EUCTR2011-001111-31-BE进行中（未招募）不适用
A Phase 1b/2 Trial of AMG 386 in Combination With Pemetrexed andCarboplatin as First Line Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer
适应症
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
- 217
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 (cytological specimens obtained by bronchial washing or brushing, or fine-needle aspiration are acceptable), unresectable stage IV non-squamous NSCLC
- •Radiographically evaluable disease (measurable or non-measurable) per RECIST 1.1 with modifications (Appendix G)
- •Men or women aged = 18 years old
- •ECOG Performance Status of 0 or 1 (see Appendix J)
- •Life expectancy = 3 months (per investigator opinion)
- •Generally well-controlled blood pressure with systolic blood pressure = 140 mmHg AND diastolic blood pressure = 90 mmHg prior to enrolment or randomization. The use of anti-hypertensive medications to control hypertension is permitted
- •Adequate organ and hematological function as evidenced by the
- •following laboratory studies
- •- Hematological function:
- •? Absolute neutrophil count (ANC) = 1.5 x 109/L
- •? Platelet count = 100 x 109/L and = 850 x 109/L
- •? Hemoglobin = 9 g/dL
- •- Coagulation function:
- •? partial thromboplastin time (PTT) or activated prothrombin
- •time (aPTT) = 1.5 x ULN per institutional laboratory range
- •? International normalized ratio (INR) = 1.5
- •- Renal function:
- •? Urinary protein of = 30 mg/dL in urinalysis or = 1+ on dipstick,
- •unless quantitative protein is = 1000 mg in a 24-hour urine
- •? Creatinine clearance (CrCl) = 45 mL/min per 24-hour urine
- •collection or calculated according to the Cockcroft-Gault formula:
- •CrCl (mL/min) =
- •(140-age) x actual body weight (kg)
- •(x 0.85) for females
- •72 x serum creatinine (mg/dL)
- •CrCl (mL/min) =
- •(140-age) x actual body weight (kg)
- •(x 0.85) for females
- •0.8136 x serum creatinine (µmol/L)
- •- Hepatic function:
- •? AST and ALT = 2.5 x ULN per institutional laboratory range
- •(or= 5 x ULN if liver metastases are present)
- •? Total bilirubin < 1.2 mg/dL
- •- Nutritional:
- •? Albumin = 2.8 g/dL
- •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 130
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 87
排除标准
- •Any prior chemotherapy or targeted therapy for non-squamous NSCLC
- •Subjects with adenosquamous histology or any histology subtype containing greater than 10% squamous cells
- •Subjects with a known epidermal growth factor receptor (EGFR)
- •mutation sensitive to treatment with a tyrosine kinase inhibitor (TKI)
- •Subjects with known anaplastic lymphoma kinase (EML4-ALK)
- •translocations
- •History or presence of central nervous system metastases.
- •Central (chest) radiation therapy within 28 days, or radiation therapy to any other site within 14 days prior to enrollment/ randomization.
- •Subjects must have recovered from all radiotherapy related toxicity
- •- If all sites of disease have been irradiated, documented progression must have occurred in at least 1 site of disease subsequent to the radiation therapy
- •History of pulmonary hemorrhage or gross hemoptysis (approximately 3 mL of bright red blood or more) within 6 months prior to enrollment/randomization
- •History of arterial or venous thromboembolism within 12 months prior to enrollment/randomization
- •History of clinically significant bleeding within 6 months prior to
- •enrollment/randomization
- •Medications
- •Enrolled in or has not yet completed a 30-day washout period prior to enrollment/randomization for an investigational device or drug trial, or is currently receiving other investigational treatment
- •Known active or ongoing infection (except uncomplicated urinary tract infection) within 14 days prior to enrollment/randomization
- •Currently or previously treated with AMG 386, or other molecules that inhibit the angiopoietins or Tie2 receptor
- •Treatment within 30 days prior to enrollment/randomization with
- •strong immune modulators including but not limited to systemic cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, methotrexate, azathioprine, rapamycin, thalidomide, and lenalidomide
- •General Medical
- •Clinically significant cardiovascular disease within 12 months prior to enrollment/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, or placement of percutaneous transluminal coronary angioplasty/stent
- •History of prior malignancy, except:
- •- Malignancy treated with curative intent and with no known active
- •disease present for = 3 years before enrollment/randomization and felt to be at low risk for recurrence by the treating physician
- •- Adequately treated non-melanoma skin cancer or lentigo maligna
- •without evidence of disease
- •- Adequately treated cervical carcinoma in situ without evidence of
- •- Prostatic intraepithelial neoplasia without evidence of prostate cancer
- •Major surgery within 28 days prior to enrollment/randomization or still recovering from prior surgery
- •Minor surgical procedures, except placement of tunneled central
- •venous access device within 3 days prior to enrollment/ randomization
- •History of allergic reactions to bacterially produced proteins
- •Pregnant (ie, positive beta-human chorionic gonadotropin test) or is breast feeding or planning to become pregnant within 6 months after the end of treatment
- •Subject not willing to use highly effective methods of birth control during treatment and for 6 months after the end of treatment
- •Known positive test(s) for human immunodeficiency virus (HIV)
- •infection, hepatitis C
研究者
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