ErythroplakiaPhase 2NCT05237960
Metformin for the Prevention of Oral Cancer in Patients With Oral Leukoplakia or Erythroplakia
A Phase 2 study testing Biopsy, Biospecimen Collection and Extended Release Metformin Hydrochloride in people with Erythroplakia and Oral Leukoplakia, run by University of Arizona at 10 sites in 2 countries.
Trial summary
This phase IIb trial tests whether metformin works in preventing oral cancer in patients with oral leukoplakia (white patches) or erythroplakia (red patches). Metformin is in a class of drugs called biguanides. Metformin helps to control the amount of glucose (sugar) in the blood. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Erythroplakia, Oral Leukoplakia
- What is being tested?
- Biopsy, Biospecimen Collection and Extended Release Metformin Hydrochloride
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 12 Jan 2023to Dec 2026
- Phase
- Phase 2
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants with oral leukoplakia or erythroplakia with mild, moderate, or severe histologic dysplasia or hyperplasia at the high risk sites (e.g., floor of mouth, tongue). Lesions arising from the radiation field are excluded as study lesions.
- Measurable disease - minimum lesion size of 8x3 mm before initial biopsy
- Age >= 21 years. Adults 18-20 are not included as Canadian law prohibits purchase of cigarettes under the age of 21; investigators wish to keep criteria consistent among all trial sites. Also, smokers aged < 20 years would most likely not have oral leukoplakia
- Current and former smokers (>= 5 packs in the lifetime)
- Karnofsky performance scale >= 70%
- Leukocytes >= 3,000/microliter
Show all 18Show fewer
- Absolute neutrophil count >= 1,000/microliter
- Platelets >= 100,000/microliter
- Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 1.5 x institutional ULN
- Estimation glomerular filtration rate (eGFR) > 45 mL/min (eGFR calculated using the equation Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] creatinine)
- Willing to use adequate contraception (barrier method, abstinence, subject or partner has had a vasectomy or partner is using effective birth control or is postmenopausal) for the duration of study participation because the effects of metformin on the developing human fetus are unknown even though it is not teratogenic in rats and rabbits at 2-6 times the maximum recommended human daily dose. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately.
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
- Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
- Patients on chronic suppressive antiviral therapy for herpes simplex virus (HSV) are eligible
- Ability to take oral medication
- Ability to understand and the willingness to sign a written informed consent document in English or Spanish
Who cannot join
- Patients with diabetes who are being treated with insulin or an anti-diabetic medication
- History of diabetic ketoacidosis
- Participants may not be receiving any other investigational agents within past 3 months at screening
- History of allergic reactions attributed to compounds of similar chemical composition to metformin or prior use of metformin within the last year
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, human immunodeficiency virus (HIV) positive, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Oral carcinoma in situ from the baseline biopsy
Show all 13Show fewer
- History of chronic alcohol use or abuse defined as any one of the following: a) average consumption of 3 or more alcohol containing beverages daily in the past 12 months; b) consumption of 7 or more alcoholic beverages within a 24 hour (hr) period in the past 12 months
- Hemoglobin A1c (HbA1c) > 8%
- Pregnancy or nursing women. Pregnant women are excluded from this study because the effects of metformin on the developing human fetus are unknown even though it is not teratogenic in rats and rabbits at 2-6 times the maximum recommended human daily dose. Because there is an unknown but potential risk for AEs in nursing infants secondary to treatment of the mother with metformin, breastfeeding should be discontinued
- Acute or chronic liver disease, evidence of hepatitis (infectious or autoimmune), cirrhosis or portal hypertension
- History of renal disease
- Have received hormone therapy, chemotherapy, immunotherapy and/or radiation for any malignancy (excluding non-melanoma skin cancer and cancers confined to organs with removal as only treatment) within the past 18 months. History of prior curatively treated cancer, including oral cancer, is allowed as long as all primary and adjuvant treatment is completed >= 18 months prior to enrollment. Ongoing adjuvant hormonal treatment (e.g., for breast cancer) is allowed.
