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Advanced CholangiocarcinomaPhase 3NCT03773302

Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations

A Phase 3 study testing BGJ398, Gemcitabine and Cisplatin in people with Advanced Cholangiocarcinoma and FGFR2 Gene Mutation, run by QED Therapeutics, a BridgeBio company at 116 sites in 15 countries.

Terminated

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

Official record
Search all trials

Trial summary

Infigratinib is an oral drug which selectively binds to fibroblast growth factor receptor (FGFR) 2 and is being developed to treat participants with FGFR2 mutated cholangiocarcinoma. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
BGJ398, Gemcitabine and Cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
116 sitesin 15 countries
Study dates
27 Dec 2019to 2 Mar 2023
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

  • Histologically or cytologically confirmed unresectable locally advanced or metastatic cholangiocarcinoma. Participants with gallbladder cancer or ampulla of Vater carcinoma are not eligible
  • Have written documentation of local laboratory or central laboratory determination of a known or likely activating FGFR2 fusion/rearrangement from a sample collected before randomization
  • Have an archival tumor tissue sample available with sufficient tumor content for FGFR2 fusion/rearrangement molecular testing by the central laboratory. However, if an archival tumor tissue sample is not available, or does not meet requirements for central testing a newly obtained (before randomization) tumor biopsy may be submitted instead. If a prestudy written documentation of FGFR2 fusion/rearrangement in tumor tissue is available from the central laboratory, an additional tumor sample does not need to be submitted.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Are able to swallow and retain oral medication
  • Are willingness to avoid pregnancy or father children

Who cannot join

  • Received treatment with any systemic anti-cancer therapy for unresectable locally advanced or metastatic cholangiocarcinoma, with following exceptions
  • Prior neoadjuvant or adjuvant therapy is permitted if completed > 6 months after the last dose of neoadjuvant or adjuvant therapy.
  • One cycle of gemcitabine-based chemotherapy for locally advanced or metastatic cholangiocarcinoma is permitted before randomization
  • History of a liver transplant
  • Received previously or currently is receiving treatment with a mitogen activated protein kinase kinase (MEK) or selective FGFR inhibitor
  • Have impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral infigratinib (such as, ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection).
Show all 21Show fewer
  • Current evidence of endocrine alterations of calcium/phosphate homeostasis, e.g., parathyroid disorders, history of parathyroidectomy, tumor lysis, tumoral calcinosis etc.
  • History and/or current evidence of extensive tissue calcification including, but not limited to, the soft tissue, kidneys, intestine, myocardium, vascular system and lung with the exception of calcified lymph nodes, minor pulmonary parenchymal calcifications, and asymptomatic coronary calcification
  • Current evidence of corneal or retinal disorder/keratopathy
  • Receiving and continued treatment or are planning to receive agents or consuming foods that are known moderate or strong inducers or inhibitors of CYP3A4 and medications which increase serum phosphorus and/or calcium concentration
  • Clinically significant or uncontrolled cardiac disease
  • Recent (≤ 3 months prior to first dose of study drug) transient ischemic attack or stroke
  • Severe hearing loss
  • Severe neuropathy
  • History of another primary malignancy within 3 years except adequately treated in-situ carcinoma of the cervix or non-melanoma skin cancer or other curatively treated malignancy that is not expected to require treatment
  • Pregnant or breastfeeding
  • Have known microsatellite instability-high (MSI-H) disease and the decision is made by the treating investigator that an alternative, non-study therapy is warranted according to standard of care.
  • Have any known hypersensitivity to gemcitabine, cisplatin, calcium-lowering agents, infigratinib, or their excipients
  • Have any contraindication to cisplatin or gemcitabine treatment according to local labeling or standard institutional practice.
  • Have taken any Chinese herbal medicine or Chinese patent medicine treatments with anticancer activity within 14 days of the first dose of study drug.
  • Have received a live vaccine within 30 days before the first dose of study drug or are planning to receive a live vaccine during participation in this study

Trial locations and contacts

116 sites in 15 countries.

