Ovary CancerNCT05081765
The Effect of Glucose Level and Diabetes Mellitus on Ctrough of Olaparib
An observational study of Ovary Cancer, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial summary
Monitored therapy of olaparib concentrations in the blood of diabetic population probably will assess the need for individual dosing of the drug. The project concerns on the monitored therapy of olaparib in a population of patients with DM, hyperglycemia and normal glucose level. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovary Cancer
- What is being tested?
- Lynparza® (AstraZeneca Pharma Poland Sp. z o.o.) and Lynparza
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 40 participants
- Where
- 1 sitePoland
- Study dates
- 20 Sep 2021to 31 Dec 2022
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The subjects of the research are patients with ovarian cancer who received olaparib as a maintance therapy after platin basen chemotherapy
Who may be able to join
- ovarian cancer patients treated with olaparib above than 4 days
- patient who gave permission to take part in the trial
- age >18 years
- no history of allergy to olaparib
Who cannot join
- allergy to olaparib,
- age under 18 years,
- status of the patient which do not allowed the patient to continue the study.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
University od Medical Sciences
Poznan
Joanna Stanislawiak-Rudowicz, MD,PhD, 0048605781967, stanisl@interia.pl
Joanna Stanislawiak-Rudowicz, MD, PhD
About this study
Official title: The Effect of Glucose Level and Diabetes Mellitus on the Plasma Minimum Steady-state Concentration Ctrough of Olaparib in Patients With Ovarian Cancer
Monitored therapy of olaparib concentrations in the blood of diabetic population probably will assess the need for individual dosing of the drug.
The project concerns on the monitored therapy of olaparib in a population of patients with DM, hyperglycemia and normal glucose level.
Currently, there are no studies assessing the effect of comorbidities and of the administered drugs on the pharmacokinetics of olaparib.
Read the detailed description
The research is conducted at the Poznan University of Medical Sciences, and the Poznan, Poland with the approval from the Bioethics Committee, University of Medical Sciences, Poznan, Poland (697/20). The subjects of the research: the C through of olaparib in the patients with ovarian cancer who received olaparib The patients included in the study if they met the following criteria: treatment with olaparib above four days, age >18 years; no history of allergy to olaparib. The chief criteria for exclusion included allergy to olaparib, age under 18 years, status of the patient which do not allowed the patient to continue the study.
Administration and blood sampling The patients with an ovarian cancer treated with olaparib (tablets in dose 300mg/12h, 250mg/12h, 200 mg/12h or capsules 400mg/12h, 200mg/12h, 100 mg/12h).
Blood samples (2 mL) collected at steady state before morning drug administration. The blood samples transferred into heparinised tubes and centrifuged at 2880 g for 10 min at 4 °C. Next the plasma transferred to propylene tubes and stored at - 20 °C until analysis.
Assays The concentrations of olaparib in plasma assayed using the high-performance liquid chromatography (HPLC) method with ultraviolet (UV) detection. The method validated according to European Medicines Agency guideline. The method validation confirmed good precision (CV% <15%), accuracy (92.3-115.0%) and linearity (r=0.9994) in the range of 100-4000 ng/mL.
The severity of olaparib adverse effects assessed by CTCAE (Common Terminology Criteria for Adverse Events) v.5.0 scale.
