NCT00120939已完成1 期
Phase I Trial of Motexafin Gadolinium (MGd) and Docetaxel Chemotherapy in the Treatment of Advanced Solid Tumors
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Determine the Dose Limiting Toxicity at 8 weeks (2 cycles), and the Maximum Tolerated Dose at 24 weeks.
研究概览
简要总结
The primary purpose of this study is to evaluate the safety, side effects, and dosage for Motexafin Gadolinium given with the chemotherapy drug docetaxel to patients with advanced cancers. Secondly, tumor response to the combined treatment, drug levels in the body, and drug interactions will be evaluated.
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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years old
- •Metastatic, or unresectable solid tumors from breast, head, and neck, gastrointestinal, genitourinary, lung, or ovarian cancer or recurrent glioblastoma multiforme
- •ECOG performance status score either 0, 1, or 2
- •Willing and able to provide written informed consent
排除标准
- •Greater than two prior cytotoxic regimens
- •Laboratory values showing adequate function of bone marrow, liver, and kidneys
- •Uncontrolled hypertension
- •Known sensitivity to or intolerable adverse effects from taxanes (eg. paclitaxel, docetaxel) or polysorbate 80
结局指标
主要结局
Determine the Dose Limiting Toxicity at 8 weeks (2 cycles), and the Maximum Tolerated Dose at 24 weeks.
次要结局
- Tumor response rate 8, 16 and 24 weeks, and common PK parameters at 24 weeks
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
Study of Motexafin Gadolinium and Docetaxel for Advanced Solid TumorsBreast NeoplasmsOvarian NeoplasmsLung NeoplasmsProstatic NeoplasmsNCT00080041Pharmacyclics LLC.20
已完成
1 期
Study of Weekly Motexafin Gadolinium (MGd) for Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic LymphomaSmall Lymphocytic LymphomaLymphomaLeukemiaChronic Lymphocytic LeukemiaNCT00290004Pharmacyclics LLC.35
已完成
1 期
A Study of Motexafin Gadolinium and Temozolomide for the Treatment of Malignant GliomasOligodendrogliomaBrain NeoplasmGlioblastomaGliomaAstrocytomaNCT00080054Pharmacyclics LLC.24
终止
1 期
Motexafin Gadolinium With Chemotherapy and Radiation Therapy for the Treatment of Advanced Head and Neck CancerHead and Neck CancerOropharynx CancerLarynx CancerHypopharynx CancerNCT00080028Pharmacyclics LLC.18
已完成
1 期
A Study of Motexafin Gadolinium (MGd) in Combination With Docetaxel and Cisplatin for Treatment of Non-Small Cell Lung Cancer (NSCLC)Non-Small-Cell Lung CarcinomaCarcinoma, BronchogenicNCT00102505Pharmacyclics LLC.36