NCT01925274终止2 期
A RANDOMIZED PHASE 2 STUDY OF PF-05212384 PLUS IRINOTECAN VERSUS CETUXIMAB PLUS IRINOTECAN IN PATIENTS WITH KRAS AND NRAS WILD TYPE METASTATIC COLORECTAL CANCER
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 19
- 试验地点
- 28
- 主要终点
- Progression Free Survival (PFS) as Assessed by Investigators
研究概览
简要总结
This study will investigate whether the combination of PF-05212384 plus Irinotecan improves progression free survival in patients with KRAS and NRAS wild type metastatic colorectal cancer when compared with the combination of cetuximab plus Irinotecan. A Japanese Lead in Cohort will assess the safety of the combination of PF-05212384 + irinotecan in patients enrolled at Japanese sites.
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
- •KRAS and NRAS wild type metastatic colorectal cancer
- •Progression following treatment for colorectal cancer with irinotecan, oxaliplatin and fluoropyrimidine therapy in the metastatic setting.
- •Eastern Cooperative Oncology Group [ECOG] Performance Status of 0, 1, or 2
- •At least one measurable lesion by Response Evaluation Criterion in Solid Tumors [RECIST]
排除标准
- •More than 2 prior cytotoxic chemotherapy regimens for metastatic colorectal cancer.
- •Prior treatment with a PI3K, mTOR, AKT or EGFR inhibitor
- •Patients who have discontinued treatment with prior irinotecan therapy due to toxicity.
- •Prior radiation to the pelvis or abdomen
- •Patients with history of interstitial lung disease.
研究组 & 干预措施
Arm A
Experimental
PF-05212384 plus Irinotecan
干预措施: PF-05212384 (Drug)
Arm A
Experimental
PF-05212384 plus Irinotecan
干预措施: Irinotecan (Drug)
Arm B
Active Comparator
Cetuximab plus Irinotecan
干预措施: Cetuximab (Drug)
Arm B
Active Comparator
Cetuximab plus Irinotecan
干预措施: Irinotecan (Drug)
结局指标
主要结局
Progression Free Survival (PFS) as Assessed by Investigators
时间窗: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
Progression-free survival (PFS) was the time from the first dose of study treatment to the first documentation of objective tumor progression or death due to any cause, whichever occurred first. Objective progression was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 mm. Median PFS was estimated based on the Kaplan-Meier method.
次要结局
- Number of Participants With ECG Maximum Increase From Baseline Meeting Pre-defined Criteria(2 years)
- Maximum Plasma Concentration (Cmax) of SN-38(Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.)
- Area Under Plasma Concentration Time Profile From Time Zero to the Time for the Last Quantifiable Concentration (AUClast) of Irinotecan(Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.)
- Area Under Plasma Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-05212384(Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 24, 72, 120 hours post PF-05212384 infusion on Cycle 1 Day 9.)
- Overall Survival (OS)(2 years)
- Number of Participants With Laboratory Test (Hematology) Abnormalities(2 years)
- Maximum Plasma Concentration (Cmax) of PF-05212384(Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 24, 72, 120 hours post PF-05212384 infusion on Cycle 1 Day 9 and Cycle 1 Day 16.)
- Time for Maximum Plasma Concentration (Tmax) of SN-38(Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.)
- Terminal Elimination Half Life (t½) of Irinotecan(Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.)
- Percentage of Participants With Objective Response(2 years)
- Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)(Administration of the first dose of study drug through 28 calendar days after the last administration of study drug)
- Duration of Response(2 years)
- Number of Participants With Laboratory Test (Chemistry) Abnormalities(2 years)
- Number of Participants With Laboratory Test (Coagulation) Abnormalities(2 years)
- Area Under Plasma Concentration Time Profile From Time Zero to the Time for the Last Quantifiable Concentration (AUClast) of SN-38(Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.)
- Area Under Plasma Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of SN-38(Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.)
- Change From Baseline in Functional Assessment of Cancer Therapy-Colorectal (FACT-C)(2 years)
- Number of Participants With Unacceptable Toxicity in Cycle 1 (Japanese LIC Only)(28 days)
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Common Terminology Criteria for Adverse Events (CTCAE) Grade(Administration of the first dose of study drug through 28 calendar days after the last administration of study drug)
- Number of Participants With Laboratory Test (Urinalysis) Abnormalities(2 years)
- Number of Participants With ECG Post-Baseline Maximum Absolute Values Meeting Pre-defined Criteria(2 years)
- Maximum Plasma Concentration (Cmax) of Irinotecan(Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.)
- Time for Maximum Plasma Concentration (Tmax) of PF-05212384(Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 24, 72, 120 hours post PF-05212384 infusion on Cycle 1 Day 9 and Cycle 1 Day 16.)
- Time for Maximum Plasma Concentration (Tmax) of Irinotecan(Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.)
- Area Under Plasma Concentration Time Profile From Time Zero to the Time for the Last Quantifiable Concentration (AUClast) of PF-05212384(Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 24, 72, 120 hours post PF-05212384 infusion on Cycle 1 Day 9.)
- Number of Participants With Expression of Pre-defined Gene Sequences in Biopsied Tumor Tissues(2 years)
- Terminal Elimination Half Life (t½) of PF-05212384(Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 24, 72, 120 hours post PF-05212384 infusion on Cycle 1 Day 9 and Cycle 1 Day 16.)
- Area Under Plasma Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Irinotecan(Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.)
- Terminal Elimination Half Life (t½) of SN-38(Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.)
- Levels of Signaling Proteins in Paired and Single Tumor Biopsies(2 years)
研究者
研究点 (28)
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