EUCTR2008-003258-14-IE进行中（未招募）不适用
A Phase 2, Randomized, Double-Blind, Placebo Controlled Study of AMG 386 in Combination with FOLFIRI in Subjects with Previously Treated Metastatic Colorectal Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Amgen Inc
- 入组人数
- 138
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 who are presenting with metastatic disease
- •One and only one prior chemotherapy regimen for metastatic disease consisting of the combination of a fluoropyrimidine-based chemotherapy and oxaliplatin-based chemotherapy. Prior adjuvant chemotherapy used prior to the onset of metastatic
- •disease is permitted. Subjects must never have received prior irinotecan
- •At least 1 uni-dimensionally measurable lesion per modified RECIST criteria (Appendix G). (All sites of disease must be evaluated = 28 days prior to enrollment)
- •Radiographically documented disease progression per modified RECIST criteria either while receiving or = 6 months after the last dose of prior chemotherapy regimen for metastatic disease
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Formalin-fixed paraffin-embedded tumor block or unstained tumor slides from the primary tumor or metastasis is required for KRAS status
- •Demographic
- •Man or woman = 18 years of age
- •Adequate organ and hematological function as evidenced by the following laboratory studies within 14 days of randomization:
- •Hematological function, as follows:
- •Absolute neutrophil count (ANC) = 1.5 x 109/L
- •Platelet count = 100 x 109/L
- •Hemoglobin = 9 g/dL
- •Renal function, as follows:
- •Creatinine clearance = 50 mL/min per 24-hour urine collection or calculated according to the Cockcroft-Gault formula
- •(140-age) x actual body weight (kg)
- •CrCl (mL/min) (x 0.85 for females)
- •72 x serum creatinine (mg/dL)
- •CrCl (140-age) x actual body weight (kg)
- •(x 0.85 for females)
- •(mL/min) 0.8136 x serum creatinine (umol/L)
- •Urinary protein quantitative value of = 30 mg/dL in urinalysis or = 1+ on dipstick, unless quantitative protein is < 1000 mg in a 24-hour urine sample
- •Hepatic function, as follows:
- •Aspartate aminotransferase (AST) = 3 x upper limit of normal (ULN) (if liver metastases are present, = 5 x ULN)
- •Alanine aminotransferase (ALT) = 3 x ULN (if liver metastases are present, = 5 x ULN)
- •Alkaline phosphatase = 3 x ULN (if bone or liver metastases are present, = 5 x ULN)
- •Bilirubin = 1.5 x ULN
- •Hemostatic function, as follows:
- •International Normalized Ratio (INR) = 1.5
- •Partial thromboplastin time (PTT) or activated partial thromboplastin (aPTT) = 1.5 x ULN per institutional laboratory range
- •Competent to comprehend, sign, and date an institutional review board (IRB) / Independent Ethics Committee (IEC) -approved informed consent form
- •Life expectancy = 3 months
- •Subject plans to begin protocol directed therapy within 7 days of randomization
- •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 104
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
- •Disease related
- •Histologically confirmed adenocarcinoma of the colon or rectum in patients who are presenting with metastatic disease
- •One and only one prior chemotherapy regimen for metastatic disease consisting of the combination of a fluoropyrimidine-based chemotherapy and oxaliplatin-based chemotherapy. Prior adjuvant chemotherapy used prior to the onset of metastatic
- •disease is permitted. Subjects must never have received prior irinotecan
- •At least 1 uni-dimensionally measurable lesion per modified RECIST criteria (Appendix G). (All sites of disease must be evaluated = 28 days prior to enrollment)
- •Radiographically documented disease progression per modified RECIST criteria either while receiving or = 6 months after the last dose of prior chemotherapy regimen for metastatic disease
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Formalin-fixed paraffin-embedded tumor block or unstained tumor slides from the primary tumor or metastasis is required for KRAS status
- •Demographic
- 另有 32 项未显示
排除标准
- •Disease Related
- •Current or prior history of central nervous system metastasis
- •History of arterial or deep venous thromboembolism within 12 months prior to randomization
- •History of clinically significant bleeding within 6 months prior to randomization
- •Medications
- •Prior irinotecan therapy
- •Systemic chemotherapy, hormonal therapy, or immunotherapy = 21 days prior to randomization
- •Experimental or approved proteins/antibodies (eg, bevacizumab) = 30 days prior to randomization
- •Unresolved toxicities from prior systemic therapy that, in the opinion of the investigator, does not qualify the patient for randomization
- •Radiotherapy = 14 days prior to randomization. Patients must have recovered from all radiotherapy-related toxicities
- •o If all sites of measurable disease have been irradiated, documented
- •progression must have occurred in at least 1 site of measurable disease
- •subsequent to the radiation therapy.
