Feasibility Study for Repurposing RET Inhibitors

NCT ID: NCT07146893

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-26
• Study Completion Date: 2028-02-23

Brief 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.

Detailed 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 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.

Conditions

Cachexia-Anorexia Syndrome

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Selpercatinib

Intervention Type: DRUG

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.

Strength Assessment

Intervention Type: OTHER

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.

Interventions

Selpercatinib

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.

Intervention Type: DRUG

Strength 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.

Intervention Type: OTHER

Other Intervention Names

RETEVMO

Eligibility Criteria

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 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Presbyterian Health Foundation

UNKNOWN

Sponsor Role: collaborator

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nirmal Choradia, MD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma - Stephenson Cancer Center

Locations

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Countries

United States

Central Contacts

Lead Onco Nurse

Role: CONTACT

SCC-IIT-Office@ouhsc.edu

405-271-8777

Nirmal Choradia, MD

Role: CONTACT

Nirmal-Choradia@ouhsc.edu

Facility Contacts

Nirmal Choradia, MD

Role: primary

Nirmal-Choradia@ouhsc.edu

Other Identifiers

PHF-CTGA

Identifier Type: OTHER

Identifier Source: secondary_id

OU-SCC-FEATHER

Identifier Type: -

Identifier Source: org_study_id