ACTRN12616001187437尚未招募2 期
Molecular profiling to identify patients with BRAF/NRAS wild type melanoma and the proportion of these patients that undergo matched targeted therapy as a result of extended molecular testing.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 1,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •INITIAL INCLUSION CRITERIA:
- •Newly diagnosed and treatment naive unresectable Stage IIIB, IIIC or Stage IV melanoma.
- •Archival or fresh metastatic tumour tissue available for genetic testing. Archival tissue from primary melanoma may be considered if no recent sample is available.
- •Male or female patients aged 18 or over.
- •Written informed consent for molecular genetic testing of tumour tissue (for both standard and research tests).
- •INCLUSION CRITERIA FOR EXTENDED MOLECULAR TESTING:
- •Standard of care molecular tumour testing which has identified BRAF / NRAS wild type tumour tissue.
- •INCLUSION CRITERIA FOR MATCHED TARGETED THERAPY:
- •Received available standard therapies for metastatic melanoma and progressed, unable to tolerate standard therapy, or standard therapy contraindicated.
- •Written informed consent to receive targeted therapy (if applicable) and clinical follow up.
- •ECOG status 0 - 2.
- •Adequate haematological, hepatic and renal organ function as defined by:
- •White cell count = or > 2.0 × 10^9/L
- •Neutrophil count = or > 1.5 × 10^9/L
- •Haemoglobin = or > 90 g/L
- •Platelet count = or >100 x 10^9/L
- •Total bilirubin < or = 3.0 x ULN
- •Alanine transaminase < or = 3.0 x ULN
- •Aspartate aminotransferase < or = 3.0 x ULN
- •Serum creatinine < or = 1.5 x the upper limit of normal (ULN).
- •Life expectancy > 30 days.
- •Women of child bearing potential (WOCBP) to use contraception to avoid pregnancy.
- •Non sterile men with female partners of CBP to use contraception to avoid pregnancy.
- •Drug specific inclusions (refer to the regulatory approved drug specific Product Information provided)
排除标准
- •EXCLUSION CRITERIA FOR MATCHED TARGETED THERAPY:
- •An expectation for the need for concurrent radiotherapy (unless safety has been established with the matched drug regimen).
- •Any investigational drug or other systemic drug therapy for melanoma within 14 days or 5 half-lives from baseline, whichever is shorter.
- •Pregnant or breast feeding females.
- •Drug specific exclusions (refer to the regulatory approved drug specific Product Information Sheet provided)
研究者
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