A Dose-finding Study of RO5323441 in Patients With Metastatic Treatment-Refractory Colorectal or Ovarian Cancer

This exploratory, open label study will assess the the dose-effect relationship, efficacy and safety of RO5323441 in patients with metastatic treatment-refractory colorectal or ovarian cancer. Cohorts of patients will receive doses of intravenous RO5323441 in the range of 25mg to 3g every 1 or 2 weeks and will undergo serial dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) assessments. In the absence of disease progression and unacceptable toxicity, patients may continue to receive their maximum dose of RO5323441 for a core treatment phase of up to a total of 6 months. Treatment with RO5323441 can be extended at the investigator’s discretion until disease progression or unacceptable toxicity occurs. Target sample size is <100.

本项探索性开放标签研究将评估RO5323441在转移性经治难治性结直肠癌或卵巢癌患者中的量效关系、疗效与安全性。受试患者队列将接受剂量范围为25mg至3g的静脉输注RO5323441，给药间隔为每1周或每2周一次，并将接受系列动态对比增强磁共振成像（dynamic contrast-enhanced magnetic resonance imaging，DCE-MRI）评估。若未出现疾病进展且未发生不可接受的毒性反应，患者可继续以最大给药剂量接受RO5323441治疗，核心治疗阶段最长总计可达6个月。RO5323441的治疗可由研究者酌情延长，直至疾病进展或出现不可接受的毒性反应。目标样本量小于100例。