Feasibility Study for Repurposing RET Inhibitors

NCT07146893 | Not Yet Recruiting Early Phase 1 DMC FDA Drug

• 2 other identifiers: OU-SCC-FEATHERPHF-CTGA
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Cachexia-Anorexia Syndrome

Keywords

RET inhibitor

Outcome Measures

Primary Outcomes (2)

• Mean (± SD) changes in body weight after 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.

  12 weeks

• Mean (± SD) percentage of doses of selpercatinib taken on time by patient

  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.

  12 weeks

Secondary Outcomes (4)

• 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

Study Arms (1)

Significant Weight Loss

EXPERIMENTAL

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.

Drug: Selpercatinib; Other: Strength Assessment

Interventions

Selpercatinib 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.

Also known as: RETEVMO

Significant Weight Loss

Strength Assessment 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.

Significant Weight Loss

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oklahoma: lead
• Presbyterian Health Foundation: collaborator

Study Sites (1)

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, 73117, United States

Location

MeSH Terms

Interventions

selpercatinib

Study Officials

• Nirmal Choradia, MD

  University of Oklahoma - Stephenson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lead Onco Nurse

CONTACT

405-271-8777; SCC-IIT-Office@ouhsc.edu

Nirmal Choradia, MD

CONTACT

Nirmal-Choradia@ouhsc.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is an open-label, single-arm feasibility study to assess the effects of selpercatinib on cachexia and anorexia in patients with NSCLC, colorectal cancer, or pancreatic cancer who are undergoing platinum-based chemotherapy

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: August 28, 2025
• Study Start: February 26, 2026
• Primary Completion (Estimated): February 23, 2027
• Study Completion (Estimated): February 23, 2028
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)