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Colorectal CancerPhase 4NCT06562543

A Trial to Evaluate the Safety and Activity of Fruquintinib in Minority Populations With Advanced, Previously Treated Colorectal Cancer

A Phase 4 study testing Fruquintinib in people with Colorectal Cancer, run by Takeda at 45 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

High blood pressure (hypertension) is a known side effect of the treatment with fruquintinib. Current research does not provide a clear answer whether minority groups such as Black/African American and/or Hispanic/Latino with refractory metastatic colorectal cancer (mCRC) have a bigger risk of higher blood pressure… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
Fruquintinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
45 sitesin 2 countries
Study dates
14 Jan 2025to 4 Oct 2027
Phase
Phase 4
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

  • Provide written (or electronic) informed consent.
  • Male or female aged more than or equal to (≥)18 years.
  • Presence of histologically and/or cytologically documented metastatic colorectal adenocarcinoma. Rat sarcoma virus (RAS) status for each participant must be documented.
  • Have been previously treated with standard approved therapies:
  • Fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy,
  • An anti-vascular endothelial growth factor (VEGF) biological therapy (e.g., bevacizumab, aflibercept, ramucirumab [regorafenib is NOT an anti-VEGF biologic]), and
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  • If RAS wild-type and medically appropriate, an anti-epidermal growth factor receptor (EGFR) therapy (e.g., cetuximab, panitumumab).
  • If known microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR) tumor and medically appropriate, a programmed cell death protein 1 (PD1) inhibitor.
  • Self-identify as Black and/or African American or Hispanic and/or Latino or as both.
  • Body weight ≥40 kilograms (kg).
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at screening.
  • Have assessable disease according to RECIST version 1.1, assessed locally.
  • In participants of childbearing potential, agreement to use highly effective form(s) of contraception, which results in a low failure rate (less than [<]1 percent [%] per year) when used consistently and correctly, starting during the screening period, continuing throughout the entire trial period, and for 2 weeks after taking the last dose of the trial intervention. Such methods include oral (PO) hormonal contraception (combined estrogen/progestogen or progestogen-only) associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system (IUS), bilateral tubal ligation, vasectomized partner, or true sexual abstinence in line with the preferred and usual lifestyle of the participant. Those assigned male sex at birth must always use a condom.

