Randomized, Placebo-controlled, Double-blind Phase 2 Study of Patritumab (U3-1287) in Combination With Cetuximab Plus Platinum-based Therapy in First Line Setting in Subjects With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 87
- 试验地点
- 32
- 主要终点
- Progression Free Survival (PFS) in the Heregulin (HRG)-High Expression Population
研究概览
简要总结
This study will test an investigational study drug called patritumab. It is a 'randomized study' which means participants have an equal chance of being assigned to receive the experimental medication (patritumab) or a substance that looks like the experimental product, but is not (placebo). Patritumab may work when combined with other medications that are approved for the treatment of head and neck cancer. They are called cetuximab, cisplatin or carboplatin. All participants will receive the other medications approved for treatment of head and neck cancer, even if they do not receive the experimental product.
详细描述
Main objective of the trial:
The main objective of the trial is to evaluate progression-free survival (PFS) in the heregulin (HRG) high expression population from subjects treated with patritumab + cetuximab + platinum-based therapy compared to placebo + cetuximab + platinum-based therapy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Has histologically confirmed recurrent disease or metastatic SCCHN tumor and/or from its lymph nodal metastases originating from the oral cavity, oropharynx, hypopharynx, and larynx
- •Has or be willing to provide tumor tissue for testing
- •Has measurable disease per Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1
- •Has Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •Has adequate hematological function per protocol
- •Has adequate renal function per protocol
- •Has adequate hepatic function per protocol
- •Agrees to use effective contraception while on the study and for 6-months after the end of the study
- •Provides written informed consent(s)
排除标准
- •Has left ventricular ejection fraction (LVEF) <50%
- •Had prior epidermal growth factor receptor (EGFR) targeted regimen
- •Had prior anti-human epidermal growth factor receptor 3 (anti-HER3) therapy
- •Had prior chemotherapy for recurrent/metastatic disease
- •Had anti-cancer therapy between biopsy and submission of sample
- •Has history of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated with no evidence of disease for ≥ 2 years
- •Has known history of brain metastases or active brain metastases
- •Has uncontrolled hypertension
- •Has clinically significant electrocardiograph (ECG) findings
- •Had myocardial infarction within 1 year before enrollment, symptomatic congestive heart failure, unstable angina, or arrhythmia requiring medication
- •Had platinum-containing drug therapy with radiotherapy less than 6 months before study drug treatment
- •Had therapeutic or palliative radiation therapy or major surgery within 4 weeks before study drug treatment
研究组 & 干预措施
Patritumab
All participants receive patritumab with cetuximab plus platinum-based therapy (cisplatin or carboplatin)
干预措施: Patritumab (Drug)
Patritumab
All participants receive patritumab with cetuximab plus platinum-based therapy (cisplatin or carboplatin)
干预措施: Cetuximab (Drug)
Patritumab
All participants receive patritumab with cetuximab plus platinum-based therapy (cisplatin or carboplatin)
干预措施: Cisplatin (Drug)
Patritumab
All participants receive patritumab with cetuximab plus platinum-based therapy (cisplatin or carboplatin)
干预措施: Carboplatin (Drug)
Placebo
All participants receive placebo with cetuximab plus platinum-based therapy (cisplatin or carboplatin)
干预措施: Cetuximab (Drug)
Placebo
All participants receive placebo with cetuximab plus platinum-based therapy (cisplatin or carboplatin)
干预措施: Cisplatin (Drug)
Placebo
All participants receive placebo with cetuximab plus platinum-based therapy (cisplatin or carboplatin)
干预措施: Carboplatin (Drug)
Placebo
All participants receive placebo with cetuximab plus platinum-based therapy (cisplatin or carboplatin)
干预措施: Placebo (Drug)
结局指标
主要结局
Progression Free Survival (PFS) in the Heregulin (HRG)-High Expression Population
时间窗: from Day 0 to end of active study (study termination) - within 12 months
PFS is defined as the time from the date of randomization to the date of the first radiographic disease progression or death due to any cause, whichever comes first. Median PFS is from Kaplan-Meier analysis. Confidence interval (CI) for median was computed using Brookmeyer-Crowley method.
次要结局
- Median Overall Survival(at approximately 25 months)
- Percentage of Participants With Best Overall Response(at approximately 22 months)