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GlioblastomaPhase 3NCT06388733

A Study Comparing Niraparib With Temozolomide in Adult Participants With Newly-diagnosed, MGMT Unmethylated Glioblastoma

A Phase 3 study testing Niraparib and Temozolomide in people with Glioblastoma and GBM, run by Ivy Brain Tumor Center at 95 sites in 11 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The goal of this Phase 3 clinical trial is to compare the efficacy of niraparib versus temozolomide (TMZ) in adult participants with newly-diagnosed, MGMT unmethylated glioblastoma multiforme (GBM). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Niraparib and Temozolomide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
450 participants
Where
95 sitesin 11 countries
Study dates
19 Jun 2024to Mar 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

  • 1. Histologic documentation of a newly-diagnosed intracranial GBM, per 2021 WHO classification guidelines through local pathology review.
  • 2. Age ≥18 years at the time of signing informed consent.
  • 3. Sufficient tissue available for retrospective central pathology review, retrospective central confirmation of MGMT promoter methylation status and genomic analysis. If insufficient tissue is available,pproval may be granted on a case-by-case basis after a review.
  • 4. Unmethylated MGMT promoter region determined locally by a validated PSQ or qMS-PCR assay compliant to local regulations. Numerical cut-off for an MGMT unmethylated tumor will be defined in the protocol.
  • 5. Suitability for SOC RT to 60 Gy in 30 fractions using ESTRO-EANO 'single phase' targeting approach [Niyazi, 2023], per investigator's judgment.
  • 6. No prior treatment for GBM (including brachytherapy or BCNU wafers), other than surgical resection or biopsy.
Show all 14Show fewer
  • 7. Female participants: Not pregnant, planning to get pregnant, or breastfeeding and one of the following conditions apply: is of nonchildbearing potential or is of childbearing potential AND using a contraceptive method that is highly effective (with a failure rate of <1% per year) from screening through at least 180 days after the last dose of study intervention. Breastfeeding is contraindicated during the study and for one month after the last dose of study intervention.
  • 8. Male participants: Must agree to the following during the study intervention period and for at least 6 months after the last dose of study intervention: refrain from donation sperm PLUS be abstinent from heterosexual activity or agree to use a male condom and be advised of the benefit for a female partner to use a contraceptive method that is highly effective (with a failure rate of <1% per year).
  • 9. The participant must be capable of providing signed informed consent, including compliance with the requirements and restrictions listed in the ICF and in this protocol.
  • 10. Karnofsky performance status of ≥70.
  • 11. Adequate organ function
  • 12. Normal blood pressure (BP) or adequately treated and controlled hypertension (defined as systolic BP ≤140 mmHg and diastolic BP ≤90 mmHg).
  • 13. Stable or decreased dose of dexamethasone, requiring no more than 5 mg daily equivalent dose, within 7 days before randomization.
  • 14. Ability to swallow oral medications whole.