Who cannot join

  • Absolute neutrophil count (ANC) <1.5 times 10^9 per liter (10^9/L), platelet count <100 times 10^9/L, or hemoglobin <9.0 grams per deciliter (g/dL). Blood transfusion within 1 week prior to enrollment for the purpose of increasing the likelihood of eligibility is not allowed.
  • Serum total bilirubin more than (>)1.5 times the upper limit of normal range (ULN). Participants with previously documented Gilbert syndrome and bilirubin <2 times ULN are eligible.
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5 times ULN in participants without hepatic metastases; ALT or AST >5 times ULN in participants with hepatic metastases.
  • Creatinine clearance <30 milliliters per minute (mL/min). Creatinine clearance can either be measured in a 24-hour urine collection or estimated by the Cockcroft-Gault equation. Where available and appropriate, other formulae may be used to estimate clearance after consultation with the trial medical monitor.
  • Urine dipstick or urinalysis with protein ≥2 positive or 24-hour urine protein ≥1.0 gram per 24 hours (g/24 hours). Participants with 1+ positive proteinuria must undergo a 24-hour urine collection to assess urine protein level.
  • Uncontrolled hypertension, defined as systolic BP ≥140 millimeter of mercury (mmHg) and/or diastolic blood pressure (BP) ≥90 mmHg despite optimal medical management. The participant must have BP below both limits. Repeated assessments are permitted.
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  • International normalized ratio (INR) >1.5 times ULN or activated partial thromboplastin time (aPTT) >1.5 times ULN, unless the participant is currently receiving or intended to receive anticoagulants for prophylactic purposes.
  • History of or active gastric/duodenal ulcer or ulcerative colitis, active hemorrhage of an unresected gastrointestinal tumor, history of perforation or fistulas, or any other condition that could, in the investigator's judgment, result in gastrointestinal hemorrhage or perforation within the 6 months prior to screening.
  • History or presence of hemorrhage from any other site (e.g, hemoptysis or hematemesis) within 2 months prior to screening.
  • History of a thromboembolic event, including deep vein thrombosis, pulmonary embolism, or arterial embolism within 6 months prior to screening.
  • Stroke and/or transient ischemic attack within 12 months prior to screening.
  • Clinically significant cardiovascular disease, including but not limited to, acute myocardial infarction or coronary artery bypass surgery within 6 months prior to enrollment, severe or unstable angina pectoris, New York Heart Association Class III/IV congestive heart failure, ventricular arrhythmias requiring treatment, or left ventricular ejection fraction <50% by echocardiogram.
  • QT interval, corrected using the Fridericia method (QTcF) >480 milliseconds or any factors that increase the risk of QT interval, corrected based on the patient's heart rate (QTc) prolongation or risk of arrhythmic events such as hypokalemia, congenital long QT syndrome, or family history of long QT syndrome.
  • Systemic antineoplastic therapies (except for that described in exclusion criterion no. 15) or any investigational therapy within 2 weeks prior to the first dose of the trial intervention, including chemotherapy, radical radiotherapy, hormonotherapy, biotherapy, and immunotherapy.
  • Systemic small molecule targeted therapies (e.g., tyrosine kinase inhibitors [TKIs]) within 5 half-lives or 4 weeks (whichever is shorter) prior to the first dose of the trial intervention.
  • Palliative radiotherapy for bone metastasis/lesion within 2 weeks prior to the initiation of the trial intervention.
  • Brachytherapy (i.e., implantation of radioactive seeds) within 60 days prior to the first dose of the trial intervention.
  • Surgery or invasive procedure (i.e., a procedure that includes a biopsy; central venous catheter placement is allowed) within 14 days prior to the first dose of the trial intervention or unhealed surgical incision.
  • Any unresolved toxicities from previous antitumor treatments greater than NCI CTCAE, version 5.0, Grade 1 (except for alopecia or neurotoxicity Grade less than or equal to [≤]2).
  • Known human immunodeficiency virus infection.
  • Known history of active viral hepatitis. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load had to be undetectable on suppressive therapy, if indicated. Participants with hepatitis C virus (HCV) infection who are currently on treatment are eligible if they have an undetectable HCV viral load.
  • Clinically uncontrolled active infection requiring intravenous (IV) antibiotics.
  • Tumor invasion of a large vascular structure (e.g., pulmonary artery or superior or inferior vena cava).
  • Those who are currently pregnant or lactating.
  • Brain metastases and/or spinal cord compression untreated with surgery and/or radiotherapy, and without clinical imaging evidence of SD for 14 days or longer; participants requiring steroids within 4 weeks prior to the start of the trial intervention are to be excluded.
  • Other malignancy, except for non-melanoma skin cancer, in situ cervical carcinoma, or bladder carcinoma (tumor in situ and T1) that had been adequately treated during the 5 years prior to screening. Participants with another primary malignancy that has been adequately treated may be included after consultation with the trial medical monitor.
  • Inability to take medication PO, dysphagia, or an active gastric ulcer resulting from previous surgery (e.g., gastric bypass) or a severe gastrointestinal disease, or any other condition that investigators believe might affect absorption of the investigational medicinal product (IMP).
  • Other disease, metabolic disorder, physical examination anomaly, abnormal laboratory result, or any other condition (e.g., current alcohol or drug abuse) that investigators suspect might prohibit use of the IMP, affect interpretation of trial results, or put the participant at undue risk of harm based on the investigator's assessment.
  • Known hypersensitivity to fruquintinib or any of its inactive ingredients, including the azo dyes Tartrazine- Federal Food, Drug, and Cosmetic Act (FD\&C) Yellow 5 and Sunset yellow For Coloring Food (FCF)-FD\&C Yellow 6.
  • Received prior fruquintinib.
  • Live vaccine ≤28 days before the first dose of the trial intervention. Seasonal vaccines for influenza are generally inactivated vaccines and are allowed. Intranasal vaccines are live vaccines and are not allowed.
  • Use of strong inducers of cytochrome P450 3A4 (CYP3A4) within 2 weeks before the first dose of the trial intervention.

