NCT01189903Unknown2 期
Clinical Evaluation - A Phase IIA Proof of Concept Study of Regorafenib (Bayer 73-4506) in Biopsy-amenable Asian Colorectal Cancer Patients
适应症
相关药物
试验速览
- 阶段
- 2 期
- 试验地点
- 2
研究概览
简要总结
- Primary Endpoints
- Biomarker data suggestive of regorafenib-mediated inhibition of the RAS-RAF- MEK-ERK signal transduction pathway,of various tyrosine kinase receptors and/or of angiogenesis.
- Evaluation of potential relationships between biomarker data and clinical activity.
- Evaluation of a novel biomarker technology (Prometheus COPIA platform)
- Secondary Endpoints
- Biomarker data suggestive of regorafenib-mediated effects on circulating rare cells.
- Comparison of tumor genetic profiles obtained using DNA isolated from plasma, tumor biopsies and circulating tumor cells.
- Patient safety data
- Pharmacokinetics of regorafenib
- Changes in tumor metabolic activity as measured by PET CT scan (optional)
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically proven metastatic colorectal adenocarcinoma that is refractory to standard therapy and not amenable to surgery with curative intent.
- •Tumor characteristics:
- •At least one lesion that is suitable for a repeated biopsy; eg. subcutaneous nodule, skin lesion, rectal tumor, colonic mass easily reached by colonoscopy, peritoneal masses at least 3cm in maximum diameter that are easily assessable by image guided core biopsy.
- •For liver lesions, more superficially located lesions at least 3cm in maximum dimension with a rim of normal liver tissue, assessable safely by image guided core biopsy as determined by an experienced interventional radiologist.
- •Eastern Cooperative Oncology Group ECOG performance status of 0 or 1 (see Appendix 10.4).
- •Adequate bone marrow function (absolute neutrophil count =1,500/mm3; platelet count =100000/mm3; hemoglobin =9g/dl
- •Adequate liver and renal function as assessed by the following laboratory requirements conducted within 7 days of starting to study treatment:
- •Total bilirubin < 1.5 x the upper limit of normal (ULN).
- •Alanine transaminase (ALT) and aspartate aminotransferase (AST) < 2.5 x ULN (< 5 x ULN for patients with liver involvement of their cancer).
- •Amylase and lipase < 1.5 x the ULN
- •Serum creatinine < 1.5 x the ULN.
- •Glomerular filtration rate (GFR) = 30 ml/min/1.73 m2 according to the MDRD (Modified diet in renal disease) abbreviated formula
- •Prothrombin time, international normalized ratio (INR) and partial thromboplastin time less than or equal to 1.2 times the ULN.
- •Male or female at least 21 years of age.
- •A female subject is eligible to enter and participate in the study if she is:
- •Non-childbearing potential (ie. physiologically incapable of becoming pregnant) including any women who:
- •Has had a hysterectomy or
- •Has bilateral oophorectomy (ovariectomy) or
- •Has bilateral tubal ligation or
- •Is postmenopausal (demonstrate total cessation of menses for greater than or
- •Childbearing potential, has a negative serum or urine pregnancy test at screening, agrees to one of the following: double barrier contraception or abstinence.
- •Predicted life expectancy of at least 12 weeks.
- •Resting oxygen saturation greater than 92% on room air.
- •Written informed consent.
- •Able to swallow and retain oral medication.
- •Prothrombin time (PT), International Normalized Ratio for PT (PT INR), and partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) within normal limits.
排除标准
- 未提供
研究者
研究点 (2)
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