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Biliary Tract CancerPhase 2NCT02711553

A Study of Ramucirumab (LY3009806) or Merestinib (LY2801653) in Advanced or Metastatic Biliary Tract Cancer

A Phase 2 study testing Ramucirumab, Merestinib and Cisplatin in people with Biliary Tract Cancer and Metastatic Cancer, run by Eli Lilly and Company at 82 sites in 18 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 main purpose of this study is to evaluate the efficacy and safety of ramucirumab or merestinib or placebo plus cisplatin and gemcitabine in participants with advanced or metastatic biliary tract cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ramucirumab, Merestinib and Cisplatin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
309 participants
Where
82 sitesin 18 countries
Study dates
19 May 2016to Dec 2026
Phase
Phase 2
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

  • Have an Eastern Cooperative Oncology Group performance status of 0 or 1.
  • Have a histologically or cytologically confirmed diagnosis of non-resectable, recurrent, or metastatic biliary tract adenocarcinoma (intrahepatic or extrahepatic cholangiocarcinoma, gallbladder cancer, or Ampulla of Vater) .
  • Have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST).
  • Have adequate biliary drainage.
  • Have adequate organ function.
  • Males and females are sterile, postmenopausal, or compliant with a highly effective contraceptive method.
  • Female participants of childbearing potential must have a negative serum pregnancy test within 7 days prior to first dose.
  • Are willing to provide blood/serum/plasma and tumor tissue samples for research purposes. Submission of blood/serum/plasma and tumor tissue samples is mandatory for participation in this study, unless restricted per local regulations.

Who cannot join

  • Previous systemic therapy for locally advanced or metastatic disease is not allowed.
  • Have a history of or have current hepatic encephalopathy of any grade, or ascites of Grade >1, or cirrhosis with Child-Pugh Stage B or higher.
  • Have ongoing or recent (≤6 months) hepatorenal syndrome.
  • Have had a major surgical procedure or significant traumatic injury including nonhealing wound, peptic ulcer, or bone fracture ≤28 days prior to randomization.
  • Anticipate having a major surgical procedure during the course of the study.
  • Has documented brain metastases, leptomeningeal disease, or uncontrolled spinal cord compression.
Show all 15Show fewer
  • Within 6 months prior to randomization, have had any arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack.
  • Have an uncontrolled arterial hypertension with systolic blood pressure ≥150 or diastolic blood pressure ≥90 millimeters of mercury (mm Hg) despite standard medical management.
  • Have a previous malignancy within 5 years of study entry or a concurrent malignancy.
  • Have a history of gastrointestinal perforation and/or fistulae within 6 months prior to randomization.
  • Have a known allergy or hypersensitivity reaction to any of the treatment components.
  • Have a history of uncontrolled hereditary or acquired thrombotic disorder.
  • Have uncontrolled metabolic disorders or other nonmalignant organ or systemic diseases or secondary effects of cancer that induce a high medical risk and/or make assessment of survival uncertain.
  • Have mixed hepatocellular biliary tract cancer histology.
  • Have a corrected QT interval >470 milliseconds as calculated by the Fridericia equation.

Trial locations and contacts

82 sites in 18 countries.

82 sites in 18 countries

United States13 sites

  • Washington University Medical School

    City of Saint Peters, Missouri, 63376

  • Washington University Medical School

    Creve Coeur, Missouri, 63141

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • University of Florida School of Medicine

