A Five-Tier, Phase 2 Open-Label Study of IMC-A12 Administered as a Single Agent Every 2 Weeks in Patients With Previously-Treated, Advanced or Metastatic Soft Tissue and Ewing's Sarcoma/PNET
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 113
- 试验地点
- 22
- 主要终点
- Percentage of Participants With Progression-Free Survival (PFS) at 12 Weeks
研究概览
简要总结
This multicenter study will enroll approximately 185 participants with metastatic or advanced sarcoma, to assess the effectiveness and safety of IMC-A12 monotherapy for this indication. Participants will be stratified into five tiers according to diagnosis:
- Ewing's sarcoma/peripheral neuroectodermal tumor (PNET)
- rhabdomyosarcoma
- leiomyosarcoma
- adipocytic sarcoma
- synovial sarcoma.
A total of 85 participants will be enrolled initially, 17 in each tier. Participants will receive single agent IMC-A12 every 2 weeks. A treatment cycle will be defined as 6 weeks, with radiological evaluation at every cycle.
Safety and response in the initial 17 participants in each tier will be used to determine whether to extend enrollment to the target total of 37 participants per tier.
详细描述
The purpose of this study is to determine the progression-free survival (PFS) rate assessed 12 weeks after the initiation of IMC-A12 monotherapy, administered every 2 weeks to participants with previously-treated, advanced or metastatic soft tissue and Ewing's sarcoma/PNET.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically-confirmed sarcoma of one of the following histologies: (1) Ewing's sarcoma / PNET; (2) rhabdomyosarcoma; (3) leiomyosarcoma; (4) adipocytic sarcoma; or (5) synovial sarcoma
- •Has measurable disease, at least one lesion ≥ 2 centimeters (cm) on conventional measurement techniques or ≥ 1 cm on spiral computed tomography (CT) scan
- •Has at least one measurable lesion located outside of a previously irradiated area
- •Has radiographic documentation of disease progression within 6 months prior to study entry
- •Has relapsed, refractory, and/or metastatic disease, incurable by surgery, radiotherapy, or other conventional systemic therapy
- •Been considered ineligible for systemic chemotherapy or received at least one previous regimen for relapsed, refractory, and/or metastatic disease
- •Adequate hematologic function
- •Has adequate hepatic function
- •Has adequate coagulation function
- •Has adequate renal function
- •Has 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
- •Has uncontrolled brain or leptomeningeal metastases
- •Not recovered to grade ≤ 1 from adverse events due to agents administered more than 3 weeks prior to study entry
- •Is receiving any other investigational agent(s)
- •Major surgery, hormonal therapy (other than replacement), chemotherapy, radiotherapy, or any form of investigational therapy within 3 weeks prior to enrollment
- •History of treatment with other agents targeting the insulin-like growth factor-I receptor (IGF-IR)
- •History of allergic reactions attributed to compounds of chemical or biologic composition similar to that of IMC-A12
- •Has poorly controlled diabetes mellitus
- •Is receiving therapy with immunosuppressive agents
- •Is pregnant or breastfeeding
研究组 & 干预措施
IMC-A12 (cixutumumab)
干预措施: IMC-A12 (cixutumumab) (Biological)
结局指标
主要结局
Percentage of Participants With Progression-Free Survival (PFS) at 12 Weeks
时间窗: Baseline to Disease Progression or Death Due to Any Cause Up To 12 Weeks
PFS at 12 weeks was reported by disease condition and defined as the percentage of participants who have neither experienced disease progression nor died at 12 weeks after the date of first dose. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. Progressive Disease (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. Percentage of participants is calculated as the total number of participants with PFS at 12 weeks divided by the total number of participants treated then multiplied by 100.
次要结局
- Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)](Baseline to measured PD (up to 105.4 weeks))
- Time to Response(Baseline to first evidence of confirmed CR or PR (up to 105.4 weeks))
- Duration of Response(Date of first response to the date of progression or death due to any cause (up to 105.4 weeks))
- Progression-Free Survival (PFS)(Baseline to measured PD (up to 105.4 weeks))
- Overall Survival (OS)(Baseline to date of death from any cause (up to 112.9 weeks))
- Percentage of Participants With Best Overall Response [Clinical Benefit Rate (CBR)](Baseline through study completion (up to 105.4 weeks))
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Deaths(Baseline through study completion (up to 112.9 weeks))
- Serum Anti-IMC-A12 Antibody Assessment (Immunogenicity)(30-day safety follow-up)