NCT00354562终止1 期
A Phase 1/2 Study Evaluating the Safety and Efficacy of ABT-751 in Combination With Docetaxel Versus Docetaxel Alone in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Abbott
- 入组人数
- 75
- 试验地点
- 32
- 主要终点
- Progression-free Survival
研究概览
简要总结
To determine the efficacy of ABT-751 when administered in combination with standard docetaxel in subjects with advanced or metastatic NSCLC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Pathologically documented NSCLC
- •Locally advanced (Stage III) or metastatic (Stage IV) NSCLC
- •Only one prior anti-tumor treatment regimen in the non-curative setting (i.e., 2nd-line therapy)
- •Only one prior anti-tumor treatment regimen in the curative setting
- •Progressive disease following the previous anti-tumor treatment regimen
- •Measurable disease by RECIST criteria
- •Brain metastasis must be stable and well-controlled
- •ECOG performance score 0-2All anti-tumor therapy discontinued at least 3 weeks prior to study entryAll adverse events from prior treatment are resolved or stableAdequate hematologic, renal, and hepatic functionFemales must not be pregnantWilling to take adequate measures to prevent pregnancyLife expectancy of at least 3 monthsAble to complete the Quality of Life questionnaireVoluntarily signed informed consent
- •Only one prior anti-tumor treatment regimen in the curative setting
- •Progressive disease following the previous anti-tumor treatment regimen
- •Measurable disease by RECIST criteria
- •Brain metastasis must be stable and well-controlled
- •ECOG performance score 0-2
- •All anti-tumor therapy discontinued at least 3 weeks prior to study entry
- •All adverse events from prior treatment are resolved or stable
- •Adequate hematologic, renal, and hepatic function
- •Females must not be pregnant
- •Willing to take adequate measures to prevent pregnancy
- •Life expectancy of at least 3 months
- •Able to complete the Quality of Life questionnaire
- •Voluntarily signed informed consent
排除标准
- •Greater that Grade 1 neurological findings
- •Allergy to sulfa medications
- •Previous treatment with ABT-751 or docetaxel
- •Receipt of more than one investigational agent for NSCLC
- •Significant weight loss (>10%) within 6 weeks of study entry
- •Glucose-6-phosphate dehydrogenase deficiency or porphyria
- •Significant systemic disease that would adversely affect participation
- •Class 3-4 New York Heart Association classification status
- •Other cancers except in situ carcinoma of the cervix, basal or squamous cell skin cancer, or any other cancer considered adequately treated and cured by the investigator
研究组 & 干预措施
A
Active Comparator
Docetaxel + ABT-751
干预措施: Docetaxel (Drug)
A
Active Comparator
Docetaxel + ABT-751
干预措施: ABT-751 (Drug)
B
Placebo Comparator
Docetaxel + placebo
干预措施: Placebo (Drug)
B
Placebo Comparator
Docetaxel + placebo
干预措施: Docetaxel (Drug)
结局指标
主要结局
Progression-free Survival
时间窗: Subjects may remain on study until disease progression
次要结局
- Overall Survival(Subject may remain on study until disease progression)
- Response Rate(Subject may remain on study until disease progression)
- Time-to-Progression (TTP)(Subject may remain on study until disease progression)
研究者
研究点 (32)
Loading locations...
相似试验
已完成
1 期
A Phase 1/2 Study Evaluating ABT-751 in Combination With Alimta in Advanced Non-Small Cell Lung CancerNon-Small-Cell Lung CancerLung CancerNSCLCNCT00297089AbbVie (prior sponsor, Abbott)165
终止
2 期
A Study of AT-101 in Combination With Docetaxel in Squamous Cell Carcinoma Of The Head and NeckSquamous Cell Carcinoma of the Head and Neck (SCCHN)NCT01285635University of Michigan Rogel Cancer Center35
撤回
2 期
A Study Of Docetaxel Or Docetaxel Plus PF-3512676 To Treat Patients With Advanced Breast Cancer.Breast NeoplasmsNCT00471159Pfizer
Unknown
1 期
A Clinical Trial of Apatinib Plus Docetaxel in Locally Advanced or Metastatic Gastric or GEJ AdenocarcinomaMetastatic Gastric AdenocarcinomaNCT03071042Sir Run Run Shaw Hospital12
已完成
2 期
Phase II Study of Docetaxel and S-1 Combination Therapy for Advanced or Recurrent Gastric CancerMetastatic gastric cancer (Advanced or recurrent gastric cancer)JPRN-C000000103Hiroshima Cancer Therapy Development Organization (HiCTDO)50