Open-label, Exploratory, Pharmacodynamic (PD) Dose-finding Study of Intravenous RO5323441 in Patients With Metastatic Treatment-refractory Colorectal and Ovarian Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 7
- 主要终点
- RO5323441 concentration - pharmacodynamic effect relationship using DCE-MRI
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients, >/=19 years of age
- •metastatic or unresectable colorectal or ovarian cancer refractory to, or unsuitable for standard therapy
- •presence of tumor lesions suitable for DCE-MRI evaluation
- •WHO performance status 0-1
- •adequate bone marrow, liver and renal function
排除标准
- •patient unsuitable for MRI scanning (e.g. metal implants, pacemaker, claustrophobia, hypersensitivity to DCE-MRI contrast material)
- •brain metastases
- •clinically significant ascites
- •active bleeding, bleeding diathesis, oral anti-vitamin K medication (other than low dose coumarin) or history of coagulation disorders
- •radiation therapy within 3 weeks, or anti-neoplastic therapy <30 days prior to first dose of study drug
- •chronic therapy with systemic steroids or another immunosuppressive agent <2 weeks prior to first dose of study drug
- •treated with bevacizumab in last regimen of systemic therapy
研究组 & 干预措施
Single Arm
干预措施: RO5323441 (Drug)
结局指标
主要结局
RO5323441 concentration - pharmacodynamic effect relationship using DCE-MRI
时间窗: up to 19.5 months
次要结局
- Feasibility of within-patient dose escalation(from baseline to Day 127 (+/-3))
- Additional DCE-MRI effects (time-course of DCE-MRI effects, test-retest reproducibility)(up to 19.5 months)
- Candidate biomarkers associated with PD effect of RO5323441(up to 19.5 months)
- Pharmacokinetics: maximum and trough concentrations of RO5323441(up to 19.5 months)
- Safety and tolerability: Adverse events, vital signs, laboratory parameters(up to 19.5 months)
- Efficacy: ORR, duration of response, progression-free survival according to RECIST criteria, CTI/MRI assessments(up to 19.5 months)