NCT01577173已完成2 期
A Phase II, Open-Label, Randomized Study of MEDH7945A Versus Cetuximab in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck Who Have Progressed During or Following Platinum-based Chemotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 122
- 主要终点
- Progression-free survival (tumor assessments according to RECIST criteria)
研究概览
简要总结
This phase II, open-label, randomized study will evaluate the efficacy and safety of MEHD7945A versus cetuximab in patients with recurrent/metastatic squamous cell carcinoma of the head and neck who have progressed during or following platinum-based chemotherapy. Patients will be randomized to receive either MEHD7945A 1100 mg intravenously (iv) every 2 weeks or cetuximab 400 mg/m2 iv loading dose followed by 250 mg/m2 iv weekly. Patients treated with cetuximab (Arm B) may cross-over to MEHD7945A (Arm A) upon central confirmation of progressive disease and upon meeting eligibility criteria. Anticipated time on study treatment is until disease progression or intolerable toxicity occurs.
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
- •Adult patients, >/= 18 years of age
- •Histologically confirmed Stage III or IV recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN)
- •Progressive disease on or after first-line platinum-based chemotherapy regimen for R/M SCCHN (maximum of 6 cycles)
- •No more than one platinum-based chemotherapy regimen for R/M SCCHN is allowed
- •Prior platinum-based treatment as definitive chemo/radiotherapy for locally advanced disease is allowed if completed/terminated >/= 6 months before the platinum-based regimen for R/M SCCHN
- •Consent to provide archival tumor tissue for biomarker testing
- •Measurable disease per RECIST v1.1
- •ECOG performance status of 0, 1 or 2
- •Adequate hematologic, renal and liver function
排除标准
- •Nasopharyngeal cancer
- •Prior treatment with an investigational or approved agent for the purpose of inhibiting HER family members
- •This includes but is not limited to cetuximab, panitumumab, erlotinib, geftinib, and lapatinib
- •Prior treatment with an EGFR inhibitor is allowed if it was administered as part of definitive therapy for locally advanced disease and completed >/=1 year before study enrollment
- •Leptomeningeal disease as the only manifestation of the current malignancy
- •Active infection requiring iv antibiotics
- •Active autoimmune disease that is not controlled by non-steroidal anti-inflammatory drugs
- •Current severe, uncontrolled systemic disease (e.g. clinically significant cardiovascular, pulmonary, or metabolic disease; wound healing disorders; ulcers; bone fractures)
- •History of heart failure or serious cardiac arrhythmia
- •History of myocardial infarction within 6 months of Cycle 1, Day 1
- •Clinically significant liver disease, including active viral, alcoholic or other hepatitis, cirrhosis, or current alcohol abuse
- •HIV infection
- •Primary central nervous system (CNS) malignancy or untreated/active CNS metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control)
- •Pregnant or lactating women
- •Malignancies other than SCCHN within 5 years prior to randomization, with the exception of adequately treated basal or squamous cell skin cancer and carcinoma in situ of the cervix
研究组 & 干预措施
A: MEHD7945A
Experimental
干预措施: MEHD7945A (Drug)
B: Cetuximab
Active Comparator
干预措施: cetuximab (Drug)
结局指标
主要结局
Progression-free survival (tumor assessments according to RECIST criteria)
时间窗: approximately 24 months
次要结局
- Immunogenicity: anti-MEHD7945A levels(Pre-dose on Day 1 of Cycles 1 and 4, and at treatment completion)
- Objective response: complete response or partial response(approximately 24 months)
- Duration of objective response(approximately 24 months)
- Disease control: complete response, partial response or stable disease(approximately 24 months)
- Time to disease progression(approximately 24 months)
- Overall survival(approximately 24 months)
- Safety: Incidence of adverse events(approximately 24 months)
- Pharmacokinetics: Cmax/Cmin(Pre-dose and 30 min after end of infusion on Day 1 of Cycles 1, 2, 3, and 4, and at treatment completion)
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