CTRI/2009/091/000822招募中2 期
A Phase 1/2 Study of the Vascular Disrupting Agent NPI-2358 in Combination with Docetaxel in Patients with Advanced Non-Small Cell Lung Cancer. (ADVANCE)
ereus Pharmaceuticals, Inc.10480 Wateridge CircleSan Diego, CA 92121USA0 个研究点目标入组 154 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 154
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
入选标准
- •1. Male and females ≥ 18 years of age
- •2. ECOG performance status ≤ 1
- •3. Pathologically or histologically confirmed advanced non-small cell lung cancer (unresectable Stage IIIb or IV) that has progressed after treatment with at least one chemotherapy regimen; measurable disease is not required for enrollment into this trial
- •4. All Adverse Events of any prior chemotherapy, surgery, or radiotherapy, must have resolved to Grade ≤ 2
- •5. Signed informed consent
排除标准
- •1. Administration of certain chemotherapy, biological, immunotherapy, radiation therapy, surgery or investigational agent within specified time frames
- •2. Significant cardiac history
- •3. Prior treatment with tumor vascular disruptive agents
- •4. Seizure disorder
- •5. Brain metastases
- •6. Active uncontrolled bacterial, viral, or fungal infection, requiring systemic therapy
- •7. Known infection with human immunodeficiency virus (HIV), or active hepatitis A, B, or C
- •8. Patients with a prior hypersensitivity reaction to product components
- •9. Pregnant or breast-feeding women.
- •10. Concurrent, active second malignancy for which the patient is receiving therapy, excluding basal cell carcinoma of the skin or carcinoma in situ of the cervix
- •11. Unwilling or unable to comply with procedures required in this protocol
研究者
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