at 6 months, following randomization, after the completion of oxaliplatin-based adjuvant chemotherapy for colon cancer.
Secondary objective:
- To assess the effect of xaliproden on patient-reported outcomes using the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity scale (FACT/GOG NTX-12 subscale).
- To assess the effect of xaliproden on the rate of at least partial recovery of grade > 2 PSN at 6 months
- To assess the effects of xaliproden on the time to complete recovery from PSN
- To evaluate the safety profile of xaliproden
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have completed an oxaliplatin-containing chemotherapy regimen post complete surgical removal of primary colon tumor no later than 6 weeks before randomization;
- •Have Grade ≥ 1 PSN, as defined by the NCI-CTCAE version 3.0
- •Have an Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2;
- •Blood tests within 14 days prior to randomization: (a) AST (SGOT) and ALT (SGPT) ≤2 x upper limit of normal (ULN); (b) serum creatinine ≤1.5 x ULN; (c)HbA1c ≤7%; (d) neutrophils ≥1.5x10^9/L ; (e) platelets ≥50x10^9/L; (f) Serum D-dimer within normal limits
排除标准
- •Pre-existing peripheral neuropathy prior to treatment with oxaliplatin
- •Receiving any further anti-cancer treatment
- •History of any recent (≤1 year) thrombo-embolic events and current clinical evidence of thrombo-embolism
- •Unstable cardiac disease
- •History of significant neurological or psychiatric disorders including dementia or seizures,
- •Active uncontrolled infection
- •Active disseminated intravascular coagulation
- •Other serious underlying medical conditions which could impair the ability of the patient to participate in the study;
- •Use of antidepressant/antiepileptic medication (for the treatment of PSN), unless commenced before informed consent form signed. The addition of these medications (for the treatment of PSN) once the patient has consented is not allowed
- •Concurrent treatment with any other experimental drugs
- •Pregnant or breast-feeding women;
- •Women of childbearing potential must be protected by effective contraceptive methods of birth control. Post-menopausal women must have been amenorrheic for at least 12 months to be considered as having non-childbearing potential
- •Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. Those conditions should be assessed with the patient before registration in the trial.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Xaliproden
Experimental
干预措施: Xaliproden (Drug)
结局指标
主要结局
Neurological sensory assessment using the National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE, Version 3.0)
时间窗: inclusion, 3 and 6 months and at the 9 and 12 moth follow-up visits
次要结局
- FACT/GOG NTX-12 subscale(AT inclusion and subsequently monthly until month 12)
- Hematological and biochemical testing(At inclusion, 3 & 6 months)
- AE graded with NCI-CTCAE (Version 3.0) and coded using Medical Dictionary for Regulatory Activities (MedDRA, version 9.1)(During the whole study period (including follow-up))
研究者
研究点 (1)
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