NCT00800865已完成1 期
A 2-Stage, Open Label, Phase Ib Clinical Trial to Evaluate Biomarkers in Patients With Solid Tumor and Receiving a Single Dose of Cytotoxics
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 主要终点
- Level of Biomarkers
研究概览
简要总结
A study to evaluate biomarkers of cancer (context-specific sensitizers) in the skin of participants already receiving cytotoxic therapy. Additional blood and urine samples will be collected for phosphorylated Histone 2AX (γH2AX) and renal toxicity biomarker testing, respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant has solid tumor that will be treated with one of the following treatments:
- •Gemcitabine monotherapy
- •Cisplatin monotherapy
- •Carboplatin monotherapy
- •Gemcitabine and cisplatin combination therapy
- •Gemcitabine and erlotinib combination therapy
- •Gemcitabine and carboplatin combination therapy
- •Cisplatin and vinorelbine combination therapy
- •Cisplatin and pemetrexed combination therapy
- •Carboplatin and vinorelbine combination therapy
- •Carboplatin and pemetrexed combination therapy
排除标准
- •Participant has had recent cancer treatments including chemotherapy or radiation
- •Participant has been in an investigational study within the last 30 days
- •Participant has a history of drug or alcohol abuse
- •Participant is Human Immunodeficiency Virus (HIV) positive or has a history of Hepatitis B or C
结局指标
主要结局
Level of Biomarkers
时间窗: Baseline, 24, 32, and 48 hours post dose
Phospho-CDC2 (pCDC2) response in the skin following the administration of cytotoxic agents. pCDC2 levels were measured by immunohistochemistry (IHC).
Ratio of pCDC2 Response in Skin Following Administration of Cytotoxic Therapy
时间窗: 24, 32, and 48 hours post dose
Ratio of Phospho-CDC2 (pCDC2) response at 24, 32, and 48 hours compared to baseline, 24, and 32 hours post chemotherapy.
次要结局
未报告次要终点
研究者
相似试验
已完成
1 期
PEP005 Gel - Biological Effects in Actinic Keratosis Assessed by Reflectance Confocal MicroscopyActinic KeratosisNCT01449513LEO Pharma24
已完成
2 期
Phase II, 2nd Line Melanoma - RAND MonotherapyMelanomaNCT00612664Bristol-Myers Squibb158
已完成
1 期
PEP005 Gel - Biological Effects in Actinic Keratosis Assessed by HistologyActinic KeratosisNCT01387711LEO Pharma27
已完成
早期 1 期
Topical Sildenafil as Pre-Treatment for Hand-Foot Skin ReactionHand Foot Skin ReactionNCT03229512Northwestern University2
招募中
2 期
A Phase 2 Clinical Study of Combination Therapy With ABSK043 and FirmonertinibNon-Small Cell Lung Cancer With EGFR MutationNCT06668103Abbisko Therapeutics Co, Ltd54