    Gainesville, Florida, 32608

  • Florida Cancer Specialists

    Nashville, Tennessee, 37203

  • Tennessee Oncology PLLC

    Nashville, Tennessee, 37203

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111-2497

  • UCSF Medical Center at Mission Bay

    San Francisco, California, 94158

  • Washington University Medical School

    St Louis, Missouri, 63110

  • Washington University Medical School

    St Louis, Missouri, 63129

  • The University of Arizona Cancer Center

    Tucson, Arizona, 85724

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

Other trials in United States

Argentina8 sites

  • Alexander Fleming

    CABA, BS, 1426

  • Hospital de Gastroenterologia Udaondo

    Capital Federal, Buenos Aires, C1264AAA

  • Fundacion Favaloro

    Ciudad de Buenos Aires, 1093

  • Fundación CORI para la Investigación y Prevención del Cáncer

    La Rioja, F5300COE

  • Centro Polivalente de Asistencia e Inv. Clinica CER-San Juan

    San Juan, J5402DIL

  • Centro Medico San Roque

    San Miguel de Tucumán, Tucumán Province, 4000

  • Fundacion Ars Medica

    San Salvador de Jujuy, Jujuy Province, Y4600APW

  • Clinica Viedma

    Viedma, Río Negro Province, R8500ACE

Other trials in Argentina

France7 sites

  • CHU de Besancon Hopital Jean Minjoz

    Besançon, 25030

  • CHU de Bordeaux Hop St ANDRE

    Bordeaux, Gironde, 33075

  • Hôpital C. HURIEZ

    Lille, 59037

  • Centre Leon Berard

    Lyon, Auvergne-Rhône-Alpes, 69008

  • CHRU de Montpellier-Hopital St Eloi

    Montpellier, 34295

  • Centre Antoine-Lacassagne

    Nice, 06189

  • Gustave Roussy

    Villejuif, 94805

Other trials in France

Germany6 sites

  • HELIOS Klinikum Berlin-Buch

    Berlin, 13125

  • Universitätsklinikum Erlangen

    Erlangen, Bavaria, 91054

  • Universitaetsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Medizinische Hochschule Hanover

    Hanover, Lower Saxony, 30625

  • Universitätsklinikum Tübingen

    Tübingen, Baden-Wurttemberg, 72076

  • Universitätsklinikum Ulm

    Ulm, Baden-Wurttemberg, 89081

Other trials in Germany

Spain5 sites

  • Hospital Clínico Universitario de Valencia

    Barcelona, 46010

  • Hospital Duran I Reynals

    L'Hospitalet de Llobregat, Barcelona, 08908

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

  • Hospital Clinico de San Carlos

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

Other trials in Spain

Taiwan5 sites

  • Chang Gung Memorial Hospital - Kaohsiung Branch

    Kaohsiung City, 83301

  • China Medical University Hospital

    Taichung, 40447

  • National Cheng-Kung Uni. Hosp.

    Tainan, 704

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Chang Gung Memorial Hospital - Linkou

    Taoyuan City, 33305

Other trials in Taiwan

Turkey (Türkiye)5 sites

  • Baskent University Dr. Turgut Noyan Research and Training Center

    Adana, 1250

  • Hacettepe University Faculty of Medicine

    Ankara, 06100

  • Akdeniz University Medical Faculty

    Antalya, 07059

  • Trakya University

    Edirne, 22030

  • Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi Yerleskesi

    Istanbul, 34098

Other trials in Turkey (Türkiye)

United Kingdom5 sites

  • Hammersmith Hospital

    Acton, London, W12 0HS

  • The Clatterbridge Cancer Centre

    Bebbington, Merseyside, CH63 4JY

  • University College Hospital - London

    London, Greater London, NW1 2BU

  • The Christie NHS Foundation Trust

    Manchester, Greater Manchester, M20 4BX

  • Royal Marsden Hospital

    Sutton, Surrey, SM2 5PT

Other trials in United Kingdom

Russia4 sites

  • Arkhangelsk Clinical Oncological Dispensary

    Arkhangelsk, 163045

  • Blokhin Cancer Research Center

    Moscow, 115478

  • Russian Scientific Center of Radiology and Surgical Technologies

    Saint Petersburg, Sankt-Peterburg, 197758

  • Saint-Petersburg City Clinical Oncology Dispensary

    Saint Petersburg, 198255

Other trials in Russia

South Korea4 sites

  • Asan Medical Center

    Seoul, Korea, 05505

  • Seoul National University Hospital

    Seoul, Seoul, Korea, 03080

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

Australia3 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Austin Health

    Heidelberg, Victoria, 3084

  • Calvary Mater Newcastle

    Waratah, New South Wales, 2298

Other trials in Australia

Austria3 sites

  • Universitätsklinikum Salzburg

    Salzburg, 5020

  • KH der Barmherzigen Brüder Wien

    Vienna, 1020

  • Landesklinikum Wr. Neustadt

    Wiener Neustadt, Lower Austria, 2700

Other trials in Austria

Belgium3 sites

  • Cliniques universitaires Saint-Luc

    Brussels, Brussels Capital, 1200

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

    Leuven, 3000

Other trials in Belgium

Czechia3 sites

  • Masarykuv onkologicky ustav

    Brno, Brno-město, 656 53

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05

  • Fakultni Nemocnice v Motole

    Prague, 150 06

Other trials in Czechia

Denmark2 sites

  • Aarhus Universitetshospital, Aarhus Sygehus

    Aarhus C, 8000

  • Odense Universitetshospital

    Odense C, 5000

Other trials in Denmark

Hungary2 sites

  • Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet

    Budapest, 1097

  • Debreceni Egyetem Klinikai Kozpont Onkologiai Tanszek

    Debrecen, Hajdú-Bihar, 4032

Other trials in Hungary

Mexico2 sites

  • Arke Estudios Clinicos S.A. de C.V.

