A Phase III Randomized Study of BBI608 and Best Supportive Care versus Placebo and Best Supportive Care in Patients with Pretreated Advanced Colorectal Carcinoma

Interventions: Group 1: Best supportive care plus BBI608. Best supportive care defined as those measures designed to provide palliation of symptoms and improve quality of life as much as possible. BBI608 will be self-administered by participants at 480mg (6 x 80mg tablets) orally twice daily (960mg total daily dose) in 28 day cycles. Patients may continue to receive protocol therapy as long as they have not experienced any adverse events requiring permanent discontinuation of study medication and are, in the opinion of the investigator, continuing to derive benefit from protocol therapy.
Patients will be asked to keep a diary of when they take the capsules and if they miss any doses to monitor adherance. Patients will also be asked to return any tablets which were not taken.
Primary outcome(s): Overall survival (death from any cause)[Patient status updates will be sought every 2-4 weeks at clinic visit whilst on treatment and then every 8 weeks until death.]
Study Design: Purpose: Treatment; Allocation: Randomised controlled trial

干预措施：第1组：最佳支持治疗联合BBI608。其中最佳支持治疗指旨在尽可能缓解症状、改善生活质量的姑息性支持措施。BBI608由受试者自行口服给药，剂量为480mg（6片80mg规格片剂），每日2次，每日总剂量为960mg，以28天为一个治疗周期。受试者若未出现需永久停用研究药物的不良事件（Adverse Event），且经研究者判断仍可从本研究方案治疗中获益，则可持续接受方案规定的治疗。
受试者需记录服药时间及漏服剂量情况，以监测治疗依从性，同时需返还未服用的剩余片剂。
主要结局指标：总生存期（Overall Survival，即任意原因导致的死亡）【治疗期间，受试者需每2~4周前往门诊随访以更新病情状态；后续改为每8周随访一次，直至受试者死亡。】
研究设计：研究目的：治疗性研究；分组方式：随机对照试验（Randomised Controlled Trial）