- •Known active or ongoing infection (except uncomplicated urinary tract
- •infection [UTI]) within 14 days prior to randomization
- •Known allergy or hypersensitivity to irinotecan, 5-FU (known dihydropyrimidine dehydrogenase deficiency) or leucovorin
- •Currently or previously treated with AMG 386, or other molecules that inhibit the angiopoietins or Tie2 receptor including but not limited to, XL-820, XL-184, or CVX-060/PF-4856884 CYP3A4 enzyme inducing anti-convulsant medication (eg phenytoin, phenobarbital or carbamazepine), rifampin and rifabutin, and St. John’s Wort
- •= 14 days before randomization
- •Ketoconazole = 7 days before randomization (Itraconazole should be used with caution)
- •Current or within 30 days of randomization treatment with immune modulators such as cyclosporine and tacrolimus
- •Any investigational agent or therapy = 30 days before randomization
- •General Medical
- •Clinically significant cardiovascular disease within 12 months prior to
- •randomization, including myocardial infarction, unstable angina, grade 2 or greater peripheral vascular disease, cerebrovascular accident, transient ischemic attack, congestive heart failure, or arrhythmias not controlled by outpatient medication, percutaneous transluminal coronary angioplasty/stent
- •Non-healing wound, ulcer (including gastrointestinal) or fracture
- •Exclude subjects with a history of prior malignancy, except:
- •Malignancy treated with curative intent and with no known active disease present for = 3 years before enrollment and felt to be at low risk for recurrence by 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
- •Major surgery within 28 days before randomization or still recovering from prior surgery
- •Minor surgical procedures, placement of central venous access device (excludes PICC or peripherally inserted central catheter lines), or fine needle aspiration within 3 days prior to randomization
- •History of allergic reactions to bacterially produced proteins
- •Subject known positive test(s) for human immunodeficiency virus (HIV) infection, hepatitis C virus, acute or chronic active hepatitis B infection
- •Any condition which in the investigator’s opinion makes the subject unsuitable for study participation
- •Any co-morbid disease or condition that could increase the risk of toxicity (eg, known dihydropyrimidine deficiency, significant ascites or pleural effusion);
- •Disease Related
- •Current or prior history of central nervous system metastasis
- •History of arterial or deep venous thromboembolism within 12 months prior to randomization
- •History of clinically significant bleeding within 6 months prior to randomization
- •Medications
- •Prior irinotecan therapy
- •Systemic chemotherapy, hormonal therapy, or immunotherapy = 21 days prior to randomization
- •Experimental or approved proteins/antibodies (eg, bevacizumab) = 30 days prior to randomization
- •Unresolved toxicities from prior systemic therapy that, in the opinion of the investigator, does not qualify the patient for randomization
- •Radiotherapy = 14 days prior to randomization. Patients must have recovered from all radiotherapy-related toxicities
- •o If all sites of measurable disease have been irradiated, documented
- •progression must have occurred in at least 1 site of measurable disease
- •subsequent to the radiation therapy.
- •Known active or ongoing infection (except uncomplicated urinary tract
- 另有 22 项未显示
研究者
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