A Randomized Phase 2 Open-Label Study of IMC-A12, as a Single Agent or in Combination With Cetuximab, in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck and Disease Progression on Prior Platinum-Based Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 15
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
The purpose of this study is to determine if IMC-A12 alone or in combination with Cetuximab (Erbitux®) can increase the time prior to disease progression in participants with Squamous Cell Head and Neck Cancer who have had disease progression and platinum-containing chemotherapeutic regimen.
详细描述
The routine cancer treatments for Squamous Cell Carcinoma Head and Neck Cancer have improved but still leave a percentage of participants with incurable disease. New alternatives for participants whose disease is refractory to existing therapies is needed.
IMC-A12 is a monoclonal antibody which binds to special receptors known as insulin-like growth factor-I receptor (IGF-IR). This binding action has been shown to inhibit the growth of a variety of human tumor cell lines.
The purpose of this study is to evaluate the effects of IMC-A12 by itself or with Cetuximab (Erbitux®) in participants with Squamous Cell Carcinoma Head and Neck Cancer that has spread to other parts of the body, and to determine how long the drug remains in the body. The study will also look at what side effects IMC-A12 may cause when a participant is receiving treatment.
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
- •Histologically or cytologically-confirmed squamous cell carcinoma of the oropharynx, hypopharynx, larynx, or oral cavity, metastasis or recurrence documented by clinical imaging studies
- •Measurable disease, lesion size ≥ 2 centimeters (cm) on conventional measurement techniques or ≥ 1 cm on spiral computed tomography (CT) scan
- •Clinical documentation of disease progression during treatment with or within 90 days after receiving the last cycle of platinum-based chemotherapy (with or without radiation therapy)
- •If prior treatment with anti-epidermal growth factor receptor (EGFR) therapy, the time to recurrence from last exposure to anti-EGFR therapy is > 90 days
- •Adequate hematologic function
- •Adequate hepatic function
- •Adequate coagulation function or is on a stable dose of an anticoagulant.
- •Adequate renal function
- •Fasting serum glucose <120 milligrams per deciliter (mg/dL) or below the upper limit of normal (ULN)
- •Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
排除标准
- •Not recovered from adverse events due to agents administered more than 4 weeks earlier. Neurotoxicity, must have recovered to grade ≤ 2
- •Is receiving any other investigational agent(s)
- •History of treatment with other agents targeting the insulin-like growth factor receptor (IGFR)
- •Is receiving concurrent treatment with other anticancer therapy, including chemotherapy, immunotherapy, hormonal therapy, radiotherapy, chemoembolization, or targeted therapy
- •History of allergic reactions attributed to compounds of chemical or biologic composition similar to those of cetuximab or IMC-A12
- •Has poorly controlled diabetes mellitus. Participants with a history of diabetes mellitus are allowed to participate, provided that their blood glucose is within normal range (fasting < 120 mg/dL or below ULN) and that they are on a stable dietary or therapeutic regimen for this condition
- •Pregnant or breastfeeding
- •Is receiving therapy with immunosuppressive agents
研究组 & 干预措施
IMC-A12 (cixutumumab) + cetuximab
干预措施: cetuximab (Erbitux ®) (Biological)
IMC-A12 (cixutumumab)
干预措施: IMC-A12 (cixutumumab) (Biological)
IMC-A12 (cixutumumab) + cetuximab
干预措施: IMC-A12 (cixutumumab) (Biological)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: Baseline to measured PD (up to 27.66 months)
PFS was defined as the interval from randomization until PD or death, whichever occurred first. Response was defined using Response Evaluation Criteria in Solid Tumors (RECIST, version 1.0) criteria. PD was defined as having at least a 20% increase in sum of the longest diameter of target lesions or the appearance of new lesions. PFS was censored at the date of the last objective progression-free disease assessment for participants who did not experience PD or death.
次要结局
- Duration of Response(Date of first response to the date of PD or death due to any cause (up to 23.98 months))
- Overall Survival (OS)(Baseline to date of death from any cause (up to 29.63 months))
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Deaths(Baseline through study completion (up to 29.63 months))
- Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)](Baseline to measured PD (up to 27.66 months))
- Percentage of Participants With PFS at 6 Months(6 months)
- Blood And Tissue Biomarkers And Development of Serum Antibodies Against IMC-A12 and Cetuximab(Biomarkers [pre-dose, Cycle 1 (Day 15), (Cycle 2 (Day 1), and end of treatment]; Immunogenicity [pre-dose, prior to first infusion for Cycle 3, Cycle 5, and 30-day safety follow-up])