EUCTR2010-019526-14-DE进行中（未招募）不适用
An Open-Label, 2-Cohort, Multicenter, Phase 2 Study of E7080 in Previously Treated Subjects With Unresectable Stage III or Stage IV Melanoma
Eisai Ltd0 个研究点目标入组 180 人开始时间: 2010年9月29日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 180
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
- •1. Histologically confirmed diagnosis of melanoma.
- •2. AJCC unresectable stage III or stage IV melanoma (Appendix 1).
- •3. Melanoma not harboring the V600E BRAF mutation (Cohort 1) and melanoma harboring the V600E BRAF mutation (Cohort 2).
- •4. Radiographic/photographic evidence of disease progression according to modified RECIST 1.1 (Appendix 2) following first-line standard of care therapy (Cohort 1) or BRAF-V600E-targeted therapy (Cohort 2) for unresectable stage III or stage IV disease.
- •5. Measurable disease meeting the following criteria:
- •– At least 1 lesion of >=1.5 cm in the longest diameter for a non-lymph node or >=1.5 cm in the short-axis diameter for a lymph node which is serially measurable according to modified RECIST 1.1 using computerized tomography/magnetic resonance imaging (CT/MRI) (see Section 8.5.1.3 Tumor Response Assessments and Appendix 2).
- •– Lesions that have had external beam radiotherapy (EBRT) or loco-regional therapies such as radiofrequency (RF) ablation must show evidence of progressive disease based on modified RECIST 1.1 to be deemed a target lesion.
- •6. ECOG performance status of 0 or 1 (Appendix 3).
- •7. Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP <=150/90 mmHg at screening and no change in antihypertensive medications within 1 week prior to the Screening Visit.
- •8. Adequate renal function defined as calculated creatinine clearance =30 mL/min per the Cockcroft and Gault formula (Appendix 4).
- •9. Adequate bone marrow function:
- •- Absolute neutrophil count (ANC) =1000/mm3 (=1.0 x 103/micro/L);
- •- Platelets =100,000/mm3 (=100 x 109/L);
- •- Hemoglobin =9.0 g/dL.
- •10. Adequate blood coagulation function as evidenced by an International Normalized Ratio (INR) <=1.5.
- •11. Adequate liver function:
- •- Bilirubin <=1.5 x the upper limit of normal (ULN) except for unconjugated hyperbilirubinaemia of Gilbert’s syndrome;
- •- Alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) <=3 x ULN (<=5 x ULN if subject has liver metastases).
- •12. Males or females age =18 years at the time of informed consent.
- •13. All females must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of beta-human chorionic gonadotropin [ß hCG]) at the Screening Visit (and/or within 72 hours of the first dose of study drug). Females of child-bearing potential must agree to use a medically acceptable method of contraception (e.g., abstinence, an intrauterine device [IUD], a double-barrier method such as condom + spermicide or condom + diaphragm with spermicide, a contraceptive implant, an oral contraceptive or have a vasectomised partner with confirmed azoospermia) throughout the entire study period and for 30 days after study drug discontinuation. The only subjects who will be exempt from this requirement are postmenopausal women (defined as women who have been amenorrheic for at least 12 consecutive months, in the appropriate age group, without other known or suspected primary cause) or subjects who have been sterilized surgically or who are otherwise proven sterile (i.e., bilateral tubal ligation with surgery at least 1 month prior to dosing, hysterectomy, or bilateral oophorectomy with surgery at least 1 month prior to dosing). All women who are of reproductive potential and who are using hormonal contraceptives must have been on a stable dose of the same hormonal contraceptive product for at least 4 weeks prior to
排除标准
- •1. Melanoma of intraocular origin.
- •2. Brain or leptomeningeal metastases.
- •3. More than 1 prior systemic chemotherapy regimen for unresectable stage III or stage IV disease or any treatment targeting vascular endothelial growth factor (VEGF)-directed angiogenesis. There is no restriction regarding prior adjuvant treatment (Cohort 1).
- •4. Subjects not previously treated with BRAF-V600E-targeted therapy for unresectable stage III or stage IV disease or subjects receiving any prior treatment targeting vascular endothelial growth factor (VEGF)-directed angiogenesis. There is no restriction regarding prior adjuvant treatment (Cohort 2).
- •5. Subjects who have received any anti-cancer treatment within 21 days or any investigational agent within 30 days prior to the first dose of study drug or who have not recovered from any acute toxicity related to previous anti-cancer treatment. The exception to this exclusion will be that subjects with rapid disease progression while receiving BRAF targeted therapy may begin E7080 treatment as soon as 14 days following the last dose of the BRAF targeted therapy.
- •6. Subjects with >1+ proteinuria on urinalysis will undergo 24-hour urine collection for quantitative assessment of proteinuria. Subjects with 24-hour urine protein =1 gm will be ineligible.
- •7. Inability to take oral medication, gastrointestinal malabsorption, or any other condition that might affect the absorption of E7080.
- •8. Major surgery within 3 weeks prior to the first dose of study drug.
- •9. Significant cardiovascular impairment: history or congestive heart failure greater than New York Heart Association (NYHA) Class II (Appendix 5); unstable angina; myocardial infarction or stroke within 6 months of the first dose of study drug; or cardiac arrhythmia requiring medical treatment.
- •10. Prolongation of QTc interval to >480 msec.
- •11. Bleeding disorder or a thrombotic disorder requiring anticoagulant therapy such as warfarin, or similar agents requiring therapeutic INR monitoring (treatment with low molecular weight heparin [LMWH] is allowed).
- •12. Active hemoptysis (bright red blood of at least ½ teaspoon) within 3 weeks prior to the first dose of study drug.
- •13. Active malignancy (except for melanoma, basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix) within the past 24 months.
- •14. Females who are pregnant or breastfeeding.
- •15. Know intolerance to the study drug (or any of the excipients).
- •16. Any medical or other condition which, in the opinion of the investigator, would preclude participation in a clinical trial.
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