drugset / Trial / NCT06648902

Safety and Preliminary Efficacy of Meldonium in Patients with Metastatic Renal Cell Carcinoma and Treatment-associated Fatigue

NCT06648902

Phase 1/2 Completed 60 enrolled Kidney Cancer Research Bureau
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

EvaluationDrugModalityDoseRoute
Subject Meldonium Small molecule 500 mg Oral
Subject Meldonium Small molecule 1000 mg Oral

Indications