NCT00603356已完成1 期
A Phase 1 Dose Escalation Study of Daily Oral OSI-930 and Erlotinib (Tarceva) in Patients With Advanced Solid Tumors
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
- 60
- 试验地点
- 2
- 主要终点
- Determine the maximum tolerated dose (MTD), evaluate the pharmacokinetic profiles
研究概览
简要总结
This is a Phase I, dose escalation, safety study of OSI-930 and Erlotinib in cancer tumors.
详细描述
Multicenter, open-label, phase 1, dose escalation study to determine the maximum tolerated dose of OSI-930 and Erlotinib.
Patients may continue to receive OSI-930 and Erlotinib until one of the following occurs: disease progression, adverse event requiring withdrawal, failure to recover from toxicity despite a 14-day dosing interruption, medical or ethical reasons, patient request, or patient death.
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
- •Histology or cytologically documented malignancy that is now advanced and/or metastatic and refractory to established forms of therapy or for which no effective therapy exists
- •Age greater than or equal to 18 years
- •ECOG PS 0-2
- •ANC greater than or equal to 1.5 x 10^9/L
- •Bilirubin less than or equal to 1.5 x upper limit of normal (ULN), AST and ALT less than or equal to 2.5 x ULN
- •Creatinine less than or equal to 1.5 ULN
- •Predicted life expectancy greater than or equal to 12 weeks
- •Prior chemotherapy is permitted provided that a minimum of 3 weeks has elapsed
- •Prior tyrosine kinase inhibitor therapy is permitted
- •Patients must have recovered from any treatment-related toxicities (with some exceptions) prior to registration
- •Prior hormonal therapy is permitted provided it is discontinued prior to registration (with the exception of prostate cancer patients who have been on hormone therapy for at least 3 months)
- •Prior radiation therapy is permitted provided that it did not exceed 25% of bone marrow reserve and patients have recovered from the toxic effects (a minimum of 21 days must have elapsed unless the radiotherapy was palliative and nonmyelosuppressive)
- •Prior surgery is permitted, provided that wound healing has occurred prior to registration
- •Patients must use proactive effective contraceptive measures throughout the study
- •Provide written informed consent
- •Accessible for repeat dosing and follow-up
- •Adequate hematopoietic, hepatic, and renal function
排除标准
- •Significant cardiac disease unless well controlled
- •Current or former smokers, unless patients stopped smoking greater than 3 months prior to registration
- •Active or uncontrolled infections of serious illnesses or medical conditions that could interfere with participation
- •History of unacceptable toxicity with previous EGFR inhibitor therapy
- •History of any psychiatric condition that might impair the patient's ability to provide informed consent or participate
- •Use of CYP3A4 inducers/inhibitors during the 14 days prior to first dose
- •Pregnant or breast-feeding females
- •Symptomatic brain metastases which are not stable, require steroids, are potentially life-threatening or that have required radiation within the last 28 days
- •History of allergic reaction attributed to a similar compound as study drug
- •GI abnormalities including inability to take oral medications, required for IV alimentation
- •Clinically significant ophthalmologic abnormalities
研究组 & 干预措施
1
Experimental
Dose Escalation
干预措施: OSI-930 and erlotinib (Drug)
结局指标
主要结局
Determine the maximum tolerated dose (MTD), evaluate the pharmacokinetic profiles
时间窗: 18 months
次要结局
- Safety, evaluate pharmacodynamic relationships(18 months)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
Phase 1 Study of OSI-930 in Cancer PatientsAdvanced Solid TumorsNCT00513851Astellas Pharma Inc60
已完成
1 期
A Phase 1 Dose-escalation Study of OSI-906 and Erlotinib (Tarceva®)Advanced Solid TumorsNCT00739453Astellas Pharma Inc95
终止
1 期
Study of the PI3K Inhibitor SL-901 in Patients With Advanced Solid TumorsAdvanced Solid TumorNCT05382936Stemline Therapeutics, Inc.20
进行中（未招募）
1 期
First-in-Human Study of EOS100850 in Patients With CancerSolid Tumor, AdultNCT03873883iTeos Therapeutics119
已完成
1 期
Treatment of Patients With Advanced Solid Tumors With Oral Agent ORIN1001 and in Combination With Standard of Care.Effect of DrugNCT05154201Orinove, Inc.150