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Feasibility Study for Repurposing RET Inhibitors

ConditionCachexia-Anorexia Syndrome
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Oklahoma

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)†

Absolute neutrophil count (ANC) <1.5 x 109/L

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

  • Strength Assessment

    Other intervention

    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.

Treatment groups

7 Participants
are divided into 1 treatment group
Group A: Significant Weight LossExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
12 weeks
2

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.

Time frame
12 weeks

Secondary outcomes

1

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.

Time frame
12 weeks
2

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.

Time frame
12 Weeks
3

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.

Time frame
12 weeks
4

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.

Time frame
12 Weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Oklahoma

Lead sponsor

Presbyterian Health Foundation

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: