A Prospective Observational Study of 1st and 2nd Line Vectibix® Use in KRAS/NRAS-wt mCRC Patients to Evaluate Pattern of Use and Overall Response Rates
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 218
- 试验地点
- 1
- 主要终点
- To describe the pattern of use of Vectibix® in combination with chemotherapy in 1st line or in 2nd line mCRC treatments as per approved Vectibix® indication.
研究概览
简要总结
The study will shed additional light on the impact of Vectibix® under the current, standard clinical conditions of mCRC treatment in Greece. It will provide data on the duration and the outcomes of Vectibix® treatment in real-life setting.
详细描述
This is a single-arm, multi-center, prospective, observational, descriptive, noninterventional study in patients with mCRC in Greece who receive Vectibix®in 1st or 2nd line according to approved indication. The aim of the study is to obtain a clear understanding of the current practices concerning real-life treatment of mCRC patients with Vectibix® in first-line in combination with chemotherapy or second-line in combination with chemotherapy in Greece. This setting will also provide the opportunity to observe in a non-selected patient population with RAS WT mCRC the real-life habits of mCRC treatment, and in particular the duration and the outcomes of Vectibix® treatment. The data generated by this study may be used for reimbursement purposes, as it becomes an increasingly common need in Greece to provide locally generated data for use of drugs in the real-life setting to regulatory agencies and/or payors. Furthermore, this study could address the existing data gap in the treatment of anti-EGFR therapy beyond progression in the real-life setting.
Primary Objective(s): To describe the pattern of use of Vectibix® in combination with chemotherapy in 1st line or in 2nd line mCRC treatments as per approved Vectibix® indication.
Secondary Objective(s): To investigate the rate of objective response (ORR, defined as either a Complete Response or a Partial Response) and the rate of stable disease as best response in 1st line or in 2nd line chemotherapy regimens of mCRC including Vectibix®.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 patient (age ≥18 years) at enrollment
- •Histological documentation of mCRC diagnosis
- •RAS WT tumor documented before study enrolment as per routine laboratory finding
- •Subjects whose care will be managed primarily by the enrolling physician and/or all records will be available
- •Measurable disease at baseline (preferably according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) if routinely used)
- •Currently under (begin up to 8 weeks before informed consent) a 1st or 2nd line treatment regimen, including Vectibix® as per indication
- •Tumor assessment (i.e. CT/MRI) within 16 weeks prior to first Vectibix® infusion
- •Signed informed consent
排除标准
- •Participation in any interventional clinical study (currently or during the three previous months from enrollment).
- •Compromised ability to give informed consent (defined per clinical judgment).
- •Unknown or mutant RAS tumor type
结局指标
主要结局
To describe the pattern of use of Vectibix® in combination with chemotherapy in 1st line or in 2nd line mCRC treatments as per approved Vectibix® indication.
时间窗: 42 months
Treatment patterns of Vectibix® and concomitant chemotherapy for mCRC will be decribed according to the following information: * Type of chemotherapy combined with Vectibix® * Starting dose and dose administration schedule of Vectibix® and chemotherapy * Cumulative dose, maximum dose, duration of exposure and total number of infusions received from the initiation of Vectibix® therapy and chemotherapy * Dose alterations for Vectibix and chemotherapy (including changes in frequency, reductions and/or delays).
次要结局
- To investigate the rate of objective response (ORR, defined as either a Complete Response or a Partial Response) and the rate of stable disease as best response in 1st line or in 2nd line chemotherapy regimens of mCRC including Vectibix®.(42 months)