NCT00965731已完成1 期
Phase 1/2, Open Label, Randomized Study Of The Safety, Efficacy, And Pharmacokinetics Of Erlotinib With Or Without Pf 02341066 In Patients With Advanced Non Small Cell Adenocarcinoma Of The Lung.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 27
- 试验地点
- 15
- 主要终点
- Number of Participants With Dose-Limiting Toxicities (DLT) (Phase 1)
研究概览
简要总结
This is a Phase 1/2 study comparing the safety and anti-tumor activity of erlotinib alone versus erlotinib in combination with PF-02341066 in patients with advanced 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
- 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 proven diagnosis of Non-Small Cell Lung Cancer (NSCLC) that is locally advanced or metastatic and of the adenocarcinoma subtype (including mixed adenosquamous histology)
- •evident disease progression by Response Evaluation Criterion in Solid Tumors (RECIST) after at least one but no more than 2 chemotherapy regimens for advanced disease
- •tumors must have measurable disease as per RECIST
排除标准
- •known interstitial lung disease
- •prior treatment with an agent that is known or proposed to be active by action on EGFR tyrosine kinase or c-Met/HGF (Phase 2 Portion)
研究组 & 干预措施
Erlotinib
Active Comparator
干预措施: Erlotinib (Drug)
Erlotinib + PF-02341066
Experimental
干预措施: Erlotinib (Drug)
Erlotinib + PF-02341066
Experimental
干预措施: PF-02341066 (Drug)
结局指标
主要结局
Number of Participants With Dose-Limiting Toxicities (DLT) (Phase 1)
时间窗: Baseline up to Day 28
Phase 1, first cycle DLT includes Grade (Gr) ≥4 hematologic possible drug-related toxicities and Gr ≥3 possible drug-related febrile neutropenia. Gr ≥3 non-hematological possible drug-related toxicities (except asymptomatic lab value elevation). Gr 3/4 nausea, vomiting or diarrhea. Gr 3 hypertension considered DLT if event unmanageable by approved pharmacologic agents or symptomatic sequelae despite medical intervention. Diagnosis of interstitial lung disease. Inability to deliver at least 80 percent (%) of planned dose during cycle 1 due to possible drug-related adverse events (AEs).
Progression-Free Survival (Phase 2)
时间窗: Baseline, every 42 days up to 20 months, disease progression, or unacceptable toxicity
Time in weeks from phase 2 study randomization to first documentation of objective disease progression or death due to any cause. Progression-Free Survival was calculated as (first event date minus randomization date plus 1) divided by 7.02. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \[PD\]), or from AE data (where the outcome was "Death"; date of death reported in notice of death was used).
次要结局
- PF-02341066 (Crizotinib) Apparent Oral Clearance (CL/F) (Phase 1)(C1D15 i.e., 15 days of giving crizotinib and erlotinib)
- Plasma Level of Soluble Marker: c-Met Ectodomain (Phase 1)(Baseline and Day 50 (Cycle 3, Day 1))
- PF-02341066 (Crizotinib) Area Under the Concentration-Time Curve During Dosing Interval (AUCtau) (Phase 1)(Cycle 1 (C1) Day 1 (D1) i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib)
- Ratio of Adjusted Means of Erlotinib AUCtau (Crizotinib + Erlotinib / Erlotinib Alone) (Phase 1)(C1D-1 (i.e., 1 day prior to initiation of continuous dosing of crizotinib) to C1D15 (i.e., 15 days of giving crizotinib and erlotinib))
- Progression-Free Survival (Phase 1)(Baseline, every 42 days until disease progression or unacceptable toxicity)
- Duration of Response (Phase 1)(Baseline, every 42 days until disease progression or unacceptable toxicity)
- Plasma Level of Soluble Marker: Hepatocyte Growth Factor (HGF) Scatter Factor (Phase 1)(Baseline and Day 50 (Cycle 3, Day 1))
- Plasma Level of Soluble Marker: c-Met Ectodomain (Phase 2)(Baseline and Day 50 (Cycle 3, Day 1))
- Plasma Concentration of Erlotinib (Phase 2)(Day 1 of cycles 1, 3, and 5 (i.e., up to 15 weeks) at 0 hours (pre-dose))
- PF-02341066 (Crizotinib) Maximum Observed Plasma Concentration (Cmax) (Phase 1)(C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib)
- PF-06260182 Area Under the Concentration-Time Curve During Dosing Interval (AUCtau) (Phase 1)(C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib)
- Molecular Weight Adjusted PF-06260182-to-PF-02341006 Ratio of AUCtau (Phase 1)(C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib)
- Erlotinib Area Under the Concentration-Time Curve During Dosing Interval (AUCtau) (Phase 1)(C1D-1 i.e., 1 day prior to initiation of continuous dosing of crizotinib; C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib)
- Erlotinib Maximum Observed Plasma Concentration (Cmax) (Phase 1)(C1D-1 i.e., 1 day prior to initiation of continuous dosing of crizotinib; C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib)
- Erlotinib Apparent Oral Clearance (CL/F) (Phase 1)(C1D15 i.e., 15 days of giving crizotinib and erlotinib)
- Ratio of Adjusted Means of Erlotinib Cmax (Crizotinib + Erlotinib / Erlotinib Alone) (Phase 1)(C1D-1 (i.e., 1 day prior to initiation of continuous dosing of crizotinib) to C1D15 (i.e., 15 days of giving crizotinib and erlotinib))
- PF-06260182 Maximum Observed Plasma Concentration (Cmax) (Phase 1)(C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib)
- Percentage of Participants With Confirmed CR, PR or Stable Disease (SD) at Phase 2(Week 6 and Week 12)
- EORTC Quality of Life Questionnaire -Lung Cancer 13 (QLQ-LC13) Score at Phase 2(Baseline and every 21 days, up to 20 months)
- Percentage of Participants With Mutations in Tumor Tissue (Phase 2)(Screening)
- Percentage of Participants With Objective Response (Phase 1)(Baseline, every 42 days until disease progression or unacceptable toxicity)
- Percentage of Participants With Objective Response (Phase 2)(Baseline, every 42 days up to 20 months, disease progression, or unacceptable toxicity)
- Overall Survival (OS) at Phase 2(Baseline until death, up to 20 months)
- European Organization for Research and Treatment of Cancer (EORTC), Quality of Life Questionnaire (QLQ-C30) Score at Phase 2(Baseline and every 21 days, up to 20 months)
- Plasma Concentration of PF-02341066 and Erlotinib (Phase 2)(Day 1 of cycles 1, 3, and 5 (i.e., up to 15 weeks) at 0 (pre-dose) and 2 to 6 hours post dose)
- Plasma Level of Soluble Marker: HGF Scatter Factor (Phase 2)(Baseline and Day 50 (Cycle 3, Day 1))
- Duration of Response (Phase 2)(Baseline, every 42 days up to 20 months, disease progression, or unacceptable toxicity)
研究者
研究点 (15)
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