Carcinoma, Renal CellNCT05745142
A Study to go Back Into Records and Observe How People With Metastatic Renal Cell Carcinoma (mRCC) Who Received a Medicine Called Sunitinib Responded to This Medicine.
An observational study of Carcinoma, Renal Cell and Clear-cell Metastatic Renal Cell Carcinoma, run by Pfizer at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to understand how patients with mRCC respond to the study medicine (called sunitinib) when they receive it as the first line of treatment after finding out the cause for the disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Renal Cell, Clear-cell Metastatic Renal Cell Carcinoma
- What is being tested?
- Sunitinib
- How many people
- 376 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Feb 2023to 23 Feb 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: RCC Registry will be screened for all patients who meets all inclusion criteria and who doesn't meet the exclusion criterion defined in the study protocol and who were treated with Sunitinib in first-line therapy for mRCC and were registered to the database between 2019 and 2022.
Who may be able to join
- Being a Turkish citizen.
- Being older than 18 years-old.
- Being clinically diagnosed with mRCC and treated.
- Being treated with Sunitinib in first line
Who cannot join
- Patients whose treatment was initiated but excluded from follow-up for any reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Registry Based Study for Evaluating Treatment Response in Patients Targeted Treated With Metastatic Renal Cell Carcinoma (mRCC) With Sunitinib in First-line Therapy
The purpose of this study is to understand how patients with mRCC respond to the study medicine (called sunitinib) when they receive it as the first line of treatment after finding out the cause for the disease.
This study will look into how different and how well groups of people with high chances of developing the disease respond to the study medicine.
Read more
All data for this study will be anonymously extracted from data already entered in RCC Registry which is owned by Turkish Oncology Group Association (TOGD).
This study will pull out records from the Registry between 01-Mar-2019 and 30-Oct-2022 that belongs to people:
- who are Turkish citizens
- who are older than 18 years
- who were found out to have mRCC
- who received sunitinib as the first line treatment after finding out the cause for the disease
This study will look at the responses, experiences and how long the patients use the study medicine sunitinib.
Read the detailed description
This study is designed as a local, non-interventional, retrospective, registry-based study to observe treatment response in patients with metastatic Renal Cell Carcinoma with Sunitinib First-Line Therapy based on data extracted and analyzed from the RCC Registry.
The annual disease burden in contributing centers to RCC Registry is approximately 100 patient/center, the treatment of an average of 250 patients per year is continued in the centers. Therefore, it is estimated that information of approximately 400 eligible patients who were registered in RCC Registry from 2019 to 2022 will be included in the analysis.
RCC Registry will be used as the sole data source for this study. For this purpose, no Case Report Forms (CRFs) or Data Collection Tools (DCTs) will be utilized, but the RCC Registry database will be used directly. Eligible patients' data will be anonymized and extracted for analysis by the registry owner, for this study.
- Being tested
- Sunitinib
- Keywords
- mRCC, Metastatic Renal Cell Carcinoma, Clear-cell metastatic renal cell carcinoma
- Medical subject headings
- Carcinoma, Renal Cell, Clear-cell metastatic renal cell carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SunitinibDrug
as provided in real world practice
| Study group | Role | What they receive |
|---|---|---|
| metastatic Renal Cell Carcinoma patients | metastatic Renal Cell Carcinoma patients with clear cell histology. Receives: Drug: Sunitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) According to Disease Risk Group in IMDC
ORR: percentage of participants with partial response (PR) and complete response (CR). As per response evaluation criteria in solid tumors (RECIST)1.1 criteria: CR = disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis); PR = at least 30% decrease in sum of diameters of target lesions taking as reference baseline sum diameters. IMDC assessed as favorable (0), intermediate (1-2) or poor (>=3) based on number of criteria present (KPS <80%; time from diagnosis to start of systemic therapy <1 year; corrected serum calcium [Ca]; neutrophils and platelets >ULN; hemoglobin [hg] <LLN).
