EUCTR2008-001451-21-SE进行中（未招募）不适用
AXITINIB (AG-013736) AS SECOND LINE THERAPY FOR METASTATIC RENALCELL CANCER: AXIS TRIA
Pfizer Inc.,235 East 42nd Street,New York,NY 100170 个研究点目标入组 650 人开始时间: 2008年5月21日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 650
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
- •Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
- •1. Histologically or cytologically confirmed renal cell cancer with a component of clear cell subtype, with metastatis.
- •2. Evidence of unidimensionally measurable disease (ie, =1 malignant tumor mass that can be accurately measured in at least 1 dimension = 20 mm with conventional computerized tomography [CT] scan or Magnetic Resonance Imaging [MRI], or =10 mm with spiral CT scan using a 5 mm or smaller contiguous reconstruction algorithm). Bone lesions, ascites, peritoneal carcinomatosis or miliary lesions, pleural or pericardial effusions, lymphangitis of the skin or lung, cystic lesions, or irradiated lesions are not considered measurable.
- •3. Must have progressive disease per RECIST (version 1.0) after one prior systemic first-line regimen for metastatic renal cell cancer. The prior regimen must have contained one or more of the following: sunitinib, bevacizumab + IFN a, temsirolimus, or cytokine(s).
- •4. Adequate organ function as defined by the following criteria:
- •absolute neutrophil count (ANC) =1500 cells/mm3;
- •platelets =75,000 cells/mm3.
- •Hemoglobin =9.0 g/d.
- •AST and ALT =2.5 x upper limit of normal (ULN), unless there are liver
- •metastases in which case AST and ALT =5.0 x ULN;
- •Total bilirubin =1.5 x ULN;
- •Serum creatinine =1.5 x ULN or calculated creatinine clearance =60 mL/min;
- •Urinary protein <2+ by urine dipstick. If dipstick is =2+ then a 24-hour urine
- •collection can be done and the patient may enter only if urinary protein is <2 g per
- •5. Male or female, age =18 years.
- •6. ECOG performance status of 0 or 1.
- •7. Life expectancy of =12 weeks.
- •8. At least 2 weeks since the end of prior systemic treatment (4 weeks for bevacizumab + IFN a), radiotherapy, or surgical procedure with resolution of all treatment-related toxicity to NCI CTCAE Version 3.0 grade =1 or back to baseline except for alopecia or hypothyroidism.
- •9. No evidence of preexisting uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart. The baseline systolic blood pressure readings must be =140 mm Hg, and the baseline diastolic blood pressure readings must be =90 mm Hg. Patients whose hypertension is controlled by antihypertensive therapies are eligible.
- •10. Women of childbearing potential must have a negative serum or urine pregnancy test within 3 days prior to treatment.
- •11. Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment.
- •12. Willingness and ability to comply with scheduled visits, treatment plans (including
- •willingness to take either AG-013736 or sorafenib according to randomization),
- •laboratory tests, and other study procedures, including completion of patient-reported outcome measures (FKSI and EQ-5D questionnaires).
- •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
- •Subjects presenting with any of the following will not be included in the trial:
- •1. Prior treatment of mRCC with more than one systemic first-line regimen.
- •2. Patients treated with any neoadjuvant or adjuvant systemic therapy.
- •3. Major surgery <4 weeks or radiation therapy <2 weeks of starting the study treatment.
- •Prior palliative radiotherapy to metastatic lesion(s) is permitted, provided there is at least one measurable lesion that has not been irradiated.
- •4. Gastrointestinal abnormalities including:
- •inability to take oral medication;
- •requirement for intravenous alimentation;
- •prior surgical procedures affecting absorption including total gastric resection;
- •treatment for active peptic ulcer disease in the past 6 months;
- •active gastrointestinal bleeding, unrelated to cancer, as evidenced by
- •hematemesis, hematochezia or melena in the past 3 months without evidence of
- •resolution documented by endoscopy or colonoscopy;
- •malabsorption syndromes.
- •5. Current use or anticipated need for treatment with drugs that are known potent CYP3A4 inhibitors (ie, grapefruit juice, verapamil, ketoconazole, miconazole, itraconazole, erythromycin, telithromycin, clarithromycin, indinavir, saquinavir, ritonavir, nelfinavir, lopinavir, atazanavir, amprenavir, fosamprenavir and delavirdine).
- •6. Current use or anticipated need for treatment with drugs that are known CYP3A4 or CYP1A2 inducers (ie, carbamazepine, dexamethasone, felbamate, omeprazole,
- •phenobarbital, phenytoin, amobarbital, nevirapine, primidone, rifabutin, rifampin, and St.John’s wort).
- •7. Requirement of anticoagulant therapy with oral vitamin K antagonists. Low-dose
- •anticoagulants for maintenance of patency of central venous access devise or prevention of deep venous thrombosis is allowed. Therapeutic use of low molecular weight heparin is allowed.
- •8. Active seizure disorder or evidence of brain metastases, spinal cord compression, or carcinomatous meningitis.
- •9. A serious uncontrolled medical disorder or active infection that would impair their ability to receive study treatment.
- •10. Any of the following within the 12 months prior to study drug administration:
- •myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack and 6 months for deep vein thrombosis or pulmonary embolism.
- •11. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
- •12. History of a malignancy (other than renal cell cancer) except those treated with curative intent for skin cancer (other than melanoma), in situ breast or in situ cervical cancer, or those treated with curative intent for any other cancer with no evidence of disease for 2 years.
- •13. Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol.
- •14. Female patients who are pregnant or lactating, or men and women of reproductive potential not willing or not able to employ an effective method of birth
- •control/contraception to prevent pregnancy during treatment and for 6 months after
- •discontinuing study treatment. The definition of effective contraception should be in
- •agreement with local regulation and based on the judgment of the principal investigator or a designated associate.
- •15. Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may
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