Feasibility Study for Repurposing RET Inhibitors for Treating Cancer Cachexia
University of Oklahoma
Summary
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.
Description
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 leas…
Interventions
- DrugSelpercatinib
Patients will be instructed to take selpercatinib orally (PO) twice daily (BID), approximately every 12 hours. While on study, they will undergo weight measurements and regular blood draws every 4 weeks. At the 16-week post-treatment follow-up, patients will return to the clinic for a weight assessment to evaluate potential changes in body weight. Patients will be administered assessments including, 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.
- OtherStrength Assessment
Several strength assessment will be conducted at baseline and at 12 weeks end-of-treatment, which will include measurements such as grip strength, hallux strength, timed chair stands, leg press, and localized ultrasound of the quadriceps.
Location
- OU Health Stephenson Cancer CenterOklahoma City, Oklahoma