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Locally Advanced Solid TumorsPhase 1/2NCT04094610

A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations

A Phase 1/2 study testing Oral repotrectinib (TPX-0005) in people with Locally Advanced Solid Tumors and Metastatic Solid Tumors, run by Turning Point Therapeutics, Inc. at 68 sites in 11 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

Phase 1 will evaluate the safety and tolerability at different dose levels of repotrectinib in pediatric and young adult subjects with advanced or metastatic malignancies harboring anaplastic lymphoma kinase (ALK), receptor tyrosine kinase encoded by the gene ROS1 (ROS1), or neurotrophic receptor kinase genes encoding… Read more about this study

Who is it for?
Ages Up to 25 years
What is being tested?
Oral repotrectinib (TPX-0005)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
68 sitesin 11 countries
Study dates
12 Mar 2020to 30 Sep 2027
Phase
Phase 1/2
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 Up to 25 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Documented genetic ROS1 point mutation, fusion, or amplification or NTRK1-3 fusion as identified by local testing in a Clinical Laboratory Improvement Amendments (CLIA) laboratory in the US or equivalently accredited diagnostic lab outside the United States (US) is required.
  • Phase 1: Age <12 years; Phase 2: Age 12- 25 years
  • Prior cytotoxic chemotherapy is allowed.
  • Prior immunotherapy is allowed.
  • Resolution of all acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 Grade less than or equal to 1.
  • All subjects must have measurable disease by RECIST v1.1 or Response Assessment in Neuro-Oncology (RANO) criteria at time of enrollment.
Show all 16Show fewer
  • Subjects with a primary CNS tumor or CNS metastases must be neurologically stable on a stable or decreasing dose of steroids for at least 7 days prior to enrollment.
  • Subjects must have a Lansky (< 16 years) or Karnofsky (≥ 16 years) score of at least 50.
  • Life expectancy greater than or equal to 12 weeks, in the investigator's opinion.
  • Adequate hematologic, renal and hepatic function.
  • Phase 2 Inclusion Criteria:
  • Cohort Specific Inclusion Criteria:
  • Cohort 1: Subjects with NTRK fusion gene positive (NTRK+) advanced solid tumors (including primary CNS tumors), that are tropomyosin receptor kinase (TRK) TKI naïve;
  • Cohort 2: subjects with NTRK+ advanced solid tumors (including primary CNS tumors), that are TRK TKI pre-treated;
  • Cohort 3: subjects with advanced solid tumors with ROS1 gene fusions or other ROS1 aberrations (including amplifications and point mutations) with measurable disease.
  • Subjects in Cohorts 1 and 2 must have prospectively confirmed measurable disease by BICR prior to enrollment.

Who cannot join

  • Subjects with neuroblastoma with only bone marrow disease evaluable by bone marrow aspiration only.
  • Major surgery within 14 days (2 weeks) of start of repotrectinib treatment. Central venous access (Broviac, Mediport, etc.) placement does not meet criteria for major surgery.
  • Known active infections requiring ongoing treatment (bacterial, fungal, viral including HIV positivity).
  • Gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would impact drug absorption.
  • Any of the following cardiac criteria:
  • Mean resting corrected QT interval (ECG interval measured from the onset of the QRS complex to the end of the T wave) for heart rate (QTc) > 480 msec obtained from three ECGs, using the screening clinic ECG machine-derived QTc value
Show all 11Show fewer
  • Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block, PR interval > 250 msec)
  • Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, congenital long QT syndrome, family history of long QT syndrome, or any concomitant medication known to prolong the QT interval
  • Peripheral neuropathy of CTCAE ≥grade 2.
  • Subjects being treated with or anticipating the need for treatment with strong CYP3A4 inhibitors or inducers.
  • Any potential allergies to repotrectinib and/or its excipients.

Trial locations and contacts

68 sites in 11 countries. Contact the study team or a site near you to ask about taking part.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact

855-907-3286

Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #. contact

68 sites in 11 countries

United States20 sites, 12 recruiting

  • Children's Healthcare of Atlanta - Egleston Hospital

    Atlanta, Georgia, 30329

    Tobey Macdonald, Site 2119, 000-000-0000

    Recruiting

  • Children's Hospital Colorado - Anschutz Medical Campus

    Aurora, Colorado, 80045

    Margaret Macy, Site 2108, 720-777-8856

    Recruiting

  • Dana Farber Cancer Institute.

    Boston, Massachusetts, 02215

    Steven Dubois, Site 2106, 415-476-3831

    Recruiting

  • Levine Children's Hospital- Pediatric Neuro-Oncology

    Charlotte, North Carolina, 28203

    Chad Jacobsen, Site 2121, 000-000-0000

    Recruiting

  • Local Institution - 2112

    Cleveland, Ohio, 44195

    Completed

  • The University of Texas Southwestern Medical Center - Harold C Simmons Comprehensive Cancer Center

    Dallas, Texas, 75390

    Tanya Carens Watt, Site 2101

    Recruiting

  • Local Institution - 2114

    Hershey, Pennsylvania, 17033

    Completed

  • Baylor College of Medicine

    Houston, Texas, 77030

    Matthew McEvoy, Site 2118

    Recruiting

  • Local Institution - 2104

    Houston, Texas, 77030

    Completed

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027-6062

    Leo Mascarenhas, Site 2111, 323-361-5418

    Recruiting

  • University of California at Los Angeles

    Los Angeles, California, 90095

    Noah Federman, Site 2109, 310-206-7625

    Recruiting

  • St. Jude Children's Research Hospital

    Memphis, Tennessee, 38015

    Alberto Pappo, Site 2103, 901-595-3300

    Recruiting

  • Local Institution - 2110

    New Brunswick, New Jersey, 08901

    Completed

  • Local Institution - 2102

    New York, New York, 10065

    Completed

  • Local Institution - 2105

    Orlando, Florida, 32806

    Completed

  • Local Institution - 2120

    Orlando, Florida, 32827

    Completed

  • Children's Hospital of Philadelphia-Center for Childhood Cancer Research

    Philadelphia, Pennsylvania, 19104

    Theodore Laetsch, Site 2117, 267-425-5544

    Recruiting

  • Children's Hospital of Richmond at VCU

    Richmond, Virginia, 23219

    Withdrawn

  • Maine Medical Center

    Scarborough, Maine, 04074

    Stanley Chaleff, Site 2115, 207-396-7565

    Recruiting

  • Washington University School of Medicine in St. Louis

    St Louis, Missouri, 63110

    Andrew Cluster, Site 2113, 443-745-4180

    Recruiting

Other trials in United States

Spain11 sites, 11 recruiting

  • Local Institution - 6105

    Barcelona, 08014

    Site 6105

    Not yet recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, 8035

    Maria Paula Perez Albert, Site 4103

    Recruiting

  • Hospital Sant Joan De Deu

    Esplugues de Llobregat, Barcelona, 08950

    Alicia Castaneda Heredia, Site 4106, 34932532100

    Recruiting

  • Hospital Infantil Universitario Nino Jesus

    Madrid, 28009

    Alvaro Lassaletta, Site 4105, +34915035938

    Recruiting

  • Local Institution - 6106

    Madrid, 28009

    Site 6106

    Not yet recruiting

  • Clinica Universidad de Navarra

    Madrid, 28022

    Elena Panizo Morgado, Site 4101, 34913531920

    Recruiting

  • HM Sanchinarro University Hospital

    Madrid, 28050

    Marta Osuna Marco, Site 4104, 34917089935

    Recruiting

  • Clínica Universidad de navarra

    Pamplona, Navarre, 31008

    Elena Panizo Morgado, Site 4102, 34913531920

    Recruiting

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

    Jose Luis Moreno, Site 4108, 955012000

    Recruiting

  • Hospital Universitario Y Politecnico La Fe

    Valencia, 46026

    Antonio Juan Ribelles, Site 4107, 961244190

    Recruiting

  • Local Institution - 6107

    Valencia, 46026

    Site 6107

    Not yet recruiting

Other trials in Spain

France10 sites, 10 recruiting

  • Centre Hospitalier Universitaire D'Angers

    Angers, 49933

    Emilie De Carli, Site 4203, 0241353863

    Recruiting

  • Centre Hospitalier Universitaire de Bordeaux - Groupe Hospitalier Pellegrin

    Bordeaux, 33076

    Stephane Ducassou, Site 4201, 0557820438

    Recruiting

  • Local Institution - 6111

    Lyon, Rhone, 69008

    Site 6111

    Not yet recruiting

  • Institut d Hematologie et d Oncologie Pediatriques

    Lyon, 69373

    Nadege Corradini, Site 4204, 33478782642

    Recruiting

  • Hôpitaux Universitaires de Marseille Timone

    Marseille, 13385

    Nicolas Andre, Site 4205, 33491386821

    Recruiting

  • Local Institution - 6110

    Marseille, 13385

    Site 6110

    Not yet recruiting

  • Local Institution - 6112

    Nantes, 44093

    Site 6112

    Not yet recruiting

  • Local Institution - 6109

    Paris, 75005

    Site 6109

    Not yet recruiting

