Selpercatinib for Cachexia-Anorexia Syndrome

(FEATHER Trial)

Overseen By Nirmal Choradia, MD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Oklahoma

Must be taking: Platinum-based therapy

Must not be taking: Anti-seizure medications

Disqualifiers: Pregnancy, Uncontrolled hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effects of selpercatinib, a targeted cancer therapy, on cachexia and anorexia—conditions involving severe weight loss and appetite issues—in patients with certain advanced cancers. It focuses on individuals with non-small cell lung cancer (NSCLC), colorectal cancer, or pancreatic cancer. Participants should have experienced significant weight loss recently, defined as more than 5% of body weight over the last six months, or have a BMI (body mass index) under 20 with a smaller weight loss. As an Early Phase 1 trial, this research aims to understand how selpercatinib works in people, offering participants a chance to be among the first to receive this new treatment.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but it does exclude those on anti-seizure medications that affect the CYP3A enzyme. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that selpercatinib is likely to be safe for humans?

Research shows that selpercatinib is generally easy for patients to handle. In earlier studies, most patients (73.3%) experienced only mild weight gain as a side effect. Animal studies demonstrated that selpercatinib helped with muscle loss and appetite issues without causing serious side effects. Although this trial is in its early stages, existing research suggests that selpercatinib is safe for humans. However, because the trial remains in the early phase, the researchers continue to collect safety information. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Selpercatinib is unique because it targets specific genetic mutations that might be involved in Cachexia-Anorexia Syndrome, a condition often associated with significant weight loss in cancer patients. Unlike standard care options like appetite stimulants or nutritional supplements, which aim to increase food intake or caloric absorption, Selpercatinib acts on the underlying biological pathways that could be contributing to the syndrome. Researchers are excited about this treatment because it offers a novel approach by potentially addressing the root cause of the weight loss rather than just alleviating symptoms.

What evidence suggests that selpercatinib might be an effective treatment for cachexia-anorexia syndrome?

Research has shown that selpercatinib, the investigational treatment in this trial, may benefit cancer patients experiencing weight and muscle loss or reduced appetite. Animal studies found that selpercatinib can lead to weight gain. In cancer patients, about 73.3% gained weight while taking selpercatinib, suggesting it might help manage these issues by promoting weight gain. Although more research is needed, early results appear promising. ^{2 3 4 6 7}

Who Is on the Research Team?

Nirmal Choradia, MD

Principal Investigator

University of Oklahoma - Stephenson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with advanced NSCLC, pancreatic cancer, or colorectal cancer who have cachexia and a life expectancy over 4 months. They must be on stable chemotherapy and not have severe systemic diseases, active infections, or certain blood disorders. Pregnant individuals or those planning pregnancy are excluded.

Inclusion Criteria

Life expectancy exceeds 4 months, as judged by investigator

Written informed consent signed and dated by the patient prior to the performance of any study-specific procedures, sampling, or analyses

I am on a stable dose of epilepsy medication.

Exclusion Criteria

I am mostly bedridden due to my health condition.

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

I am currently taking medication for seizures that affects my liver enzyme levels.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive selpercatinib for 12 weeks with regular assessments

12 weeks

4 visits (in-person) at baseline, 4, 8, and 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person) at 16 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Selpercatinib

Trial Overview The study tests the effects of selpercatinib on cachexia-anorexia syndrome in patients with specific cancers. It includes strength assessments to evaluate physical changes alongside medication effectiveness.

How Is the Trial Designed?

Group I: Significant Weight Loss Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+

Presbyterian Health Foundation

Collaborator

Trials

2

Recruited

80+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39778760/

Selpercatinib mitigates cancer cachexia independent of anti ... Our data demonstrate that selpercatinib could alleviate anorexia and cancer cachexia in an animal model and that weight gain in selpercatinib-treated patients ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07146893

Feasibility Study for Repurposing RET Inhibitors (FEATHER) The purpose of this study is to assess the effects of selpercatinib on cachexia and anorexia in patients diagnosed with NSCLC, colorectal cancer ...

3. withpower.com withpower.com/trial/early-phase-1-cachexia-anorexia-syndrome-10-2025-1c70e

Selpercatinib for Cachexia-Anorexia Syndrome 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 ...

4. researchgate.net researchgate.net/publication/387753182_Selpercatinib_mitigates_cancer_cachexia_independent_of_anti-tumor_activity_in_the_HT1080_tumor_model

Selpercatinib mitigates cancer cachexia independent of ... Our results are consistent with the recent study with the FDA approved drug Selpercatinib which had similar limited effect on tumor burden while exhibiting ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11189099/

Weight Gain in Cancer Patients Treated with Brain ... The majority of patients (73.3%, n=85) developed weight gain ≥ grade 1 while on therapy (Figure 1). Grade 1 toxicity was the maximum grade of ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0304383525000084

Selpercatinib mitigates cancer cachexia independent of ... Our data demonstrate that selpercatinib could alleviate anorexia and cancer cachexia in an animal model and that weight gain in selpercatinib-treated patients ...

7. linkedin.com linkedin.com/pulse/breakthrough-ret-inhibitor-selpercatinib-invisible-warrior-against-xdpie

The "Invisible Warrior" Against Cancer Cachexia This drug significantly improves muscle atrophy, appetite loss, and metabolic disorders in tumor model mice, with its efficacy unrelated to tumor suppression.