Trial locations and contacts

45 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Takeda Contact contact

+1-877-825-3327

medinfoUS@takeda.com

45 sites in 2 countries

United States44 sites, 32 recruiting

  • Emory University

    Atlanta, Georgia, 30322

    Site Contact, 404-778-1900, olatunji.alese@emory.edu

    Olatunji Alese

    Recruiting

  • Mercy Medical Center

    Baltimore, Maryland, 21202

    Site Contact, 410-783-5858, pledakis@mdmercy.com

    Panayotis Ledakis

    Recruiting

  • Our Lady of the Lake Physician Group - LSU Health Baton Rouge Oncology

    Baton Rouge, Louisiana, 70805

    Site Contact, 225-358-2312, stagg.patrick@yahoo.com

    Marshall Stagg

    Recruiting

  • Central Alabama Research

    Birmingham, Alabama, 35209

    Site Contact, 205-949-1907, kashraf@centralalabamaresearch.com

    Khaleel Ashraf

    Recruiting

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35249

    Site Contact, 205-996-2106, ggupta@uabmc.edu

    Garima Gupta

    Recruiting

  • Boston Medical Center

    Boston, Massachusetts, 02118

    Withdrawn

  • Ironwood Cancer and Research Centers

    Chandler, Arizona, 85224

    Site Contact, 480-969-3637, dharia@ironwoodcrc.com

    Neel Dharia

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Withdrawn

  • Zangmeister Cancer Center

    Columbus, Ohio, 43219

    Site Contact, 614-383-6194, smikhail@zangcenter.com

    Sameh Mikhail

    Recruiting

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

    Site Contact, 214-648-4180, Nilesh.Verma@UTSouthwestern.edu

    Nilesh Verma

    Recruiting

  • Renovatio Clinical

    El Paso, Texas, 79915

    Site Contact, 713-703-2398, mary.crow@renovatioclinical.com

    Mary Crow

    Recruiting

  • University of Florida

    Gainesville, Florida, 32610

    Completed

  • Hattiesburg Clinic

    Hattiesburg, Mississippi, 39401

    Site Contact, 601-261-1700, bo.hrom@hattiesburgclinic.com

    John Hrom

    Recruiting

  • Hope and Healing Cancer Services

    Hinsdale, Illinois, 60521

    Site Contact, 630-560-0121, sgundala@hopenheal.care

    Srilata Gundala

    Recruiting

  • Oncology Consultants - Memorial City Location

    Houston, Texas, 77030

    Site Contact, 713-600-0071, jpeguero@OncologyConsultants.com

    Julio Peguero

    Recruiting

  • Baylor College of Medicine

    Houston, Texas, 77054

    Site Contact, 713-798-4951, karen.riggins@bcm.edu

    Karen Riggins

    Recruiting

  • Indiana University

    Indianapolis, Indiana, 46202

    Site Contact, 317-944-0920, aalhader@iu.edu

    Anita Turk

    Recruiting

  • Saint Luke's Cancer Institute

    Kansas City, Missouri, 64111

    Withdrawn

  • Midwest Oncology Associates - Kansas City

    Kansas City, Missouri, 64132

    Site Contact, 816-974-5050, jaswinder.singh@amrllc.com

    Jaswinder Singh

    Recruiting

  • BRCR Global

    Katy, Texas, 77450

    Withdrawn

  • University of California San Diego

    La Jolla, California, 92093

    Site Contact, 858-822-3115, gbotta@ucsd.edu

    Gregory Botta

    Recruiting

  • University of Southern California

    Los Angeles, California, 90033

    Site Contact, 323-865-3000, algaze@usc.edu

    Sandra Algaze

    Recruiting

  • University of Tennessee -- Memphis

    Memphis, Tennessee, 38163

    Site Contact, 475-434-0816, schokshi@uthsc.edu

    Saurin Chokshi

    Recruiting

  • University of Miami

    Miami, Florida, 33146

    Withdrawn

  • Baptist Health - Miami Cancer Institute

    Miami, Florida, 33176

    Withdrawn

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212