116 sites in 15 countries

United States25 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Charleston Oncology

    Charleston, South Carolina, 29414

  • Levine Cancer Institute - Charlotte

    Charlotte, North Carolina, 28204

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45267

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43202

  • Parkland Health and Hospital System

    Dallas, Texas, 75343

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Barbara Ann Karmanos Cancer Institute - Lawrence and Idell Weisberg Cancer Treatment Center

    Detroit, Michigan, 48201

  • Frederick Regional Healthcare Systems/James M. Stockman Cancer Institute

    Frederick, Maryland, 21702

  • St. Joseph Heritage Healthcare

    Fullerton, California, 92835

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

  • Cancer and Hematology Centers of Western Michigan

    Grand Rapids, Michigan, 49503

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Baylor College of Medicine

    Houston, Texas, 77096

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • USC Norris Cancer Center

    Los Angeles, California, 90033

  • University of California Los Angeles

    Los Angeles, California, 90095

  • University Medical Center - New Orleans

    New Orleans, Louisiana, 70112

  • NYU Langone Medical Center

    New York, New York, 10016

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10021

  • Florida Hospital Medical Group

    Orlando, Florida, 32804

  • UF Health Cancer Center at Orlando Health

    Orlando, Florida, 32806

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073

  • University of Arizona

    Tucson, Arizona, 85724

Other trials in United States

Spain12 sites

  • Hospital Universitario Germans Trias i Pujol

    Badalona, Catalonia, 08916

  • Instituto Catalan de Oncologio ICO I'Hospitalet

    Barcelona, Catalonia, 08907

  • Hospital Universitario Vall d'Hebrón - PPDS

    Barcelona, 08035

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario HM Sanchinarro - CIOCC

    Madrid, 28050

  • Complejo Asistencial Universitario de Salamanca - Hospital Clinico

    Salamanca, Castille and León, 37007

  • Hospital Universitario Virgen Macarena

    Seville, Andalusia, 41009

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026

  • Hospital Universitario Miguel Servet

    Zaragoza, Aragon, 50009

Other trials in Spain

France10 sites

  • Hopital Henri Mondor

    Créteil, Val-de-Marne, 94000

  • CHRU Dijon

    Dijon, 21000

  • Centre Georges-Francois Leclerc

    Dijon, 21079

  • Hopital Claude Huriez Rue Michel Polonovski (CHRU) Lille

    Lille, 59000

  • Groupement Hospitalier Edouard Herriot

    Lyon, 69437

  • Hopital Nord Franche-Comte

    Montbéliard, 25200

  • Groupe Hospitalier Archet I Et II

    Nice, 06202

  • Hopital Cochin

    Paris, 75014

  • Hôpital Saint Antoine

    Paris, 75571

  • L'Institut Mutualiste Montsouris

    Paris, 75674

Other trials in France

Portugal10 sites

  • Hospital Garcia de Orta

    Almada, 2801-951

  • Centro Hospitalar E Universitário de Coimbra EPE

    Coimbra, 3000-075

  • Instituto Português de Oncologia Francisco Gentil Centro Regional de Oncologia de Coimbra EPE

    Coimbra, 3000-075

  • Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E.

    Lisbon, 1099-023

  • Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria

    Lisbon, 1649-035

  • Hospital CUF Descobertas

    Lisbon, 1998-018

  • Hospital Beatriz Angelo

    Loures, Lisbon District, 2674-514

  • Centro Hospitalar do Porto - Hospital de Santo António

    Porto, 4099-001

  • Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS

    Porto, 4200-072

  • Centro Hospitalar de São João, E.P.E.

