A Phase 1/2, Modified Dose Escalation, Open Label Trial to Determine the Therapeutic Effect and Safety of INCB007839 Combined With Trastuzumab in Patients With Previously Untreated HER2 Positive Metastatic Breast Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 68
- 主要终点
- Overall response rate (complete + partial response) using RECIST (Response Evaluation Criteria in Solid Tumor) criteria
研究概览
简要总结
This is a single arm, modified dose escalation, open label trial with the objectives of: (1) Determining a safe optimal dose of INCB007839 in combination with trastuzumab and docetaxel (2) Determining clinical efficacy and safety of INCB007839 in combination with trastuzumab and docetaxel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed metastatic breast carcinoma that is HER2 positive
- •Measurable disease as defined by the RECIST criteria
- •Life expectancy greater than or equal to 6 months
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
排除标准
- •Received any anticancer medications in the 28 days prior to enrollment into this study
- •Received any anticancer medications for cancers other than breast cancer within 6 months prior to enrollment in this study.
- •History of deep venous thrombosis within the last year
- •Contraindication to low dose warfarin therapy
- •Clinically significant cardiomyopathy
- •Prior treatment with INCB007839 or trastuzumab or lapatinib
研究组 & 干预措施
Treatment A - INCB007839 and Trastuzumab
INCB007839 100 mg BID and trastuzumab
In Cycle 1, trastuzumab will be administered at a loading dose of 8 mg/kg as a 90 minute intravenous infusion on Day 8. In all subsequent 21-day cycles, trastuzumab will be administered at 6 mg/kg as a 90 minute intravenous infusion on Day 1.
干预措施: INCB007839 (Drug)
Treatment A - INCB007839 and Trastuzumab
INCB007839 100 mg BID and trastuzumab
In Cycle 1, trastuzumab will be administered at a loading dose of 8 mg/kg as a 90 minute intravenous infusion on Day 8. In all subsequent 21-day cycles, trastuzumab will be administered at 6 mg/kg as a 90 minute intravenous infusion on Day 1.
干预措施: trastuzumab (Drug)
Treatment B - INCB007839 and Trastuzumab
INCB007839 200 mg BID and trastuzumab
In Cycle 1, trastuzumab will be administered at a loading dose of 8 mg/kg as a 90 minute intravenous infusion on Day 8. In all subsequent 21-day cycles, trastuzumab will be administered at 6 mg/kg as a 90 minute intravenous infusion on Day 1.
干预措施: INCB007839 (Drug)
Treatment B - INCB007839 and Trastuzumab
INCB007839 200 mg BID and trastuzumab
In Cycle 1, trastuzumab will be administered at a loading dose of 8 mg/kg as a 90 minute intravenous infusion on Day 8. In all subsequent 21-day cycles, trastuzumab will be administered at 6 mg/kg as a 90 minute intravenous infusion on Day 1.
干预措施: trastuzumab (Drug)
Treatment C - INCB007839 and Trastuzumab
INCB007839 300 mg BID and trastuzumab
In Cycle 1, trastuzumab will be administered at a loading dose of 8 mg/kg as a 90 minute intravenous infusion on Day 8. In all subsequent 21-day cycles, trastuzumab will be administered at 6 mg/kg as a 90 minute intravenous infusion on Day 1.
干预措施: INCB007839 (Drug)
Treatment C - INCB007839 and Trastuzumab
INCB007839 300 mg BID and trastuzumab
In Cycle 1, trastuzumab will be administered at a loading dose of 8 mg/kg as a 90 minute intravenous infusion on Day 8. In all subsequent 21-day cycles, trastuzumab will be administered at 6 mg/kg as a 90 minute intravenous infusion on Day 1.
干预措施: trastuzumab (Drug)
Treatment D - INCB007839 and Docetaxel
INCB007839 300mg BID with docetaxel
干预措施: INCB007839 (Drug)
Treatment D - INCB007839 and Docetaxel
INCB007839 300mg BID with docetaxel
干预措施: Docetaxel (Drug)
结局指标
主要结局
Overall response rate (complete + partial response) using RECIST (Response Evaluation Criteria in Solid Tumor) criteria
时间窗: Day 1 of each completed subsequent 21-day treatment cycle and the End of Study Visit.
次要结局
- To determine the plasma pharmacokinetic (PK) profile of INCB007839 and trastuzumab when given in combination(Monthly)