Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2026-01-11 @ 4:35 PM
Study NCT ID:
NCT06648902
Status:
COMPLETED
Last Update Posted:
2024-10-18
First Post:
2024-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Preliminary Efficacy of Meldonium in Patients with Metastatic Renal Cell Carcinoma and Treatment-associated Fatigue
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007680', 'term': 'Kidney Neoplasms'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C050147', 'term': '3-(2,2,2-trimethylhydrazine)propionate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-17', 'studyFirstSubmitDate': '2024-09-22', 'studyFirstSubmitQcDate': '2024-10-17', 'lastUpdatePostDateStruct': {'date': '2024-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Treatment-Emergent Adverse Events', 'timeFrame': 'From enrollment to the end of treatment at 6 weeks', 'description': 'Incidence of meldonium-related adverse events'}, {'measure': 'Changes in fatigue levels based on FACIT Fatigue Scale', 'timeFrame': 'From enrollment to the end of treatment at 6 weeks', 'description': 'Changes in fatigue levels, measured at six weeks using the FACIT Fatigue Scale (Version 4).'}], 'secondaryOutcomes': [{'measure': 'Toxicity of anti-cancer systemic therapy', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks', 'description': 'Rate of adverse events'}, {'measure': 'Rate of discontinuation of anti-cancer therapy and/or dose reduction of the drug', 'timeFrame': 'From enrollment to the end of treatment at 12 weeks', 'description': 'Rate of discontinuation of anti-cancer therapy and/or dose reduction of the drug'}, {'measure': 'Rate of arterial hypertension', 'timeFrame': 'From enrollment to the end of treatment at 12 weeks', 'description': 'Rate of arterial hypertension as an adverse event of targeted therapy'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Renal Cell Cancer Metastatic', 'Kidney Cancer', 'Fatigue Related to Cancer Treatment']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nMeldonium 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* metastatic renal cell carcinoma\n* measurable disease based on RECIST 1.1 criteria\n* systemic therapy with targeted or immunotargeted therapy\n* any grade of fatigue associated with targeted or immunotargeted therapy\n* ECOG PS \\<2\n* signed informed consent\n\nExclusion Criteria:\n\n* Any treatment for fatigue\n* Uncompensated hypothyroidism\n* Anemia\n* Pregnant or nursing\n* Local and/or systemic infections requiring antibiotics or COVID-19 within 28 days prior to study entry\n* Other malignancy\n* Brain metastases'}, 'identificationModule': {'nctId': 'NCT06648902', 'briefTitle': 'Safety and Preliminary Efficacy of Meldonium in Patients with Metastatic Renal Cell Carcinoma and Treatment-associated Fatigue', 'organization': {'class': 'OTHER', 'fullName': 'Kidney Cancer Research Bureau'}, 'officialTitle': 'A Phase 1/2 Study of the Safety and Preliminary Efficacy of Meldonium in Patients with Metastatic Renal Cell Carcinoma and Treatment-associated Fatigue.', 'orgStudyIdInfo': {'id': 'KCRB-0102-MEL'}}, 'armsInterventionsModule': {'armGroups': [{'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.', 'interventionNames': ['Drug: meldonium']}], 'interventions': [{'name': 'meldonium', 'type': 'DRUG', 'description': '500 mg (Arm A) or 1,000 mg (Arms B and C) orally daily, weeks 1-6', 'armGroupLabels': ['Arm A: First-line TKI therapy, Meldonium 500 mg', 'Arm B: Second-line TKI therapy, Meldonium 1,000 mg', 'Arm C: First-line IO-TKI therapy, Meldonium 1,000 mg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tirana', 'country': 'Albania', 'facility': 'Megis medical clinic', 'geoPoint': {'lat': 41.32744, 'lon': 19.81866}}, {'city': 'Baku', 'country': 'Azerbaijan', 'facility': 'National Center of Oncology', 'geoPoint': {'lat': 40.37767, 'lon': 49.89201}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'STOONCO clinic', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kidney Cancer Research Bureau', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}