Renal Cell Cancer MetastaticPhase 1/2NCT06648902
Safety and Preliminary Efficacy of Meldonium in Patients with Metastatic Renal Cell Carcinoma and Treatment-associated Fatigue
A Phase 1/2 study testing meldonium in people with Renal Cell Cancer Metastatic and Kidney Cancer, run by Kidney Cancer Research Bureau at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Cancer Metastatic, Kidney Cancer, Fatigue Related to Cancer Treatment
- What is being tested?
- meldonium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 1 Feb 2022to 1 Sep 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: A Phase 1/2 Study of the Safety and Preliminary Efficacy of Meldonium in Patients with Metastatic Renal Cell Carcinoma and Treatment-associated Fatigue.
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.
Read the 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.
- Being tested
- meldonium
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
meldoniumDrug
500 mg (Arm A) or 1,000 mg (Arms B and C) orally daily, weeks 1-6
| Study group | Role | What they receive |
|---|---|---|
| Arm A: First-line TKI therapy, Meldonium 500 mg | Experimental | meldonium 500 mg orally daily for six weeks. Receives: Drug: meldonium |
| Arm B: Second-line TKI therapy, Meldonium 1,000 mg | Experimental | meldonium 1,000 mg orally daily for six weeks. Receives: Drug: meldonium |
| Arm C: First-line IO-TKI therapy, Meldonium 1,000 mg | Experimental | meldonium 1,000 mg orally daily for six weeks. Receives: Drug: meldonium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
Incidence of meldonium-related adverse events
Measured: 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).
Measured: From enrollment to the end of treatment at 6 weeks
Secondary outcomes (3)
Toxicity of anti-cancer systemic therapy
Rate of adverse events
Measured: From enrollment to the end of treatment at 8 weeks
Rate of discontinuation of anti-cancer therapy and/or dose reduction of the drug
Rate of discontinuation of anti-cancer therapy and/or dose reduction of the drug
Measured: From enrollment to the end of treatment at 12 weeks
Rate of arterial hypertension
Rate of arterial hypertension as an adverse event of targeted therapy
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start1 Feb 2022
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell Cancer MetastaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kidney Cancer Research Bureau
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06648902
- Sponsor's protocol ID
- KCRB-0102-MEL
- Status last verified
- Sep 2024
- First submitted
- 22 Sep 2024
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study of the Safety and Preliminary Efficacy of Meldonium in Patients with Metastatic Renal Cell Carcinoma and Treatment-associated Fatigue.
- ClinicalTrials.gov ID
- NCT06648902
- Acronym / sponsor ID
- KCRB-0102-MEL
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kidney Cancer Research BureauUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 18 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A: First-line TKI therapy, Meldonium 500 mg | Experimental | Drug: meldoniummeldonium 500 mg orally daily for six weeks. |
| Arm B: Second-line TKI therapy, Meldonium 1,000 mg | Experimental | Drug: meldoniummeldonium 1,000 mg orally daily for six weeks. |
| Arm C: First-line IO-TKI therapy, Meldonium 1,000 mg | Experimental | Drug: meldoniummeldonium 1,000 mg orally daily for six weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| meldonium500 mg (Arm A) or 1,000 mg (Arms B and C) orally daily, weeks 1-6 | Drug | 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 |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: From enrollment to the end of treatment at 6 weeks
Incidence of meldonium-related adverse events
Changes in fatigue levels based on FACIT Fatigue Scale
Time frame: From enrollment to the end of treatment at 6 weeks
Changes in fatigue levels, measured at six weeks using the FACIT Fatigue Scale (Version 4).
3 secondary outcomes
Toxicity of anti-cancer systemic therapy
Time frame: From enrollment to the end of treatment at 8 weeks
Rate of discontinuation of anti-cancer therapy and/or dose reduction of the drug
Time frame: From enrollment to the end of treatment at 12 weeks
Rate of arterial hypertension
Time frame: From enrollment to the end of treatment at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing meldonium in people with Renal Cell Cancer Metastatic and Kidney Cancer, run by Kidney Cancer Research Bureau at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Albania, Azerbaijan, Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (time frame: From enrollment to the end of treatment at 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2024.