- Conditions
- Ovary Cancer
- Being tested
- Lynparza® (AstraZeneca Pharma Poland Sp. z o.o.), Lynparza
- Keywords
- olaparib, blood-level testing, C through, diabetes melitus, hyperglycemia
- Medical subject headings
- Ovarian Neoplasms, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lynparza® (AstraZeneca Pharma Poland Sp. z o.o.)Drug
Also called olaparib
correlation between C through and taken drug
LynparzaDevice
Also called olaparib
correlation between C through and taken drug
| Study group | Role | What they receive |
|---|---|---|
| Patients with diabetes mellitus | olaparib 2 x 300mg /24h tablets = olaparib 2 x 400mg/24 olaparib 2 x 250mg/24h tablets = olaparib 2 x 200mg/24h olaparib 2 x 200mg/24h tablets = olaparib 2 x 100mg/24h Receives: Drug: Lynparza® (AstraZeneca Pharma Poland Sp. z o.o.); Device: Lynparza | |
| Patients with hyperglycemia, | olaparib 2 x 300mg /24h tablets = olaparib 2 x 400mg/24 olaparib 2 x 250mg/24h tablets = olaparib 2 x 200mg/24h olaparib 2 x 200mg/24h tablets = olaparib 2 x 100mg/24h Receives: Drug: Lynparza® (AstraZeneca Pharma Poland Sp. z o.o.); Device: Lynparza | |
| Patient with normal glucose level | olaparib 2 x 300mg /24h tablets = olaparib 2 x 400mg/24 olaparib 2 x 250mg/24h tablets = olaparib 2 x 200mg/24h olaparib 2 x 200mg/24h tablets = olaparib 2 x 100mg/24h Receives: Drug: Lynparza® (AstraZeneca Pharma Poland Sp. z o.o.); Device: Lynparza |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between glucose level and C through.olaparib in the blood of the patients with ovarian cancer
There is idea to check the correlation of C through of the olaparib taken by the patients with diabetes melitus and ovarian cancer and the correlation of C through and glucose of the patients with hyperglycemia diagnosed during olaparib treatment
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start20 Sep 2021
- Primary completion15 Oct 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Ovary CancerStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Poznan University Hospital of Lord's Transfiguration
- Responsible party
- Principal investigator, Stanisławiak-Rudowicz Joanna, Poznan University of Medical Sciences
- Investigators
- Joanna J Stanisławiak - Rudowicz, Principal investigator, University of Medical Sciences Poznań, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05081765
- Sponsor's protocol ID
- 697/20
- Status last verified
- Oct 2021
- First submitted
- 1 Oct 2021
- Last updated
- 18 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: To check C through of olaparib and morphology, Alat, Aspat and GFR and glucose level
Publications
Debska S, Kubicka J, Czyzykowski R, Habib M, Potemski P. [PARP inhibitors--theoretical basis and clinical application]. Postepy Hig Med Dosw (Online). 2012 May 30;66:311-21. doi: 10.5604/17322693.999033. Polish.
PubMed 22706117Wisnik E, Ryksa M, Koter-Michalak M. [PARP1 inhibitors: contemporary attempts at their use in anticancer therapy and future perspective]. Postepy Hig Med Dosw (Online). 2016 Apr 13;70:280-94. doi: 10.5604/17322693.1199303. Polish.
PubMed 27117104Ledermann J, Harter P, Gourley C, Friedlander M, Vergote I, Rustin G, Scott CL, Meier W, Shapira-Frommer R, Safra T, Matei D, Fielding A, Spencer S, Dougherty B, Orr M, Hodgson D, Barrett JC, Matulonis U. Olaparib maintenance therapy in patients with platinum-sensitive relapsed serous ovarian cancer: a preplanned retrospective analysis of outcomes by BRCA status in a randomised phase 2 trial. Lancet Oncol. 2014 Jul;15(8):852-61. doi: 10.1016/S1470-2045(14)70228-1. Epub 2014 May 31.
PubMed 24882434Friedlander M, Banerjee S, Mileshkin L, Scott C, Shannon C, Goh J. Practical guidance on the use of olaparib capsules as maintenance therapy for women with BRCA mutations and platinum-sensitive recurrent ovarian cancer. Asia Pac J Clin Oncol. 2016 Dec;12(4):323-331. doi: 10.1111/ajco.12636.
PubMed 27917619Szalek E, Karbownik A, Sobanska K, Grabowski T, Polom W, Lewandowska M, Wolc A, Matuszewski M, Grzeskowiak E. The pharmacokinetics and hypoglycaemic effect of sunitinib in the diabetic rabbits. Pharmacol Rep. 2014 Oct;66(5):892-6. doi: 10.1016/j.pharep.2014.05.011. Epub 2014 Jun 6.
PubMed 25149997Karbownik A, Szalek E, Sobanska K, Grabowski T, Wolc A, Grzeskowiak E. The alteration of pharmacokinetics of erlotinib and OSI420 in type 1 diabetic rabbits. Pharmacol Rep. 2016 Oct;68(5):964-8. doi: 10.1016/j.pharep.2016.04.015. Epub 2016 May 6.
