NL-OMON43804尚未招募2 期
A Phase I/II Open-Label, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of GSK525762 in Subjects with NUT Midline Carcinoma (NMC) and Other Cancers (BET115521) - BET115521
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 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
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Males and females, 16 years and above (NL: 18 years and above).
- •Diagnosis:
- •NUT Midline Carcinoma as diagnosed by the Central Laboratory. Subjects may be treatmentnaïve or have had prior therapy.
- •SCLC, CRPC, TNBC and ER+BC
- •Subjects with solid tumors, with the exception of CRPC, must demonstrate measurable disease (NMC: see protocol page 50 for details).
- •ECOG Performance Status 0-2 (NMC), 0-1 (other tumor types).
- •Females of childbearing potential and males: adequate method of contraception.
- •CRPC subjects:
- •Histologically or cytologically confirmed prostate adenocarcinoma, surgically castrated or continuously medically castrated (for *8 weeks)
- •Persistent disease with evidence of disease progression following standard therapy(ies). See protocol page 52 for details.
- •Serum testosterone level <1.7 nmol/l.
- •PSA level >=2.0 ng/mL.
排除标准
- •Prior and current treatments: see protocol page 53 for details.
- •Evidence of severe or uncontrolled systemic diseases. See protocol page 53 for details.
- •Cardiac and or ECG abnormalities. See protocol page 54 for details.
- •GSK525762 is a benzodiazepine class molecule. Any serious known immediate or delayed hypersensitivity reaction(s) to GSK525762 or idiosyncrasy to drugs chemically related to the investigational drug.
- •Hemoptysis > 1 teaspoon in 24 hours within the last 28 days.
- •History of major gastrointestinal bleeding within the last 6 months. Any evidence of active gastrointestinal bleeding.
- •Pregnancy or breastfeeding.
研究者
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