A Phase I Study of Everolimus (mTOR Inhibitor) and OSI-906 (Dual IGFR and IR Tyrosine Kinase Inhibitor) for the Treatment of Patients With Refractory Metastatic Colorectal Cancer

SCRI Development Innovations, LLC2 个研究点分布在 1 个国家目标入组 18 人开始时间: 2010年7月最近更新: 2022年5月3日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: SCRI Development Innovations, LLC
入组人数: 18
试验地点: 2
主要终点: To Determine the Maximum Tolerated Dose (MTD) of the Combination of OSI-906 and Everolimus for the Treatment of Patients With Refractory Metastatic Colorectal Cancer.

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to determine the maximum tolerated dose (MTD) of the combination of OSI-906 and everolimus for the treatment of patients with refractory metastatic colorectal cancer.

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

•Metastatic cancer of the colon or rectum that has progressed on or for which the patient is intolerant to or not a candidate for: fluoropyrimidines, oxaliplatin, irinotecan, bevacizumab, and cetuximab or panitumumab.
•Testing for Kras mutation performed;Patients with mutated or wild type Kras are eligible.
•ECOG PS of 0-1
•Life expectancy of ≥ 3 months
•Adequate hematological function with ANC 1500, Platelets of 100,000, and hemoglobin of 9.0
•AST, ALT and Alk. Phos. ≤2.5 x ULN or ≤5 x ULN if known hepatic metastases and a total bilirubin ≤1.5 ULN
•Serum creatinine of ≤1.5 x ULN
•Fasting blood glucose <150 mg/dL
•Measurable disease according to RECIST 1.1
•Able to swallow whole pills
•INR ≤1.5 - Anticoagulation is allowed with LMW heparin
•Fasting serum cholesterol ≤300 mg/dL OR ≤7.75 mmol/L AND fasting triglycerides ≤2.5 x ULN;If these thresholds are exceeded, the patient can be included after initiation of lipid lowering medication

排除标准

•Patients who have received any cancer therapies <4 weeks or 5 half lives (whichever is shorter) of initiating study therapy
•Treatment with any investigational drug ≤ 4 weeks, or 5 half-lives of the drug, whichever is shorter
•Patients who require coumadin for anticoagulation
•Patients who have had major surgery or significant traumatic injury ≤4 weeks of the of study treatment
•Minor surgery (with the exception of port placement) must be completed ≤ 7days prior to study therapy
•Previous treatment with an IGFR inhibitor or MTOR Inhibitor
•Chronic, systemic treatment with corticosteroids or another immunosuppressive agent
•Patients with QTc interval >450ms
•Patients who require drugs that can prolong QTc.
•Patients with congenital long QT syndrome, history of ventricular tachycardia, or ventricular fibrillation, or Torsades de Pointes with bradycardia.
•Immunization with attenuated live vaccines within 1 week of beginning study therapy or during study period;Close contact to anyone that has received live virus vaccine should be avoided
•Meningeal or brain metastasis
•Other malignancies < 3 years, with the exception of adequately treated basal or squamous cell carcinomas of the skin, or carcinoma in situ of the cervix
•Patients with known HIV
•Patients with positive testing for hepatitis B or C
•Patients with risk factors for hepatitis must be tested for hepatitis viral loadHepatitis risk factors include the following:
•Lived in Asia, Africa, Central and South America, Eastern Europe, Spain, Portugal, and Greece Any blood transfusions before 1990 Any IV drug use Any dialysis Household contact with a Hep B infected patient Mother had Hep B High-risk sexual activity Body piercing/tattoos
•History suggestive of hepatitis B
•Any severe or uncontrolled conditions that could affect their study participation such as:Severely impaired lung function;DCLO ≤ 50% of normal predicted value;O² Sat <88% at rest on room air
•Congestive Heart Failure of NYHA Class III or IV
•Unstable angina, symptomatic CHF, MI ≤ 6 months, serious uncontrolled cardiac arrhythmia or any other clinically significant heart disease
•CVA, TIA, angioplasty, or cardiac stenting <12 months
•Ventricular arrhythmia requiring medication
•Known history of diabetes and/or patients who require ongoing use of insulin or oral anti-hyperglycemic therapy
•Known liver disease
•Impairment of GI function or gastrointestinal disease that in may significantly alter the absorption of study drugs
•Concurrent treatment with drugs that are strong CYP3A4 inducers or moderate/strong CYP3A4 inhibitors
•Concurrent treatment with drugs that are strong CYP1A2 inhibitors or inducers Women who are pregnant or breastfeeding.
•Concurrent severe, intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements