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AzTrials

Advanced CholangiocarcinomaPhase 3FOENIX-CCA3NCT04093362

Futibatinib Versus Gemcitabine-Cisplatin Chemotherapy as First-Line Treatment of Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements

A Phase 3 study testing Futibatinib, Cisplatin and Gemcitabine in people with Advanced Cholangiocarcinoma and FGFR2 Gene Rearrangements, run by Taiho Oncology, Inc. at 103 sites in 20 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This is an open-label, multinational, parallel 2-arm, randomized Phase 3 study evaluating the efficacy and safety of futibatinib versus gemcitabine-cisplatin chemotherapy as first-line treatment of participants with advanced, metastatic, or recurrent unresectable intrahepatic cholangiocarcinoma (iCCA) harboring FGFR2… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Futibatinib, Cisplatin and Gemcitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
103 sitesin 20 countries
Study dates
6 Jan 2021to 22 Apr 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • A participant must meet all of the following inclusion criteria to be eligible for enrollment in this study:
  • Provide written informed consent.
  • Is ≥18 years of age (or meets the country's regulatory definition for legal adult age).
  • The participant has histologically confirmed, locally advanced, or metastatic, or recurrent unresectable iCCA harboring FGFR2 gene rearrangements based on testing performed by the designated central laboratory.
  • Participant has radiographically measurable disease per RECIST 1.1.
  • Participants who have received treatment for locally advanced disease (for example, trans-arterial chemoembolization, selective internal radiation therapy, external beam radiation) must have evidence of radiographic progression with measurable disease outside the previously-treated lesions.
Show all 18Show fewer
  • Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1.
  • Adequate organ function as defined by the following criteria:
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 ×upper limit of normal (ULN); if liver function abnormalities are due to underlying liver metastasis, AST and ALT ≤ 5 × ULN.
  • Total bilirubin ≤ 1.5 × ULN, or ≤ 3.0 × ULN for participants with Gilbert's syndrome.
  • White Blood Count (WBC) ≥ 2000/mm3 (≥ 2.0 × 109/L)
  • Absolute neutrophil count (ANC) ≥ 1000/mm3 (ie, ≥ 1.0 × 109/L by International Units [IU])
  • Platelet count ≥ 100,000/mm3 (IU: ≥ 100 × 109/L)
  • Hemoglobin ≥ 9.0 g/dL
  • Phosphorus ≤ 1.5 × ULN
  • Creatinine clearance: ≥ 60 mL/min
  • Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to administration of the first dose of futibatinib. Female participants are not considered to be of child bearing potential if they have a history of hysterectomy or are post menopausal defined as no menses for 12 months without an alternative medical cause. Both males and females of reproductive potential must agree to use effective birth control during the study prior to the first dose and for 6 months after the last dose.
  • Willing and able to comply with scheduled visits and study procedures.

Who cannot join

  • A participant will be excluded from this study if any of the following criteria are met:
  • Participant has received previous systemic anticancer therapy.
  • •Participants receiving adjuvant or neoadjuvant treatment and completed ≥6 months prior to randomization are eligible.
  • Participant has mixed hepatocellular carcinoma - iCCA disease.
  • History and/or current evidence of any of the following disorders:
  • Non-tumor related alteration of calcium-phosphorus homeostasis that is clinically significant in the opinion of the Investigator.
Show all 25Show fewer
  • Ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, or myocardia and lung, considered clinically significant in the opinion of the Investigator.
  • Retinal disorder confirmed by retinal examination and considered clinically significant in the opinion of the ophthalmologist.
  • History or current evidence of uncontrolled ventricular arrhythmias
  • Fridericia's corrected QT interval (QTcF) > 470 milliseconds (ms) on electrocardiogram (ECG) conducted during Screening.
  • Treatment with any of the following within the specified time frame prior to the first dose of study therapy, or failure to recover from side effects of these prior therapies:
  • Major surgery within the previous 4 weeks (the surgical incision should be fully healed prior to the first dose of study therapy).
  • Radiotherapy (any dose) for extended field within 4 weeks or limited field radiotherapy within 2 weeks, and/or has not recovered from acute impact of radiotherapy.
  • Participants with locoregional therapy, e.g. transarterial chemoembolization (TACE), selective internal radiotherapy (SIRT) or ablation within 4 weeks.
  • Any history of liver transplant.
  • A serious illness or medical condition(s) including, but not limited to, the following:
  • Brain metastases that are untreated or clinically or radiologically unstable (that is, have been stable for <1 month).
  • Known acute systemic infection.
  • Myocardial infarction, severe/unstable angina, or symptomatic congestive heart failure within the previous 6 months.
  • Chronic nausea, vomiting, or diarrhea considered to be clinically significant in the opinion of the Investigator.
  • Congenital long QT syndrome, or any known history of torsade de pointes, or family history of unexplained sudden death.
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that in the judgment of the Investigator would make the participant inappropriate for entry into this study.
  • Participants with a history of another primary malignancy that is currently clinically significant, and has potential for metastases or currently requires active intervention.
  • Pregnant or breast-feeding female.
  • The participant is unable to take oral medication.

Trial locations and contacts

103 sites in 20 countries.

103 sites in 20 countries

Japan12 sites

  • Chiba University Hospital

    Chiba, Chiba, 260-8677

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, 104-0045

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, Fukuoka, 811-1395

  • National Cancer Center Hospital East

    Kashiwa-Shi, Chiba, 277-8577

  • The Cancer Institute Hospital of JFCR

    Koto-Ku, Tokyo, 135-8550

  • Kyorin University Hospital

    Mitaka-shi, Tokyo, 181-8611

  • Nagasaki University Hospital

    Nagasaki, Nagasaki, 852-8501

  • Nagoya University Hospital

    Nagoya, Aichi-ken, 466-8560

  • Osaka city University Hospital

    Osaka, Osaka, 545-8586

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648

  • Osaka University Hospital

    Suita-shi, Osaka, 565-0871

  • Kanagawa Cancer Center

    Yokohama, Kanagawa, 241-8515

Other trials in Japan

Brazil9 sites

  • IOP - Instituto de Oncologia do Parana

    Curitiba, Paraná, 80520-174

  • Instituto Nacional de Cancer Jose Alencar Gomes da Silva - INCA

    Rio de Janeiro, Rio de Janeiro, 20231-050

  • Instituto Americas

    Rio de Janeiro, Rio de Janeiro, 22775-001

  • Cepho-Fm Abc

    Santo André, São Paulo, 09060-650

  • Hospital de Base de Sao Jose do Rio Preto

    São José do Rio Preto, São Paulo, 15090-000

  • Instituto do Cancer do Estado de Sao Paulo

    São Paulo, São Paulo, 01246-000

  • Fundacao Antonio Prudente - A.C.Camargo Cancer Center

    São Paulo, São Paulo, 01509-010

  • Hospital Municipal Vila Santa Catarina

    São Paulo, São Paulo, 04377-035

  • Hospital Santa Marcelina HSM

    São Paulo, São Paulo, 08270-120

Other trials in Brazil

Italy9 sites

  • Candiolo Cancer Institute - FPO IRCCS

    Candiolo

  • Ospedale Versilia

    Lucca, 555041

  • AOU di Cagliari

    Monserrato, 9042

  • Ospedale Maggiore della Carita di Novara

    Novara, 28100

  • Servizio Sanitario Regionale Emilia-Romagna - Azienda Ospedaliero-Universitaria di Parma Ospedale Maggiore

    Parma, 43126

  • Policlinico Uni. Campus Bio-Medico

    Roma, 12800

  • Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte

    Siena, 53100

  • AOUI Verona - Ospedale Borgo Roma

    Verona, 37134

  • Azienda ULSS 8 Berica

    Vicenza, 36100

Other trials in Italy

United States8 sites

  • New Mexico Cancer Care Alliance

    Albuquerque, New Mexico, 87131

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

  • City of Hope National Medical Center

    Duarte, California, 91010

  • Norton Cancer Institute Audubon Hospital Campus Medical Plaza

    Louisville, Kentucky, 40217

  • Carbone Comprehensive Cancer Center

    Madison, Wisconsin, 53792

  • Medical College of Wisconsin - Froedtert Hospital

    Milwaukee, Wisconsin, 53226

  • Utah Cancer Specialists

    Salt Lake City, Utah, 84106

  • Medical Oncology Associates, PS - Summit Cancer Centers

    Spokane, Washington, 99208

Other trials in United States

France8 sites

  • Hopitaux Universitaires Paris Nord Val de Seine - Hopital Beaujon

    Clichy, 92110

  • Centre Georges-Francois Leclerc

    Dijon, 21000

  • Centre Hospitalier Universitaire de Grenoble

    La Tronche, 38700

  • Centre Leon Berard

    Lyon, 69008

  • CHRU Besancon

    Montbéliard, 25 200

  • CHU Reims

    Reims, 51092

  • Institut de Cancerologie Strasbourg Europe ICAENS

    Strasbourg, 67033

  • CHU de TOURS - Hopital Trousseau

    Tours, 37044

Other trials in France

South Korea8 sites

  • Dong-A University Hospital

    Busan, 49201

  • Kyungpook National University Hospital

    Daegu, 41944

  • Chonnam National University Hwasun Hospital

    Hwasun, Jeollanam-do, 58128

  • Seoul National University Hospital

    Jungni I Gu, Seoul, 3080

  • CHA Bundang Medical Center

    Seongnam, 13496

  • Asan Medical Center

    Seoul, Seoul, 5505

  • Yonsei University Health System - Severance Hospital

    Seoul, 3722

  • Samsung Medical Center

    Seoul, 6351

Other trials in South Korea

Spain8 sites

  • Onkologikoa

    Donostia / San Sebastian, Gipuzkoa, 20014

  • Hospital Universitario Virgen de la Arrixaca HUVA

    El Palmar, Murcia, 30120

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007

  • Clinica Universidad de Navarra

    Madrid, 28022

  • MD Anderson Cancer Center

    Madrid, 28033

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Universitario 12 de Octubre

    Madrid, 28043

  • Clinica Universidad de Navarra

    Pamplona

Other trials in Spain

Taiwan6 sites

  • Chang Gung Memorial Hospital CGMH - Kaohsiung Branch

    Kaohsiung City, 83301

  • Chang Gung Memorial Hospital, Linkou

    Taichung, 40447

  • National Cheng Kung University Hospital NCKUH

    Tainan, 704

  • Chi Mei Medical Center CMMC - Yongkang branch

    Tainan, 710

  • National Taiwan University Hospital

    Taipei, 10002

  • Taipei Veterans General Hospital

    Taipei, 11217

Other trials in Taiwan

Thailand5 sites

  • Chulabhorn Hospital, HRH Princess Chulabhorn College of Medical Science, Chulabhorn Royal Academy

    Bangkok, 10210

  • Rajavithi hospital

    Bangkok, 10400

  • Maharaj Nakorn Chiang Mai Hospital, Faculty of Medicine, Chiang Mai University

    Chiang Mai, 50200

  • Songklanagarind Hospital, Faculty of Medicine, Prince of Songkla University

    Hat Yai, Changwat Songkhla, 90110

  • Khon Kaen University KKU - Faculty of Medicine-Srinagarind Hospital

    Khon Kaen, Muang, 40002

Other trials in Thailand

Belgium4 sites

  • UZ Antwerpen

    Edegem, Antwerpen, 2650

  • CHC MontLégia

    Liège, Liege, 4000

  • Algemeen Ziekenhuis AZ Sint-Maarten

    Mechelen, Antwerpen, 2800

  • AZ Delta Roeselare

    Roeselare, Flanders, 8800

Other trials in Belgium

Peru4 sites

  • Hospital Goyeneche

    Arequipa, 04001

  • Hospital Daniel Alcides Carrion

    Bellavista, Provincia Constitucional del Callao, 07016

  • Hospital Nacional Arzobispo Loayza

    Lima, 15082

  • Instituto Nacional de Enfermedades Neoplasicas (INEN)

    Surquillo, Lima region, 15038

Other trials in Peru

Australia3 sites

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3002

  • Newcastle Private Hospital

    Newcastle, New South Wales, 2305

Other trials in Australia

Germany3 sites

  • Charite - Universitaetsmedizin Berlin

    Berlin, 13353

  • Universitaetsmedizin Mainz

    Mainz, 55131

  • Technische Universitaet Muenchen - Klinikum rechts der Isar

    München, Muenchen

Other trials in Germany

Mexico3 sites

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    Mexico City, MX, 14080

  • Hospital Universitario Jose Eleuterio Gonzalez

    Monterrey, Nuevo León, 64460

  • Centro de Estudios y Prevencion del Cancer (CEPREC)

    Tuxtla Gutiérrez, Chiapas, 29038

Other trials in Mexico

Portugal3 sites

  • Fundacao Champalimaud

    Lisbon, 1400-038

  • CUF Porto Hospital

    Porto, 4100-180

  • Instituto Portugues de Oncologia do Porto

    Porto, 4200-072

Other trials in Portugal

United Kingdom3 sites

  • University Hospitals Bristol NHS Foundation Trust

    Bristol, BS2 8ED

  • University College London Hospital NHS Foundation Trust

    London, NW1 2PG

  • Royal Free London NHS Foundation Trust

    London, NW3 2QG

Other trials in United Kingdom

Argentina2 sites

  • Fundacion Favaloro para la Docencia e Investigacion Medica

    Buenos Aires, Buenos Aires F.D., C1093

  • Hospital de Gastroenterologia Dr. C. Bonorino Udaondo

    Buenos Aires, Buenos Aires F.D., CP1264

Other trials in Argentina

Hong Kong2 sites

  • The University of Hong Kong, Queen Mary Hospital

    Hong Kong, 2255-4249

  • The Chinese University of Hong Kong Prince of Wales Hospital

    Shatin

Other trials in Hong Kong

Poland2 sites

  • Centrum Medyczne HCP Sp. z o.o.

    Poznan, Greater Poland Voivodeship, 61-485

  • Szpital Kliniczny Przemienienia Pańskiego UM im. Karola Marcinkowskiego w Poznaniu

    Poznan, Woj. Wielkopolskie, 60-569

Other trials in Poland

Netherlands1 site

  • Radboud University Medical Center

    Nijmegen, GA, 6525

Other trials in Netherlands

About this study

Official title: A Phase 3, Open-Label, Randomized Study of Futibatinib Versus Gemcitabine-Cisplatin Chemotherapy as First-Line Treatment of Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements FOENIX-CCA3

This is an open-label, multinational, parallel 2-arm, randomized Phase 3 study evaluating the efficacy and safety of futibatinib versus gemcitabine-cisplatin chemotherapy as first-line treatment of participants with advanced, metastatic, or recurrent unresectable intrahepatic cholangiocarcinoma (iCCA) harboring FGFR2 gene rearrangements

Read the detailed description

Study TAS-120-301 is an open-label, multinational, parallel 2-arm, randomized Phase 3 study evaluating the efficacy and safety of futibatinib versus gemcitabine-cisplatin chemotherapy as first-line treatment of participants with advanced, metastatic, or recurrent unresectable iCCA harboring FGFR2 gene rearrangements. Eligible participants will be randomized on a 1:1 basis to the following study arms:

  • Experimental Arm: Participants will receive futibatinib at an oral dose of 20 mg, administered daily (QD) on every day of a 21-day cycle.
  • Control Arm: On Days 1 and 8 of a 21-day cycle, participants will receive:
  • Cisplatin 25 mg/m2 in 1000 mL 0.9% saline by intravenous (IV) infusion over 1 hour, followed by 500 millilliteres (mL) 0.9 percent (%) saline over 30 minutes; and
  • Gemcitabine 1000 mg/m2 in 250-500 mL 0.9% saline by IV infusion over 30 minutes, beginning after completion of the cisplatin and saline infusions.

Participants in the Experimental Arm may continue to receive continuous futibatinib until documentation of progressive disease (PD) per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v 1.1), or until other withdrawal criteria are met, whichever comes first. However, treatment may continue following PD per RECIST 1.1 if the participants is clinically stable and is considered by the Investigator to be deriving continued clinical benefit from futibatinib.

