Cachexia-Anorexia SyndromeEarly Phase 1FEATHERNCT07146893
Feasibility Study for Repurposing RET Inhibitors
A Early Phase 1 study testing Selpercatinib and Strength Assessment in people with Cachexia-Anorexia Syndrome, run by University of Oklahoma at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cachexia-Anorexia Syndrome
- What is being tested?
- Selpercatinib and Strength Assessment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2026to 23 Feb 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nirmal Choradia, MD contact
United States1 site
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, 73117
Nirmal Choradia, MD, Nirmal-Choradia@ouhsc.edu
Nirmal Choradia, MD
About this study
Official title: Feasibility Study for Repurposing RET Inhibitors for Treating Cancer Cachexia
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.
Read the 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
- Being tested
- Selpercatinib, Strength Assessment
- Keywords
- RET inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SelpercatinibDrug
Also called RETEVMO
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 AssessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Selpercatinib; Other: Strength Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 weeks
Secondary outcomes (4)
Mean (± SD) changes in anorexic behaviors after 12 weeks
Patients will be administered a Functional Assessment of Anorexia Cachexia- Anorexia Cachexia Subscale (FAACT-ACS) at baseline, and again at 12 weeks. The FAACT-ACS is designed to assess patient well-being and concerns using a Likert scale, where responses range from 0 to 4. A score of 0 indicates "Not at all," representing the lowest level of agreement or concern, while a score of 4 indicates "Very much," representing the highest level.
Measured: 12 weeks
Mean (± SD) changes in skeletal muscle while taking selpercatinib
Regular blood draws every 4 weeks while on selpercatinib will be taken with the goal of quantifying GDF-15 levels in each patient. Also a lumbar muscle assessment using a CT scan at baseline and again at 12 weeks to assess for muscle changes while taking selpercatinib.
Measured: 12 Weeks
Mean (± SD) changes in Strength outcomes in patients taking selpercatinib
A Hallux Strength Test will be conducted at baseline and repeated at 12 weeks (+/- 2 weeks), measuring grip strength, timed chair stands, leg press, and localized ultrasound of the quadriceps.
Measured: 12 weeks
Mean (± SD) changes in plasma GDF-15 while taking selpercatinib
Regular blood draws every 4 weeks while on selpercatinib will be taken with the goal of quantifying GDF-15 levels in each patient.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start26 Feb 2026 (estimated)
- Primary completion23 Feb 2027 (estimated)
- Study completion23 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cachexia-Anorexia SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 7 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- Presbyterian Health Foundation
- Responsible party
- Sponsor
- Investigators
- Nirmal Choradia, MD, Principal investigator, University of Oklahoma - Stephenson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07146893
- Sponsor's protocol ID
- OU-SCC-FEATHER
- Other IDs
- PHF-CTGA
- Acronym
- FEATHER
- Status last verified
- Jan 2026
- First submitted
- 21 Aug 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study for Repurposing RET Inhibitors for Treating Cancer Cachexia
- ClinicalTrials.gov ID
- NCT07146893
- Acronym / sponsor ID
- FEATHER / OU-SCC-FEATHER
- Conditions
- Cachexia-Anorexia Syndrome
- Keywords
- RET inhibitor
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- Presbyterian Health Foundation
- Study start
- 26 Feb 2026 (estimated)
- Primary completion
- 23 Feb 2027 (estimated)
- Study completion
- 23 Feb 2028 (estimated)
- First posted
- 28 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Significant Weight Loss | Experimental | Drug: Selpercatinib, Other: Strength AssessmentPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (17 listed)
- 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:
- Ongoing treatment with anti-seizure medications that induce the CYP3A enzyme
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SelpercatinibAlso: RETEVMOPatients 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. | Drug | Significant Weight Loss |
| Strength AssessmentSeveral 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. | Other | Significant Weight Loss |
Primary outcome
Mean (± SD) changes in body weight after 12 weeks
Time frame: 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
Time frame: 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.
4 secondary outcomes
Mean (± SD) changes in anorexic behaviors after 12 weeks
Time frame: 12 weeks
Mean (± SD) changes in skeletal muscle while taking selpercatinib
Time frame: 12 Weeks
Mean (± SD) changes in Strength outcomes in patients taking selpercatinib
Time frame: 12 weeks
Mean (± SD) changes in plasma GDF-15 while taking selpercatinib
Time frame: 12 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nirmal Choradia, MD contact
Nirmal Choradia, MD principal investigator
University of Oklahoma - Stephenson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Selpercatinib and Strength Assessment in people with Cachexia-Anorexia Syndrome, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lead Onco Nurse (405-271-8777, SCC-IIT-Office@ouhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean (± SD) changes in body weight after 12 weeks (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.