NCT00372073终止2 期
A Phase IIb Randomized Study of Oral Seliciclib in Patients With Previously Treated Non-Small Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 187
- 试验地点
- 20
- 主要终点
- Progression-free survival
研究概览
简要总结
A phase 2 study to evaluate efficacy of oral seliciclib in treating non-small cell lung cancer (NSCLC).
详细描述
A randomized Phase II study of an experimental anti-cancer drug called seliciclib with objectives of evaluating safety and efficacy in patients with non-small cell lung cancer.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Adult patients with histologically-confirmed recurrent non-small cell lung cancer have had at least two prior systemic treatment regimens
- •Must have measurable disease according to RECIST
- •Eastern Cooperative Oncology Group performance status 0-1
- •Adequate bone marrow, hepatic and renal function
- •Ability to swallow capsules
- •At least 3 weeks from prior systemic treatments including investigational anti-cancer therapy, at least 7 days from prior radiation therapy and have recovered from prior toxicities
- •At least 3 weeks from major surgery
排除标准
- •Non-small cell cancer histology contains a component of small cell lung cancer
- •Previously untreated CNS metastasis or progressive CNS metastasis
- •Prior treatment with a CDK inhibitor
- •Currently receiving radiotherapy, biological therapy, or any other investigational therapy
- •Uncontrolled intercurrent illness
- •Having other cancers that have been treated with chemotherapy or biological therapy in the past 5 years with the exception of adequately treated in situ cervical cancer or basal cell skin cancer
- •Pregnant or lactating women
- •Known to be HIV-positive
- •Active hepatitis B and/or hepatitis C infection
研究组 & 干预措施
Arm 1 with seliciclib
Active Comparator
Oral seliciclib at 1200mg b.i.d. for 3 consecutive days as an outpatient beginning on day 1 every 2 weeks for 3 cycles as run-in. Patients (randomized) continue on treatment if derived clinical benefit during run-in period.
干预措施: seliciclib (Drug)
Arm 2 with placebo control
Placebo Comparator
Randomized to placebo after run-in period.
干预措施: placebo (Drug)
结局指标
主要结局
Progression-free survival
时间窗: over the course of the study
Time until the disease starts progressing
次要结局
未报告次要终点
研究者
研究点 (20)
Loading locations...
相似试验
已完成
2 期
Concomitant Radio-chemotherapy in the ElderlyNon Small Cell Lung CancerNCT01029678University Hospital, Limoges48
Unknown
2 期
Investigation of Safety and Efficacy of SB Injection in Patients With Advanced and Metastatic Non-small Cell Lung CancerNon Small Cell Lung CancerNCT01305967SBPharmaceutical IND, Co., LTD20
招募中
2 期
Efficacy & Safety of Olvimulogene Nanivacirepvec & Platinum-doublet + Physician's Choice of Immune Checkpoint Inhibitor Compared to Docetaxel in NSCL CancerAdvanced Non-squamous Non-small-cell Lung CancerAdvanced Squamous Non-Small Cell Lung CarcinomaMetastatic Non-squamous Non Small Cell Lung CancerMetastatic Squamous Non-Small Cell Lung CarcinomaNon-small Cell Lung Cancer Stage IIINon-small Cell Lung Cancer Stage IVNon-small Cell Lung Cancer RecurrentNon-small Cell Lung CancerNCT06463665Genelux Corporation142
已完成
2 期
Gemcitabine/Platinum Containing Regimens as Preoperative Chemotherapy for Patients With Non Small Cell Lung CancerCarcinoma, Non Small Cell LungNCT00191230Eli Lilly and Company70
终止
1 期
An Open Study of ASP8273 in Patients With Non-Small-Cell Lung Cancer (NSCLC) Who Have Epidermal Growth Factor Receptor (EGFR) MutationsNon-small Cell Lung CancerNCT02192697Astellas Pharma Inc124