EUCTR2009-012665-61-DE进行中（未招募）1 期
A PHASE 2, OPEN-LABEL STUDY TO ASSESS THE EFFICACY AND SAFETY OF LENALIDOMIDE IN COMBINATION WITH CETUXIMAB IN PRETREATED SUBJECTS WITH KRAS MUTANT METASTATIC COLORECTAL CANCER
Celgene Corporation0 个研究点目标入组 220 人开始时间: 2009年10月14日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 220
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Histologically or cytologically confirmed metastatic colorectal adenocarcinoma.
- •2.At least one unidimensionally measurable lesion.
- •3.Documented KRAS mutant tumor (paraffin tumor blocks or approximately 25 unstained slides must be sent for KRAS mutation testing and results reported by central pathology laboratory prior to study enrollment).
- •4.Imaging confirmed (CT/MRI) disease progression within 42 days of previous treatment.
- •5.Disease progression on oxaliplatin- AND irinotecan-containing regimens in the metastatic setting, with at least one of these regimens containing bevacizumab.
- •6.Eastern Cooperative Oncology Group performance status of = 1.
- •7.Women of childbearing potential must undergo pregnancy testing based on the frequency outlined in Section 21.3 or 21.4 and pregnancy results must be negative.
- •8.Unless practicing complete abstinence from heterosexual intercourse, sexually active WCBP must agree to use adequate contraceptive methods as specified in Section 21.3 or 21.4.
- •9.Males (including those who have had a vasectomy) must use barrier contraception (condom) when engaging in sexual activity with WCBP as specified in Section 21.3 or 21.4.
- •10.Males must agree not to donate semen or sperm during the duration specified in Section 21.3 or 21.4.
- •11. All subjects must:
- •Understand that the investigational product could have a potential teratogenic risk.
- •Agree to abstain from donating blood while taking investigational product and following discontinuation of investigational product (see Section 21.3 or 21.4).
- •Agree not to share study medication with another person.
- •Be counseled about pregnancy precautions and risks of fetal exposure (see Section 21.3 or 21.4).
- •12.Understand and voluntarily sign an ICF.
- •13.Age = 18 years at the time of signing the ICF.
- •14.Able to adhere to the study visit schedule and other protocol requirements.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Use of chemotherapy, hormonal therapy, immunotherapy, or any other anticancer or experimental therapy = 28 days prior to Cycle 1 Day 1.
- •2.Radiotherapy to = 30% of the bone marrow.
- •3.Surgery = 28 days prior to Cycle 1 Day 1 (minimally invasive procedures for the purpose of diagnosis or staging of the disease are permitted).
- •4.Prior therapy with cetuximab.
- •5.Prior therapy with panitumumab.
- •6.Prior therapy with pomalidomide (CC-4047), lenalidomide, or thalidomide.
- •7.Absolute neutrophil count (ANC) < 1.5 x 109/L.
- •8.Platelet count < 100 x 109/L.
- •9.Creatinine Clearance < 50 mL/min (by Cockroft- Gault).
- •10.Bilirubin > 1.5 x ULN (> 2.0 x ULN in the presence of Gilbert’s Syndrome).
- •11.Serum AST or ALT > 3.0 x ULN (> 5 x ULN in the presence of liver metastases).
- •12.Hemoglobin < 9 g/dL.
- •13.Untreated, symptomatic brain metastases (brain imaging not required).
- •14.Venous thromboembolism = 6 months prior to Cycle 1 Day 1.
- •15.Current congestive heart failure (New York Heart Association class II-IV).
- •16.Myocardial Infarction (MI) = 12 months prior to Cycle 1 Day 1.
- •17.Uncontrolled hypertension.
- •18.Prior malignancies within 5 years, with the exception of treated basal cell/squamous cell carcinoma of the skin or in-situ” carcinoma of the cervix or breast.
- •19.Any condition (psychological, familial, sociological or geographical), including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he/she were to participate in the study, confound the ability to interpret data from the study, or not allow the subject to comply with the requirements of the study protocol.
- •20.Pregnant or lactating women.
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