drugset / Trial / NCT06648902
Safety and Preliminary Efficacy of Meldonium in Patients with Metastatic Renal Cell Carcinoma and Treatment-associated Fatigue
Non-randomizedSequentialOpen-labelSupportive care
Summary
Fatigue is a prevalent adverse event associated with systemic therapy using tyrosine kinase inhibitors (TKIs). Meldonium, a fatty acid oxidation inhibitor, modifies the carnitine pathway, a nutrient critical for fat metabolism. The World Anti-Doping Agency (WADA) classified meldonium as a banned substance due to its documented use by athletes aiming to enhance physical performance. In this study, the safety and preliminary efficacy of meldonium in treatment-related fatigue will be assessed.
Timeline
- Start
- 2022-02-01
- Primary completion
- 2024-09-01
- Completion
- 2024-09-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Meldonium | Small molecule | 500 mg | Oral |
| Subject | Meldonium | Small molecule | 1000 mg | Oral |