Measured: From initiation of sunitinib treatment (retrospective data) till PR and CR or death or progression (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database]
Response Rates According to Disease Risk Group in IMDC
RECIST1.1- CR: disappearance of all lesions \& normalization of tumor marker level. Any pathological lymph nodes must have reduction in short axis to <10 mm. All lymph nodes must be non-pathological in size (<10 mm short axis); PR: at least 30% decrease in sum of diameters of target lesions taking as reference baseline sum diameters; progressive disease (PD): at least 20% increase in sum of longest dimensions of target lesions, reference to the smallest sum of the longest dimensions recorded since treatment started, or appearance of 1 or more new lesions or increase of at least 5 mm in addition to the relative increase of 20%; stable disease (SD): neither shrinkage for CR/PR nor increase for PD taking as reference smallest sum of longest diameters since treatment start. IMDC: favorable (0), intermediate (1-2) or poor (>=3) based on number of criteria present (KPS <80%; time from diagnosis to start of systemic therapy <1 year; corrected serum Ca]; neutrophils \& platelets >ULN; hg <LLN).
Measured: From initiation of sunitinib treatment (retrospective data) till PR/ CR/ SD/ death or progression (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database]
ORR According to Disease Risk Group in MSKCC
ORR: percentage of participants with PR and CR. As per RECIST 1.1 criteria: CR = disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis); PR = at least 30% decrease in sum of diameters of target lesions taking as reference baseline sum diameters. MSKCC assessed as favorable (0), intermediate (1-2) or poor (>=3) based on number of criteria present [KPS <80%, time from diagnosis to start of systemic therapy <12 months, lactate dehydrogenase >1.5*ULN, hemoglobin <LLN, serum calcium >10 mg/dL].
Measured: From initiation of sunitinib treatment (retrospective data) till PR and CR or death or progression (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database]
Response Rates According to Disease Risk Group in MSKCC
RECIST1.1- CR: disappearance of all lesions and normalization of tumor marker level. Any pathological lymph nodes must have reduction in short axis to <10 mm. All lymph nodes must be non-pathological in size (<10 mm short axis); PR: at least 30% decrease in sum of diameters of target lesions taking as reference baseline sum diameters; PD: at least 20% increase in sum of longest dimensions of target lesions, reference to the smallest sum of the longest dimensions recorded since treatment started, or the appearance of 1 or more new lesions or increase of at least 5 mm in addition to the relative increase of 20%; SD: neither shrinkage for CR/PR nor increase for PD taking as reference smallest sum of longest diameters since treatment start. MSKCC assessed as favourable (0), intermediate (1-2) or poor (>=3) based on number of criteria present [KPS <80%, time from diagnosis to start of systemic therapy <12 months, lactate dehydrogenase >1.5*ULN, hemoglobin <LLN, serum calcium >10 mg/dL].
Measured: From initiation of sunitinib treatment (retrospective data) till PR/ CR/ SD/ death or progression (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database]
Secondary outcomes (4)
Overall Survival (OS) Rate According to Disease Risk Group in IMDC
OS was defined as the time from the start of the treatment until the date of death. If no death was recorded, data was censored at latest available date in data. IMDC assessed as favorable (0), intermediate (1-2) or poor (>=3) based on number of criteria present (KPS <80%; time from diagnosis to start of systemic therapy <1 year; corrected serum Ca; neutrophils and platelets >ULN; hg <LLN).
Measured: From initiation of sunitinib treatment (retrospective data) till death or censored date (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database]
Progression-Free Survival (PFS) According to Disease Risk Group in IMDC
PFS: duration from start of treatment to disease progression (PD), end of treatment date or date of death. PD: at least 20% increase in sum of longest dimensions of target lesions, reference to the smallest sum of the longest dimensions recorded since treatment started, or the appearance of 1 or more new lesions or increase of at least 5 mm in addition to the relative increase of 20%. IMDC assessed as favorable (0), intermediate (1-2) or poor (>=3) based on number of criteria present (KPS <80%; time from diagnosis to start of systemic therapy <1 year; corrected serum Ca; neutrophils and platelets >ULN; hg <LLN).
Measured: From initiation of sunitinib treatment (retrospective data) till progression end of treatment date or date of death (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database]
OS According to Disease Risk Group in MSKCC
OS was defined as the time from the start of the treatment until the date of death. If no death was recorded, data was censored at latest available date in data. MSKCC assessed as favourable (0), intermediate (1-2) or poor (>=3) based on number of criteria present [KPS <80%, time from diagnosis to start of systemic therapy <12 months, lactate dehydrogenase >1.5*ULN, hemoglobin <LLN, serum calcium >10 mg/dL].
