CLINICAL PHASE 2 MULTICENTER TRIAL OF PF-00299804 IN PATIENTS WITH RECURRENT OR METASTATIC SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 69
- 试验地点
- 9
- 主要终点
- Percentage of Participants With Objective Response (OR) of Complete Response (CR) or Partial Response (PR)
研究概览
简要总结
This study will investigate the safety and efficacy of oral PF-00299804 in patients who have not yet undergone any other drug treatment for recurrent and/ or metastatic head and neck squamous cell cancer.
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
- •Recurrent or metastatic Squamous Cell Cancer of the Head and Neck;
- •Measurable disease;
- •Eastern Cooperative Oncology Group (ECOG) 0-1 in Stage 1 = first 23 patients;
- •Eastern Cooperative Oncology Group (ECOG) 0-2 in Stage 2 = 33 patients;
排除标准
- •prior therapy for recurrence;
- •platelets < 75,000;
- •prior Epidermal Growth Factor Receptor (EGFR) therapy;
- •interstitial lung disease;
- •primary of nasopharynx
研究组 & 干预措施
A
干预措施: PF-00299804 (Drug)
结局指标
主要结局
Percentage of Participants With Objective Response (OR) of Complete Response (CR) or Partial Response (PR)
时间窗: Baseline up to 18 months
Percentage of participants with best OR of confirmed CR or PR according to Response Evaluation Criteria in Solid Tumors (RECIST) relative to total number of evaluable participants for response. CR defined as disappearance of all target/non-target lesions. PR defined as at least a 30 percent (%) decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions. Confirmed responses (CR and PR) were those that persisted on a follow-up imaging assessment greater than or equal to (≥)4 weeks after the initial objective documentation of response.
次要结局
- Duration of Response (DR)(Baseline up to 18 months)
- Duration of Stable Disease (SD)(Baseline up to 18 months)
- Progression-Free Survival (PFS)(Baseline up to 18 months)
- Progression-Free Survival (PFS) at 6 Months and at 1 Year(Baseline up to 52 weeks)
- Overall Survival (OS)(Baseline up to 18 months)
- Overall Survival at 6 Months and 1 Year(Baseline up to Week 52)
- Trough Plasma Concentrations (Ctrough) of Dacomitinib After Repeat Dosing(Predose on Day 1 of Cycles 2, 3, and 4 and predose on Day 8 of Cycle 1)
- Ctrough of Dacomitinib After Repeat Dosing In Participants Requiring Administration of Dacomitinib With a Feeding Tube(Predose on Day 1 of Cycles 2, 3, and 4 and predose on Day 8 of Cycle 1)
- Maximum Observed Plasma Concentration (Cmax) In Participants Requiring Administration of Dacomitinib With a Feeding Tube(Cycle 1 Day 1 at predose and 1, 2, 4, 6, 8, 10, and 24 hours postdose)
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) In Participants Requiring Administration of Dacomitinib With a Feeding Tube(Cycle 1 Day 1 at predose and 1, 2, 4, 6, 8, 10, and 24 hours postdose)
- Time to Reach Maximum Observed Plasma Concentration (Tmax) In Participants Requiring Administration of Dacomitinib With a Feeding Tube(Cycle 1 Day 1 at predose and 1, 2, 4, 6, 8, 10, and 24 hours postdose)
- Plasma Decay Half-Life (t1/2)(Cycle 1 Day 1 at predose and 1, 2, 4, 6, 8, 10, and 24 hours postdose)
- Correlation Between Biomarkers Status and Best Overall Response(Baseline up to 18 months)
- H-Score at Baseline and Post-baseline for Paired Biopsy Biomarkers(Baseline up to 18 Months)
- H-Score at Ratio to Baseline for Paired Biopsy Biomarkers(Baseline up to 18 Months)