跳至主要内容
临床试验/NCT00538681
NCT00538681终止2 期

Randomized, Double-Blind, Placebo Controlled, Phase 2 Study of Pemetrexed and Cisplatin Plus Enzastaurin Versus Pemetrexed and Cisplatin Plus Placebo in Chemonaive Patients With Advanced, Unresectable, or Metastatic (Stage IIIB or IV) Nonsquamous Non-Small Cell Lung Cancer

Eli Lilly and Company1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2007年9月最近更新:
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
35
试验地点
1
主要终点
Part 1: Evaluate Safety [Toxicity, Serious Adverse Events (SAEs) and Reasons for Participant's Discontinuation]

研究概览

简要总结

This study is intended for participants with advanced, not amenable to surgery, or metastatic lung cancer who have not received any prior chemotherapy. The study will be conducted in 2 parts:

  • Part 1 is intended to evaluate safety of pemetrexed + cisplatin + enzastaurin combination chemotherapy
  • Part 2 whose main objective is to compare the efficacy of pemetrexed + cisplatin + enzastaurin versus pemetrexed + cisplatin + placebo. Participants to be included in Part 2 are those with Nonsquamous Non-Small Cell Lung Cancer (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
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

入选标准

  • diagnosis of advanced NSCLC not amenable to curative treatment. Participants enrolling in Part 2 of the study must have the above stated diagnosis of NSCLC that is also of nonsquamous histology.
  • no prior systemic therapies [chemotherapy, et cetera (etc.)] or pleurodesis with chemotherapy for this disease
  • prior radiotherapy is allowed but must be completed at least 2 weeks before study enrollment and participant must be recovered from the acute toxic effects
  • have a good performance status
  • participant must sign an informed consent document

排除标准

  • participant had myocardial infarction occurring less than 6 months before inclusion, uncontrolled arrhythmia, symptomatic angina pectoris, or cardiac failure not controlled by medications
  • participant is unable to swallow tablets
  • participant is taking a certain medicine to control seizure activity, called "enzyme inducing antiepileptic drugs" and is not able to stop taking the medicine prior to enrolling in the study
  • participant is unable to interrupt aspirin and/or other anti-inflammatory agents
  • participant is unwilling or unable to take vitamin supplementation (folic acid and vitamin B12) or medications to prevent side effects

研究组 & 干预措施

Enzastaurin + Pemetrexed + Cisplatin

Experimental

干预措施: enzastaurin (Drug)

Enzastaurin + Pemetrexed + Cisplatin

Experimental

干预措施: pemetrexed (Drug)

Enzastaurin + Pemetrexed + Cisplatin

Experimental

干预措施: cisplatin (Drug)

Placebo + Pemetrexed + Cisplatin

Placebo Comparator

干预措施: pemetrexed (Drug)

Placebo + Pemetrexed + Cisplatin

Placebo Comparator

干预措施: cisplatin (Drug)

Placebo + Pemetrexed + Cisplatin

Placebo Comparator

干预措施: placebo (Drug)

结局指标

主要结局

Part 1: Evaluate Safety [Toxicity, Serious Adverse Events (SAEs) and Reasons for Participant's Discontinuation]

时间窗: Cycle 1 (28-day cycle), Cycles 2, 3, 4, 5, and 6 (21-day cycles) and 30-day follow up

Presented are data that evaluates safety based on toxicity using Common Terminology Criteria for Adverse Events (CTCAE v3.0), SAEs, and discontinuations due to SAEs or other non-serious adverse events (AE's) of study participants. A summary of SAEs and other non-serious AEs regardless of causality is located in the Reported Adverse Event module.

Part 2: Compare Progression-Free Survival (PFS) Between the 2 Treatment Arms Through the Assessment of Tumor Response

时间窗: Baseline to measured PD up to 5 months

PFS was defined as the time from date of first dose to the first observation of disease progression or death due to any cause. For participants not known to have died as of the data cut-off date and who did not have objective progressive disease (PD), PFS was censored at the date of the last objective progression-free assessment. For participants who received subsequent anticancer therapy (after discontinuation from the study treatment) prior to objective disease progression or death, PFS was censored at the date of last objective progression-free assessment prior to the initiation of post discontinuation anticancer therapy. PFS was calculated and analyzed based on an alternative definition of censoring; for each participant who is not known to have died or who have had objective disease progression as of the data cut-off date, PFS was censored at the date of last prior contact. Zero participants were analyzed in this outcome as study was terminated early.

次要结局

  • Part 2: Number of Participants With a Complete Response (CR) or Partial Response (PR) (Response Rate)(Baseline to measured progressive disease (PD) up to 5 months)
  • Part 2: To Assess Biomarkers of the Disease State and Their Correlation to Clinical Outcome(Baseline, Cycle 1 (28-day cycle), Cycles 2, 3, 4, 5, and 6 (21-day cycles) and end of study up to 5 months)
  • Part 2: Overall Survival (OS)(Baseline to date of death from any cause up to 5 months)
  • Part 2: To Evaluate the Safety and Toxicity Profile of Study Treatments(Cycle 1 (28-day cycle), Cycles 2, 3, 4, 5, and 6 (21-day cycles) and 30-day follow-up)
  • Part 2: Duration of Disease Control (DDC) and Response(Baseline to measured PD up to 5 months)
  • Part 2: Time to Worsening of Symptoms (TWS)(Cycle 1 (28-day cycle), Cycles 2, 3, 4, 5, and 6 (21-day cycles) and 30-day follow-up)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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