Who cannot join

  • 1. Presence of metastatic or predominant leptomeningeal disease.
  • 2. Current active pneumonitis or any history of pneumonitis requiring steroids (any dose) or immunomodulatory treatment within 90 days of planned start of the study.
  • 3. Participant is at an increased bleeding risk due to concurrent conditions (e.g., major injuries or major surgery within the past 28 days prior to start of study treatment with the exception of tumor resection).
  • 4. Any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach and/or bowels.
  • 5. Has cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal/gastric varices, or persistent jaundice. NOTE: Stable noncirrhotic chronic liver disease (including Gilbert's syndrome or asymptomatic gallstones), hepatobiliary involvement of malignancy, or chronic stable HBV infection (in a participant for whom HDV infection has been excluded) or chronic HCV infection is acceptable if the participant otherwise meets entry criteria.
  • 6. Known human immunodeficiency virus (HIV) unless participants meet all of the following criteria:
Show all 27Show fewer
  • Cluster of differentiation 4 ≥350/µL and viral load <400 copies/mL.
  • No history of acquired immunodeficiency syndrome-defining opportunistic infections within 12 months prior to enrollment.
  • No history of HIV-associated malignancy for the past 5 years.
  • Concurrent antiretroviral therapy as per the most current National Institutes of Health (NIH) Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV [NIH, 2021] started >4 weeks prior to study enrollment.
  • 7. MDS/AML or with features suggestive of MDS/AML.
  • 8. History of another malignancy within 2 years prior to registration. Participants with a past history of adequately treated carcinoma-in-situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or superficial transitional cell carcinoma of the bladder are eligible. Participants with a history of other malignancies are eligible if they have been treated with curative intent or continuously disease free for at least 2 years after definitive primary treatment.
  • 9. Prior history of posterior reversible encephalopathy syndrome (PRES).
  • 10. Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study requirements and/or follow-up procedures.
  • 11. Inability to undergo MRI brain with IV contrast.
  • 12. Biopsy and/or resection (whichever is later) occurring >6 weeks prior to planned RT start date.
  • 13. Surgical wound complication recovery at the time of enrollment.
  • 14. Known hypersensitivity to the components of niraparib, TMZ, or their formulation excipients.
  • 15. Known hypersensitivity to dacarbazine (DTIC).
  • 16. Prior therapy with PARP inhibitors for systemic cancer.
  • 17. Received a live vaccine within 30 days before the planned start of study intervention. Coronavirus disease 2019 (COVID-19) vaccines that do not contain live viruses are allowed. Note: mRNA and adenoviral-based COVID-19 vaccines are considered non-live.
  • 18. Received a transfusion (platelets or red blood cells) or colony-stimulating factors (e.g., granulocyte macrophage colony-stimulating factor or recombinant erythropoietin) within 4 weeks of the planned start of study intervention.
  • 19. Treatment with another investigational drug or other intervention within 5 half-lives of the investigational product.
  • 20. Treatment with tumor treating fields (e.g., Optune) for GBM.
  • 21. Presence of known isocitrate dehydrogenase (IDH) mutation.
  • 22. Presence of known H3 mutation.
  • 23. Previous diagnosis of WHO Grade 2 or 3 glioma.

Trial locations and contacts

95 sites in 11 countries.

95 sites in 11 countries

United States32 sites
  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 48109

  • The NeuroMedical Center

    Baton Rouge, Louisiana, 70809

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • The University of Vermont Medical Center

    Burlington, Vermont, 05401

  • Medical University of South Carolina - Department of Neurosurgery

    Charleston, South Carolina, 29425

  • University of Cincinnati Cancer Institute

    Cincinnati, Ohio, 45267

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • The Ohio State University

    Columbus, Ohio, 43210

  • Duke Cancer Center Brain Tumor Clinic

    Durham, North Carolina, 27710

  • Smilow Cancer Hospital at Yale New Haven

    Guilford, Connecticut, 06437

  • Indiana University

    Indianapolis, Indiana, 46202

  • Saint Lukes Neuro Oncology

    Kansas City, Missouri, 64111

  • Scripps Cancer Center

    La Jolla, California, 92037

  • Moores UCSD Cancer Center

    La Jolla, California, 92093

  • University of Wisconsin Cancer Center

    Madison, Wisconsin, 53706

  • Allina Health

    Minneapolis, Minnesota, 55407

  • University of Minnesota Health Clinics and Surgery Center, Minneapolis

    Minneapolis, Minnesota, 55455

  • Jersey Shore University Medical Center

    Neptune City, New Jersey, 07753

  • Northwell Health

    New Hyde Park, New York, 11042

  • New York University Ambulatory Care Center

    New York, New York, 10016

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Ivy Brain Tumor Center

    Phoenix, Arizona, 85013

  • University of Pittsburgh Medical Center Health System

    Pittsburgh, Pennsylvania, 15232

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • University of Washington Medical Center