Measured: From initiation of sunitinib treatment (retrospective data) till death or censored date (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database]
PFS According to Disease Risk Group in MSKCC
PFS: duration from start of treatment to PD, end of treatment date or date of death. PD: at least 20% increase in sum of longest dimensions of target lesions, reference to the smallest sum of the longest dimensions recorded since treatment started, or the appearance of 1 or more new lesions or increase of at least 5 mm in addition to the relative increase of 20%. MSKCC assessed as favourable (0), intermediate (1-2) or poor (>=3) based on number of criteria present [KPS <80%, time from diagnosis to start of systemic therapy <12 months, lactate dehydrogenase >1.5*ULN, hemoglobin <LLN, serum calcium >10 mg/dL].
Measured: From initiation of sunitinib treatment (retrospective data) till progression end of treatment date or date of death (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start23 Feb 2023
- Primary completion23 Feb 2023
- Study completion23 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Carcinoma, Renal CellStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 376 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05745142
- Sponsor's protocol ID
- A6181235
- Status last verified
- Feb 2024
- First submitted
- 26 Jan 2023
- Last updated
- 5 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Registry Based Study for Evaluating Treatment Response in Patients Targeted Treated With Metastatic Renal Cell Carcinoma (mRCC) With Sunitinib in First-line Therapy
- ClinicalTrials.gov ID
- NCT05745142
- Acronym / sponsor ID
- A6181235
- Keywords
- mRCC, Metastatic Renal Cell Carcinoma, Clear-cell metastatic renal cell carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 376 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 23 Feb 2023 (actual)
- Primary completion
- 23 Feb 2023 (actual)
- Study completion
- 23 Feb 2023 (actual)
- First posted
- 27 Feb 2023 (actual)
- Results
- Posted 5 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to understand how patients with mRCC respond to the study medicine (called sunitinib) when they receive it as the first line of treatment after finding out the cause for the disease.
This study will look into how different and how well groups of people with high chances of developing the disease respond to the study medicine.
All data for this study will be anonymously extracted from data already entered in RCC Registry which is owned by Turkish Oncology Group Association (TOGD).
This study will pull out records from the Registry between 01-Mar-2019 and 30-Oct-2022 that belongs to people:
- who are Turkish citizens
- who are older than 18 years
- who were found out to have mRCC
- who received sunitinib as the first line treatment after finding out the cause for the disease
This study will look at the responses, experiences and how long the patients use the study medicine sunitinib.
Detailed description
This study is designed as a local, non-interventional, retrospective, registry-based study to observe treatment response in patients with metastatic Renal Cell Carcinoma with Sunitinib First-Line Therapy based on data extracted and analyzed from the RCC Registry.
The annual disease burden in contributing centers to RCC Registry is approximately 100 patient/center, the treatment of an average of 250 patients per year is continued in the centers. Therefore, it is estimated that information of approximately 400 eligible patients who were registered in RCC Registry from 2019 to 2022 will be included in the analysis.
RCC Registry will be used as the sole data source for this study. For this purpose, no Case Report Forms (CRFs) or Data Collection Tools (DCTs) will be utilized, but the RCC Registry database will be used directly. Eligible patients' data will be anonymized and extracted for analysis by the registry owner, for this study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| metastatic Renal Cell Carcinoma patients | – | Drug: Sunitinibmetastatic Renal Cell Carcinoma patients with clear cell histology. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- RCC Registry will be screened for all patients who meets all inclusion criteria and who doesn't meet the exclusion criterion defined in the study protocol and who were treated with Sunitinib in first-line therapy for mRCC and were registered to the database between 2019 and 2022.
Key inclusion criteria (4 listed)
- Being a Turkish citizen.
- Being older than 18 years-old.
- Being clinically diagnosed with mRCC and treated.
- Being treated with Sunitinib in first line
Key exclusion criteria (1 listed)
- Patients whose treatment was initiated but excluded from follow-up for any reason.
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 |
|---|---|---|
| Sunitinibas provided in real world practice | Drug | metastatic Renal Cell Carcinoma patients |
Primary outcome
Objective Response Rate (ORR) According to Disease Risk Group in IMDC
Time frame: From initiation of sunitinib treatment (retrospective data) till PR and CR or death or progression (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database]
ORR: percentage of participants with partial response (PR) and complete response (CR). As per response evaluation criteria in solid tumors (RECIST)1.1 criteria: CR = disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis); PR = at least 30% decrease in sum of diameters of target lesions taking as reference baseline sum diameters. IMDC assessed as favorable (0), intermediate (1-2) or poor (>=3) based on number of criteria present (KPS <80%; time from diagnosis to start of systemic therapy <1 year; corrected serum calcium [Ca]; neutrophils and platelets >ULN; hemoglobin [hg] <LLN).