PubMed 27372922Dostalek M, Court MH, Yan B, Akhlaghi F. Significantly reduced cytochrome P450 3A4 expression and activity in liver from humans with diabetes mellitus. Br J Pharmacol. 2011 Jul;163(5):937-47. doi: 10.1111/j.1476-5381.2011.01270.x.
PubMed 21323901Dostalek M, Akhlaghi F, Puzanovova M. Effect of diabetes mellitus on pharmacokinetic and pharmacodynamic properties of drugs. Clin Pharmacokinet. 2012 Aug 1;51(8):481-99. doi: 10.2165/11631900-000000000-00000.
PubMed 22668340Tran M, Elbarbry F. Influence of diabetes mellitus on pharmacokinetics of drugs. MOJ Bioequiv Availab. 2016;2(1):3-4.
Porazka J, Szalek E, Polom W, Czajkowski M, Grabowski T, Matuszewski M, Grzeskowiak E. Influence of Obesity and Type 2 Diabetes Mellitus on the Pharmacokinetics of Tramadol After Single Oral Dose Administration. Eur J Drug Metab Pharmacokinet. 2019 Aug;44(4):579-584. doi: 10.1007/s13318-019-00543-1.
PubMed 30778911Stachowiak A, Szalek E, Karbownik A, Lojko A, Porazka J, Przewozna I, Grabowski T, Wolc A, Grzeskowiak E. The Influence of Diabetes Mellitus on Glucuronidation and Sulphation of Paracetamol in Patients with Febrile Neutropenia. Eur J Drug Metab Pharmacokinet. 2019 Apr;44(2):289-294. doi: 10.1007/s13318-018-0508-4.
PubMed 30187443Karbownik A, Szalek E, Sobanska K, Klupczynska A, Plewa S, Grabowski T, Wolc A, Moch M, Kokot ZJ, Grzeskowiak E. A pharmacokinetic study on lapatinib in type 2 diabetic rats. Pharmacol Rep. 2018 Apr;70(2):191-195. doi: 10.1016/j.pharep.2017.09.003. Epub 2017 Sep 18.
PubMed 29471066Karbownik A, Stachowiak A, Urjasz H, Sobanska K, Szczecinska A, Grabowski T, Stanislawiak-Rudowicz J, Wolc A, Grzeskowiak E, Szalek E. The oxidation and hypoglycaemic effect of sorafenib in streptozotocin-induced diabetic rats. Pharmacol Rep. 2020 Feb;72(1):254-259. doi: 10.1007/s43440-019-00021-0. Epub 2020 Jan 8.
PubMed 32016844
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Glucose Level and Diabetes Mellitus on the Plasma Minimum Steady-state Concentration Ctrough of Olaparib in Patients With Ovarian Cancer
- ClinicalTrials.gov ID
- NCT05081765
- Acronym / sponsor ID
- 697/20
- Conditions
- Ovary Cancer
- Keywords
- olaparib, blood-level testing, C through, diabetes melitus, hyperglycemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Collaborators
- Poznan University Hospital of Lord's Transfiguration
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 15 Oct 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 18 Oct 2021 (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.
Monitored therapy of olaparib concentrations in the blood of diabetic population probably will assess the need for individual dosing of the drug.
The project concerns on the monitored therapy of olaparib in a population of patients with DM, hyperglycemia and normal glucose level.
Currently, there are no studies assessing the effect of comorbidities and of the administered drugs on the pharmacokinetics of olaparib.
Detailed description
The research is conducted at the Poznan University of Medical Sciences, and the Poznan, Poland with the approval from the Bioethics Committee, University of Medical Sciences, Poznan, Poland (697/20). The subjects of the research: the C through of olaparib in the patients with ovarian cancer who received olaparib The patients included in the study if they met the following criteria: treatment with olaparib above four days, age >18 years; no history of allergy to olaparib. The chief criteria for exclusion included allergy to olaparib, age under 18 years, status of the patient which do not allowed the patient to continue the study.
Administration and blood sampling The patients with an ovarian cancer treated with olaparib (tablets in dose 300mg/12h, 250mg/12h, 200 mg/12h or capsules 400mg/12h, 200mg/12h, 100 mg/12h).
