ACTRN12616000440426招募中1 期
Pilot Early phase II study of Decitabine and Carboplatin in patients with advanced melanoma
niversity of Newcastle0 个研究点目标入组 10 人开始时间: 2016年4月6日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
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
- •1. Age>= 18 years
- •2. Before study enrolment written informed consent to participate in the trial must be given according to ICH/GCP and national/local regulations
- •3. Resistance to all approved treatments for melanoma
- •4. Tumour material is mandatory- tumour tissue selected must not be previously irradiated; treatment should start only after complete wound healing from surgery
- •5. Disease status before first treatment should be documented by full CT scan of brain, chest, abdo and pelvis and PET scan and MRI brain if indicated
- •6. BRAF mutation status
- •7. ECOG Performance Status 0,1,2
排除标准
- •1. mucosal or ocular melanoma
- •2. CNS metastases
- •3. Patient demonstrates inadequate organ function- hematologic, hepatic and renal
- •4. History of pneumonitis, interstitial lung disease, inflammatory bowel disease or active auto-immune disease that required systemic treatment in past 2 years (with use of disease modifying agents, corticosteroids or immune suppressive drugs)
- •5. History of immune related toxicity to previous immunotherapy of grade 2 or higher except endocrinology related toxicity that is treated and stable and on replacement therapy for adrenal, pituitary or thyroid deficiency (thyroxine, insulin or physiologic corticosteroid therapy allowed)
- •6. Diagnosis of immunodeficiency
- •7. Known history of HIV; active Hep B/C
- •8. Systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment
- •9. Patients who received treatment with live vaccines within 30 days prior to first dose of study medication
- •10. Patient is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used and investigation device within 4 week prior to first dose of treatment
- •11. History of hematologic or primary solid tumour malignancy, unless no evidence of that disease for 5 years
- •12. Pregnancy and Contraception- Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the first dose of study treatment
- •13. Female patients who are breast feeding should discontinue nursing prior to the first dose of study treatment and until 120 days after the last dose of the study drug
研究者
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