- Current use of carbonic anhydrase inhibitors (e.g. topiramate, zonisamide, acetazolamide, or dichlorphenamide) or ranolazine
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States8 sites
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Louisiana State University
Lafayette, Louisiana, 70503
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, 55455
NYU College of Dentistry
New York, New York, 10010
UC San Diego Medical Center - Hillcrest
San Diego, California, 92103
Moffitt Cancer Center
Tampa, Florida, 33612
University of Arizona Cancer Center-North Campus
Tucson, Arizona, 85719
Canada2 sites
Dalhousie University
Halifax, Nova Scotia, B3H 4R2
British Columbia Cancer Agency
Vancouver, British Columbia, V5Z 4E6
About this study
Official title: M4OC-Prevent 2.0: Phase IIb Trial of Metformin for Oral Cancer Prevention
This phase IIb trial tests whether metformin works in preventing oral cancer in patients with oral leukoplakia (white patches) or erythroplakia (red patches). Metformin is in a class of drugs called biguanides. Metformin helps to control the amount of glucose (sugar) in the blood. It decreases the amount of glucose patients absorb from food and the amount of glucose made by the liver. Metformin also increases the body's response to insulin, a natural substance that controls the amount of glucose in the blood. This trial may help researchers determine if metformin can stop changes in the mouth that are related to pre-cancer growths in the mouth.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine the histological response to metformin hydrochloride (metformin) intervention in the target lesion.
SECONDARY OBJECTIVES:
- Clinical response to metformin intervention in the target lesion. II. Effect of metformin on cell proliferation (Ki67) and its molecular targets (pS6 and nuclear YAP) in the target lesion.
III. Metformin effect on serum metabolic markers (C-peptide, glucose and HbA1c).
IV. Trough plasma metformin concentrations.
EXPLORATORY OBJECTIVES:
- Expression of dysregulated molecular mechanisms in the target lesion, including, in order of priority, p53, PTEN, p16, EGFR, and pEGFR.
II. Immune cell infiltration and markers of inflammation in the target lesion. III. Analysis of genomic alterations in the target lesion and blood deoxyribonucleic acid (DNA).
IV. Microbiome in oral rinses.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive extended release metformin hydrochloride orally (PO) once daily (QD) for 24 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood and biopsy at baseline and week 24.
ARM II: Patients receive a placebo PO QD for 24 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood and biopsy at baseline and week 24.
After completion of study treatment, patients are followed for up to 3 weeks.
- Conditions
- Erythroplakia, Oral Leukoplakia
- Being tested
- Biopsy, Biospecimen Collection, Extended Release Metformin Hydrochloride, Placebo Administration
- Medical subject headings
- Erythroplasia, Leukoplakia, Oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyProcedure or surgery
Also called BIOPSY_TYPE, Bx
Undergo biopsy
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Correlative studies
Extended Release Metformin HydrochlorideDrug
Also called ER Metformin Hydrochloride, Extended-release Metformin Hydrochloride, Glucophage XR, Glumetza
Given PO
Placebo AdministrationDrug
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Arm I (extended release metformin) | Experimental | Patients receive extended release metformin hydrochloride PO QD for 24 weeks in the absence of disease progression or unacceptable toxicity. Patients will also undergo biopsies and blood collections on study. Receives: Procedure: Biopsy; Procedure: Biospecimen Collection; Drug: Extended Release Metformin Hydrochloride |
| Arm II (placebo) | Placebo comparator | Patients receive a placebo PO QD for 24 weeks in the absence of disease progression or unacceptable toxicity. Patients will also undergo biopsies and blood collections on study. Receives: Procedure: Biopsy; Procedure: Biospecimen Collection; Drug: Placebo Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histologic Response to Metformin
Histologic response will be evaluated by the following criteria: complete response (CR): Complete reversal of dysplasia or hyperplasia to normal epithelium in the target lesion. Partial response (PR): Improvement of the degree of dysplasia or hyperplasia in the target lesion. No change (NC): No change in the degree of dysplasia or hyperplasia in the target lesion, anything that is not CR, PR or PD. Progressive disease (PD): Increase in the severity of grade of histology in the target lesion. Histologic response is CR or PR.
Measured: Up to 24 weeks
Secondary outcomes (6)
Clinical Response to Metformin
Clinical response will be evaluated by the following criteria: CR: disappearance of all evidence of lesion(s). PR: greater than or equal to 50% reduction in the sum of the products of diameters of lesion(s) measurable at baseline. Non-measurable lesion(s) may not increase greater than or equal to 25% in size and no new lesion may appear. NC: no change in the size of the lesion(s) identified at baseline and no new lesions appearing, i.e., anything that is not CR, PR, or PD. PD: any increase greater than or equal to 25% in the product of the diameters of any lesion(s) measurable at baseline or in the estimated size of lesion(s) nonmeasurable at baseline or the appearance of an unequivocal new lesion. Clinical response is CR or PR.
