Glioblastoma, IDH-wildtypePhase 2NCT06359379
Ropidoxuridine as a Radiosensitizer in Newly Diagnosed IDH-Wildtype Glioblastoma With Unmethylated MGMT Promoter
A Phase 2 study testing Ropidoxuridine in people with Glioblastoma, IDH-wildtype, run by Shuttle Pharmaceuticals, Inc. at 6 sites in United States.
Trial summary
This is a randomized, open-label, phase 2 study evaluating the safety and efficacy of oral ropidoxuridine as a radiation-sensitizing agent in patients with newly diagnosed wild-type isocitrate dehydrogenase glioblastoma with an unmethylated O6-methylguanine-DNA methyltransferase promoter, undergoing standard 60 Gy… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma, IDH-wildtype
- What is being tested?
- Ropidoxuridine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 6 sitesUnited States
- Study dates
- 2 Sep 2024to 1 Dec 2025
- Phase
- Phase 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
- Written informed consent form signed and dated by patient or legally authorized representative according to local guidelines, prior to the performance of any study-specific procedures, sampling, or analyses. Participants with impaired decision-making capacity must have a close caregiver or legally authorized representative present.
- Histologically confirmed supratentorial glioblastoma isocitrate dehydrogenase (IDH) wild-type classification (2021 World Health Organization Classification of Tumours, 5th Edition, Volume 6) with unmethylated O6-methylguanine-DNA-methyltransferase (MGMT) promoter (defined as MGMT methylation status ≤20% by pyrosequencing, and no prior radiation, electric field, or systemic therapy. Glucocorticoid therapy for symptom control is allowed.
- Patients should, in the opinion of the investigator, be candidates for 60 Gy radiotherapy in 2 Gy fractions over 6 weeks, per standard of care. Hypofractionated radiotherapy schedules (e.g., 36 Gy in 3 Gy fractions) are not allowed.
- Eastern Cooperative Oncology Group performance status of 0, 1 or 2.
- Adequate renal, liver and bone marrow function:
- Hemoglobin >9.0 g/dL
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- Absolute neutrophil count >1.5 × 10^9/L
- Platelet count >100 × 10^9/L
- Total bilirubin ≤1.5 × upper limit of normal (ULN), unless due to documented Gilbert's disease (≤3 × ULN)
- Aspartate aminotransferase / alanine aminotransferase ≤4×ULN
- Creatinine clearance ≥60 mL/min calculated as per Cockcroft-Gault equation.
- Life expectancy ≥12 weeks.
- Have recovered from the immediate post-operative period and is maintained on a stable corticosteroid regimen (no increase for 5 days) prior to initiation of study treatment.
- Female patients, of childbearing potential, must have a negative serum pregnancy test within 7 days prior to taking study medication and agree to use at least one highly effective form of contraception during study treatment and for at least 120 days after the last dose of study treatment.
- Male patients must agree to use an adequate method of contraception from enrollment through 120 days after the last dose of study treatment.
Who cannot join
- Any prior treatment for glioblastoma, including chemotherapy, immunotherapy, targeted therapy or therapy with biologic agent (including immunotoxins, immunoconjugates, antisense, peptide receptor antagonists, interferons, interleukins, lymphokine-activated killer cell therapy or gene therapy), or radiotherapy. Glucocorticoid therapy is permitted.
- Second primary malignancy expected to require active treatment within a 6-month period (except basal cell or early-stage squamous cell carcinoma of the skin that may be excised). Patients who had another malignancy in the past but have been free of active disease for more than 1 year, are eligible even if under active surveillance, at the discretion of the Investigator. Adjuvant anti hormonal treatment for prior breast or prostate cancer is allowed, but no other concomitant anticancer treatment.
- Any investigational therapy (for any concomitant condition) within 28 days or within 5 half-lives of study entry (whichever is shorter).
- Use of acid-reducing agents including proton pump inhibitors and histamine-2 blockers.
- Inability to comply with protocol or study procedures.
- Women who are pregnant or breastfeeding.
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- Inability to swallow oral medication or gastrointestinal disorder expected to severely affect drug absorption (e.g., short bowel syndrome).
- Ongoing bacterial, viral, or fungal infection requiring systemic therapy. Prophylactic therapy is allowed. Patients with a history of Human Immunodeficiency Virus, Hepatitis B virus, Hepatitis C virus infection are allowed if treated with effective anti-viral therapy that results in undetectable viral load.
