Feasibility Study for Repurposing RET Inhibitors for Treating Cancer Cachexia
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Mean (± SD) changes in body weight after 12 weeks
研究概览
简要总结
The purpose of this study is to assess the effects of selpercatinib on cachexia and anorexia in patients diagnosed with NSCLC, colorectal cancer, or pancreatic cancer.
详细描述
This clinical trial aims to evaluate the feasibility of selpercatinib in addressing cachexia and anorexia among patients with non-small cell lung cancer (NSCLC), colorectal cancer, or pancreatic cancer who are eligible for platinum-based chemotherapy per standard of care. Participants will undergo blood draws at baseline and at 4, 8, and 12 weeks while on selpercatinib. At 16 weeks patients will return to the clinic for a weight assessment.
Study evaluations will include the Functional Assessment of Anorexia Cachexia Therapy (FAACT), administered at screening, at 12 weeks post-discontinuation of the study drug, and again at the 16-week follow-up. In addition, several assessments of overall muscle strength and function will be conducted including a hallux strength assessment, sub-maximal leg press, sit-to-stand timing, grip strength, and ultrasound of the quadriceps. These will be conducted at baseline and again at 12 weeks end-of-treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Histologically confirmed and documented locally advanced or metastatic NSCLC, pancreatic ductal adenocarcinoma, or colorectal cancer
- •Patient is currently receiving platinum-based therapy for cancer treatment
- •Patients on stable EPI
- •Written informed consent signed and dated by the patient prior to the performance of any study-specific procedures, sampling, or analyses
- •At least 18 years-of-age at the time of signature of the informed consent form (ICF)
- •Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2
- •Plasma GDF-15 level is at least 1500pg/mL
- •Life expectancy exceeds 4 months, as judged by investigator
- •Cachexia, defined as weight loss of >5% body weight in the past 6 months, OR weight loss of >2% body weight in the past 6 months with BMI < 20
排除标准
- •ECOG Performance Score of 3 or 4
- •Is pregnant or plans to become pregnant during study duration (if patient is of childbearing potential) or plans to make someone pregnant during study duration.
- •Patient has not experienced significant weight loss (defined as loss of >5% body weight in the past 6 months, OR loss of >2% body weight in the past 6 months with BMI < 20)†
- •Out-of-range laboratory values defined as:
- •Absolute neutrophil count (ANC) <1.5 x 109/L
- •Hemoglobin (Hgb)90 g/L or <9 g/dL
- •Platelets <100 x 109/L
- •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >2.5 x the upper limit of normal (ULN) if no demonstrable liver metastases or >5 times ULN in the presence of liver metastases
- •Total bilirubin >1.5 x ULN (unless the patient has Grade 1 bilirubin elevation due to Gilbert's disease or a similar syndrome involving slow conjugation of bilirubin)
- •Creatinine >1.5 times ULN (patients may enter if creatinine is >1.5 x ULN and estimated glomerular filtration rate (eGFR) is >30 mL/min/1.73 m2 according to the Chronic Kidney Disease Epidemiology Collaboration equation); confirmation of eGFR is only required when creatinine is >1.5 X ULN
- •International Normalization Ratio (INR) >2
- •Ongoing treatment with anti-seizure medications that induce the CYP3A enzyme
- •Presence of active gastrointestinal disease or other conditions that will interfere significantly with the absorption, distribution, metabolism, or excretion of selpercatinib(e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea Grade ≥2)
- •As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, uncontrolled diabetes mellitus, active bleeding diatheses, or active infection including hepatitis B, hepatitis C, and human immunodeficiency virus. Screening for chronic conditions is not required.
- •Presence of other active invasive cancers other than the ones treated in this study within 5 years prior to screening, except appropriately treated basal cell carcinoma of the skin, or in situ carcinoma of uterine cervix, or other local tumors considered cured by local treatment.
- •Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and/or follow-up procedures outlined in the protocol.
- •Pneumonitis or QTc prolongation.
研究组 & 干预措施
Significant Weight Loss
Patients will be weighed at baseline, 4, 8, and 12 weeks while on treatment and again at the 16-weeks after treatment has been discontinued to asses for changes in weight.
干预措施: Selpercatinib (Drug)
Significant Weight Loss
Patients will be weighed at baseline, 4, 8, and 12 weeks while on treatment and again at the 16-weeks after treatment has been discontinued to asses for changes in weight.
干预措施: Strength Assessment (Other)
结局指标
主要结局
Mean (± SD) changes in body weight after 12 weeks
时间窗: 12 weeks
At screening, patients will have their initial weight recorded. While on study, they will take selpercatinib orally twice daily, with weight assessments conducted every four weeks (Weeks 4, 8, and 12). Selpercatinib will be discontinued at Week 12, and at the 16-week post-treatment follow-up, patients will return to the clinic for a final weight assessment.
Mean (± SD) percentage of doses of selpercatinib taken on time by patient
时间窗: 12 weeks
A pill diary will be provided to patients to record the time, date, and dose (40 mg or 80 mg) of selpercatinib before starting the study drug.
次要结局
- Mean (± SD) changes in anorexic behaviors after 12 weeks(12 weeks)
- Mean (± SD) changes in skeletal muscle while taking selpercatinib(12 Weeks)
- Mean (± SD) changes in Strength outcomes in patients taking selpercatinib(12 weeks)
- Mean (± SD) changes in plasma GDF-15 while taking selpercatinib(12 Weeks)