  • Institut Gustave-Roussy

    Villejuif, 94805

    Samuel Abbou, Site 4202, 142114211

    Recruiting

  • Local Institution - 6108

    Villejuif, 94805

    Site 6108

    Not yet recruiting

Other trials in France

United Kingdom6 sites, 5 recruiting

  • Local Institution - 4403

    Birmingham, B4 6DH

    Completed

  • University Hospital of Wales

    Cardiff, CF14 4XW

    Madeleine Adams, Site 4401, 02920742107

    Recruiting

  • Royal Hosp. for Children

    Glasgow, G51 4TF

    Milind Ronghe, Site 4406

    Recruiting

  • Alder Hey Children's NHS Foundation Trust

    Liverpool, England, L12 2AP

    Lisa Howell, Site 4404, +441512933679

    Recruiting

  • The Royal Marsden NHS Foundation Trust

    London, SW3 6JJ

    Linley Marchall, Site 4405, 209156161

    Recruiting

  • Great Ormond Street Hospital For Children NHS Foundation Trust

    London, WC1N 3JH

    Elwira Szychot, Site 4402, 447849760509

    Recruiting

Other trials in United Kingdom

Australia4 sites, 3 recruiting

  • Perth Childrens Hospital

    Nedlands, Western Australia, 6009

    Nick Gottardo, Site 6101

    Recruiting

  • Local Institution - 6104

    Randwick, New South Wales, 2031

    Site 6104

    Recruiting

  • Children's Health Queensland Hospital and Health Service

    South Brisbane, Queensland, 4101

    Timothy Hassall, Site 6102, 61730681111

    Recruiting

  • Local Institution - 6103

    Westmead, New South Wales, 0

    Completed

Other trials in Australia

Canada4 sites, 4 recruiting

  • University Of Calgary

    Calgary, Alberta, T3B 6A8

    Victor Lewis, Site 2202, 14039557203

    Recruiting

  • Stollery Children'S Hospital

    Edmonton, Alberta, T6G 2B7

    Sunil desai, Site 2201, 17802485415

    Recruiting

  • St Justine Hospital

    Montreal, Quebec, H3T 1C5

    Sebastien Perreault, Site 2205, 4384958893

    Recruiting

  • Children'S Hospital Of Eastern Ontario

    Ottawa, Ontario, K1H 8L1

    Lesleigh Abbott, Site 2203, 61373776002370

    Recruiting

Other trials in Canada

Italy4 sites, 2 recruiting

  • Fondazione IRCCS - Istituto Nazionale dei Tumori

    Milan, 20133

    Michela Casanova, Site 4301, 390223902593

    Recruiting

  • Local Institution - 6113

    Padova, 35128

    Withdrawn

  • Local Institution - 4302

    Rome, 00165

    Site 4302

    Not yet recruiting

  • Local Institution - 6114

    Torino, 10126

    Withdrawn

Other trials in Italy

South Korea4 sites, 2 recruiting

  • Local Institution - 6303

    Seoul, Seodaemun-gu, 03722

    Completed

  • Seoul National University Hospital

    Seoul, 03080

    Hyoung Jin Kang, Site 6301, 82220723304

    Recruiting

  • Asan Medical Center

    Seoul, 05505

    Kyung Nam Koh, Site 6302, +82230105994

    Recruiting

  • Local Institution - 6304

    Seoul, 06351

    Completed

Other trials in South Korea

Singapore2 sites, 2 recruiting

  • National University Hospital

    Singapore, 119228

    Allen Yeoh, Site 6401, 67724406

    Recruiting

  • KK Women's and Children's Hospital

    Singapore, 229899

    Shui Yen Soh, Site 6402, 6563941045

    Recruiting

Other trials in Singapore

Taiwan2 sites, 1 recruiting

  • Local Institution - 6202

    Taipei, 100225

    Completed

  • Taipei Medical University Hospital

    Taipei, 11031

    Yen-Lin Liu, Site 6201, 886970749572

    Recruiting

Other trials in Taiwan

Denmark1 site, 1 recruiting

  • Rigshospitalet - Glostrup

    Copenhagen, 2100

    Karsten Nysom, Site 4901, 4535450809

    Recruiting

Other trials in Denmark

About this study

Official title: A Phase 1/2, Open-label, Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity Study of Repotrectinib in Pediatric and Young Adult Subjects With Advanced or Metastatic Malignancies Harboring ALK, ROS1, or NTRK1-3 Alterations (CARE)

Phase 1 will evaluate the safety and tolerability at different dose levels of repotrectinib in pediatric and young adult subjects with advanced or metastatic malignancies harboring anaplastic lymphoma kinase (ALK), receptor tyrosine kinase encoded by the gene ROS1 (ROS1), or neurotrophic receptor kinase genes encoding TRK kinase family (NTRK1-3) alterations to estimate the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) and select the Pediatric Recommended Phase 2 Dose (RP2D).