    Seattle, Washington, 98109

  • MaineHealth Maine Medical Center Care

    South Portland, Maine, 04106

  • Washington University, School of Medicine

    St Louis, Missouri, 63110

  • Atlantic Health System

    Summit, New Jersey, 07901

  • Baylor Scott & White Health

    Temple, Texas, 76508

  • Montefiore Medical Center

    The Bronx, New York, 10461

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27157

Other trials in United States

Spain12 sites
  • Hospital del Mar

    Barcelona, Barcelona, 08003

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona, 08035

  • Hospital Clinic de Barcelona

    Barcelona, Barcelona, 08036

  • ICO l'Hospitalet - Hospital Duran i Reynals

    Barcelona, 08906

  • Hospital Universitario Reina Sofia

    Córdoba, Córdoba, 14004

  • ICO Girona - Hospital Universitari de Girona Dr Josep Trueta

    Girona, Girona, 17007

  • Hospital Universitario Ramon y Cajal

    Madrid, Madrid, 28034

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid, 28041

  • Hospital Universitario HM Madrid Sanchinarro

    Madrid, Madrid, 28050

  • Clinica Universidad de Navarra

    Pamplona, Navarre, 31008

  • Hospital Clinico Universitario de Salamanca

    Salamanca, Salamanca, 37370

  • Hospital Universitario Virgen del Rocio

    Seville, Sevilla, 41013

Other trials in Spain

France10 sites
  • CHU Amiens-Picardie - Site Sud

    Amiens, Somme, 80054

  • Centre Hospitalier Universitaire de Lyon-Hospices Civils de Lyon-Hopital Pierre Wertheimer

    Bron, Rhone, 69500

  • Centre Georges François Leclerc

    Dijon, 21079

  • Centre Leon Berard

    Lyon, Rhone, 69008

  • Hôpital de la Timone

    Marseille, Bouches-du-Rhône, 13385

  • Institut du Cancer de Montpellier

    Montpellier, Herault, 34298

  • CHU Nice - Hôpital Pasteur

    Nice, Alpes Maritimes, 06001

  • Groupe Hospitalier Pitie-Salpetriere

    Paris, Paris, 75013

  • CRLCC Eugene Marquis

    Rennes, Ille et Vilaine, 35000

  • ICO - Site René Gauducheau

    Saint-Herblain, Loire Atlantique, 44800

Other trials in France

Germany8 sites
  • Vivantes Klinikum Neukoelln

    Berlin, State of Berlin, 12351

  • Universitaetsklinikum Bonn AoeR

    Bonn, North Rhine-Westphalia, 53127

  • Klinikum Chemnitz gGmbH

    Chemnitz, Saxony, 09116

  • Universitaetsklinikum Heidelberg

    Heidelberg, Baden-Wurttemberg, 69120

  • Universitaetsklinikum Leipzig

    Leipzig, Saxony, 04103

  • Universitaetsmedizin Mannheim

    Mannheim, Baden-Wurttemberg, 68167

  • Universitaetsklinikum Regensburg

    Regensburg, Bavaria, 93053

  • Universitaetsklinikum Tuebingen

    Tübingen, Baden-Wurttemberg, 72076

Other trials in Germany

Italy8 sites
  • IRCCS Istituto delle Scienze Neurologiche di Bologna

    Bologna, Bologna, 40139

  • Azienda Ospedaliera Universitaria Careggi

    Florence, Firenze, 50134

  • Fondazione IRCCS Istituto Neurologico Carlo Besta

    Milan, Milano, 20133

  • A.S.L. Napoli 1 Centro Ospedale del Mare

    Naples, Napoli, 80147

  • IOV - Istituto Oncologico Veneto IRCCS

    Padova, Padova, 35128

  • Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza

    Rome, Roma, 00161

  • Istituto Clinico Humanitas

    Rozzano, Milano, 20089

  • Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino

    Torino, Torino, 10124

Other trials in Italy

United Kingdom8 sites
  • Queen Elizabeth Hospital

    Birmingham, West Midlands, B15 2TH

  • Bristol Haematology and Oncology Centre

    Bristol, Avon, BS2 8ED

  • Addenbrooke's Hospital

    Cambridge, Cambridgeshire, CB2 0QQ

  • Velindre Cancer Centre

    Cardiff, South Glamorgan, CF14 2TL

  • Beatson West of Scotland Cancer Centre

    Glasgow, Strathclyde, G12 0YN

  • Guy's Hospital

    London, SE1 9RT

  • The Christie Hospital

    Manchester, Greater Manchester, M20 4BX

  • The Clatterbridge Cancer Centre

    Metropolitan Borough of Wirral, Merseyside, CH63 4JY

Other trials in United Kingdom

Canada5 sites
  • CHUM (Centre hospitalier de l'Université de Montréal)

