Ignite Creation Date:
2024-10-25 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06648902
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-22
Brief Title:
Safety and Preliminary Efficacy of Meldonium in Patients with Metastatic Renal Cell Carcinoma and Treatment-associated Fatigue
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 12 Study of the Safety and Preliminary Efficacy of Meldonium in Patients with Metastatic Renal Cell Carcinoma and Treatment-associated Fatigue
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Fatigue is a frequent symptom of cancer and the most common adverse event of treatment with tyrosine kinase inhibitors For example in phase 2 randomized study 59 of patients with metastatic renal cell carcinoma experienced any grade fatigue during treatment with the combination of lenvatinib and everolimus Fourteen percent of patients had grade 3 fatigue or asthenia Fatigue was also most frequently reported treatment-related adverse event in patients with unresectable hepatocellular carcinoma 30 and advanced thyroid cancer 60 treated with lenvatinib Additionally fatigue is one of the most common adverse events associated with the administration of checkpoint inhibitors Frequency of fatigue was 55 in patients with endometrial cancer treated with combination of pembrolizumab and lenvatinib
Meldonium is a fatty acid oxidation inhibitor and it is now principally used for heart conditions such as angina heart attack heart failure and others The compound works by altering pathways for carnitine a nutrient involved in fat metabolism Meldonium received the greatest fame in sport The World Anti-Doping Agency WADA added meldonium to their list of banned substances in 2016 because of evidence of its use by athletes with the intention of enhancing performance Center for Preventive Doping Research and European Monitoring Center for Emerging Doping Agents showed that mildronate demonstrates an increase in endurance performance of athletes improved rehabilitation after exercise protection against stress and enhanced activations of the central nervous system functions Based on these data meldonium can be a possible option in cancer patients with fatigue treated with targeted or imminotargeted therapy Moreover the compound could decrease the number of vascular adverse events of TKIs
Meldonium is a fatty acid oxidation inhibitor and it is now principally used for heart conditions such as angina heart attack heart failure and others The compound works by altering pathways for carnitine a nutrient involved in fat metabolism Meldonium received the greatest fame in sport The World Anti-Doping Agency WADA added meldonium to their list of banned substances in 2016 because of evidence of its use by athletes with the intention of enhancing performance Center for Preventive Doping Research and European Monitoring Center for Emerging Doping Agents showed that mildronate demonstrates an increase in endurance performance of athletes improved rehabilitation after exercise protection against stress and enhanced activations of the central nervous system functions Based on these data meldonium can be a possible option in cancer patients with fatigue treated with targeted or imminotargeted therapy Moreover the compound could decrease the number of vascular adverse events of TKIs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None