NCT05078775已完成不适用
Prospective, Single Arm Medical Food Study to Evaluate a Standardized Nonessential Amino Acid Restriction (NEAAR) Medical Food for the Dietary Management of Advanced/Metastatic Pancreatic Cancer
Faeth Therapeutics9 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2021年12月21日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 9
- 主要终点
- Demonstrate tolerability of the NEAAR medical food.
研究概览
简要总结
This is a single arm study evaluating the tolerability and markers of pancreatic cancer with a specially designed medical food restricted in specific amino acids for the dietary management of subjects with locally advanced and unresectable or metastatic pancreatic adenocarcinoma. Subjects who are eligible to receive two FDA approved first line drug therapies, gemcitabine and nab-paclitaxel (gem+nabP), routinely prescribed in combination for pancreatic cancer may be included in this study.
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
- •Signed informed consent form (ICF) by subject.
- •Histologically or cytologically confirmed pancreatic adenocarcinoma.
- •Locally advanced and unresectable or metastatic pancreatic adenocarcinoma.
- •Eligible for standard of care treatment with the gem+nabP regimen.
- •18 years of age or older.
- •Measurable disease as determined by RECIST 1.1 (at least one measurable lesion must not have been irradiated in the past).
- •ECOG Performance Status of ≤
- •Adequate organ function during screening evaluation
- •Available pancreatic adenocarcinoma tissue samples from a primary or metastatic site that has been biopsied within the last 12 months and provide consent for them to be obtained and analyzed by the study sponsor to assist in determining final eligibility. A minimum of five (ten preferred) formalin fixed paraffin embedded (FFPE) archival or fresh tumor tissue slides are required.
排除标准
- •Any prior neoadjuvant or adjuvant therapy for pancreatic cancer within 6 months of screening.
- •Any prior therapy for metastatic pancreatic cancer or locally advanced and unresectable pancreatic cancer (except for neoadjuvant or adjuvant therapy as noted above in exclusion criteria 1)
- •Known cerebral metastasis.
- •Diagnosis of another malignancy within the past 2 years (excluding a history of carcinoma in situ of the cervix, superficial non-melanoma skin cancer, or superficial bladder cancer that has been adequately treated, or stage 1 prostate cancer that does not require treatment or requires only treatment with luteinizing hormone-releasing hormone agonists or antagonists if initiated at least 30 days prior to beginning the NEAAR medical food).
- •Body mass index (BMI) <18.5 kg/m2 or >40 kg/m2 or serious or refractive cachexia or anorexia that, in the investigator's judgment, prohibits subjects from having energy or appetite sufficient to reliably engage in a strict medical food regimen for an extended time.
- •Presence of any significant comorbidity including clinically significant cardiac disease (e.g., congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication), myocardial infarction or unstable angina within the 12 months prior to screening, or any major organ failure.
- •Known hypersensitivity, allergy, or religious restrictions regarding pork or pork-derived products; or known allergy to any of the major food allergens as defined by U.S. law (milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, soybeans and sesame); or known allergy or hypersensitivity to , gemcitabine or nab-paclitaxel, PERT products (e.g., Pancreaze), or formulary excipients in these products (refer to the FDA-approved package insert).
- •Major surgery or significant traumatic injury within 14 days of planned start of NEAAR medical food or the anticipation of the need for a major surgical procedure during the study.
- •Unwillingness to consume small quantities of meat products and byproducts (e.g., fish sauce, bone marrow, chicken broth).
- •Diagnosed with an eating disorder, irritable bowel syndrome (IBS), Crohn's disease, ulcerative colitis, or gluten-sensitive enteropathy.
研究组 & 干预措施
Nonessential Amino Acid Restriction (NEAAR) Medical Food
Experimental
This is a single arm study in which all subjects will receive NEAAR medical food.
干预措施: NEAAR Medical Food (Other)
结局指标
主要结局
Demonstrate tolerability of the NEAAR medical food.
时间窗: Through study completion (average of 6 months)
The primary endpoint is the rate of the most common Grade 3 and 4 adverse event (AE) related to the NEAAR medical food.
次要结局
- Overall response rates(Through study completion (average of 6 months))
- Duration of best response(Through study completion (average of 6 months))
- Changes in biomarkers(Through study completion (average of 6 months))
- Progression-free survival(Through study completion (average of 6 months))
研究者
研究点 (9)
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