    Montreal, Quebec, H2X 0C1

  • Centre Hospitalier Universitaire de Sherbrooke

    Sherbrooke, Quebec, J1H 5N4

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • University Health Network - Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

  • BC Cancer - Vancouver

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Australia4 sites
  • St Vincent's Hospital Melbourne

    Fitzroy, Victoria, 3065

  • Austin Health

    Heidelberg, Victoria, 3084

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000

  • Bayside Health (formerly The Alfred Hospital)

    Melbourne, Victoria, 3004

Other trials in Australia

Switzerland4 sites
  • Universitaetsspital Basel

    Basel, 4031

  • Ente Ospedaliero Cantonale

    Bellinzona, 6500

  • Inselspital - Universitaetsspital Bern

    Bern, 3010

  • Universitaetsspital Zürich

    Zurich, 8091

Other trials in Switzerland

Netherlands2 sites
  • Maastricht UMC

    Maastricht, 6229 HX

  • UMC Utrecht

    Utrecht, 3584 CX

Other trials in Netherlands

Norway2 sites
  • Oslo Universitetssykehus HF, Radiumhospitalet

    Oslo, 0379

  • St. Olavs Hospital Hf, Universitetssykehuset i Trondheim

    Trondheim, 7030

Other trials in Norway

About this study

Official title: A Phase 3, Open-label, Randomized 2-arm Study Comparing the Clinical Efficacy and Safety of Niraparib With Temozolomide in Adult Participants With Newly-diagnosed, MGMT Unmethylated Glioblastoma

The goal of this Phase 3 clinical trial is to compare the efficacy of niraparib versus temozolomide (TMZ) in adult participants with newly-diagnosed, MGMT unmethylated glioblastoma multiforme (GBM). The main question it aims to answer is:

Does niraparib improve overall survival (OS) compared to TMZ?

Read more

Participants will be randomly assigned to one of two treatment arms: niraparib or TMZ.

  • study drug (Niraparib) or
  • comparator drug (Temozolomide - which is the standard approved treatment for MGMT unmethylated glioblastoma).

The study medication will be taken daily while receiving standard of care radiation therapy (RT) for 6-7 weeks.

Participants may continue to take the niraparib or TMZ adjuvantly as long as the cancer does not get worse or completion of 6 cycles of treatment (TMZ). A total of 450 participants will be enrolled in the study.

Participants' tasks will include:

  • Complete study visits as scheduled
  • Complete a diary to record study medication
Being tested
Niraparib, Temozolomide
Medical subject headings
Glioblastoma, Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NiraparibDrug

    Also called Zejula

    Participants will receive niraparib 200 mg orally once daily starting on Day 1 of RT. Following completion of RT, participants will continue niraparib adjuvant therapy orally once daily on Days 1 to 28 of each 28-day cycle until progression by BICR

  • TemozolomideDrug

    Also called Temodar, TMZ

    Participants randomized to the comparator arm (Arm B) will receive SOC TMZ 75 mg/m2 orally once daily with RT starting on Day 1 of RT. Following completion of RT, participants will complete a 4-week rest period, and then receive adjuvant TMZ 150 to 200 mg/m2 orally once daily on Days 1 to 5 of each 28-day cycle until progression by BICR or for a maximum of 6 cycles.

Study groups in NCT06388733
Study groupRoleWhat they receive
Arm A: NiraparibExperimentalNot described
Receives: Drug: Niraparib
Arm B: TemozolomideActive comparatorNot described
Receives: Drug: Temozolomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

    Overall survival, defined as the time from the date of randomization to the date of death due to any cause.

    Measured: 24 months

Secondary outcomes (11)
  1. Progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR)

    Progression-free survival, defined as the time from the date of randomization to the date of first disease progression per RANO 2.0 by BICR assessment or death from any cause, whichever occurs first.

    Measured: 24 months

  2. Overall response rate

    Percentage of patients who achieved confirmed complete response or confirmed partial response to treatment evaluated using RANO 2.0 by BICR.

