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

NCT06648902 | Completed Phase 1 DMC

• 1 other identifier: KCRB-0102-MEL
• Study Type: interventional
• Target: 60
• Locations: 3 countries
• Sites: 3

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.

Conditions

Renal Cell Cancer Metastatic; Kidney Cancer; Fatigue Related to Cancer Treatment

Outcome Measures

Primary Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events

  Incidence of meldonium-related adverse events

  From enrollment to the end of treatment at 6 weeks

• Changes in fatigue levels based on FACIT Fatigue Scale

  Changes in fatigue levels, measured at six weeks using the FACIT Fatigue Scale (Version 4).

  From enrollment to the end of treatment at 6 weeks

Secondary Outcomes (3)

• Toxicity of anti-cancer systemic therapy

  From enrollment to the end of treatment at 8 weeks

• Rate of discontinuation of anti-cancer therapy and/or dose reduction of the drug

  From enrollment to the end of treatment at 12 weeks

• Rate of arterial hypertension

  From enrollment to the end of treatment at 12 weeks

Study Arms (3)

Arm A: First-line TKI therapy, Meldonium 500 mg

EXPERIMENTAL

meldonium 500 mg orally daily for six weeks.

Drug: meldonium

Arm B: Second-line TKI therapy, Meldonium 1,000 mg

EXPERIMENTAL

meldonium 1,000 mg orally daily for six weeks.

Drug: meldonium

Arm C: First-line IO-TKI therapy, Meldonium 1,000 mg

EXPERIMENTAL

meldonium 1,000 mg orally daily for six weeks.

Drug: meldonium

Interventions

meldonium DRUG

500 mg (Arm A) or 1,000 mg (Arms B and C) orally daily, weeks 1-6

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kidney Cancer Research Bureau: lead

Study Sites (3)

Megis medical clinic

Tirana, Albania

Location

National Center of Oncology

Baku, Azerbaijan

Location

STOONCO clinic

Moscow, Russia

Location

MeSH Terms

Conditions

Kidney Neoplasms

Interventions

3-(2,2,2-trimethylhydrazine)propionate

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2024
• First Posted: October 18, 2024
• Study Start: February 1, 2022
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: October 18, 2024

Record last verified: 2024-09

Locations

AL (1); AZ (1); RU (1)