EUCTR2007-001421-10-DE进行中（未招募）不适用
A Randomized, Double-Blind, Phase III Trial of STA-4783 in Combination with Paclitaxel versus Paclitaxel Alone for Treatment of Chemotherapy-Naïve Subjects with Stage IV Metastatic Melanoma
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 630
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
- •A subject is eligible for the study if all of the following criteria are met:
- •-must be at least 18 years of age
- •-if female or childbearing potential or male, willing to use two forms of effective contraception during study treatment
- •-must have histologically confirmed melanoma of cutaneous origin
- •-must have Stage IV melanoma
- •-must have Eastern Coorporative Oncology Group (ECOG) performance status of -must have measurable disease according to modified RECIST
- •-if subject has received prior systemic therapy, must have evidence of persistent or progressive disease or the inability to tolerate previous treatment due to toxicity, in the opinion of the investigator
- •-must not have received any prior cytotoxic chemotherapeutic agent for melanoma (eg, DTIC, carmustine, taxanes, microtubule inhibitors, hyperthermic isolated limb perfusion)
- •-must not have received more than one regimen of kinase inhibitor, immunotherapy, biologic therapy, vaccine or investigational non-chemotherapeutic treatment for melanoma
- •-at least 4 weeks must have passed between the last kinase inhibitor, immunotherapy, biologic therapy, vaccine or investigational non-chemotherapeutic treatment (excluding anti-CTLA4) and the first dose of study medication
- •-at least 8 weeks must have passed between the last treatment with anti-CTLA4 and the first dose of study medication
- •-at least 2 weeks must have passed between the last radiotherapy treatment and the first dose of study medication.
- •-must have a life expectancy of greater than 12 weeks
- •-must have clinical laboratory values at screening as defined below:
- •*LDH < or = to 2.0 x ULN
- •*Hemoglobin >or = 8g/dL
- •*Absolute neutrophil count > or = 1500/mm3
- •*Platelet count > or = to 100,000/mm3
- •*Creatinine < or = 1.5 mg/dL (NOTE: If creatinine is > 1.5 mg/dL, subject is eligible if
- •creatinine clearance > or = to 60 mL/min using the Cockgroft-Gault equation)
- •*Total bilirubin < or = to 1.2 mg/dL
- •*Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline
- •phosphatase (ALP) < or = to 2.5 x ULN
- •-must have ability to understand and the willingness to sign a written informed consent document
- •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
- •A subject is excluded from the study if any of the folllowing criteria are met:
- •-female subjects who are pregnant or nursing
- •-presence or history (> or = 5 years) of a second malignancy other than nonmelanoma skin cancer or cervical carcinoma in situ
- •-presence of an active infection requiring intravenous antibiotics, a serious local infection (eg, cellulitis, abscess) or systemic infection (eg, pneumonia, septicemia) which required systemic antibiotic treatment within 2 weeks prior to the first dose of study medication
- •-presence of a potentially drug-induced peripheral neuropathy that is assessed as Grade 2 or greater based on the NCI CTCAE criteria version 3.0
- •-history of or clinical symptoms of central nervous system metastases
- •-presence of any brain metastases (as determined by contrast computed tomography (CT) or magnetic resonance imaging (MRI) scan performed during screening
- •-presence of clinically significant cardiac arrhythmias
- •-known to be HIV positive
- •-needs chronic immunosuppressive therapy (eg, cyclophosphamide following transplantation)
- •-has had surgery within 2 weeks (1 week for minor surgery, eg, procedures requiring only local anesthetics) prior to the first dose of study medication
- •-use of complementary anti-cancer therapy (prescription or over the counter, including herbal remedies or high-dose antioxidants) within 2 weeks prior to the first dose of study medication and for the duration of the study
- •-presence of a serious concurrent illness or other condition (eg, psychological, family, sociological, or geographical circumstances) that does not permit adequate follow-up and compliance with the protocol
研究者
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