    Site Contact, 317-944-0920, brooke.d.looney@vumc.org

    Brooke Looney

    Recruiting

  • Columbia University

    New York, New York, 10032

    Withdrawn

  • Christiana Care Health Services

    Newark, Delaware, 19713

    Site Contact, 302-366-1200, jmisleh@cbg.org

    Jamal Misleh

    Recruiting

  • Medstar Speciality Hospital

    Northwest, Washington, 20010

    Site Contact, 202-877-4072, marcus.s.noel@gunet.georgetown.edu

    Marcus Noel

    Recruiting

  • Hightower Clinical Research

    Oklahoma City, Oklahoma, 73102

    Completed

  • UC Irvine Medical Center - Chao Family Comprehensive Cancer

    Orange, Virginia, 22960

    Site Contact, 714-456-2242, fdayyani@uci.edu

    Farshid Dayyani

    Recruiting

  • Capital Health Medical Center - Hopewell

    Pennington, New Jersey, 08534

    Site Contact, 609-303-0747, ALoaiza-Bonilla@capitalhealth.org

    Hongyan Liang

    Recruiting

  • Jefferson Health

    Philadelphia, Pennsylvania, 19107

    Site Contact, 267-402-0579, Atrayee.BasuMallick@jefferson.edu

    Atrayee Basu-Mallick

    Recruiting

  • Fox Chase Cancer Center | Philadelphia, PA

    Philadelphia, Pennsylvania, 19111

    Withdrawn

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

    Site Contact, 804-628-2945, khalid.matin@vcuhealth.org

    Khalid Matin

    Recruiting

  • Willis Knighton Cancer Center

    Shreveport, Louisiana, 71103

    Site Contact, 318-212-8620, jfeagin@wkhs.com

    Joyce Feagin

    Recruiting

  • SSM Health St. Louis DePaul Hospital

    St Louis, Missouri, 63044

    Site Contact, 314-209-5142, brian.smith@ssmhealth.com

    Brian Smith

    Recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63108

    Site Contact, 314-273-3564, nikolaos@wustl.edu

    Nikolaos Andreatos

    Recruiting

  • Albert Einstein College of Medicine

    The Bronx, New York, 10461

    Withdrawn

  • James J Peters Veterans Administration Medical Center - NAVREF

    The Bronx, New York, 10468

    Withdrawn

  • Renovatio Clinical

    The Woodlands, Texas, 77380

    Site Contact, 713-703-2398, jonathan.lu@renovatioclinical.com

    Jonathon Lu

    Recruiting

  • University of Arizona

    Tucson, Arizona, 85719

    Site Contact, 520-626-3199, ajscott@arizona.edu

    Aaron Scott

    Recruiting

  • Tranquil Research

    Webster, Texas, 77598

    Site Contact, 713-907-6054, drknecht@cls.health

    John Knecht

    Recruiting

  • PIH Health Whittier Hospital

    Whittier, California, 90602

    Site Contact, 156-269-8081, Andrew.Pham@pihhealth.org

    Andrew Pham

    Recruiting

Other trials in United States

Puerto Rico1 site

  • Fundacion de Investigacion de Diego (FDI Clinical Research)

    San Juan, 00927

    Completed

Other trials in Puerto Rico

About this study

Official title: A Single Arm Phase 4 Trial to Evaluate the Safety and Efficacy of Oral Fruquintinib in the Treatment of Refractory Metastatic Colorectal Cancer in Patients From Minority Populations Underrepresented in Prior Fruquintinib Studies

High blood pressure (hypertension) is a known side effect of the treatment with fruquintinib. Current research does not provide a clear answer whether minority groups such as Black/African American and/or Hispanic/Latino with refractory metastatic colorectal cancer (mCRC) have a bigger risk of higher blood pressure after treatment with fruquintinib. The main aim of this study is to learn how often adults of a minority group experience hypertension after they have been treated with fruquintinib for refractory mCRC. Other aims are to learn how safe fruquintinib is and how well it is tolerated by participants.

