EUCTR2012-002891-15-NL进行中（未招募）1 期
Phase II study of sunitinib rechallenge in patients with metastatic renal cell carcinoma. - Sunitinib rechallenge
VU University Medical Center0 个研究点目标入组 45 人开始时间: 2012年9月18日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 45
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
入选标准
- •1. Patients with histologically or cytologically confirmed clear-cell mRCC.
- •2. Patients who progressed on first-line treatment with sunitinib and who had clinical benefit defined as a response (according to RECIST 1.1 criteria) or SD for more than 6 months on this treatment.
- •3. Patients who progressed after second-line treatment (mTOR inhibitor or other treatment as long as patients are not treated with a VEGF targeted TKI, see exclusion criteria), or who progressed after a treatment-free interval of at least 3 months since discontinuation of first-line sunitinib treatment.
- •4. Patients with radiological (and/or clinical) confirmed progressive disease according to RECIST 1.1 criteria.
- •5. Measurable or evaluable disease as defined by RECIST 1.1.
- •6. WHO performance status 0-2.
- •7. Life expectancy of at least 12 weeks.
- •8. Age 18 years or older.
- •9. Able to receive oral medication.
- •10. Able to provide written informed consent.
- •11. Adequate hematologic function: ANC = 1.5 x 109/L, platelets = 100 x 109/L, Hb = 6.0 mmol/L.
- •12. Patients with brain metastases are eligible if they have been stable for at least two months post-radiation therapy or surgery.
- •13. No other current malignant disease, except for basal cell carcinoma of the skin.
- •14. Adequate hepatic function: serum bilirubin = 1.5 x ULN, ALT and AST = 2.5 x ULN (or = 5 times ULN if liver metastases are present).
- •15. Renal function: estimated glomerular filtration rate = 40 ml/min.
- •16. Patients with reproductive potential must use effective contraception. Female patients must have a negative pregnancy test.
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •1. Patients treated with any VEGF targeted TKI (sorafenib, pazopanib, axitinib, dovitinib) as second-line treatment after progression on first-line sunitinib treatment.
- •2. Uncontrolled hypertension. Blood pressure must be =160/95 mmHg at the time of screening on a stable antihypertensive regimen. Blood pressure must be stable on at least 2 separate measurements on at least 2 separate days.
- •3. Active infection or serious intercurrent illness.
- •4. Presence of unstable angina, recent myocardial infarction (within the previous 3 months).
- •5. Macroscopic hematuria.
- •6. Presence of any significant central nervous system or psychiatric disorder(s) that would hamper the patient’s compliance.
- •7. Any other major illness that, in the investigator’s judgment, substantially increases the risk associated with the subject’s participation in the study.
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