JPRN-jRCT2080221129未知1 期
A Phase 1, Open-Label, Dose Escalation Study Evaluating the Safety, Tolerability and Pharmacokinetics of AMG 479 in Adult Japanese Patients with Advanced Solid Tumors
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 74age old（—）
- 性别
- All
入选标准
- •Major inclusion criteria include the following:
- •1)Histologically or cytologically documented and definitively diagnosed, advanced solid tumor that is refractory to standard treatment or for which no curative therapy is available
- •2)Eastern Cooperative Oncology Group (ECOG) performance status : 0 or 1
- •3)20 to 74 years old at the time of obtaining the informed consent
排除标准
- •Major exclusion criteria include the following:
- •1)Hematological malignancies
- •2)Primary central nervous system (CNS) tumors, including primary CNS lymphoma
- •3)Presence of untreated CNS metastases
- •4)Presence of symptomatic CNS metastases
- •5)Unresolved Common Terminology Criteria for Adverse Events (CTCAE) hematologic toxicities >= grade 2 from prior anti-cancer therapy. Lymphopenia >= 500/microL and hemoglobin >= 9.0 g/dL will be acceptable.
- •6)Unresolved CTCAE non-hematological toxicities >= grade 2 from prior anti-cancer therapy, excluding alopecia. AST or ALT <= 5 x ULN will be acceptable if the subject has liver metastases.
- •7)Uncontrolled diabetes, defined as having hemoglobin A1c (HbA1c) >= 6.5% and fasting blood glucose level >= 130 mg/d
研究者
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