    Porto, 4200-319

Other trials in Portugal

China8 sites

  • Peking University People's Hospital

    Beijing, 100033

  • Beijing Cancer Hospital

    Beijing, 100142

  • Peking University Third Hospital

    Beijing, 100191

  • Hunan Cancer Hospital

    Changsha, 410006

  • Guangzhou First People's Hospital

    Guangzhou, 510080

  • Hubei Cancer Hospital

    Hubei, 430079

  • Liaoning Cancer Hospital & Institute

    Shenyang, 110042

  • The First Affiliated Hospital, Sun Yat-sen University

    Zhongshan, 510060

Other trials in China

South Korea8 sites

  • Pusan National University Hospital

    Pusan

  • Seoul National University Bundang Hospital

    Seongnam-si

  • SMG - SNU Boramae Medical Center

    Seoul, 07061

  • Samsung Medical Center

    Seoul

  • Seoul National University Hospital

    Seoul

  • Severance Hospital Yonsei University Health System

    Seoul

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul

  • Ajou University Hospital

    Suwon

Other trials in South Korea

Taiwan8 sites

  • National Taiwan University Hospital - YunLin Branch

    Huwei, 632

  • Chang Gung Memorial Hospital - Kaohsiung

    Kaohsiung City, 833

  • China Medical University Hospital

    Taichung, 40447

  • National Cheng Kung University Hospital

    Tainan, Tainan, 704

  • Chi Mei Hospital, Liouying

    Tainan, 73657

  • Taipei Veterans General Hospital

    Taipei, 11217

  • National Taiwan University Hospital

    Taipei

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan City, 333

Other trials in Taiwan

Australia6 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia

  • Monash Medical Centre

    Bentleigh East, Victoria

  • Chris O'Brien Lifehouse Hospital

    Camperdown, New South Wales

  • Blacktown Hospital

    Darlinghurst, New South Wales

  • Peninsula & South Eastern Haematology and Oncology Group

    Frankston, Victoria

  • St John of God Hospital Subiaco

    Subiaco, Western Australia

Other trials in Australia

Italy6 sites

  • Azienda Socio Sanitaria Territoriale di Cremona (ASST)

    Cremona, 26100

  • Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST

    Meldola, 47014

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    Milan, 20122

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162

  • Istituto Oncologico Veneto - I.R.C.C.S.

    Padova, 35128

  • Policlinico Universitario Campus Biomedico Di Roma

    Roma, 00128

Other trials in Italy

Thailand6 sites

  • Chulalongkorn University

    Bangkok, 10330

  • Ramathibodi Hospital Mahidol University

    Bangkok

  • Maharaj Nakorn Chiang Mai Chiang Mai University

    Chiang Mai, 50200

  • Songklanagarind Hospital, Prince of Songkla University

    Hat Yai, Changwat Songkhla, 90110

  • Srinagarind Hospital

    Khon Kaen

  • Naresuan University

    Phitsanulok

Other trials in Thailand

United Kingdom5 sites

  • The Clatterbridge Cancer Centre NHS Foundation Trust

    Bebington, Wirral, CH63 4JY

  • Guys Hospital

    London, SE1 9RT

  • The Christie NHS Foundation Trust - PPDS

    Manchester, M20 4BX

  • Nottingham City Hospital

    Nottingham, Nottinghamshire, NG5 1PB

  • Royal Marsden Hospital

    Sutton, Surrey, SM2 5PT

Other trials in United Kingdom

Canada4 sites

  • Cross Cancer Institute

    Edmonton, Alberta

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • Ottawa Hospital

    Ottawa, Ontario, K1H 8L6

  • St. Josephs Health Centre

    Toronto, Ontario

Other trials in Canada

Germany4 sites

  • Klinikum Dortmund gGmbH

    Dortmund, 44137

  • University Clinic Heidelberg

    Heidelberg, 69120

  • Klinikum rechts der Isar der Technischen Universität München

    München, Bavaria, 81675

  • Universitätsklinikum Tübingen

    Tübingen, Baden-Wurttemberg, 72076

Other trials in Germany

Belgium3 sites

  • Cliniques Universitaires Saint-Luc

    Brussels, Brussels Capital, 1200

  • Grand Hopital de Charleroi

    Charleroi, 6000

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650

Other trials in Belgium

Puerto Rico1 site

  • Hospital Oncologico, Puerto Rico Medical Center

    Rio Piedras, 00935

Other trials in Puerto Rico

About this study

Official title: A Phase 3 Multicenter, Open-Label, Randomized, Controlled Study of Oral Infigratinib Versus Gemcitabine With Cisplatin in Subjects With Advanced/Metastatic or Inoperable Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations: The PROOF Trial

Infigratinib is an oral drug which selectively binds to fibroblast growth factor receptor (FGFR) 2 and is being developed to treat participants with FGFR2 mutated cholangiocarcinoma. The purpose of the study is to evaluate the efficacy and safety of the investigational agent oral infigratinib vs standard of care chemotherapy (gemcitabine plus cisplatin) in first-line treatment of participants with unresectable locally advanced or metastatic cholangiocarcinoma with FGFR2 fusion/rearrangement. Subjects will be randomized 2:1 to receive infigratinib or gemcitabine plus cisplatin.

