A PHASE 2, OPEN-LABEL, TWO ARM TRIAL TO EVALUATE THE EFFICACY OF PF-00299804 IN PATIENTS WITH ADVANCED NSCLC AFTER FAILURE OF AT LEAST ONE PRIOR CHEMOTHERAPY REGIMEN AND FAILURE OF PRIOR TREATMENT WITH ERLOTINIB
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 66
- 试验地点
- 19
- 主要终点
- Best Overall Response (BOR) in Participants With Adenocarcinoma Histology
研究概览
简要总结
To assess the antitumor efficacy measured by the objective response rate of oral PF-00299804 taken daily, as single agent in patients with advanced NSCLC who failed at least one chemotherapy + erlotinib.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Advanced Non-Small Cell Lung Cancer (NSCLC)
- •Prior treatment with and failure of at least one regimen of chemotherapy and erlotinib.
- •Prior treatment with no more than two chemotherapy regimens, including adjuvant or combined modality treatment.
- •Measurable disease .
- •Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
- •Tissue available for KRAS/ EGFR testing
- •Creatinine clearance > 40 cc/min or serum creat < 1.5 x ULN
排除标准
- •Chemotherapy
- •Radiotherapy
- •Biological or investigational agents within 4 weeks of baseline disease assessment.
- •Patients who lack of tolerance of erlotinib therapy.
研究组 & 干预措施
1
descriptive: adenocarcinoma histology
干预措施: PF-00299804 (Drug)
2
descriptive: non-adenocarcinoma histology
干预措施: PF-00299804 (Drug)
结局指标
主要结局
Best Overall Response (BOR) in Participants With Adenocarcinoma Histology
时间窗: Baseline, end of every even-numbered cycle up to end of treatment (Day 936)
BOR:best response recorded from treatment start until disease progression as per Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response: disappearance of all lesions. Partial Response (PR):greater than or equal to (\>=)30% decrease in sum of longest diameters (SLDs) of target lesions (TLs) taking as reference baseline SLD. Progressive disease (PD):\>=20% increase in SLD of TLs taking as reference smallest SLD since treatment start, or appearance of \>=1 new lesion. Stable disease:neither shrinkage for PR nor increase for PD taking as reference smallest SLD since treatment start.
次要结局
- European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score(Baseline (C1D1), C2D1 thereafter every subsequent cycle up to C43)
- European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score(Baseline (C1D1), C2D1 thereafter every subsequent cycle up to C43)
- Dermatology Life Quality Index (DLQI) Score(Baseline (C1D1), C2D1 thereafter every subsequent cycle up to C43)
- Duration of Response (DR)(Baseline, end of every even-numbered cycle up to end of treatment (Day 936))
- Percent Probability of Progression-free Survival (PFS) at Month 6(Up to 6 months after the start of study medication)
- Percent Probability of Overall Survival at Months 6 and 12(Months 6, 12)
- Area Under the Curve From Time Zero to 24 Hours [AUC (0-24)](0.5-2, 3-5, 6-8, 22-26 hours post dose on Day 1 of Cycle 1)
- Maximum Observed Plasma Concentration (Cmax)(0.5-2, 3-5, 6-8, 22-26 hours post dose on Day 1 of Cycle 1)
- Time to Reach Maximum Observed Plasma Concentration (Tmax)(0.5-2, 3-5, 6-8, 22-26 hours post dose on Day 1 of Cycle 1)
- Human Epidermal Growth Factor-2 (HER-2) and Epidermal Growth Factor Receptor (EGFR) Levels in Serum(Baseline [pre-dose on Cycle 1 Day 1 (C1D1)], then pre-dose on Day 1 of each cycle, end of treatment (Day 936))
- Number of Participants With Human Epidermal Growth Factor Family (HER-Family) and Kirsten Rat Sarcoma (KRAS) Gene Mutation Status From Free Tumor Deoxy- Ribonucleic Acid (DNA) in Blood at Screening(Screening)
- Best Overall Response (BOR) in Participants With Non-Adenocarcinoma Histology(Baseline, end of every even-numbered cycle up to end of treatment (Day 936))
- Percentage of Participants With Progression-free Survival (PFS)(Month 6)