Participants will receive fruquintinib in 4-week treatment cycles until their condition worsens, they do no longer tolerate the treatment or stop the treatment for other reasons. After the last treatment, participants will be checked upon every 3 months until study completion.

Being tested
Fruquintinib
Keywords
colorectal cancer, fruquintinib
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • FruquintinibDrug

    Also called Fruzaqla™

    Oral capsules

Study groups in NCT06562543
Study groupRoleWhat they receive
Fruquintinib 5 mgExperimentalParticipants will receive fruquintinib capsule at a dose of 5 mg, orally (PO), once daily (QD), for the first 21 days of each 28-day treatment cycle until progressive disease (PD), unacceptable toxicity, or other discontinuation criteria are met.
Receives: Drug: Fruquintinib

What is being measured

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

  1. Number of Participants with Treatment Emergent Grade 3 and Grade 4 Hypertension

    A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving the first dose of the study drug and within 30 days after the last dose of the study drug or the initiation of subsequent anti-cancer therapy, whichever occurs earlier. Severity (toxicity grade) for hypertension will be determined using the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.

    Measured: From the first dose of the study drug up to end of study (approximately 35 months)

Secondary outcomes (7)

  1. Number of Participants with TEAEs, Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and Deaths

    An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of the trial intervention. It does not necessarily have to have a causal relationship with trial intervention. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. An AESI is an AE of scientific and medical concern (including palmar-plantar erythrodysesthesia syndrome [hand-foot syndrome]) specific to the study drug or the same class of drugs (vascular endothelial growth factor [VEGF] inhibitors) for which ongoing monitoring and rapid communication by the investigator to Takeda may be appropriate. An SAE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect, or is considered medically significant event.

    Measured: From the first dose of the study drug up to end of study (approximately 35 months)

  2. Overall Survival (OS)

    OS will be defined as the interval from the first dose of fruquintinib until death.

    Measured: Up to approximately 35 months

  3. Progression Free Survival (PFS)

    PFS will be defined as the interval from the first dose of fruquintinib until the first radiographic documentation of objective progression assessed by investigator using Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1, or death from any cause.

    Measured: Up to approximately 35 months

  4. Confirmed Objective Response Rate (cORR)

    Confirmed ORR is defined as the percentage of participants achieving a best overall response of confirmed complete response (CR) or partial response (PR), assessed by investigator per RECIST version 1.1. To be qualified for stable disease (SD), the duration of SD should last for at least 7 weeks.

    Measured: Up to approximately 35 months

  5. Disease Control Rate (DCR)

    DCR is defined as the percentage of participants achieving a best overall response of confirmed CR, PR, or SD, as assessed by investigator per RECIST version 1.1.

    Measured: Up to approximately 35 months

  6. Duration of Response (DOR)

    DOR is defined as the interval from the first occurrence of PR or CR, whichever comes first, until the date of radiographic PD or death. DOR will be determined for participants with the best overall response of confirmed CR or PR as assessed by investigator per RECIST version 1.1.

    Measured: Up to approximately 35 months

  7. Plasma Concentration for Fruquintinib

    Measured: Pre-dose (within 1 hour) on Day 21 of Cycles 1 and 2; 2 hours post-dose on Days 1 and 21 of Cycles 1 to 4 and 3 hours post-dose on Days 1 and 21 of Cycles 1 and 2 (cycle length=28 days)

Timeline

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

  1. First posted20 Aug 2024
  2. Study start14 Jan 2025
  3. Primary completion4 Oct 2027 (estimated)
  4. Study completion4 Oct 2027 (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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
78 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06562543
Sponsor's protocol ID
TAK-113-4002
Status last verified
Jul 2026
First submitted
16 Aug 2024
Last updated
7 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Fruquintinib in people with Colorectal Cancer, run by Takeda at 45 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 13 inclusion and 32 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: looking for participants now, as of the sponsor's last update on 7 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 45 sites in United States, Puerto Rico. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Contact Takeda Contact (+1-877-825-3327, medinfoUS@takeda.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Treatment Emergent Grade 3 and Grade 4 Hypertension (time frame: From the first dose of the study drug up to end of study (approximately 35 months)). 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 NCT06562543.

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 7 Jul 2026.

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