Trials / Not Yet Recruiting
Not Yet RecruitingNCT07146893
Feasibility Study for Repurposing RET Inhibitors
Feasibility Study for Repurposing RET Inhibitors for Treating Cancer Cachexia
- Status
- Not Yet Recruiting
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 7 (estimated)
- Sponsor
- University of Oklahoma · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Selpercatinib | 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. |
| OTHER | Strength Assessment | 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. |
Timeline
- Start date
- 2026-02-26
- Primary completion
- 2027-02-23
- Completion
- 2028-02-23
- First posted
- 2025-08-28
- Last updated
- 2026-01-15
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07146893. Inclusion in this directory is not an endorsement.