EUCTR2008-005301-19-FR进行中（未招募）1 期
A Phase 2, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safetyand Efficacy of FOLFIRI in Combination With AMG 479 or AMG 655 Versus FOLFIRI for the Second-line Treatment of KRAS-mutant Metastatic Colorectal Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Amgen Inc
- 入组人数
- 150
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
- •Disease Related
- •Histologically confirmed adenocarcinoma of the colon or rectum in patients with
- •metastatic disease
- •Mutant-type KRAS tumor status confirmed by central laboratory assessment of
- •formalin-fixed paraffin-embedded tumor tissue from the primary tumor or metastasis
- •One and only one prior anti-cancer therapy regimen for metastatic disease
- •consisting of the combination of a fluoropyrimidine and oxaliplatin-based
- •chemotherapy with or without anti-VEGF therapy. Prior adjuvant or neoadjuvant
- •chemotherapy used prior to the onset of metastatic disease is permitted.
- •Documented disease progression while receiving or = 6 months after the last dose of prior first-line fluoropyrimidine and oxaliplatin-based chemotherapy with or without
- •bevacizumab for metastatic disease
- •Measurable or non-measurable disease according to modified RECIST criteria.
- •Lesions must not be chosen from a previously irradiated field, unless there has been
- •documented disease progression in that field after irradiation and prior to
- •randomization. All sites of disease must be evaluated = 28 days prior to randomization.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Demographic
- •Men or women 18 years of age or older at the time the informed consent is obtained
- •To be performed = 7 days prior to randomization, unless otherwise specified:
- •Hematologic function within the following limits:
- •- Absolute neutrophil count (ANC) = 1.5 x 109/L
- •- Platelet count = 100 x 109/L (without platelet transfusion = 14 days prior to
- •randomization)
- •- Hemoglobin = 9.0 g/dL
- •Renal function within the following limits:
- •- Creatinine clearance (GFR) = 40 mL/min calculated by the Cockcroft-Gault
- •method as follows:
- •o Male creatinine clearance = (140 – age in years) x (weight in Kg) / (serum
- •creatinine in mg/dL x 72)
- •o Female creatinine clearance = (140 – age) x (weight in Kg) x 0.85 / (serum
- •creatinine in mg/dL x 72)
- •Hepatic function within the following limits
- •- Total bilirubin = 1.5 mg/dL;
- •- Alkaline phosphatase = 2.5 x ULN (if liver metastases, = 5 x ULN)
- •- Aspartate aminotransferase (AST) = 2.5 x ULN (if liver metastases, = 5 x ULN)
- •- Alanine aminotransferase (ALT) = 2.5 x ULN (if liver metastases, = 5 x ULN)
- •Coagulation function within the following limits:
- •- Partial thromboplastin time (PTT)/activated partial thromboplastin time (aPTT)
- •= 1.3 x ULN and international normalized ratio (INR) = 1.5, unless subject is on
- •anti-coagulation therapy. Subjects on therapeutic anti-coagulation are eligible if:
- •o there is no bleeding and they are on a stable dose of anticoagulation therapy
- •(eg, warfarin with an INR of 2 to 3) for at least 14 days before randomization,
- •and o the patient has no active bleeding or pathological condition that carries high
- •risk of bleeding (eg, tumor involving major vessels or known varices)
- •Subjects with diabetes (Type 1 or 2) must be adequately controlled with glycosylated hemoglobin (HgbA1c) = 8% and fasting blood glucose level =160 mg/dL; diabetic subjects who have recently had their glycemic control regimens adjusted and have documented fasting blood glucose concentrations = 160 mg/dL may be considered, regardless of HgbA1c value, if per investigator discretion they are considered to have adequate glycemic function
- •Negative pregnancy test = 3 days prior to randomization (for woman of childbearing potential only)
- •Competent to comprehend, sign, and date an institutional review board (IRB)/
- •Independent Ethics C
排除标准
- •Disease Related
- •History or known presence of central nervous system (CNS) metastases
- •History of other malignancy, except:
- •- Malignancy treated with curative intent and with no known active disease present
- •for = 3 years prior to randomization and felt to be at low risk for recurrence by the
- •treating physician
- •- Adequately treated non-melanomatous skin cancer or lentigo maligna without
- •evidence of disease
- •- Adequately treated cervical carcinoma in situ without evidence of disease
- •- Prostatic intraepithelial neoplasia without evidence of prostate cancer
- •Cancer Therapy
- •Prior irinotecan-based chemotherapy for advanced/metastatic disease
- •Prior death receptor agonists (such as rhApo2/TRAIL [AMG 951]), apomab,
- •mapatumumab, lexatumumab, CS-1008), or other systemic IGF-1R antagonists
- •(such as CP-751, 951, MK0646, IMC-A12) in any setting.
- •Systemic chemotherapy, hormonal therapy, immunotherapy or experimental or
- •approved anticancer proteins/antibodies therapy = 21 days prior to randomization
- •Radiotherapy = 14 days prior to randomization. Subjects must have recovered from
- •all radiotherapy-related toxicities.
- •Unresolved toxicities from prior anti-cancer therapy that, in the opinion of the
- •investigator, exclude subject from participation
- •Other Medications
- •Course of systemic anti-infective that was completed = 14 days before randomization
- •(exception can be made at the judgment of the investigator for oral treatment of an
- •uncomplicated urinary tract infection [UTI])
- •Myocardial infarction, grade 2 or greater peripheral vascular disease,
- •cerebrovascular accident, transient ischemic attack, congestive heart failure,
- •percutaneous transluminal coronary angioplasty/stent, hypertension not stably
- •controlled pharmacologically, ongoing arrhythmias requiring medication or unstable
- •angina = 24 weeks prior to randomization
- •Pulmonary embolism, deep vein thrombosis, or other venous/arterial thromboembolic events = 12 months before randomization
- •Active inflammatory bowel disease or other bowel disease causing chronic diarrhea
- •(defined as = CTCAE grade 2, [CTCAE version 3.0])
- •Major surgical procedure = 28 days before randomization or not yet recovered from
- •prior major surgery
- •Anticipation of need for major elective surgical procedures during the course of the
- •Minor surgical procedure = 7 days before randomization or not yet recovered from
- •prior minor surgery (Uncomplicated placement of vascular access device, fine needle
- •aspiration, thoracocentesis or paracentesis = 3 days prior to enrollment is
- •acceptable)
- •Any co-morbid disease or condition that in the judgment of the investigator could
- •increase the risk of toxicity (such as clinically significant ascites)
- •Subjects known to be human immunodeficiency virus positive or known to have
- •chronic or active hepatitis B or C infection
- •Subject is currently enrolled in, or = 30 days has passed since subject completed
- •another investigational device or drug study(s), or subject is receiving other
- •investigational agent(s)
- •Woman of child-bearing potential is pregnant or is breast feeding
- •Women of childbearing potential and men who do not consent to use adequate
- •contraception during the course of the study and 24 weeks (for men) or 12 weeks
- 另有 4 项未显示
研究者
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