- Any medical condition, which in the opinion of the Investigator, places the patient at an unacceptably high risk for toxicities, or makes the patient unsuitable for study participation.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
University of Virginia
Charlottesville, Virginia, 22903
John Theurer Cancer Center at the Hackensack University Medical Center
Hackensack, New Jersey, 07601
Miami Cancer Institute
Miami, Florida, 33176
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, 20007
About this study
Official title: Phase 2 Study of Ropidoxuridine as a Radiation Sensitizing Agent During Radiotherapy in Patients With Newly Diagnosed IDH-Wildtype Glioblastoma With Unmethylated MGMT Promoter
This is a randomized, open-label, phase 2 study evaluating the safety and efficacy of oral ropidoxuridine as a radiation-sensitizing agent in patients with newly diagnosed wild-type isocitrate dehydrogenase glioblastoma with an unmethylated O6-methylguanine-DNA methyltransferase promoter, undergoing standard 60 Gy radiotherapy.
Read the detailed description
This is a randomized, open-label phase 2 study to assess the safety and efficacy of oral ropidoxuridine as a radiation sensitizing agent in patients with newly diagnosed wildtype isocitrate dehydrogenase glioblastoma with unmethylated O6-methylguanine-DNA methyltransferase promoter, receiving standard 60 Gy radiotherapy.
In the dose optimization phase, a group of 40 patients will be evenly divided, with a 1:1 randomization, to receive ropidoxuridine for a duration of 7 weeks. They will be administered daily ropidoxuridine at two dose levels: either 960 mg or 1200 mg. This administration will occur 5 days a week, from Monday to Friday. Treatment with ropidoxuridine will start one week before radiotherapy (induction period) and continue concomitantly with 60 Gy standard radiotherapy fractionated in 2 Gy daily doses (Monday through Friday weeks 2 to 7, treatment period)), followed by a 4-week rest period. Following completion of this 11-week active study period, maintenance therapy, including temozolomide, tumor treating field device (Optune®), or other available treatment modalities, may be initiated at the discretion of the Investigator.
Analysis of the pharmacokinetic, safety and tolerability data for the two cohorts will determine the optimal dose of ropidoxuridine, to be administered to the next cohort of 14 patients for determination of efficacy, compared to historical controls.
A magnetic resonance imaging ( MRI) will be performed at the end of the active study period (Week 11). This MRI should not be used for disease assessment due to increased contrast enhancement in the acute radiation reaction phase, unless there is evidence of progression outside the radiotherapy fields. Radiographic disease assessment will be performed in accordance with community standard of care guidelines, every 3 months until disease progression. After the confirmed disease progression, survival monitoring follow-ups will occur every three months.
- Conditions
- Glioblastoma, IDH-wildtype
- Being tested
- Ropidoxuridine
- Keywords
- radiotherapy, radiation sensitizing agent, ropidoxuridine, unmethylated MGMT promoter
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopidoxuridineDrug
Also called 5-iodo-2-pyrimidinone-2'-deoxyribose
Ropidoxuridine is administered daily, 5 days a week, for 7 weeks, starting one week prior to radiotherapy, and then concurrently with a standard 60 Gy radiotherapy, followed by a 4-week rest period.
| Study group | Role | What they receive |
|---|---|---|
| Ropidoxuridine 960 mg | Experimental | Ropidoxuridine is administered orally at 960 mg, 5 days a week for a total of 7 weeks, starting 1 week before the initiation of radiotherapy. Receives: Drug: Ropidoxuridine |
| Ropidoxuridine 1200 mg | Experimental | Ropidoxuridine is administered orally at 1200 mg, 5 days a week for a total of 7 weeks, starting 1 week before the initiation of radiotherapy. Receives: Drug: Ropidoxuridine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients treated with oral ropidoxuridine at dose levels of 960 and 1200 mg once daily, with treatment-related adverse events assessed by CTCAE v5.0.
Measured: From the first day of treatment start until 30 days after treatment completion
adiographic response rate, disease control rate, best overall response, and duration of overall response in patients treated with oral ropidoxuridine at 960 and 1200 mg daily doses, assessed using the Response Assessment in Neuro-Oncology criteria.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
Maximum plasma concentration for orally administered ropidoxuridine, at dose levels of 960 and 1200 mg once daily.
Measured: he first 36 days of treatment.
Trough plasma concentration of orally administered ropidoxuridine, at dose levels of 960 and 1200 mg once daily
Measured: The first 36 days of treatment.
Time to maximum plasma concentration for orally administered ropidoxuridine, at dose levels of 960 and 1200 mg once daily.
Measured: The first 36 days of treatment.
Area under the curve for orally administered ropidoxuridine, at dose levels of 960 and 1200 mg once daily.
Measured: The first 36 days of treatment.
