NCT00274443已完成2 期
An Open -Label, Phase II Trial of Increasing Doses of ABI-007 and Carboplatin in Patients With Advanced Non Small Cell Lung Cancer (NSCLC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Celgene
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Efficacy Outcomes: percentage of patients who achieve an objective confirmed complete or partial overall antitumor response
研究概览
简要总结
This is an open-label dose escalation trial using ABI-007 plus carboplatin.
详细描述
This is a multicenter study conducted at study sites in Russia and the Ukraine where various doses of ABI-007 (Abraxane) will be given in combination with carboplatin to patients with non-small cell lung cancer to determine the recommended dose and schedule for this combination therapy for Phase III trials. The primary objective of this study is to obtain preliminary information on the antitumor activity and adverse events of ABI-007 in combination with carboplatin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Histologically or cytologically confirmed NSCLC Stage IIIB with pleural effusion or evidence of inoperable local recurrence or metastasis (Stage IV).
- •Male or non-pregnant and non-lactating female, and ≥ 18 years of age. ( )If a female patient is of child-bearing potential, as evidenced by regular menstrual periods, she must have a negative serum pregnancy test (β-hCG) documented within 72 hours of the first administration of study drug. ( )If sexually active, the patient must agree to utilize contraception considered adequate and appropriate by the investigator.
- •No other current active malignancy.
- •Measurable disease
- •Patients must have received no prior therapy for the treatment of metastatic disease.
- •Patient has the following blood counts at baseline:
- •( ) ANC ≥ 1.5 x 109/L; ( ) platelets ≥ 100 x 109/L; ( ) Hgb ≥ 9 g/dL.
- •Patient has the following blood chemistry levels at baseline:
- •( ) AST (SGOT), ALT (SGPT) ≤ 1.5x upper limit of normal range (ULN); ( ) total bilirubin NORMAL; ( ) creatinine ≤ 1.5 mg/dL.
- •Expected survival of > 12 weeks.
- •ECOG performance status 0 or
- •Patient or his/her legally authorized representative or guardian has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent form prior to participation in any study-related activities.
排除标准
- •Evidence of active brain metastases, including leptomeningeal involvement. Prior evidence of brain metastasis permitted only if treated and stable off therapy for at least 1 month.
- •The only evidence of metastasis is bone metastases or other nonmeasurable disease.
- •Patient has pre-existing peripheral neuropathy of grade 2, 3, or
- •Patient received radiotherapy in last 4 weeks, except if to a non-target lesion only. Prior radiation to a target lesion is permitted only if there has been clear progression of the lesion since radiation was completed.
- •Patient has a clinically significant concurrent illness.
- •Patient is, in the investigator's opinion, unlikely to be able to complete the study through the End of Study visit.
- •Patient has received treatment with any other cytotoxic chemotherapeutic agent or investigational drug within the previous 4 weeks;
- •Patient has a history of allergy or hypersensitivity to the study drug.
- •Patient has serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive an experimental research drug.
- •Patient is enrolled in any other clinical protocol or investigational trial.
研究组 & 干预措施
ABI-007 and Carboplatin
Experimental
ABI-007 and Carboplatin in patients with Advanced Non-Small Cell Lung Cancer.
干预措施: ABI-007 (Abraxane) and Carboplatin (Drug)
结局指标
主要结局
Efficacy Outcomes: percentage of patients who achieve an objective confirmed complete or partial overall antitumor response
时间窗: Treatment duration
Safety Outcomes: incidence of treatment emergent adverse events.
时间窗: Treatment duration
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
终止
1 期
AB1 in Adult Patients with Sickle Cell Disease (SCD)Sickle Cell DiseaseNCT05261711Nirmish Shah16
进行中（未招募）
1 期
Study to Assess SLN124 in Patients With Polycythemia VeraPolycythemia VeraNCT05499013Silence Therapeutics plc69
进行中（未招募）
1 期
A Study of LM-108 as Monotherapy or in Combination With Antitumor Therapies in Subjects With Advanced Solid TumorsAdvanced Solid TumorNCT05518045LaNova Medicines Limited392
进行中（未招募）
1 期
AAV Gene Therapy Study for Subjects with PKUPhenylketonuria (PKU)NCT04480567BioMarin Pharmaceutical100
招募中
2 期
Allogenic Hepatocyte Transplantation Into Periduodenal Lymph NodesEnd Stage Liver DiseaseNCT04496479LyGenesis, Inc.12