Blood samples (2 mL) collected at steady state before morning drug administration. The blood samples transferred into heparinised tubes and centrifuged at 2880 g for 10 min at 4 °C. Next the plasma transferred to propylene tubes and stored at - 20 °C until analysis.
Assays The concentrations of olaparib in plasma assayed using the high-performance liquid chromatography (HPLC) method with ultraviolet (UV) detection. The method validated according to European Medicines Agency guideline. The method validation confirmed good precision (CV% <15%), accuracy (92.3-115.0%) and linearity (r=0.9994) in the range of 100-4000 ng/mL.
The severity of olaparib adverse effects assessed by CTCAE (Common Terminology Criteria for Adverse Events) v.5.0 scale.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with diabetes mellitus | – | Drug: Lynparza® (AstraZeneca Pharma Poland Sp. z o.o.), Device: Lynparzaolaparib 2 x 300mg /24h tablets = olaparib 2 x 400mg/24 olaparib 2 x 250mg/24h tablets = olaparib 2 x 200mg/24h olaparib 2 x 200mg/24h tablets = olaparib 2 x 100mg/24h |
| Patients with hyperglycemia, | – | Drug: Lynparza® (AstraZeneca Pharma Poland Sp. z o.o.), Device: Lynparzaolaparib 2 x 300mg /24h tablets = olaparib 2 x 400mg/24 olaparib 2 x 250mg/24h tablets = olaparib 2 x 200mg/24h olaparib 2 x 200mg/24h tablets = olaparib 2 x 100mg/24h |
| Patient with normal glucose level | – | Drug: Lynparza® (AstraZeneca Pharma Poland Sp. z o.o.), Device: Lynparzaolaparib 2 x 300mg /24h tablets = olaparib 2 x 400mg/24 olaparib 2 x 250mg/24h tablets = olaparib 2 x 200mg/24h olaparib 2 x 200mg/24h tablets = olaparib 2 x 100mg/24h |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The subjects of the research are patients with ovarian cancer who received olaparib as a maintance therapy after platin basen chemotherapy
Key inclusion criteria (4 listed)
- ovarian cancer patients treated with olaparib above than 4 days
- patient who gave permission to take part in the trial
- age >18 years
- no history of allergy to olaparib
Key exclusion criteria (3 listed)
- allergy to olaparib,
- age under 18 years,
- status of the patient which do not allowed the patient to continue the study.
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 |
|---|---|---|
| Lynparza® (AstraZeneca Pharma Poland Sp. z o.o.)Also: olaparibcorrelation between C through and taken drug | Drug | Patient with normal glucose level, Patients with diabetes mellitus, Patients with hyperglycemia, |
| LynparzaAlso: olaparibcorrelation between C through and taken drug | Device | Patient with normal glucose level, Patients with diabetes mellitus, Patients with hyperglycemia, |
Primary outcome
correlation between glucose level and C through.olaparib in the blood of the patients with ovarian cancer
Time frame: through study completion, an average of 1 year
There is idea to check the correlation of C through of the olaparib taken by the patients with diabetes melitus and ovarian cancer and the correlation of C through and glucose of the patients with hyperglycemia diagnosed during olaparib treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2021.
- Background: PubMed 22706117Debska S, Kubicka J, Czyzykowski R, Habib M, Potemski P. [PARP inhibitors--theoretical basis and clinical application]. Postepy Hig Med Dosw (Online). 2012 May 30;66:311-21. doi: 10.5604/17322693.999033. Polish.
- Background: PubMed 27117104Wisnik E, Ryksa M, Koter-Michalak M. [PARP1 inhibitors: contemporary attempts at their use in anticancer therapy and future perspective]. Postepy Hig Med Dosw (Online). 2016 Apr 13;70:280-94. doi: 10.5604/17322693.1199303. Polish.
- Background: PubMed 24882434Ledermann J, Harter P, Gourley C, Friedlander M, Vergote I, Rustin G, Scott CL, Meier W, Shapira-Frommer R, Safra T, Matei D, Fielding A, Spencer S, Dougherty B, Orr M, Hodgson D, Barrett JC, Matulonis U. Olaparib maintenance therapy in patients with platinum-sensitive relapsed serous ovarian cancer: a preplanned retrospective analysis of outcomes by BRCA status in a randomised phase 2 trial. Lancet Oncol. 2014 Jul;15(8):852-61. doi: 10.1016/S1470-2045(14)70228-1. Epub 2014 May 31.