Measured: Up to 24 weeks
Cell Proliferation
Effect of metformin on cell proliferation (Ki67) and its molecular targets (pS6 and nuclear YAP) in the target lesion. The change (pre to post) will be compared between arms.
Measured: Up to 24 weeks
Change in C-peptide
Metformin effect on serum metabolic markers (C-peptide, glucose and HbA1c). The change (pre to post) in serum metabolic markers will be compared between arms.
Measured: Up to 24 weeks
Change in Glucose
Metformin effect on serum metabolic markers (C-peptide, glucose and HbA1c). The change (pre to post) in serum metabolic markers will be compared between arms.
Measured: Up to 24 weeks
Change in HbA1C
Metformin effect on serum metabolic markers (C-peptide, glucose and HbA1c). The change (pre to post) in serum metabolic markers will be compared between arms.
Measured: Up to 24 weeks
Plasma Metformin Concentrations
The plasma metformin concentrations will be determined in the pre- and post-intervention samples.
Measured: From baseline, up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start12 Jan 2023
- Primary completion7 Nov 2025
- Study completionDec 2026 (estimated)
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ErythroplakiaStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Patricia Thompson, University of Arizona
- Investigators
- Scott M Lippman, Principal investigator, University of California, San Diego Moores Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05237960
- Sponsor's protocol ID
- NCI-2022-00596
- Other IDs
- NCI-2022-00596, Pending12, UAZ21-07-01, P30CA023074, UG1CA242596
- Status last verified
- Sep 2026
- First submitted
- 4 Feb 2022
- Last updated
- 28 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page
Publications
Puri A, Wuertz B, Rhodus NL, Ondrey FG. Safety of oral mucosal punch biopsy and other oral biospecimen collections in clinical research. Oral Surg Oral Med Oral Pathol Oral Radiol. 2025 Mar;139(3):344-351. doi: 10.1016/j.oooo.2024.10.084. Epub 2024 Oct 30.
PubMed 39532605
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- M4OC-Prevent 2.0: Phase IIb Trial of Metformin for Oral Cancer Prevention
- ClinicalTrials.gov ID
- NCT05237960
- Acronym / sponsor ID
- NCI-2022-00596
- Conditions
- Erythroplakia, Oral Leukoplakia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 12 Jan 2023 (actual)
- Primary completion
- 7 Nov 2025 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 14 Feb 2022 (actual)
- Results
- Posted 2 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase IIb trial tests whether metformin works in preventing oral cancer in patients with oral leukoplakia (white patches) or erythroplakia (red patches). Metformin is in a class of drugs called biguanides. Metformin helps to control the amount of glucose (sugar) in the blood. It decreases the amount of glucose patients absorb from food and the amount of glucose made by the liver. Metformin also increases the body's response to insulin, a natural substance that controls the amount of glucose in the blood. This trial may help researchers determine if metformin can stop changes in the mouth that are related to pre-cancer growths in the mouth.
Detailed description
PRIMARY OBJECTIVE:
- To determine the histological response to metformin hydrochloride (metformin) intervention in the target lesion.
SECONDARY OBJECTIVES:
- Clinical response to metformin intervention in the target lesion. II. Effect of metformin on cell proliferation (Ki67) and its molecular targets (pS6 and nuclear YAP) in the target lesion.
III. Metformin effect on serum metabolic markers (C-peptide, glucose and HbA1c).
IV. Trough plasma metformin concentrations.
EXPLORATORY OBJECTIVES:
- Expression of dysregulated molecular mechanisms in the target lesion, including, in order of priority, p53, PTEN, p16, EGFR, and pEGFR.
II. Immune cell infiltration and markers of inflammation in the target lesion. III. Analysis of genomic alterations in the target lesion and blood deoxyribonucleic acid (DNA).
IV. Microbiome in oral rinses.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive extended release metformin hydrochloride orally (PO) once daily (QD) for 24 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood and biopsy at baseline and week 24.
ARM II: Patients receive a placebo PO QD for 24 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood and biopsy at baseline and week 24.