    Mexico City, Mexico City, 06700

  • Centro de Alta Especialidad Reumatologia Inv del Potosi SC

    San Luis Potosí City, 78213

Other trials in Mexico

Sweden2 sites

  • Skåne universitetssjukhus

    Malmö, 20502

  • Karolinska Universitetssjukhuset i Solna

    Stockholm, 17176

Other trials in Sweden

About this study

Official title: Randomized, Double-Blind, Phase 2 Study of Ramucirumab or Merestinib or Placebo Plus Cisplatin and Gemcitabine as First-Line Treatment in Patients With Advanced or Metastatic Biliary Tract Cancer

The main purpose of this study is to evaluate the efficacy and safety of ramucirumab or merestinib or placebo plus cisplatin and gemcitabine in participants with advanced or metastatic biliary tract cancer.

Being tested
Ramucirumab, Merestinib, Cisplatin, Gemcitabine, Placebo Oral
Medical subject headings
Biliary Tract Neoplasms, Neoplasm Metastasis

What participants receive

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

  • RamucirumabDrug

    Also called LY3009806

    Administered IV

  • MerestinibDrug

    Also called LY2801653

    Administered orally

  • CisplatinDrug

    Administered IV

  • GemcitabineDrug

    Also called LY188011

    Administered IV

  • Placebo OralDrug

    Administered orally

  • Placebo IVDrug

    Administered IV

Study groups in NCT02711553
Study groupRoleWhat they receive
8 mg/kg Ramucirumab + 25 mg/m² Cisplatin + 1000 mg/m² GemcitabineExperimentalParticipants received 8 mg/kg ramucirumab plus 25 mg/square meter (mg/m²) cisplatin and 1000 mg/m² gemcitabine intravenously (IV) on days 1 and 8, every 21 days (1 cycle). Participants may continue on study drug for up to 8 cycles (for cisplatin and gemcitabine therapy) or until disease progression, unacceptable toxicity, or other withdrawal criterion is met (for ramucirumab therapy).
Receives: Drug: Ramucirumab; Drug: Cisplatin; Drug: Gemcitabine
Placebo IV + 25 mg/m² Cisplatin + 1000 mg/m² GemcitabinePlacebo comparatorParticipants received placebo (indistinguishable and equivalent volume to ramucirumab) plus 25 mg/m² cisplatin and 1000 mg/m² gemcitabine IV on days 1 and 8, every 21 days (1 cycle). Participants may continue on study drug for up to 8 cycles (for cisplatin and gemcitabine therapy) or until disease progression, unacceptable toxicity, or other withdrawal criterion is met (for placebo therapy).
Receives: Drug: Cisplatin; Drug: Gemcitabine; Drug: Placebo IV
80 mg Merestinib + 25 mg/m² Cisplatin + 1000 mg/m² GemcitabineExperimentalParticipants received 80 mg merestinib orally each day, plus 25 mg/m² cisplatin and 1000 mg/m² gemcitabine IV on Days 1 and 8, every 21 days (1 cycle). Participants may continue on study drug for up to 8 cycles (for cisplatin and gemcitabine therapy) or until disease progression, unacceptable toxicity, or other withdrawal criterion is met (for merestinib therapy).
Receives: Drug: Merestinib; Drug: Cisplatin; Drug: Gemcitabine
Placebo Oral + 25 mg/m² Cisplatin + 1000 mg/m² GemcitabinePlacebo comparatorParticipants received placebo (indistinguishable to merestinib) orally each day, plus 25 mg/m² cisplatin and 1000 mg/m² gemcitabine IV on Days 1 and 8, every 21 days. Participants may continue on study drug for up to 8 cycles (for cisplatin and gemcitabine therapy) or until disease progression, unacceptable toxicity, or other withdrawal criterion is met (for placebo therapy).
Receives: Drug: Cisplatin; Drug: Gemcitabine; Drug: Placebo Oral

What is being measured

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

  1. Progression Free Survival (PFS)

    PFS time was measured from the date of randomization until the first radiographic documentation of progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of first dose, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.

    Measured: Randomization to Progressive Disease or Death from Any Cause (Up To 20 Months)

Secondary outcomes (9)

  1. Overall Survival (OS)

    OS defined as the time from from randomization to the date of death due to any cause. For each participant who is not known to have died as of the data-inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive.

    Measured: Randomization to Date of Death from Any Cause (Up To 48 Months)

  2. Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR): Objective Response Rate (ORR)

    ORR was the number of participants who achieve a best overall response of CR or PR divided by the total number of participants randomized to the corresponding treatment arm as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.

    Measured: Randomization to Disease Progression (Up To 30 Months)

  3. Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD): Disease Control Rate (DCR)

    Disease Control Rate (DCR) was the number of participants who achieve a best overall response of CR, PR, or SD divided by the total number of participants randomized to the corresponding treatment arm as per RECIST v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.

