An Open-Label, Dose-Finding Study to Evaluate the Safety of AMG 706 Plus Panitumumab Plus Gemcitabine-Cisplatin in the Treatment of Subjects With Advanced Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Amgen
- 入组人数
- 41
- 主要终点
- Participant Incidence of Adverse Events
研究概览
简要总结
The purpose of this study is to characterize the safety and tolerability of AMG 706 plus panitumumab when administered with gemcitabine and cisplatin chemotherapy. This is a Phase 1b clinical study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Competent to comprehend, sign, and date an Institutional Review Board (IRB) approved informed consent form
- •Subjects with advanced cancer in whom the gemcitabine and cisplatin chemotherapy regimen is clinically indicated
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Adequate hematological function
- •Adequate renal function
- •Adequate hepatic function
- •Life expectancy of greater than or equal to 3 months as documented by the investigator
排除标准
- •More than 1 prior chemotherapy regimen
- •History of venous thrombosis
- •Myocardial infarction, cerebrovascular accident, transient ischemic attack, percutaneous transluminal coronary angioplasty/stent, or unstable angina within 1 year before study enrollment
- •History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on screening chest computed tomograph (CT) scan
- •Average systolic blood pressure of greater than 145 mm Hg or average diastolic blood pressure of greater than 85 mm Hg
- •Radiotherapy within 28 days of study enrollment or within 14 days of study enrollment for peripheral lesions
- •Prior AMG 706, panitumumab, or another anti-EGFr monoclonal antibody (mAb) (e.g., cetuximab [Erbitux®] or EMD 72000)
- •Systemic chemotherapy within 28 days before study enrollment
- •Major surgery within 28 days or minor surgery within 14 days of study enrollment
- •Central nervous system metastases (Exception: subjects with treated asymptomatic central nervous system metastases, those who have been clinically stable in the judgment of the investigator and off steroids for at least 30 days before the study enrollment are eligible)
研究组 & 干预措施
50 mg QD AMG 706 + panitumumab + Gem/Cis
AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine (gem) 1250 mg/m^2 on Day 1 and Day 8, and cisplatin (cis) 75 mg/m^2 on Day 1 of each 3-week cycle.
干预措施: AMG 706 (Drug)
Panitumumab + Gem/Cis
Panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine (gem) 1250 mg/m^2 on Day 1 and Day 8, and cisplatin (cis) 75 mg/m^2 on Day 1 of each 3-week cycle.
干预措施: Panitumumab (Biological)
Panitumumab + Gem/Cis
Panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine (gem) 1250 mg/m^2 on Day 1 and Day 8, and cisplatin (cis) 75 mg/m^2 on Day 1 of each 3-week cycle.
干预措施: Gemcitabine (Drug)
Panitumumab + Gem/Cis
Panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine (gem) 1250 mg/m^2 on Day 1 and Day 8, and cisplatin (cis) 75 mg/m^2 on Day 1 of each 3-week cycle.
干预措施: Cisplatin (Drug)
50 mg QD AMG 706 + panitumumab + Gem/Cis
AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine (gem) 1250 mg/m^2 on Day 1 and Day 8, and cisplatin (cis) 75 mg/m^2 on Day 1 of each 3-week cycle.
干预措施: Panitumumab (Biological)
50 mg QD AMG 706 + panitumumab + Gem/Cis
AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine (gem) 1250 mg/m^2 on Day 1 and Day 8, and cisplatin (cis) 75 mg/m^2 on Day 1 of each 3-week cycle.
干预措施: Gemcitabine (Drug)
50 mg QD AMG 706 + panitumumab + Gem/Cis
AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine (gem) 1250 mg/m^2 on Day 1 and Day 8, and cisplatin (cis) 75 mg/m^2 on Day 1 of each 3-week cycle.
干预措施: Cisplatin (Drug)
75 mg QD AMG 706 + panitumumab + Gem/Cis
AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine (gem) 1250 mg/m^2 on Day 1 and Day 8, and cisplatin (cis) 75 mg/m^2 on Day 1 of each 3-week cycle.
干预措施: AMG 706 (Drug)
75 mg QD AMG 706 + panitumumab + Gem/Cis
AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine (gem) 1250 mg/m^2 on Day 1 and Day 8, and cisplatin (cis) 75 mg/m^2 on Day 1 of each 3-week cycle.
干预措施: Panitumumab (Biological)
75 mg QD AMG 706 + panitumumab + Gem/Cis
AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine (gem) 1250 mg/m^2 on Day 1 and Day 8, and cisplatin (cis) 75 mg/m^2 on Day 1 of each 3-week cycle.
