MOUNTAINEER: A Phase II, Open Label Study of Tucatinib Combined With Trastuzumab in Patients With HER2+ Metastatic Colorectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Seagen Inc.
- 入组人数
- 117
- 试验地点
- 56
- 主要终点
- Confirmed Objective Response Rate (cORR) Per RECIST v1.1 Per Blinded Independent Central Review (BICR) in Pooled Cohorts A+B
研究概览
简要总结
This trial studies how well the drug tucatinib works when given with trastuzumab and when given by itself. The participants in this trial have HER2-positive (HER2+) metastatic colorectal cancer (mCRC). 'Metastatic' means that the cancer has spread to other parts of the body.
In the first part of this study, participants enrolled into Cohort A and received both tucatinib and trastuzumab. In the second part of this study, participants are randomly assigned to either Cohort B or Cohort C. Participants in Cohort B will receive tucatinib and trastuzumab. Participants in Cohort C will receive tucatinib. Participants in Cohort C who do not respond to therapy may have an option to receive tucatinib plus trastuzumab.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cohort C: Tucatinib Monotherapy
Randomized cohort. Participants take tucatinib twice per orally every day. Participants who do not respond to therapy may have the option to receive tucatinib and trastuzumab.
干预措施: Tucatinib (Drug)
Cohort A: Tucatinib + Trastuzumab
Non-randomized cohort. Participants take tucatinib twice per day orally on Days 1-21 and trastuzumab intravenously (into the vein; IV) on Day 1. Cycles repeat every 21 days.
干预措施: Trastuzumab (Drug)
Cohort A: Tucatinib + Trastuzumab
Non-randomized cohort. Participants take tucatinib twice per day orally on Days 1-21 and trastuzumab intravenously (into the vein; IV) on Day 1. Cycles repeat every 21 days.
干预措施: Tucatinib (Drug)
Cohort B: Tucatinib + Trastuzumab
Randomized cohort. Participants take tucatinib twice per day orally on Days 1-21 and trastuzumab intravenously (into the vein; IV) on Day 1. Cycles repeat every 21 days.
干预措施: Trastuzumab (Drug)
Cohort B: Tucatinib + Trastuzumab
Randomized cohort. Participants take tucatinib twice per day orally on Days 1-21 and trastuzumab intravenously (into the vein; IV) on Day 1. Cycles repeat every 21 days.
干预措施: Tucatinib (Drug)
结局指标
主要结局
Confirmed Objective Response Rate (cORR) Per RECIST v1.1 Per Blinded Independent Central Review (BICR) in Pooled Cohorts A+B
时间窗: Up to 46.6 months
cORR was defined as the percentage of participants with confirmed CR or PR according to RECIST v1.1. CR was defined as the disappearance of all target lesions and each target lymph node must have reduction in short axis to less than (\<)1.0 centimeter (cm). PR was defined as at least a 30 percentage (%) decrease in post-baseline sum of the diameters (sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation) taking as reference the baseline sum of diameters.
次要结局
- ORR by 12 Weeks of Treatment Per RECIST v1.1 According to BICR Assessment(Up to 3 months)
- Duration of Response (DOR) Per RECIST v1.1 According to BICR Assessment(Up to 64.1 months)
- Progression-Free Survival (PFS) Per RECIST v1.1 According to BICR Assessment for Pooled Cohorts A+B(Up to 64.1 months)
- Overall Survival (OS) in Pooled Cohorts A+B(Up to 71.8 months)
- Number of Participants With Adverse Events (AEs): Interim Analysis(Up to 49.3 months)
- Number of Participants With AEs: Final Analysis(Up to 65.1 months)
- Number of Participants With AEs Resulting in Dose Modification: Interim Analysis(Up to 49.3 months)
- Number of Participants With AEs Resulting in Dose Modification: Final Analysis(Up to 65.1 months)
- Number of Participants With Treatment-Emergent Laboratory Abnormalities (Hematology): Interim Analysis(Up to 49.3 months)
- Number of Participants With Treatment-Emergent Laboratory Abnormalities (Hematology): Final Analysis(Up to 65.1 months)
- Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Interim Analysis(Up to 49.3 months)
- Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Final Analysis(Up to 65.1 months)
- Number of Participants With Clinically Significant Vital Signs: Final Analysis(Up to 65.1 months)