NCT00077246已完成1 期
An Open-Label, Phase I/II Trial Of ABI-007 (A CREMOPHOR® El-Free, Protein Stabilized, Nanoparticle Paclitaxel) Administered Weekly In Chemotherapy Naive Patients With Advanced Non-Small Cell Lung Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of ABI-007
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as ABI-007, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase I/II trial is studying the side effects and best dose of ABI-007 and to see how well it works in treating patients with stage IV non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose and dose-limiting toxicity of paclitaxel (albumin-stabilized Nanoparticle formulation) (ABI-007) in patients with chemotherapy-naïve stage IV non-small cell lung cancer.
- Determine the antitumor activity of this drug in these patients.
- Determine the safety and tolerability of this drug in these patients.
Secondary
- Determine the time to disease progression in patients treated with this drug.
- Determine duration of response in patients treated with this drug.
- Determine survival of patients treated with this drug.
研究设计
- 研究类型
- Interventional
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of ABI-007
Objective target lesion response (complete or partial) as measured by RECIST criteria
次要结局
- Nadir of myelosuppression
- Changes in physical examination
- Changes in hematologic and clinical chemistry values
- Percentage of patients with complete or partial target response (total response)
- Duration of response
- Incidence of treatment-emergent adverse events and serious adverse events
- Percentage of patients with stable disease for ≥ 16 weeks
- Incidence of dose modifications, dose interruptions, and/or premature discontinuation of study treatment
- Time to disease progression
- Survival
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
ABI-007 in Treating Patients With Inoperable Locally Recurrent or Metastatic MelanomaMelanoma (Skin)NCT00081042Jonsson Comprehensive Cancer Center
已完成
3 期
A Trial of ABI-007 Versus Dacarbazine in Previously Untreated Patients With Metastatic Malignant MelanomaMalignant MelanomaNCT00864253Celgene529
已完成
1 期
ABT-751 in Treating Young Patients With Refractory Solid TumorsBrain and Central Nervous System TumorsChildhood Germ Cell TumorExtragonadal Germ Cell TumorKidney CancerUnspecified Childhood Solid Tumor, Protocol SpecificSarcomaLiver CancerOvarian CancerNeuroblastomaNCT00036959National Institutes of Health Clinical Center (CC)90
已完成
2 期
Phase II Trial Comparing ABI-007 (Abraxane®, Nab®-Paclitaxel) to Taxotere in First Line Therapy of Patients With Stage IV Breast CancerMetastatic Breast CancerNCT00274456Celgene302
已完成
1 期
Trial of ABI-007 Administered Weekly in Chemotherapy Naive Patients With Advanced Non-Small Cell Lung CancerNon-Small Cell Lung CancerNCT00073723Celgene Corporation75