Half-life for orally administered ropidoxuridine, at dose levels of 960 and 1200 mg once daily.
Measured: The first 36 days of treatment.
Secondary outcomes (10)
Overall survival at 12 months
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.
Radiographic Response Rate
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
Disease Control Rate
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
Best Overall Response
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
Duration of Response
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
Overall Survival
Measured: From date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months.
Progression-Free Survival
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
Six-Month Progression-Free Survival
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months.
Fraction of patients with tumor progression outside of the treatment area.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
Quantification of 9 relevant neurologic domains based on the NANO scale.
The Neurologic Assessment in Neuro-Oncology (NANO) scale is a clinical tool used to measure neurological function in patients with brain tumors. The scale can range from a score of 0 to a maximum score that depends on the severity and number of deficits. Higher scores on the NANO scale typically indicate a greater degree of neurological impairment.
Measured: Measured from the time of study enrollment until 28 (±7) days following the completion of study treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start2 Sep 2024
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Why it stopped: Terminated due to the sponsor's decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma, IDH-wildtypeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shuttle Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06359379
- Sponsor's protocol ID
- S22-11168
- Status last verified
- Dec 2025
- First submitted
- 24 Mar 2024
- Last updated
- 18 Dec 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Ropidoxuridine as a Radiation Sensitizing Agent During Radiotherapy in Patients With Newly Diagnosed IDH-Wildtype Glioblastoma With Unmethylated MGMT Promoter
- ClinicalTrials.gov ID
- NCT06359379
- Acronym / sponsor ID
- S22-11168
- Conditions
- Glioblastoma, IDH-wildtype
- Keywords
- radiotherapy, radiation sensitizing agent, ropidoxuridine, unmethylated MGMT promoter
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to the sponsor's decision.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Shuttle Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Sep 2024 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 11 Apr 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.
This is a randomized, open-label, phase 2 study evaluating the safety and efficacy of oral ropidoxuridine as a radiation-sensitizing agent in patients with newly diagnosed wild-type isocitrate dehydrogenase glioblastoma with an unmethylated O6-methylguanine-DNA methyltransferase promoter, undergoing standard 60 Gy radiotherapy.
Detailed description
This is a randomized, open-label phase 2 study to assess the safety and efficacy of oral ropidoxuridine as a radiation sensitizing agent in patients with newly diagnosed wildtype isocitrate dehydrogenase glioblastoma with unmethylated O6-methylguanine-DNA methyltransferase promoter, receiving standard 60 Gy radiotherapy.
In the dose optimization phase, a group of 40 patients will be evenly divided, with a 1:1 randomization, to receive ropidoxuridine for a duration of 7 weeks. They will be administered daily ropidoxuridine at two dose levels: either 960 mg or 1200 mg. This administration will occur 5 days a week, from Monday to Friday. Treatment with ropidoxuridine will start one week before radiotherapy (induction period) and continue concomitantly with 60 Gy standard radiotherapy fractionated in 2 Gy daily doses (Monday through Friday weeks 2 to 7, treatment period)), followed by a 4-week rest period. Following completion of this 11-week active study period, maintenance therapy, including temozolomide, tumor treating field device (Optune®), or other available treatment modalities, may be initiated at the discretion of the Investigator.
Analysis of the pharmacokinetic, safety and tolerability data for the two cohorts will determine the optimal dose of ropidoxuridine, to be administered to the next cohort of 14 patients for determination of efficacy, compared to historical controls.
A magnetic resonance imaging ( MRI) will be performed at the end of the active study period (Week 11). This MRI should not be used for disease assessment due to increased contrast enhancement in the acute radiation reaction phase, unless there is evidence of progression outside the radiotherapy fields. Radiographic disease assessment will be performed in accordance with community standard of care guidelines, every 3 months until disease progression. After the confirmed disease progression, survival monitoring follow-ups will occur every three months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ropidoxuridine 960 mg | Experimental | Drug: RopidoxuridineRopidoxuridine is administered orally at 960 mg, 5 days a week for a total of 7 weeks, starting 1 week before the initiation of radiotherapy. |
| Ropidoxuridine 1200 mg | Experimental | Drug: RopidoxuridineRopidoxuridine is administered orally at 1200 mg, 5 days a week for a total of 7 weeks, starting 1 week before the initiation of radiotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Written informed consent form signed and dated by patient or legally authorized representative according to local guidelines, prior to the performance of any study-specific procedures, sampling, or analyses. Participants with impaired decision-making capacity must have a close caregiver or legally authorized representative present.
