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Feasibility Study for Selpercatinib in Cachexia-Anorexia Syndrome

This study is looking at whether a drug called selpercatinib can help with cachexia (severe weight loss and muscle wasting) and anorexia (loss of appetite) in people with advanced non-small cell lung cancer, pancreatic cancer, or colorectal cancer. You would take selpercatinib by mouth twice a day. Researchers want to see if selpercatinib helps you gain weight and how well you take the medication. They will also measure your strength. To join, you must be 18 or older, have one of these cancers, and be receiving platinum-based chemotherapy. The study is currently unclear on its recruitment status and plans to enroll 7 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It is a feasibility study, not yet in a specific phase, and plans to enroll 7 participants.
What's involved
You would take selpercatinib orally twice daily for 12 weeks, have regular blood draws every 4 weeks, and undergo weight measurements. Strength assessments will be done at the start and at 12 weeks, and you'll return for a weight assessment at 16 weeks.
Compensation
Not stated in the trial record.
Follow-up
You will have a follow-up weight assessment at 16 weeks after treatment starts. You will also complete a questionnaire at 12 weeks post-discontinuation of the study drug and again at the 16-week follow-up.

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NCT07146893

Feasibility Study for Repurposing RET Inhibitors

Not Yet Recruiting
EARLY_PHASE1Ages 18+InterventionalTreatment
University of Oklahoma
~7 participants
Updated 2026-01-15 on ClinicalTrials.gov
What's tested:SelpercatinibStrength Assessment

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean (± SD) changes in body weight after 12 weeks
Measured over 12 weeks
+1 more outcome measured

Conditions

Cachexia-Anorexia Syndrome

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Colorectal CarcinomaLung Non-Small Cell CarcinomaPancreatic CarcinomaSolid NeoplasmGDF15 Gene

Where it's being run

1 sites across 1 states
Oklahoma1

Study leadership

  • Nirmal Choradia, MD · PRINCIPAL_INVESTIGATOR · University of Oklahoma - Stephenson Cancer Center

Who to contact

Lead Onco Nurse
[email protected]
405-271-8777
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Mean (± SD) changes in body weight after 12 weeks12 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 patient12 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.