EUCTR2008-006210-14-BE进行中（未招募）1 期
Phase 2 Open-Label Single-Arm, Multi-Center Study to Evaluate the Safety and Efficacy of Sunitinib Malate in Combination with AMG 386 as First Line or Second Line Therapy for Subjects with Metastatic Renal Cell Carcinoma
适应症
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
- 85
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
- •Subjects must have a histologically confirmed metastatic RCC with a clear cell component
- •Low or intermediate risk according to the Memorial Sloan Kettering Cancer Center (MSKCC) prognostic risk classification defined as meeting between 0 and 2 of the following risk factors:
- •o Karnofsky performance status < 80%
- •o Time from diagnosis of RCC to first systemic treatment < 1 year
- •o Serum lactate dehydrogenase > 1.5 x upper limit of normal (ULN)
- •o Serum hemoglobin < lower limit of normal (LLN) for their institution
- •o Serum calcium (corrected) > 10 mg/dL
- •*For the corrected calcium value, the following formula should be used:
- •Corrected calcium = Total serum calcium [mg/dL] + (0.8 x (4 – serum albumin [g/dL]))
- •Note: If the units of calcium measurement are in mmol/L (or mmoles/L or mM), then the conversion to mg/dL is as follows:
- •?? Calcium (mmol/L) x 4 = Calcium (mg/dL)
- •?? Calcium (mg/dL) x 0.25 = Calcium (mmol/L)
- •Measurable disease with at least one unidimensionally measurable lesion per RECIST (see Appendix E).
- •Left ventricular ejection fraction (LVEF) = 45% as measured by Muga scan or ECHO within 28 days prior to enrollment
- •Demographic
- •Men or women > 18 years old
- •ECOG of 0 or 1
- •Adequate organ and hematological function as evidenced by the following laboratory studies within 14 days of enrollment:
- •Hematological function, as follows:
- •o Absolute neutrophil count (ANC) = 1.5 x 109/L
- •o Platelet count = 100 x 109/L
- •o Hemoglobin = 9 g/dL
- •Renal function, as follows:
- •o Creatinine clearance > 40 mL/min per 24 hour urine collection or calculated according to the Cockcroft- Gault formula
- •(140-age) x actual body weight (kg) ( x 0.85 for
- •CrCl (mL/min) 72 x serum creatinine (mg/dL) females)
- •CrCl (140-age) x actual body weight (kg) ( x 0.85 for
- •(mL/min) 0.8136 x serum creatinine (umol/L) females)
- •o Urinary protein quantitative value of < 30 mg in urinalysis or < 1+ on dipstick, unless quantitative protein is < 1000 mg in a 24 hour urine sample
- •Hepatic function, as follows:
- •o Aspartate aminotransferase (AST) < 2.5 x upper limit of normal (ULN) (if liver metastases are present, = 5 x ULN)
- •o Alanine aminotransferase (ALT) < 2.5 x ULN (if liver metastases are present, = 5 x ULN)
- •o Alkaline phosphatase < 2.0 x ULN (if bone or liver metastases are present, = 5 x ULN)
- •o Bilirubin < 2.0 x ULN
- •Hemostatic function, as follows:
- •o International Normalized Ratio (INR) < 1.5 per institutional laboratory range
- •o Partial thromboplastin time (PTT) or activated partial thromboplastin (aPTT) = 1.5 x ULN per institutional laboratory range
- •Able to tolerate infusions and self-administer oral medications
- •Competent to comprehend, sign, and date an institutional review board (IRB)/ Independent Ethics Committee (IEC) -approved informed consent form
- •Subject plans to begin protocol directed therapy within 7 days of enrollment
- •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 47
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 38
排除标准
- •Disease Related
- •Primary tumor in situ
- •o Subjects must have their primary tumor resected to be eligible for this study
- •Any existing tumor thrombus must be removed before enrollment
- •Known history of central nervous system metastases. An MRI or CT scan of the brain or head will be performed within 28 days of enrollment.
- •History of arterial or venous thromboembolism within 12 months prior to enrollment
- •History of clinically significant bleeding within 6 months prior to enrollment
- •Previous treatment (excluding surgery, prior cytokine-based immunotherapy and palliative radiotherapy) for advanced or metastatic renal cell carcinoma
- •Focal radiation therapy for palliation of pain from bony metastases within 14 days of enrollment.
- •Subjects who received radiation therapy must have recovered from all radiation induced toxicities prior to enrollment
- •Medications
- •Currently or previously treated with sunitinib or other small molecule inhibitors of VEGF including, but not limited to AMG 706 (motesanib), SU11248 (sunitinib), sorafenib, PTK787 (vatalinib), AZD 2171 (recentin), AEE-788
- •Currently or previously treated with agents that neutralizing VEGF such as bevacizumab, or VEGF-TRAP
- •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
- •Currently or previously treated with agents inhibiting the mammalian target of rapamycin (mTOR)
- •Current or within 30 days prior to enrollment treatment with immune modulators such as systemic cyclosporine and tacrolimus
- •Concomitant or previous use within 30 days prior to enrollment of any strong inducer of CYP3A4 including, but not limited to, rifampin, St. John’s wort, phenytoin, carbamazepine, phenobarbital and dexamethasone.
- •Dexamethasone as bolus injection or premedication is allowed.
- •Concomitant or previous use within 30 days prior to enrollment of any strong inhibitors of CYP3A4 including, but not limited to, ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole, grapefruit, and grapefruit juice
- •Concomitant or previous use of amiodarone within 6 months prior to enrollment
- •General Medical
- •Known ongoing pancreatitis
- •Clinically significant cardiovascular disease within 12 months prior to enrollment, 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
- •History of allergic reactions to bacterially produced proteins
- •Pregnant (i.e., positive beta-human chorionic gonadotropin test) or is breast feeding
- •Subjects with 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 prior to enrollment or still recovering from prior surgery
- •Minor surgical procedures, placement of tunneled
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