    Measured: 24 months

  3. Compare symptoms, function, and Health-related quality of life (HRQoL) and symptoms by EORTC QLQ-C30-item Core module (EORTC QLQ-C30) (Scores on a scale)

    EORTC QLQ-C30 is a validated questionnaire to assess overall health-related quality of life in participants with cancer.

    Measured: on Day 1 pre-dose or up to 7 days prior, on any day during the 6th week of RT, and on days of MRI at 4- and 12- weeks after RT, every 16 weeks thereafter on days of MRI

  4. Compare symptoms, function, and Health-related quality of life (HRQoL) and symptoms by EORTC QLQ-BN20-item Core module (EORTC QLQ-BN20) (Scores on a scale)

    EORTC QLQ-BN20 is a clinically valid and useful tool for assessing disease- and treatment-specific symptoms in brain neoplasm participants.

    Measured: on Day 1 pre-dose or up to 7 days prior, on any day during the 6th week of RT, and on days of MRI at 4- and 12- weeks after RT, every 16 weeks thereafter on days of MRI

  5. Compare symptoms, function, and Health-related quality of life (HRQoL) and symptoms by EQ-5D-3L

    The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.

    Measured: on Day 1 pre-dose or up to 7 days prior, on any day during the 6th week of RT, and on days of MRI at 4- and 12- weeks after RT, every 16 weeks thereafter on days of MRI

  6. Changes from baseline in neurocognitive function assessed by Hopkins Verbal Learning test

    The Hopkins Verbal Learning Test is designed to evaluate memory. It requires participants to memorize a list of 12 items for 3 consecutive tests (recall), to identify the same 12 items from a list of semantically related or unrelated items (recognition), and to recall the same 12 items after a 15-minute delay (delayed recall).

    Measured: on Day 1 pre-dose or up to 7 days prior, on any day during the 6th week of RT, and on days of MRI at 4- and 12- weeks after RT, every 16 weeks thereafter on days of MRI

  7. Changes from baseline in neurocognitive function assessed by Controlled Oral Word Association

    The Controlled Oral Word Association Test is designed to evaluate verbal fluency. It requires participants to name words beginning with a specific letter with increasing associated activity, in 3 one-minute periods.

    Measured: on Day 1 pre-dose or up to 7 days prior, on any day during the 6th week of RT, and on days of MRI at 4- and 12- weeks after RT, every 16 weeks thereafter on days of MRI

  8. Changes from baseline in neurocognitive function assessed by Trail Making Test Parts A and B

    The Trail Making Test Part A is designed to evaluate visual motor scanning speed, and the Trail Making Test Part B is designed to evaluate executive function. These tests require participants to connect circles in numerical (Part A) or alternating numerical and alphabetical sequence (Part B) within a timed interval of less than 5 minutes for each test.

    Measured: on Day 1 pre-dose or up to 7 days prior, on any day during the 6th week of RT, and on days of MRI at 4- and 12- weeks after RT, every 16 weeks thereafter on days of MRI

  9. Incidence of participants with adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESIs)

    AEs, SAEs and AESIs will be collected

    Measured: 24 months

  10. Incidence of treatment discontinuations, dose interruptions, and dose reductions due to AEs, SAEs, or AESIs, changes in Karnofsky performance status, changes in clinical laboratory results, and vital sign measurements

    Treatment discontinuations, dose interruptions, and dose reductions

    Measured: 24 months

  11. Frequency and severity of symptomatic AEs based on PRO-CTCAE

    The PRO-CTCAE is a patient-reported outcome measure developed to evaluate symptomatic toxicity in patients on cancer clinical trials.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2024
  2. Study start19 Jun 2024
  3. Primary completionDec 2027 (estimated)
  4. Study completionMar 2028 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
450 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06388733
Sponsor's protocol ID
IVY P3-24-021
Status last verified
Jun 2026
First submitted
24 Apr 2024
Last updated
1 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Niraparib and Temozolomide in people with Glioblastoma and GBM, run by Ivy Brain Tumor Center at 95 sites in 11 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 14 inclusion and 27 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 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 95 sites in United States, Spain, France, Germany, Italy and 6 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Overall survival (time frame: 24 months). 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 1 Jul 2026.

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