Participants in the Control Arm may receive gemcitabine-cisplatin chemotherapy for up to 8 cycles or until PD or other withdrawal criteria are met, whichever comes first. Participants who discontinue gemcitabine-cisplatin due to documented disease progression (by ICR) may receive treatment with futibatinib ("crossover"), if medically appropriate in the opinion of the Investigator and if criteria for futibatinib treatment are met.

Being tested
Futibatinib, Cisplatin, Gemcitabine
Keywords
Futibatinib, Advanced Cholangiocarcinoma, FGFR2, Fusion, Rearrangement, TAS-120

What participants receive

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

Study groups in NCT04093362
Study groupRoleWhat they receive
FutibatinibExperimentalParticipants received futibatinib at an oral dose of 20 milligrams (mg), administered once daily (QD) on every day of a 21-day cycle up to disease progression.
Receives: Drug: Futibatinib
Cisplatin/GemcitabineActive comparatorParticipants received cisplatin 25 milligrams per square meter (mg/m^2) IV infusion followed by gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle up to 8 cycles.
Receives: Drug: Cisplatin; Drug: Gemcitabine

What is being measured

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

  1. Progression-free Survival (PFS)

    PFS was defined as the time from date of randomization to the date of documentation of disease progression by independent central review (ICR), or date of death, whichever occurs first. Response assessments were made based on Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1, 2009)

    Measured: Up to approximately 28 months

Secondary outcomes (5)

  1. Objective Response Rate (ORR)

    ORR was defined as the proportion of participants experiencing a best overall response of partial response (PR) or complete response (CR) as per RECIST 1.1, based on ICR. PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum diameters and persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to less than (<)10 millimeters (mm) and disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10-mm short axis)

    Measured: Up to approximately 28 months

  2. Disease Control Rate (DCR)

    DCR was defined as the proportion of participants experiencing a best overall response of stable disease (SD), PR or CR as per RECIST 1.1, based on central assessment of radiologic images. PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the baseline sum diameters and persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. CR was defined as disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to <10 mm and disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10-mm short axis).

    Measured: Up to approximately 28 months

  3. Overall Survival (OS)

    OS was defined as the time from the date of randomization until the date of death due to any cause.

    Measured: Up to approximately 28 months

  4. Progression-Free Survival (PFS) Per Investigator Assessment

    PFS per investigator assessment is defined as the time from date of randomization to the date of disease progression based on investigator assessment of radiographic images or death, whichever occurs first.

    Measured: Up to approximately 28 months

  5. Number of Participants With Treatment-emergent Adverse Events (TEAEs), and Serious Adverse Events (SAEs)

    An adverse event (AE) was defined as any untoward medical condition in clinical investigation participant administered drug; it does not necessarily have to have causal relationship with this treatment. A TEAE was defined as an AE that started or worsened at the time of or after first dose of study drug administration and within 30 days after last dose of study drug and does not necessarily have a causal relationship to use of the study drug. TEAEs were assessed by Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0). SAE was any untoward medical occurrence that at any dose: results in death, is life-threatening, required in participant hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is congenital anomaly/birth defect, important medical event. TEAEs included any clinically significant changes in clinical laboratory tests, vital signs, ophthalmological exams, and 12-lead electrocardiogram (ECG).

    Measured: Up to approximately 28 months

Timeline

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

  1. First posted18 Sep 2019
  2. Study start6 Jan 2021
  3. Primary completion22 Apr 2024
  4. Study completion22 Apr 2024

Why it stopped: Due to Poor Recruitment

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
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04093362
Sponsor's protocol ID
TAS-120-301
Other IDs
2019-004630-42, 2019
Acronym
FOENIX-CCA3
Status last verified
Feb 2025
First submitted
16 Sep 2019
Last updated
7 Feb 2025
Data monitoring committee
No
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 Futibatinib, Cisplatin and Gemcitabine in people with Advanced Cholangiocarcinoma and FGFR2 Gene Rearrangements, run by Taiho Oncology, Inc. at 103 sites in 20 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 25 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 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 103 sites in Japan, Brazil, Italy, United States, France and 15 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?

Yes. Results are posted in the registry (first posted 7 Feb 2025). 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?

Progression-free Survival (PFS) (time frame: Up to approximately 28 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 NCT04093362.

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 Feb 2025.

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