EUCTR2005-004710-33-GB进行中（未招募）1 期
A PHASE II STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PTK787 IN PATIENTS WITH METASTATIC CUTANEOUS MELANOMA
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 34
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
- •Patients with histologically or cytologically confirmed unresectable, metastatic cutaneous melanoma.
- •Life expectancy > 12 weeks.
- •Performance status 0, 1 or 2 (ECOG performance scale : Appendix A).
- •Presence of 1 or more bidimensionally measurable lesions, either clinically or radiologically (by chest x-ray, CT or conventional MRI scan as appropriate), using RECIST criteria.
- •Age > 18 years.
- •Laboratory parameters:
- •Hb > 10 g/dl, platelets > 100,000 mm3, WCC > 3.0 x109/L, ANC > 1.5x109/L
- •Bili < 1.5 x ULN, Alk phos < 3 x ULN, transaminases < 3 x ULN, (or alk phos and transaminases < 5 if liver metastases are present)
- •Cr < 1.5 x ULN
- •Measured creatinine clearance > 50 ml/min and total urinary protein < 500 mg/24 hour .
- •Written informed consent provided by the patient.
- •Prior adjuvant therapy is allowed.
- •One line of prior systemic therapy for advanced disease is allowed.
- •Prior radiotherapy is allowed. However, measurable target lesions must not have been irradiated.
- •Patients must not have a history of other malignant disease other than adequately treated non-melanomatous skin cancer or in situ carcinoma of the cervix.
- •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
- •Any previous chemotherapy, immunotherapy or investigational agent within the last 4 weeks.
- •Any other serious or uncontrolled illness which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial.
- •Any medical or psychiatric condition which would influence the ability to provide informed consent.
- •Patients with a history of renal (eg. glomerulonephritis) or renal vascular disease.
- •Acute or chronic active liver disease (e.g., hepatitis, cirrhosis).
- •Surgery within 2 weeks of entry on to the study.
- •Incomplete recovery from previous surgery or non-surgical treatment.
- •History or presence of central nervous system (CNS) disease i.e., primary brain tumor, malignant seizures, clinically symptomatic CNS metastases or carcinomatous meningitis.
- •Any of the following concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study:
- •Uncontrolled high blood pressure, history of labile hypertension, or history of poor compliance with an antihypertensive regimen;
- •Unstable angina pectoris;
- •Symptomatic congestive heart failure;
- •Myocardial infarction = 6 months prior to randomization;
- •Serious uncontrolled cardiac arrhythmia;
- •Uncontrolled diabetes;
- •Active or uncontrolled infection.
- •Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of PTK787/ZK 222584 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhoea which might result in malabsorption, any known malabsorption syndrome, bowel obstruction, or inability to swallow the capsules/tablets).
- •Patients who are taking warfarin or other similar oral anticoagulants that are metabolised by the cytochrome p450 system; heparin is acceptable.
- •Pregnant or lactating women.
- •Patients of both genders with reproductive potential not employing an effective method of birth control. Barrier contraceptives must be used throughout the trial. Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study.
- •Women of childbearing potential must have a negative serum pregnancy test within 48 hours of trial entry.
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