Clinical trial · Interventional
Safety and Preliminary Efficacy of Meldonium in Patients with Metastatic Renal Cell Carcinoma and Treatment-associated Fatigue
A Phase 1/2 Study of the Safety and Preliminary Efficacy of Meldonium in Patients with Metastatic Renal Cell Carcinoma and Treatment-associated Fatigue.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fatigue Related to Cancer Treatment | — | UNRESOLVED | — |
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
| Renal Cell Cancer Metastatic | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| meldonium | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm A: First-line TKI therapy, Meldonium 500 mg
- description
- meldonium 500 mg orally daily for six weeks.
- interventionNames
- Drug: meldonium
- type
- EXPERIMENTAL
- label
- Arm B: Second-line TKI therapy, Meldonium 1,000 mg
- description
- meldonium 1,000 mg orally daily for six weeks.
- interventionNames
- Drug: meldonium
- type
- EXPERIMENTAL
- label
- Arm C: First-line IO-TKI therapy, Meldonium 1,000 mg
- description
- meldonium 1,000 mg orally daily for six weeks.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * metastatic renal cell carcinoma * measurable disease based on RECIST 1.1 criteria * systemic therapy with targeted or immunotargeted therapy * any grade of fatigue associated with targeted or immunotargeted therapy * ECOG PS \<2 * signed informed consent Exclusion Criteria: * Any treatment for fatigue * Uncompensated hypothyroidism * Anemia * Pregnant or nursing * Local and/or systemic infections requiring antibiotics or COVID-19 within 28 days prior to study entry * Other malignancy * Brain metastases
References
Publications (0)
Data not yet available