A Registry to Capture Patient Outcomes With KRAS G12R Altered Advanced Pancreatic Ductal Adenocarcinoma Treated With MEK Inhibitor-based Combination Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- The number of subjects with no progression.
研究概览
简要总结
This is an observational precision oncology study designed to collect and analyze data that allows us to characterize the safety and efficacy of several different mitogen-activated protein kinase kinase inhibitor (MEKi) -based treatment strategies and the feasibility of administering MEKi combination therapies to patients with KRAS G12R mutated advanced pancreatic ductal adenocarcinoma (PDAC).
详细描述
Patient medical records, obtained both retrospectively and prospectively, will be examined for results of molecular profiling obtained through standard of care testing to help understand how well KRAS G12R pancreatic patients respond to MEKi-based combination matched therapy. Patient outcome parameters including but not limited to tumor response, patient survival, and toxicity will be analyzed. Moreover, metrics will be collected to ascertain whether a future clinical trial involving a MEKi-based combination therapy is feasible to carry out.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Age ≥18 years.
- •Diagnosis of advanced pancreatic ductal adenocarcinoma as determined by the treating physician or tumor board.
- •Tumor must have KRAS G12R mutation, as determined by a next generation sequencing (NGS) panel or circulating tumor DNA panel of choice of the treating physician.
- •Ability to understand a written informed consent document and the willingness to sign it.
排除标准
- •Age <18 years.
- •Primary cancer diagnosis other than advanced pancreatic ductal adenocarcinoma
- •Tumor does not have a KRAS G12R mutation.
研究组 & 干预措施
Therapy with MEKi- Hydroxychloroquine (HCQ)
Subjects have advanced PDAC with KRAS G12R mutation. Subjects' tumors must have KRAS G12R mutation, as determined by a next generation sequencing (NGS) panel or circulating tumor DNA panel of choice of the treating physician. Subjects will receive therapy with MEKi and HCQ.
干预措施: combination therapy with MEKi-HCQ (Drug)
Therapy with no MEKi
Subjects have advanced PDAC with KRAS G12R mutation. Subjects' tumors must have KRAS G12R mutation, as determined by a next generation sequencing (NGS) panel or circulating tumor DNA panel of choice of the treating physician. Subjects will receive therapy with no MEKi.
干预措施: combination therapy with no MEKi (Other)
Therapy with MEKi-Other
Subjects have advanced PDAC with KRAS G12R mutation. Subjects' tumors must have KRAS G12R mutation, as determined by a next generation sequencing (NGS) panel or circulating tumor DNA panel of choice of the treating physician. Subjects will receive combination therapy with MEKi and a specified drug combination.
干预措施: combination therapy with MEKi. (Drug)
Therapy with MEKi- Epidermal growth factor receptor inhibitor (EGFRi)
Subjects have advanced PDAC with KRAS G12R mutation. Subjects' tumors must have KRAS G12R mutation, as determined by a next generation sequencing (NGS) panel or circulating tumor DNA panel of choice of the treating physician. Subjects will receive combination therapy with MEKi and EGFRi.
干预措施: combination therapy with MEKi-EGFRi (Drug)
结局指标
主要结局
The number of subjects with no progression.
时间窗: 6 months
This is defined as the time from the start of treatment until six months on treatment, or disease progression, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death, whichever occurs first.
次要结局
- The number of subjects who have a complete response.(2 years)
- The number of subjects who have a partial response.(2 years)
- The number of grade 3 adverse events at least possibly related to a drug.(2 years)
- The number of grade 4 adverse events at least possibly related to a drug.(2 years)
研究者
Mandana Kamgar, MD
Assistant Professor
Medical College of Wisconsin