NCT06648902CompletedPhase 1/2
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 · Last updated 18 Oct 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 22 Sept 2024
- Start date
- 1 Feb 2022
- Primary completion date
- 1 Sept 2024
- Lead sponsor
- Kidney Cancer Research Bureau
- Diseases
- Kidney cancer
- NCT number
- NCT06648902
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 60
- From 1 Feb 2022 to the primary completion date, 1 Sept 2024
- 3 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Local and/or systemic infections requiring antibiotics or COVID-19 within 28 days prior to study entry
Other illness
- Other malignancy
Other
- Any treatment for fatigue
- Uncompensated hypothyroidism
- Anemia
- Pregnant or nursing
- Brain metastases
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Megis medical clinic Coordinator of this site? Confirm its status | Tirana | Albania | Unknown status |
| National Center of Oncology Coordinator of this site? Confirm its status | Baku | Azerbaijan | Unknown status |
| STOONCO clinic Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.