EUCTR2006-001456-12-GB进行中（未招募）1 期
A Phase II, Multi-centre, Open-Label, Parallel Group, Randomised Study To Compare the Efficacy of AZD6244 vs Temozolomide in Patients with Unresectable AJCC Stage 3 or 4 Malignant Melanoma
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
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.Provision of informed consent
- •2.Female or male aged 18 years and over
- •3.Histological or cytological confirmation of unresectable AJCC stage 3 or 4 malignant melanoma
- •4.At least one measurable site of disease (using imaging techniques) as defined by RECIST
- •5.WHO performance status 0-2 (patients performance status 2 must have been stable with no deterioration over the previous 2 weeks)
- •6.Willing to provide a fresh, or archival tumour biopsy for determination of BRAF and NRAS mutational status
- •7.Evidence of post-menopausal status, or negative urinary pregnancy test for female pre-menopausal patients
- •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
- •1.Laboratory values as listed below:
- •-Absolute Neutrophil Count (ANC) <1500 per cubic mm
- •-Platelets <100,000 per cubic mm
- •-Haemoglobin (Hgb) =9.0 g/dL
- •-Serum bilirubin =1.5 times the upper limit of normal (ULN)
- •-Aspartate aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT) =2.5 times ULN
- •-Serum creatinine =1.5 mg/dL
- •2.Calculated serum creatinine clearance =30 mL/min (using Cockcroft-Gault formula)
- •3.Any radiotherapy (not including palliative radiotherapy at focal sites) or chemotherapy. Previous treatment with immunomodulatory agent, vaccine therapy or gene therapy alone is acceptable (combination biochemotherapy is not permitted)
- •4.Participation in an investigational drug study within the 30 days prior to entry or who have not recovered from side effects of an investigational study drug
- •5.Recent major surgery within 4 weeks prior to informed consent
- •6.Brain metastases or spinal cord compression unless treated and stable (for at least 3 months) off steroids
- •7.Patients with a history of another primary malignancy other than basal cell carcinoma in situ
- •8.Any evidence of severe or uncontrolled systemic disease (eg, severe hepatic impairment, severe renal impairment, uncontrolled diabetes, acute uncontrolled infection) or current unstable or uncompensated respiratory or cardiac conditions or peripheral vascular disease including diabetic vasculopathy
- •9.Evidence of active infection or active bleeding diatheses
- •10.Documented cases of human immunodeficiency virus (HIV) or hepatitis B or C
- •11.Refractory nausea and vomiting, chronic gastrointestinal diseases (eg, inflammatory bowel disease), or significant bowel resection that would preclude adequate absorption
- •12.Mean QTc interval >450 ms
- •13.Presence of factors that may increase the risk of QT prolongation or arrhythmic events (eg, heart failure, hypokalaemia, family history, or long QT syndrome)
- •14.Receiving concomitant medication that may cause QT prolongation
- •15.Known hypersensitivity to AZD6244, Captisol®, or temozolomide
- •16.Female patients who are breast feeding, or patients of reproductive potential not employing an effective method of birth control
- •17.Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site)
- •18.Previous enrolment or randomisation of treatment in the present study
研究者
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