ACTRN12616001639415尚未招募2 期
Improving sunitinib efficacy and tolerability in patients with metastatic clear cell carcinoma of the kidney by using a 14/7 day schedule and toxicity-adjusted dosing
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •1. Histologically or cytologically confirmed metastatic renal cell cancer with a component of clear cell histology.
- •2. Evidence of unidimensionally measurable disease, defined as: greater than or equal to 1 malignant tumour mass that can be accurately measured in at least 1 dimension greater than or equal to 20 mm with conventional computerized tomography [CT] scan or Magnetic Resonance Imaging [MRI], or greater than or equal to 10 mm with spiral CT scan using a 5 mm or smaller contiguous reconstruction algorithm).
- •3. 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.
- •4. Adequate organ function as defined by the following criteria:
- •(a) absolute neutrophil count (ANC) greater than or equal to1.5 x10^9/L and
- •(b) platelets greater than or equal to 75 x10^9/L and
- •(c) haemoglobin greater than or equal to 90 g/L and
- •(d) AST and ALT less than or equal to 2.5 x upper limit of normal (ULN), unless there are liver metastases in which case AST and ALT less than or equal to 5.0 x ULN and
- •(e) total bilirubin is less than or equal to 1.5 x ULN and
- •(f) Serum creatinine is greater than or equal to 2.0 x ULN or calculated creatinine clearance is greater than or equal to 30 mL/min;
- •5. ECOG performance status of 0 or 1.
- •6. Life expectancy of greater than or equal to 12 weeks.
- •7. No evidence of pre-existing uncontrolled hypertension
- •8. Women of childbearing potential must have a negative serum or urine pregnancy test within 3 days prior to treatment.
- •9. 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 enrolment.
- •10. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures, including completion of patient-reported outcome measures.
排除标准
- •1. Prior systemic treatment of metastatic renal cell cancer;
- •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:
- •(a) inability to take oral medication;
- •(b) requirement for intravenous alimentation;
- •(c) prior surgical procedures affecting absorption including total gastric resection;
- •(d) treatment for active peptic ulcer disease in the past 6 months; active gastrointestinal bleeding, unrelated to cancer, as evidenced by haematemesis, haematochezia or melena in the past 3 months without evidence of resolution documented by endoscopy or colonoscopy;
- •(e) malabsorption syndromes;
- •(f) history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to beginning study treatment;
- •5. CYP3A4 inhibitors or inducers: Use with drugs that are known potent CYP3A4 inhibitors or inducers should be avoided if possible. Patients may receive these agents if they are on a stable dose and are planned to continue throughout the study period
- •6. 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.
- •7. Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 3 months before randomization. Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of randomization.
- •8. A serious uncontrolled medical disorder or active infection that would impair their ability to receive study treatment.
- •9. Any of the following within the 12 months prior to study drug administration: myocardial infarction, severe/unstable 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.
- •10. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
- •11. 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.
- •12. Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol.
- •13. 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.
- •14.Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participat
研究者
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