- Background: PubMed 27917619Friedlander M, Banerjee S, Mileshkin L, Scott C, Shannon C, Goh J. Practical guidance on the use of olaparib capsules as maintenance therapy for women with BRCA mutations and platinum-sensitive recurrent ovarian cancer. Asia Pac J Clin Oncol. 2016 Dec;12(4):323-331. doi: 10.1111/ajco.12636.
- Background: PubMed 25149997Szalek E, Karbownik A, Sobanska K, Grabowski T, Polom W, Lewandowska M, Wolc A, Matuszewski M, Grzeskowiak E. The pharmacokinetics and hypoglycaemic effect of sunitinib in the diabetic rabbits. Pharmacol Rep. 2014 Oct;66(5):892-6. doi: 10.1016/j.pharep.2014.05.011. Epub 2014 Jun 6.
- Background: PubMed 27372922Karbownik A, Szalek E, Sobanska K, Grabowski T, Wolc A, Grzeskowiak E. The alteration of pharmacokinetics of erlotinib and OSI420 in type 1 diabetic rabbits. Pharmacol Rep. 2016 Oct;68(5):964-8. doi: 10.1016/j.pharep.2016.04.015. Epub 2016 May 6.
- Background: PubMed 21323901Dostalek M, Court MH, Yan B, Akhlaghi F. Significantly reduced cytochrome P450 3A4 expression and activity in liver from humans with diabetes mellitus. Br J Pharmacol. 2011 Jul;163(5):937-47. doi: 10.1111/j.1476-5381.2011.01270.x.
- Background: PubMed 22668340Dostalek M, Akhlaghi F, Puzanovova M. Effect of diabetes mellitus on pharmacokinetic and pharmacodynamic properties of drugs. Clin Pharmacokinet. 2012 Aug 1;51(8):481-99. doi: 10.2165/11631900-000000000-00000.
- BackgroundTran M, Elbarbry F. Influence of diabetes mellitus on pharmacokinetics of drugs. MOJ Bioequiv Availab. 2016;2(1):3-4.
- Background: PubMed 30778911Porazka J, Szalek E, Polom W, Czajkowski M, Grabowski T, Matuszewski M, Grzeskowiak E. Influence of Obesity and Type 2 Diabetes Mellitus on the Pharmacokinetics of Tramadol After Single Oral Dose Administration. Eur J Drug Metab Pharmacokinet. 2019 Aug;44(4):579-584. doi: 10.1007/s13318-019-00543-1.
- Background: PubMed 30187443Stachowiak A, Szalek E, Karbownik A, Lojko A, Porazka J, Przewozna I, Grabowski T, Wolc A, Grzeskowiak E. The Influence of Diabetes Mellitus on Glucuronidation and Sulphation of Paracetamol in Patients with Febrile Neutropenia. Eur J Drug Metab Pharmacokinet. 2019 Apr;44(2):289-294. doi: 10.1007/s13318-018-0508-4.
- Background: PubMed 29471066Karbownik A, Szalek E, Sobanska K, Klupczynska A, Plewa S, Grabowski T, Wolc A, Moch M, Kokot ZJ, Grzeskowiak E. A pharmacokinetic study on lapatinib in type 2 diabetic rats. Pharmacol Rep. 2018 Apr;70(2):191-195. doi: 10.1016/j.pharep.2017.09.003. Epub 2017 Sep 18.
- Summary of product characteristicLink provided by the sponsor.
- Onkol Prakt Klin Edu 2018;4(3):167-178.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. To check C through of olaparib and morphology, Alat, Aspat and GFR and glucose level
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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.
Joanna J Stanisławiak - Rudowicz principal investigator
University of Medical Sciences Poznań, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovary Cancer, run by Poznan University of Medical Sciences at 1 site in Poland.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 18 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joanna i Stanislawiak-Rudowicz, MD, PhD (0048605781967, stanisl@interia.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation between glucose level and C through.olaparib in the blood of the patients with ovarian cancer (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05081765, which also lists 13 linked publications.
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 2021.