    Measured: Randomization to Disease Progression (Up To 30 Months)

  4. Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab

    PK was determined by the minimum observed plasma concentration (Cmin). 1 Cycle (C) = 21 days (D).

    Measured: C1 D8, C2 D1, C3 D1, C4 D1,C5 D1,C7 D1, C9 D1 and C13 D1: Within 3 days Prior to Infusion(PTI)

  5. PK: Plasma Concentration of Merestinib

    PK was presented through graphical overlay comparison versus historic data. No numerical summary of data was intended or produced.

    Measured: C1 D8; C2 D1; C4 D1; C6 D1; C8 D1; C2 D8; C4 D8; C6 D8; C8 D8: Morning

  6. Number of Participants With Treatment-Emergent Anti-Ramucirumab Antibodies

    Number of participants with positive treatment emergent anti-ramucirumab antibodies (ADA) was summarized by treatment group.

    Measured: Predose Cycle 1 Day 1 through Follow Up (Up To 48 Months)

  7. Change From Baseline in Functional Assessment of Cancer Therapy Hepatobiliary Questionnaire (FACT-Hep)

    FACT-Hep consists of 45 items in five subscales (1) physical well-being (PWB) score rage 0 -28; (2) social well-being (SWB) score range 0-28; (3) emotional well-being (EWB) score range 0-24; (4) functional well-being (FWB) score range 0-28; and (5) the hepatobiliary cancer subscale (HCS) Score range 0-72. The Trial Outcomes Index (TOI) is the sum of the PWB, FWB and Hep subscales with a scores range of 0 to 128. The Total FACT-Hep score was the sum of all questions with a scores range of 0 to 180.Total FACT-G score was the sum of the 27 questions in the PWB, SFWB, EWB and FWB with a scores range of 0 to 108. The FACT-Hep Symptoms Index with 8 key questions and scores range of 0 to 32 from the Hep Subscale. Higher score in sub-score or total score indicates better QOL and better health state. Participants were classified as "Improved" if they had positive change from baseline, "Worsened" if they had negative change from baseline, and "Stable" otherwise.

    Measured: Baseline, Follow Up (Up To 48 Months)

  8. Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score

    EQ-5D-5L is a 2-part questionnaire that assesses general health status for 'today'. The first part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using country-specific algorithms, with scores ranging from less than 0 (where zero is a health state equivalent to death; negative values are valued as worse than dead) to 1 (perfect health). Index values were calculated using the US algorithm (-0.109 to 1). A higher score indicates better health state.

    Measured: Baseline, Follow Up (Up To 48 Months)

  9. Change From Baseline in Participant-Reported EQ-5D-5L Visual Analog Scale (VAS) Score

    EQ-5D-5L is a 2-part questionnaire that assesses general health status 'today'. The second part is assessed using a VAS on which the patient rates their perceived health state, ranging from 0 millimeter (the worst health you can imagine) to 100 millimeter (the best health you can imagine).

    Measured: Baseline, Follow Up (Up To 48 Months)

Timeline

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

  1. First posted17 Mar 2016 (estimated)
  2. Study start19 May 2016
  3. Primary completion16 Feb 2018
  4. Study completionDec 2026 (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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
309 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02711553
Sponsor's protocol ID
16329
Other IDs
I3O-MC-JSBF, 2015-004699-31, 2015
Status last verified
Jul 2026
First submitted
14 Mar 2016
Last updated
22 Jul 2026
Data monitoring committee
No
Individual data sharing
Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Publications

  • Valle JW, Vogel A, Denlinger CS, He AR, Bai LY, Orlova R, Van Cutsem E, Adeva J, Chen LT, Obermannova R, Ettrich TJ, Chen JS, Wasan H, Girvan AC, Zhang W, Liu J, Tang C, Ebert PJ, Aggarwal A, McNeely SC, Moser BA, Oliveira JM, Carlesi R, Walgren RA, Oh DY. Addition of ramucirumab or merestinib to standard first-line chemotherapy for locally advanced or metastatic biliary tract cancer: a randomised, double-blind, multicentre, phase 2 study. Lancet Oncol. 2021 Oct;22(10):1468-1482. doi: 10.1016/S1470-2045(21)00409-5.

    PubMed 34592180

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ramucirumab, Merestinib and Cisplatin in people with Biliary Tract Cancer and Metastatic Cancer, run by Eli Lilly and Company at 82 sites in 18 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 8 inclusion and 15 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 22 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 82 sites in United States, Argentina, France, Germany, Spain and 13 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Feb 2021). 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: Randomization to Progressive Disease or Death from Any Cause (Up To 20 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 NCT02711553, 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 22 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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