- Histologically confirmed supratentorial glioblastoma isocitrate dehydrogenase (IDH) wild-type classification (2021 World Health Organization Classification of Tumours, 5th Edition, Volume 6) with unmethylated O6-methylguanine-DNA-methyltransferase (MGMT) promoter (defined as MGMT methylation status ≤20% by pyrosequencing, and no prior radiation, electric field, or systemic therapy. Glucocorticoid therapy for symptom control is allowed.
- Patients should, in the opinion of the investigator, be candidates for 60 Gy radiotherapy in 2 Gy fractions over 6 weeks, per standard of care. Hypofractionated radiotherapy schedules (e.g., 36 Gy in 3 Gy fractions) are not allowed.
- Eastern Cooperative Oncology Group performance status of 0, 1 or 2.
- Adequate renal, liver and bone marrow function:
Key exclusion criteria (9 listed)
- Any prior treatment for glioblastoma, including chemotherapy, immunotherapy, targeted therapy or therapy with biologic agent (including immunotoxins, immunoconjugates, antisense, peptide receptor antagonists, interferons, interleukins, lymphokine-activated killer cell therapy or gene therapy), or radiotherapy. Glucocorticoid therapy is permitted.
- Second primary malignancy expected to require active treatment within a 6-month period (except basal cell or early-stage squamous cell carcinoma of the skin that may be excised). Patients who had another malignancy in the past but have been free of active disease for more than 1 year, are eligible even if under active surveillance, at the discretion of the Investigator. Adjuvant anti hormonal treatment for prior breast or prostate cancer is allowed, but no other concomitant anticancer treatment.
- Any investigational therapy (for any concomitant condition) within 28 days or within 5 half-lives of study entry (whichever is shorter).
- Use of acid-reducing agents including proton pump inhibitors and histamine-2 blockers.
- Inability to comply with protocol or study procedures.
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 |
|---|---|---|
| RopidoxuridineAlso: 5-iodo-2-pyrimidinone-2'-deoxyriboseRopidoxuridine is administered daily, 5 days a week, for 7 weeks, starting one week prior to radiotherapy, and then concurrently with a standard 60 Gy radiotherapy, followed by a 4-week rest period. | Drug | Ropidoxuridine 1200 mg, Ropidoxuridine 960 mg |
Primary outcome
Number of patients treated with oral ropidoxuridine at dose levels of 960 and 1200 mg once daily, with treatment-related adverse events assessed by CTCAE v5.0.
Time frame: From the first day of treatment start until 30 days after treatment completion
adiographic response rate, disease control rate, best overall response, and duration of overall response in patients treated with oral ropidoxuridine at 960 and 1200 mg daily doses, assessed using the Response Assessment in Neuro-Oncology criteria.
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
Maximum plasma concentration for orally administered ropidoxuridine, at dose levels of 960 and 1200 mg once daily.
Time frame: he first 36 days of treatment.
Trough plasma concentration of orally administered ropidoxuridine, at dose levels of 960 and 1200 mg once daily
Time frame: The first 36 days of treatment.
Time to maximum plasma concentration for orally administered ropidoxuridine, at dose levels of 960 and 1200 mg once daily.
Time frame: The first 36 days of treatment.
Area under the curve for orally administered ropidoxuridine, at dose levels of 960 and 1200 mg once daily.
Time frame: The first 36 days of treatment.
Half-life for orally administered ropidoxuridine, at dose levels of 960 and 1200 mg once daily.
Time frame: The first 36 days of treatment.
10 secondary outcomes
Overall survival at 12 months
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.
Radiographic Response Rate
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
Disease Control Rate
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
Best Overall Response
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
Duration of Response
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
Overall Survival
Time frame: From date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months.
Progression-Free Survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
Six-Month Progression-Free Survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months.
Fraction of patients with tumor progression outside of the treatment area.
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
Quantification of 9 relevant neurologic domains based on the NANO scale.
Time frame: Measured from the time of study enrollment until 28 (±7) days following the completion of study treatment.
Results and safety
The study was stopped early (reason given: Terminated due to the sponsor's decision.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ropidoxuridine in people with Glioblastoma, IDH-wildtype, run by Shuttle Pharmaceuticals, Inc. at 6 sites in United States.
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 15 inclusion and 9 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: stopped early, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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 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?
The study was stopped early (reason given: Terminated due to the sponsor's decision.). Results are not available in the source record.
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?
Number of patients treated with oral ropidoxuridine at dose levels of 960 and 1200 mg once daily, with treatment-related adverse events assessed by CTCAE v5.0. (time frame: From the first day of treatment start until 30 days after treatment completion). The study lists 7 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 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.