After completion of study treatment, patients are followed for up to 3 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (extended release metformin) | Experimental | Procedure: Biopsy, Procedure: Biospecimen Collection, Drug: Extended Release Metformin HydrochloridePatients receive extended release metformin hydrochloride PO QD for 24 weeks in the absence of disease progression or unacceptable toxicity. Patients will also undergo biopsies and blood collections on study. |
| Arm II (placebo) | Placebo comparator | Procedure: Biopsy, Procedure: Biospecimen Collection, Drug: Placebo AdministrationPatients receive a placebo PO QD for 24 weeks in the absence of disease progression or unacceptable toxicity. Patients will also undergo biopsies and blood collections on study. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Participants with oral leukoplakia or erythroplakia with mild, moderate, or severe histologic dysplasia or hyperplasia at the high risk sites (e.g., floor of mouth, tongue). Lesions arising from the radiation field are excluded as study lesions.
- Measurable disease - minimum lesion size of 8x3 mm before initial biopsy
- Age >= 21 years. Adults 18-20 are not included as Canadian law prohibits purchase of cigarettes under the age of 21; investigators wish to keep criteria consistent among all trial sites. Also, smokers aged < 20 years would most likely not have oral leukoplakia
- Current and former smokers (>= 5 packs in the lifetime)
- Karnofsky performance scale >= 70%
Key exclusion criteria (13 listed)
- Patients with diabetes who are being treated with insulin or an anti-diabetic medication
- History of diabetic ketoacidosis
- Participants may not be receiving any other investigational agents within past 3 months at screening
- History of allergic reactions attributed to compounds of similar chemical composition to metformin or prior use of metformin within the last year
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, human immunodeficiency virus (HIV) positive, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
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 |
|---|---|---|
| BiopsyAlso: BIOPSY_TYPE, BxUndergo biopsy | Procedure or surgery | Arm I (extended release metformin), Arm II (placebo) |
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionCorrelative studies | Procedure or surgery | Arm I (extended release metformin), Arm II (placebo) |
| Extended Release Metformin HydrochlorideAlso: ER Metformin Hydrochloride, Extended-release Metformin Hydrochloride, Glucophage XR, GlumetzaGiven PO | Drug | Arm I (extended release metformin) |
| Placebo AdministrationGiven PO | Drug | Arm II (placebo) |
Primary outcome
Histologic Response to Metformin
Time frame: Up to 24 weeks
Histologic response will be evaluated by the following criteria: complete response (CR): Complete reversal of dysplasia or hyperplasia to normal epithelium in the target lesion. Partial response (PR): Improvement of the degree of dysplasia or hyperplasia in the target lesion. No change (NC): No change in the degree of dysplasia or hyperplasia in the target lesion, anything that is not CR, PR or PD. Progressive disease (PD): Increase in the severity of grade of histology in the target lesion. Histologic response is CR or PR.
6 secondary outcomes
Clinical Response to Metformin
Time frame: Up to 24 weeks
Cell Proliferation
Time frame: Up to 24 weeks
Change in C-peptide
Time frame: Up to 24 weeks
Change in Glucose
Time frame: Up to 24 weeks
Change in HbA1C
Time frame: Up to 24 weeks
Plasma Metformin Concentrations
Time frame: From baseline, up to 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39532605Puri A, Wuertz B, Rhodus NL, Ondrey FG. Safety of oral mucosal punch biopsy and other oral biospecimen collections in clinical research. Oral Surg Oral Med Oral Pathol Oral Radiol. 2025 Mar;139(3):344-351. doi: 10.1016/j.oooo.2024.10.084. Epub 2024 Oct 30.
- Individual participant dataSharing planned: Yes. NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page
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Metformin Hydrochloride in Preventing Oral Cancer in Patients With an Oral Premalignant Lesion
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SYsteMatical Trained learnIng aLgorithms for Oral carcInogenesiS Interpretation by Optical Coherence Tomography
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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.
Scott M Lippman principal investigator
University of California, San Diego Moores Cancer Center
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Biopsy, Biospecimen Collection and Extended Release Metformin Hydrochloride in people with Erythroplakia and Oral Leukoplakia, run by University of Arizona at 10 sites in 2 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 18 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
Yes. Results are posted in the registry (first posted 2 Sep 2026). 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?
Histologic Response to Metformin (time frame: Up to 24 weeks). 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 NCT05237960, which also lists 1 linked publication.
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 28 Sep 2026.