NCT01143740已完成1 期
An Exploratory Biomarker Study of RO5045337 in Patients With Liposarcomas Prior to Debulking Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- Biomarker evidence of MDM2 and p53 pathway alterations (histologic, molecular and imaging analyses)
研究概览
简要总结
This open-label study will evaluate efficacy, safety and tolerability of RO5045337 in patients with liposarcoma who are eligible for debulking surgery. Prior to surgery, patients will receive 2-3 cycles of RO5045337, orally for 10 days followed by 18 days of rest per cycle. Anticipated time on study treatment is 3 months. Patients with an incomplete resection may be treated for an additional 3 cycles with RO5045337.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients, >/=18 years of age
- •well differentiated and/or dedifferentiated liposarcoma eligible for tumor debulking surgery
- •willing to undergo tumor biopsies before, during and after treatment
- •ECOG performance status 0-1
排除标准
- •previous chemotherapy and/or radiation for liposarcoma; previous debulking surgery is acceptable
- •patients receiving any other agent or therapy to treat their malignancy
- •patients requiring anticoagulant therapy and/or anti-platelet therapy
- •pre-existing gastrointestinal disorders which may interfere with absorption of drugs
- •history of seizure disorders or unstable CNS metastases
- •clinically significant cardiovascular disease
- •history of long QT syndrome
研究组 & 干预措施
Single Arm
Experimental
干预措施: RO5045337 (Drug)
结局指标
主要结局
Biomarker evidence of MDM2 and p53 pathway alterations (histologic, molecular and imaging analyses)
时间窗: from baseline to week 12
次要结局
- Tumor response according to RECIST criteria assessed by CT or MRI(from baseline to week 7)
- Safety and tolerability: Adverse events, laboratory parameters, ECG(up to approximately 4 months after study start)
- Correlation pharmacokinetics (AUC, Cmax, tmax, t1/2, CL/V, V/F) - pharmacodynamics/biomarkers(multiple sampling weeks 1 and 2)
研究者
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