Response Rates According to Disease Risk Group in IMDC
Time frame: From initiation of sunitinib treatment (retrospective data) till PR/ CR/ SD/ death or progression (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database]
RECIST1.1- CR: disappearance of all lesions \& normalization of tumor marker level. Any pathological lymph nodes must have reduction in short axis to <10 mm. All lymph nodes must be non-pathological in size (<10 mm short axis); PR: at least 30% decrease in sum of diameters of target lesions taking as reference baseline sum diameters; progressive disease (PD): at least 20% increase in sum of longest dimensions of target lesions, reference to the smallest sum of the longest dimensions recorded since treatment started, or appearance of 1 or more new lesions or increase of at least 5 mm in addition to the relative increase of 20%; stable disease (SD): neither shrinkage for CR/PR nor increase for PD taking as reference smallest sum of longest diameters since treatment start. IMDC: favorable (0), intermediate (1-2) or poor (>=3) based on number of criteria present (KPS <80%; time from diagnosis to start of systemic therapy <1 year; corrected serum Ca]; neutrophils \& platelets >ULN; hg <LLN).
ORR According to Disease Risk Group in MSKCC
Time frame: From initiation of sunitinib treatment (retrospective data) till PR and CR or death or progression (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database]
ORR: percentage of participants with PR and CR. As per RECIST 1.1 criteria: CR = disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis); PR = at least 30% decrease in sum of diameters of target lesions taking as reference baseline sum diameters. MSKCC assessed as favorable (0), intermediate (1-2) or poor (>=3) based on number of criteria present [KPS <80%, time from diagnosis to start of systemic therapy <12 months, lactate dehydrogenase >1.5*ULN, hemoglobin <LLN, serum calcium >10 mg/dL].
Response Rates According to Disease Risk Group in MSKCC
Time frame: From initiation of sunitinib treatment (retrospective data) till PR/ CR/ SD/ death or progression (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database]
RECIST1.1- CR: disappearance of all lesions and normalization of tumor marker level. Any pathological lymph nodes must have reduction in short axis to <10 mm. All lymph nodes must be non-pathological in size (<10 mm short axis); PR: at least 30% decrease in sum of diameters of target lesions taking as reference baseline sum diameters; PD: at least 20% increase in sum of longest dimensions of target lesions, reference to the smallest sum of the longest dimensions recorded since treatment started, or the appearance of 1 or more new lesions or increase of at least 5 mm in addition to the relative increase of 20%; SD: neither shrinkage for CR/PR nor increase for PD taking as reference smallest sum of longest diameters since treatment start. MSKCC assessed as favourable (0), intermediate (1-2) or poor (>=3) based on number of criteria present [KPS <80%, time from diagnosis to start of systemic therapy <12 months, lactate dehydrogenase >1.5*ULN, hemoglobin <LLN, serum calcium >10 mg/dL].
4 secondary outcomes
Overall Survival (OS) Rate According to Disease Risk Group in IMDC
Time frame: From initiation of sunitinib treatment (retrospective data) till death or censored date (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database]
Progression-Free Survival (PFS) According to Disease Risk Group in IMDC
Time frame: From initiation of sunitinib treatment (retrospective data) till progression end of treatment date or date of death (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database]
OS According to Disease Risk Group in MSKCC
Time frame: From initiation of sunitinib treatment (retrospective data) till death or censored date (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database]
PFS According to Disease Risk Group in MSKCC
Time frame: From initiation of sunitinib treatment (retrospective data) till progression end of treatment date or date of death (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database]
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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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.
Pfizer CT.gov Call Center study director
Pfizer
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 Carcinoma, Renal Cell and Clear-cell Metastatic Renal Cell Carcinoma, run by Pfizer at 1 site in Turkey (Türkiye).
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 1 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 5 Aug 2024. 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 Turkey (Türkiye). 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?
Yes. Results are posted in the registry (first posted 5 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Objective Response Rate (ORR) According to Disease Risk Group in IMDC (time frame: From initiation of sunitinib treatment (retrospective data) till PR and CR or death or progression (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database]). The study lists 4 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 5 Aug 2024.