Being tested
BGJ398, Gemcitabine, Cisplatin
Keywords
cholangiocarcinoma, unresectable cholangiocarcinoma, metastatic cholangiocarcinoma, fibroblast growth factor receptor inhibitor, FGFR2, FGFR2 gene fusions/translocations, BGJ398
Medical subject headings
Cholangiocarcinoma

What participants receive

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

  • BGJ398Drug

    Also called Infigratinib

    Infigratinib (BGJ398) 125 mg orally daily, 3 weeks on, 1 week off.

  • GemcitabineDrug

    Gemcitabine 1000 mg/m2 IV D1 and D8 for a 21-day cycle. Participants who experience disease progression while receiving gemcitabine + cisplatin will be allowed to cross over and receive infigratinib.

  • CisplatinDrug

    Cisplatin 25 mg/m2 IV D1 and D8 for a 21-day cycle. Participants who experience disease progression while receiving gemcitabine + cisplatin will be allowed to cross over and receive infigratinib.

Study groups in NCT03773302
Study groupRoleWhat they receive
Infigratinib (BGJ398) 125 mgExperimentalInfigratinib (BGJ398) 125 mg orally daily, 3 weeks on, 1 week off.
Receives: Drug: BGJ398
Gemcitabine + CisplatinActive comparatorParticipants who experience disease progression while receiving gemcitabine + cisplatin will be allowed to cross over and receive infigratinib if certain criteria are met.
Receives: Drug: Gemcitabine; Drug: Cisplatin

What is being measured

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

  1. Progression-free Survival (Central Imaging Assessment)

    Defined as the time from randomization until date of disease progression by blinded independent central imaging assessment (Response Evaluation Criteria in Solid Tumors [RECIST] v. 1.1) or death, whichever occurs first.

    Measured: From the time of randomization to end of treatment due to confirmed disease progression or death. Note: PFS is an event driven endpoint. Subjects without confirmed disease progression at the end of study were censored at their last valid tumor assessment.

Secondary outcomes (8)

  1. Overall Survival (OS) in Participants Treated With Infigratinib Versus Gemcitabine With Cisplatin

    OS by investigator assessment, defined as time from date of randomization until death due to any cause

    Measured: From the time of randomization to time of death. Note: OS is an event driven endpoint. Subjects who had not died (no record of death) or were lost to follow-up were censored at the date of last known to be alive.

  2. Investigator Assessed Progression Free Survival in Participants Treated With Infigratinib Compared to Gemcitabine and Cisplatin

    Defined as the time from randomization until date of disease progression by site investigator (RECIST v1.1) or death, whichever occurs first.

    Measured: From the time of randomization to end of treatment due to confirmed disease progression or death. Note: PFS is an event driven endpoint. Subjects without confirmed disease progression at the end of study were censored at their last valid tumor assessment.

  3. Overall Response Rate (ORR) Determined by Blinded Independent Central (BICR) and Investigator Assessment

    ORR is defined as the proportion of subjects with a best overall response (BOR) of either confirmed partial response (PR) or confirmed complete response (CR) as assessed by BICR and the investigator according to RECIST v1.1 among patients with measurable disease at baseline

    Measured: From the time of randomization to end of study treatment (an average of approx.6.5 months [max: 23 months] for the infigratinib arm and approx. 4 months [max: 11-13 months] for the gemcitabine + cisplatin arm up to the time of termination of the study).

  4. Best Overall Response (BOR) Determined by Blinded Independent Central Assessment and the Investigator.

    BOR was defined as the best response a subject ever achieved after study treatment prior to crossover and any subsequent anticancer therapy, complete response (CR) and partial response (PR) were claimed only if the criteria for each were met at a subsequent time point at least 4 weeks apart. In the case of stable disease (SD), measurements must have met the SD criteria at least once post-baseline no less than 6 weeks from the randomization date.

