NCT01605526已完成1 期
A Multi-center, Open-label Phase IB Study of Escalating Doses of RO5045337, an Oral Small Molecule MDM2 Antagonist, in Combination With Doxorubicin in Patients With Soft Tissue Sarcoma
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
- 23
- 主要终点
- Maximum tolerated dose/dose-limiting toxicities
研究概览
简要总结
This multicenter, open-label, Phase 1b study will evaluate the safety, pharmacokinetics and efficacy of RO5045337 in combination with doxorubicin in patients with soft tissue sarcoma. Cohorts of patients will receive escalating doses of RO5045337 orally on Days 1-5 (1-3) of each 28-day cycle in combination with doxorubicin 60 mg/m2 intravenously on Day 1 of each cycle for up to 6 cycles.
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
- •Histologically or cytologically confirmed soft tissue sarcoma
- •Evaluable disease according to RECIST version 1.1 criteria
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
- •Eligible for doxorubicin therapy
- •Acute toxicities from prior anti-tumor therapy, surgery or radiotherapy must have resolved to NCI-CTCAE Grade </= 1 prior to start of study
- •Adequate bone marrow, hepatic and renal function
- •Patients with stable CNS metastases are eligible
排除标准
- •Previous treatment with limiting doses of doxorubicin
- •Patients receiving any other investigational or commercial agents or therapies administered with the intention to treat their malignancy or other ailment </= 28 days from Day 1 dosing on study treatment
- •History of seizure disorders or unstable CNS metastases
- •Severe and/or uncontrolled medical conditions or other conditions that could affect the participation in the study
- •Pregnant or breastfeeding women
- •HIV positive patients who are currently receiving combination anti-retroviral therapy
- •Patients with known coagulopathy, platelet disorder or history of non-drug induced thrombocytopenia
- •Patients receiving oral or parenteral anti-coagulants/anti-platelet agents
研究组 & 干预措施
Single Arm
Experimental
干预措施: RO5045337 (Drug)
Single Arm
Experimental
干预措施: doxorubicin (Drug)
结局指标
主要结局
Maximum tolerated dose/dose-limiting toxicities
时间窗: approximately 12 months
Safety: Incidence of adverse events
时间窗: approximately 12 months
次要结局
- Pharmacokinetics of RO5045337 and doxorubicin in combination therapy: Area under the concentration-time curve (AUC)(Pre-dose and up to 72 hours post-dose Days 1 and 5 of Cycle 1)
- Pharmacodynamics: Serum macrophage inhibitory cytokine-1 (MIC-1) levels(Pre-dose and up to 72 hours post-dose on Days 1 and 5 of Cycle 1)
研究者
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