干预措施: Gemcitabine (Drug)
75 mg QD AMG 706 + panitumumab + Gem/Cis
AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine (gem) 1250 mg/m^2 on Day 1 and Day 8, and cisplatin (cis) 75 mg/m^2 on Day 1 of each 3-week cycle.
干预措施: Cisplatin (Drug)
100 mg QD AMG 706 + panitumumab + Gem/Cis
AMG 706 100 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine (gem) 1250 mg/m^2 on Day 1 and Day 8, and cisplatin (cis) 75 mg/m^2 on Day 1 of each 3-week cycle.
干预措施: AMG 706 (Drug)
100 mg QD AMG 706 + panitumumab + Gem/Cis
AMG 706 100 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine (gem) 1250 mg/m^2 on Day 1 and Day 8, and cisplatin (cis) 75 mg/m^2 on Day 1 of each 3-week cycle.
干预措施: Panitumumab (Biological)
100 mg QD AMG 706 + panitumumab + Gem/Cis
AMG 706 100 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine (gem) 1250 mg/m^2 on Day 1 and Day 8, and cisplatin (cis) 75 mg/m^2 on Day 1 of each 3-week cycle.
干预措施: Gemcitabine (Drug)
100 mg QD AMG 706 + panitumumab + Gem/Cis
AMG 706 100 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine (gem) 1250 mg/m^2 on Day 1 and Day 8, and cisplatin (cis) 75 mg/m^2 on Day 1 of each 3-week cycle.
干预措施: Cisplatin (Drug)
125 mg QD AMG 706 + panitumumab + Gem/Cis
AMG 706 125 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine (gem) 1250 mg/m^2 on Day 1 and Day 8, and cisplatin (cis) 75 mg/m^2 on Day 1 of each 3-week cycle.
干预措施: AMG 706 (Drug)
125 mg QD AMG 706 + panitumumab + Gem/Cis
AMG 706 125 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine (gem) 1250 mg/m^2 on Day 1 and Day 8, and cisplatin (cis) 75 mg/m^2 on Day 1 of each 3-week cycle.
干预措施: Panitumumab (Biological)
125 mg QD AMG 706 + panitumumab + Gem/Cis
AMG 706 125 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine (gem) 1250 mg/m^2 on Day 1 and Day 8, and cisplatin (cis) 75 mg/m^2 on Day 1 of each 3-week cycle.
干预措施: Gemcitabine (Drug)
125 mg QD AMG 706 + panitumumab + Gem/Cis
AMG 706 125 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine (gem) 1250 mg/m^2 on Day 1 and Day 8, and cisplatin (cis) 75 mg/m^2 on Day 1 of each 3-week cycle.
干预措施: Cisplatin (Drug)
75 mg BID AMG 706 + panitumumab + Gem/Cis
AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine (gem) 1250 mg/m^2 on Day 1 and Day 8, and cisplatin (cis) 75 mg/m^2 on Day 1 of each 3-week cycle.
干预措施: AMG 706 (Drug)
75 mg BID AMG 706 + panitumumab + Gem/Cis
AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine (gem) 1250 mg/m^2 on Day 1 and Day 8, and cisplatin (cis) 75 mg/m^2 on Day 1 of each 3-week cycle.
干预措施: Panitumumab (Biological)
75 mg BID AMG 706 + panitumumab + Gem/Cis
AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine (gem) 1250 mg/m^2 on Day 1 and Day 8, and cisplatin (cis) 75 mg/m^2 on Day 1 of each 3-week cycle.
干预措施: Gemcitabine (Drug)
75 mg BID AMG 706 + panitumumab + Gem/Cis
AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine (gem) 1250 mg/m^2 on Day 1 and Day 8, and cisplatin (cis) 75 mg/m^2 on Day 1 of each 3-week cycle.
干预措施: Cisplatin (Drug)
结局指标
主要结局
Participant Incidence of Adverse Events
时间窗: From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days.
The number of participants who experienced at least one treatment-emergent adverse event. Additional details regarding specfic adverse events are provided in the Adverse Event section of this posting.
次要结局
- Number of Participants With an Objective Tumor Response(From enrollment until date of last follow-up visit. The median follow-up time was 24 weeks, with a range of 3 to 73 weeks.)
- Tmax(Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose.)
- Cmax(Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose.)
- AUC0-24(Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose.)
- AUC0-inf(Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose.)