NCT00088114已完成1 期
A Phase I Trial of STA-4783 in Patients Receiving Paclitaxel for Treatment of 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
- 50
- 试验地点
- 2
研究概览
简要总结
The purpose of this study is to determine the safety, toxicity and maximum tolerated dose of single doses of STA-4783/paclitaxel in combination when administered intravenously to patients with refractory cancer. To determine the pharmacokinetics of STA-4783 and paclitaxel when co-administered.
To assess the anti-tumor activity of STA-4783 and paclitaxel when co-administered.
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
- •Male and female patients greater than or equal to 18 years of age with histologically confirmed malignancy that is metastatic or unresectable and for which no standard therapy exists.
- •Patients must not have received prior chemotherapy or radiation for greater than or equal to 4 weeks before study enrollment.
- •Patients may be entered if they have received prior radiation therapy involving less than or equal to 30% of the bone marrow. Any prior radiation therapy must have been administered greater than or equal to 4 weeks before study enrollment and the patient must be recovered from the acute toxic effects of the treatment prior to study entry.
- •Patients may be enrolled with a history of treated brain metastases that are clinically stable for greater than or equal to 4 weeks prior to enrollment.
- •ECOG Performance Status of less than or equal to
- •Life expectancy of greater than 12 weeks.
- •No peripheral neuropathy > grade 1 on NCI CTC version 2 scale, no history of stroke or other significant neurological limitations as determined by the investigator.
- •Patients must have acceptable organ and marrow function at screening and pre-dose visits as defined below.
- •Absolute neutrophil count greater than or equal to 1,500/ul
- •Platelets greater than or equal to 100,000 cells/ul
- •Total bilirubin must be within normal limits
- •AST(SGOT) less than or equal to 2.5 times the upper limit of normal
- •Serum creatinine < 1.5 mg/dl or a measured creatine clearance greater than or equal to 50 mL/min
- •Electrocardiogram without evidence of clinically significant conduction abnormalities or active ischemia as determined by investigator.
- •The effects of STA-4783 on the developing human fetus are unknown, however taxanes are known to be teratogenic. Therefore, women of childbearing potential (defined as women less than or equal to 50 years of age or history of amenorrhea for < 12 months prior to study entry) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Women who are pregnant or lactating.
- •Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- •Patients with previous high dose chemotherapy with autologous stem cell rescue bone marrow transplantation.
- •Use of any investigational agents within 4 weeks of study enrollment.
- •History of severe allergic reactions to paclitaxel or docetaxel including severe hypersensitivity reactions defined as greater than or equal to 3 based on NCI CTC version
- •Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social situations that would limit compliance with study requirements, as determined by the investigator.
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
A Phase I Study of STA-5312 in Subjects With Advanced or Metastatic Solid TumorsAdvanced or Metastatic Solid TumorsNCT00276913Synta Pharmaceuticals Corp.30
已完成
1 期
STA-5312 Administered on Alternate Weekdays Every Two Weeks to Patients With Hematologic Malignancies and Patients With Solid TumorsHematological MalignanciesMetastatic or Unresectable Solid TumorsLymphomaLeukemiaNCT00088101Synta Pharmaceuticals Corp.42
已完成
1 期
Phase 1 Clinical Trial of RHN-001 in Healthy Adult VolunteersTolerabilitySafetyPharmacokineticsNCT05847218RH Nanopharmaceuticals64
已完成
1 期
Phase I Clinical Study of E7389CancerNCT00326950Eisai Co., Ltd.15
已完成
1 期
A Phase 1, Safety, Tolerability and Pharmacokinetic Profile of Intravitreous Injections of E10030 (Anti-PDGF Pegylated Aptamer) in Subjects With Neovascular Age-Related Macular DegenerationAge-related Macular DegenerationNCT00569140Ophthotech Corporation18