    Measured: From the time of randomization to end of study treatment (an average of approx.6.5 months [max: 23 months] for the infigratinib arm and approx. 4 months [max: 11-13 months] for the gemcitabine + cisplatin arm up to the time of termination of the study).

  5. Duration of Response (DOR) Determined by Blinded Independent Central Assessment and the Investigator.

    DOR is defined as the time from initiation of confirmed partial response (PR) or confirmed complete response (CR) to the time of confirmed progressive disease (PD) or death. If subjects do not reach PD or death before crossover, the DOR is censored at the last valid tumor assessment before crossover.

    Measured: From the time of randomization to end of study treatment (an average of approx.6.5 months [max: 23 months] for the infigratinib arm and approx. 4 months [max: 11-13 months] for the gemcitabine + cisplatin arm up to the time of termination of the study).

  6. Disease Control Rate (DCR=PR+CR+SD) Determined by Blinded Independent Central Assessment and the Investigator.

    DCR is defined as the proportion of subjects with a best overall response (BOR) of either confirmed partial response (PR), confirmed complete response (CR) or stable disease (SD) or non-CR/non-PD before crossover.

    Measured: From the time of randomization to end of study treatment (an average of approx.6.5 months [max: 23 months] for the infigratinib arm and approx. 4 months [max: 11-13 months] for the gemcitabine + cisplatin arm up to the time of termination of the study).

  7. Number of Participants With Adverse Events (AEs)

    Safety analyses were performed for subjects in the safety analysis population for each group. Unless otherwise specified, summaries were provided only for the on-treatment safety assessments, which are the assessments occurring or taken during the on-treatment period

    Measured: From baseline to last dose date of study treatment + 30 days (an average of 7.5 months for the infigratinib arm and 5 months for the gemcitabine + cisplatin arm).

  8. Number of Participants With Serious Adverse Events (SAEs)

    Safety analyses were performed for subjects in the safety analysis population for each group. Unless otherwise specified, summaries were provided only for the on-treatment safety assessments, which are the assessments occurring or taken during the on-treatment period

    Measured: From baseline to last dose date of study treatment + 30 days (an average of 7.5 months for the infigratinib arm and 5 months for the gemcitabine + cisplatin arm).

Timeline

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

  1. First posted12 Dec 2018
  2. Study start27 Dec 2019
  3. Primary completion2 Mar 2023
  4. Study completion2 Mar 2023

Why it stopped: The sponsor has decided to close the study due to the discontinuation of infigratinib development in oncology within the sponsor's territory. The discontinuation of the study was not due to safety issues.

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
Model description
Multicenter, Open Label, 2:1 Randomized, Controlled Phase 3
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03773302
Sponsor's protocol ID
QBGJ398-301
Other IDs
2018-004004-19, 2018
Status last verified
Apr 2024
First submitted
10 Dec 2018
Last updated
8 May 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Makawita S, K Abou-Alfa G, Roychowdhury S, Sadeghi S, Borbath I, Goyal L, Cohn A, Lamarca A, Oh DY, Macarulla T, T Shroff R, Howland M, Li A, Cho T, Pande A, Javle M. Infigratinib in patients with advanced cholangiocarcinoma with FGFR2 gene fusions/translocations: the PROOF 301 trial. Future Oncol. 2020 Oct;16(30):2375-2384. doi: 10.2217/fon-2020-0299. Epub 2020 Jun 25.

    PubMed 32580579

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BGJ398, Gemcitabine and Cisplatin in people with Advanced Cholangiocarcinoma and FGFR2 Gene Mutation, run by QED Therapeutics, a BridgeBio company at 116 sites in 15 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 6 inclusion and 21 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 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 116 sites in United States, Spain, France, Portugal, China and 10 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 8 May 2024). 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 (Central Imaging Assessment) (time frame: From the time of randomization to end of treatment due to confirmed disease progression or death. Note: PFS is an event driven endpoint. Subjects without confirmed disease progression at the end of study were censored at their last valid tumor assessment.). 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 NCT03773302, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.

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