A Randomized, Double-blind, Placebo-controlled, Multi-national, Multi-center, Parallel-group, Phase 2b Assessing ART-123's Effect on Preventing Sensory Symptoms of OIPN in Unresectable mCRC Subjects Receiving Oxaliplatin-containing Chemo
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 主要终点
- FACT/GOG-NTX-12 (4 items) Total Score at Cycle 9
研究概览
简要总结
To evaluate the efficacy and safety of ART-123 on sensory symptoms of oxaliplatin-induced peripheral neuropathy (OIPN) in patients with unresectable metastatic colorectal cancer who receive oxaliplatin-containing chemotherapy
详细描述
To compare the efficacy and safety of ART-123 (low and high dose) to placebo on sensory symptoms of oxaliplatin-induced peripheral neuropathy (OIPN) in patients with unresectable metastatic colorectal cancer who receive oxaliplatin-containing chemotherapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •18 years of age or older
- •Unresectable metastatic colorectal cancer; pathologically confirmed adenocarcinoma of the colon or rectum
- •ECOG performance status of 0 or 1
- •The most recent laboratory findings (including for liver and kidney) within 14 days prior to randomization remain within acceptable ranges
- •Willingness of the patient and the sexual partner to use a highly effective contraceptive method during the course of the study
- •Able to sufficiently understand the clinical study and give written informed consent
排除标准
- •Prior treatment history with nerve toxic chemotherapeutic agent
- •Peripheral neuropathy or central nervous system damage
- •Psychiatric disorder
- •History of major hemorrhage
- •High risk of hemorrhage
- •History of other malignancies
- •Active ulcer
- •Patients using anti-coagulants and fibrinolytic drugs
- •Active Hepatitis B, or known HBs antigen positive
- •Prior treatment history with thrombomodulin alfa
- •Administration of another investigational medicinal product within 30 days prior to randomization
- •Patient is pregnant (positive urine human chorionic gonadotropin) or breastfeeding or intends to get pregnant during the Treatment period
- •Patients otherwise deemed as inappropriate to participate in the study by the Investigator
研究组 & 干预措施
Low Dose
Reconstituted lyophilized ART-123 with sterile water for injection administered by intravenous drip infusion over approximately 30 minutes on Day 1 of each chemotherapy cycle.
干预措施: thrombomodulin alfa (Drug)
High Dose
Reconstituted lyophilized ART-123 with sterile water for injection administered by intravenous drip infusion over approximately 30 minutes on Day 1 of each chemotherapy cycle.
干预措施: thrombomodulin alfa (Drug)
Placebo
Reconstituted lyophilized placebo with sterile water for injection administered by intravenous drip infusion over approximately 30 minutes on Day 1 of each chemotherapy cycle.
干预措施: Placebo (Drug)
结局指标
主要结局
FACT/GOG-NTX-12 (4 items) Total Score at Cycle 9
时间窗: Cycle 9 (each cycle is 2 weeks)
Change from baseline in total score of the first 4 items of the FACT/GOG-NTX-12 at the end of Cycle 9
次要结局
- FACT/GOG-NTX-12 (4 items) Proportional Score at Cycle 9 (each cycle is 2 weeks)(Cycle 9 (each cycle is 2 weeks))
- FACT/GOG-NTX-12 (4 items) Total Score at 9 Months(9 months)
- FACT/GOG-NTX-12 (4 items) Cumulative Score at Cycle 9(Cycle 9 (each cycle is 2 weeks))
- FACT/GOG-NTX-12 (12 items) Total Score at Cycle 9(Cycle 9 (each cycle is 2 weeks))
- NRS (Pain) Scores (feet) at Cycle 9(Cycle 9 (each cycle is 2 weeks))
- NRS (Pain) Scores (hands) at Cycle 9(Cycle 9 (each cycle is 2 weeks))
- Side Effect Questionnaire Score(Cycle 9 (each cycle is 2 weeks))
- CTCAE: Peripheral Sensory Neuropathy(Cycle 9 (each cycle is 2 weeks))
- CTCAE: Peripheral Motor Neuropathy(Cycle 9 (each cycle is 2 weeks))
- mTCNS Score(Cycle 9 (each cycle is 2 weeks))
- Grooved Pegboard Change(Cycle 9 (each cycle is 2 weeks))
- EQ-5D-5L Change(Cycle 9 (each cycle is 2 weeks))