A Phase I Study of Onivyde and 5-FU in Combination With Xilonix for Advanced Pancreatic Cancer With Cachexia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Number of Participants With Dose Limiting Toxicities (DLT) in the First Cycle for the determination of the Maximum Tolerated Dose (MTD)
研究概览
简要总结
This study is being conducted to examine the safety of the investigational drug, Xilonix(™), in addition to standard doses of Onivyde® (nanoliposomal irinotecan) and 5- fluorouracil (5FU)/folinic acid (leucovorin) for pancreatic cancer patients with cachexia. Cachexia is a syndrome that includes involuntary weight loss and physical deterioration that can contribute to poor outcomes of cancer treatment. In other studies, Xilonix has increased lean body mass in advanced cancer patients. This increase could lead to improved weight maintenance and quality of life.
详细描述
This study will prospectively evaluate advanced pancreatic adenocarcinoma patients. The intervention will be interleukin-1-alpha antagonist (Xilonix) in addition to standard chemotherapy. The first aim is to assess the safety and identify the maximum tolerated dose of Onivyde with 5-fluorouracil/folinic acid in combination with the study agent, Xilonix. The study will also create a repository of serum, tissue, and fecal specimens to investigate novel biomarkers related to cachexia with pancreatic adenocarcinoma and interleukin-1-alpha blockade. Lastly, the study will assess for a correlation between cachexia, activity, and PROs on domains of quality of life.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Advanced or locally advanced pancreatic cancer patients (can include new or recurrent diagnosis) referred to SOCCI-CSMC for chemotherapy that has progressed through or intolerant to gemcitabine based chemotherapy
- •Cachexia defined as greater than 5% unexplained weight loss within any 6 month period prior to screening visit OR as documented by the medical physician based on standard diagnosis of cachexia
- •Age ≥ 18 years
- •ECOG performance status 0-2 or Karnofsky PS >60%
- •Patients must have normal organ and marrow function
- •Ability to understand and the willingness to sign a written informed consent
- •Negative pregnancy test for WOCBP
- •WOCBP and men must agree to use of adequate contraception
排除标准
- •Patients who are currently receiving any other investigational agents
- •Patients who have received more than one chemotherapeutic regimen in metastatic setting
- •Patients with CNS metastases
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Patients with unresolved grade 3/4 adverse effects of prior therapy at time of enrollment
- •Subjects with history of hypersensitivity to compounds of similar chemical or biologic composition to Xilonix or Onivyde
- •Women who are pregnant or breastfeeding
- •Dementia or altered mental status that would prohibit the understanding or rendering of informed consent
- •Patients with known Dihydropyrimidine dehydrogenase deficiency (DPD deficiency)
- •Patients known to be UGT1A1*28 allele homozygous
- •Patients who have had a live vaccine within 3 months of enrollment
研究组 & 干预措施
Xilonix plus Onivyde and 5FU
interleukin-1-alpha antagonist (Xilonix) in addition to standard chemotherapy of onivyde and 5-fluorouracil/folinic acid (leucovorin)
干预措施: Xilonix plus Onivyde and 5FU (Drug)
结局指标
主要结局
Number of Participants With Dose Limiting Toxicities (DLT) in the First Cycle for the determination of the Maximum Tolerated Dose (MTD)
时间窗: 28 days (first cycle)
Assess safety of novel combination
Maximum Tolerated Dose (MTD) of onivyde, 5-fluorouracil/folinic acid in combination with Xilonix
时间窗: 28 days (first cycle)
Assess MTD of Onivyde in combination with novel therapy
次要结局
- Weight stability(6 months)
- Lean Body Mass(6 months)
- Overall Survival(12 months)
- Progression Free Survival(12 months)
- Mean change in global quality of life (QOL) score (EORTC Pan26)(6 months)
- Mean change in global score of patient-reported response to therapy (FAACT questionnaire- Functional Assessment of Anorexia/Cachexia Therapy)(6 months)
研究者
Andrew Hendifar, MD
Assistant Professor of Medicine
Cedars-Sinai Medical Center