ISRCTN00191981已完成2 期
A Phase II study to evaluate the efficacy and safety of PTK787 in patients with metastatic cutaneous melanoma
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 34
研究概览
简要总结
- 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20800475
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Life expectancy >12 weeks
- •2. Performance status 0, 1 or 2 (Eastern Cooperative Oncology Group [ECOG] performance scale)
- •3. Presence of one or more bi-dimensionally measurable lesions, either clinically or radiologically (by chest x-ray, computerised tomography [CT] or conventional magnetic resonance imaging [MRI] scan as appropriate) using response evaluation criteria in solid tumors (RECIST) criteria
- •4. Age >18 years
- •5. Hb >10 g/dl, platelets >100,000 mm^3, white cell count (WCC) >3.0 x 10^9 /l, absolute neutrophil count (ANC) >1.5 x 10^9 /l
- •6. Bilirubin <1.5 x upper limit of normal (ULN), alkaline phosphatase <3 x ULN, transaminases <3 x ULN, (or alkaline phosphatase and transaminases <5 if liver metastases are present)
- •7. Creatinine <1.5 x ULN
- •8. Measured creatinine clearance >50 ml/min and total urinary protein <500 mg per 24 hours
- •9. Written informed consent provided by the patient
- •10. 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.
- •11. Prior adjuvant therapy is allowed, as long as it was completed at least six months previously
- •12. One line of prior chemotherapy for advanced disease is allowed, as long as the best response to this treatment was complete response, partial response or stable disease, determined after a minimum of two cycles of planned treatment, using RECIST criteria
- •13. Prior radiotherapy is allowed, however measurable target lesions must not have been irradiated
- •14. 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
排除标准
- •1. Patients who have received a first line therapy for advanced disease, when the initial response was documented to be disease progression, using RECIST criteria
- •2. Any previous chemotherapy, immunotherapy or investigational agent within the last four weeks
- •3. Any other serious or uncontrolled illness, which in the opinion of the investigator makes it undesirable for the patient to enter the trial
- •4. Any medical or psychiatric condition, which would influence the ability to provide informed consent
- •5. Patients with a history of renal (e.g. glomerulonephritis) or renal vascular disease
- •6. Acute or chronic active liver disease (e.g. hepatitis, cirrhosis)
- •7. Surgery within two weeks of entry into the trial
- •8. Incomplete recovery from previous surgery or non-surgical treatment
- •9. History or presence of central nervous system (CNS) disease i.e. primary brain tumour, malignant seizures, clinically symptomatic CNS metastases or carcinomatous meningitis
- •10. Any of the following concurrent severe and/or uncontrolled medical conditions, which could compromise participation in the trial:
- •a. Uncontrolled high blood pressure, history of labile hypertension, or history of poor compliance with an antihypertensive regimen
- •b. Unstable angina pectoris
- •c. Symptomatic congestive heart failure
- •d. Myocardial infarction under six months prior to randomisation
- •e. Serious uncontrolled cardiac arrhythmia
- •f. Uncontrolled diabetes
- •g. Active or uncontrolled infection
- •h. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of PTK787/ZK222584 (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)
- •11. Patients who are taking warfarin or other similar oral anticoagulants that are metabolised by the cytochrome P450 system, heparin is acceptable
- •12. Pregnant or lactating women
- •13. Women of childbearing potential must have a negative serum pregnancy test with 48 hours of trial entry
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