Phase 2 will determine the anti-tumor activity of repotrectinib in pediatric and young adult subjects with advanced or metastatic malignancies harboring ROS1 or NTRK1-3 alterations.

Read the detailed description

Enrollment of subjects into Phase 1 will proceed concurrently by age as follows:

  • Subjects <12 years old will initially be enrolled in the Phase 1 part to determine the pediatric RP2D for this age group; once the pediatric RP2D is determined, subjects age <12 years old may be enrolled into the Phase 2 part of the study.
  • Subjects 12 to 25 years old will be directly enrolled into the Phase 2 part concurrent with Phase 1 enrollment.

Phase 1:

Approximately 12 pediatric subjects with locally advanced or metastatic solid tumors, including a primary central nervous system (CNS) tumor, or anaplastic large cell lymphoma (ALCL), with disease progression or who are non-responsive or intolerant to available therapies and for which no standard or available curative therapy exists.

Phase 2:

Subjects will be enrolled in one of 3 cohorts as follows:

Cohort 1: approximately 15 subjects with solid tumors characterized by NTRK fusion, TRK tyrosine kinase inhibitor (TKI)-naïve, and centrally confirmed measurable disease at baseline.

Cohort 2: approximately 23 subjects with solid tumors characterized by NTRK fusion, TRK TKI-pretreated, and centrally confirmed measurable disease at baseline.

Cohort 3: approximately 23 subjects with solid tumors or ALCL characterized by other ALK/ROS1/NTRK alterations or NTRK fusions without centrally confirmed measurable disease not otherwise eligible for Cohort 1 or 2. As of the current protocol amendment, only patients with ROS1 alterations will be enrolled to this cohort.

Being tested
Oral repotrectinib (TPX-0005)
Keywords
ALK, ROS1, NTRK1-3, Primary CNS tumor, anaplastic large cell lymphoma, metastatic solid tumor, advanced solid tumor, sarcoma, infantile fibrosarcoma, glioblastoma, soft tissue schwannoma, solitary fibrous tumor, glioma, inflammatory myofibroblastic tumor, pediatric
Medical subject headings
Lymphoma, Lymphoma, Large-Cell, Anaplastic, Neoplasm Metastasis, Sarcoma, Glioblastoma, Solitary Fibrous Tumors, Glioma, Granuloma, Plasma Cell

What participants receive

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

  • Oral repotrectinib (TPX-0005)Drug

    Also called Oral repotrectinib (TPX-0005) capsules, Oral repotrectinib (TPX-0005) oral suspension, repotrectinib

    Oral repotrectinib (TPX-0005)

Study groups in NCT04094610
Study groupRoleWhat they receive
Repotrectinib (TPX-0005)ExperimentalPhase 1 Oral repotrectinib (TPX-0005): Safety and tolerability at different dose levels Phase 2 Oral repotrectinib (TPX-0005): 3 cohorts Cohort 1: TKI-naive NTRK fusion Cohort 2: Prior TKI NTRK fusion Cohort 3: ROS1 gene fusions or other ROS1 aberrations
Receives: Drug: Oral repotrectinib (TPX-0005)

What is being measured

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

  1. Dose limiting toxicities (DLTs) (Phase 1)

    Define the dose limiting toxicities (DLTs) (Phase 1)

    Measured: Within 28 days of the first repotrectinib dose

  2. Pediatric Recommended Phase 2 Dose (RP2D) (Phase 1)

    To determine the pediatric RP2D (Phase 1)

    Measured: Within 28 days of the last patient dosed in escalation

  3. Overall Response Rate (ORR) (Phase 2)

    To determine the confirmed ORR of repotrectinib (TPX-0005) as assessed by Blinded Independent Central Review (Phase 2)

    Measured: Two to three years after first dose of repotrectinib

Secondary outcomes (12)

  1. Overall Response Rate (ORR) (Phase 1)

    To determine the overall response rate (ORR) by Blinded Independent Central Review (BICR) (Phase 1)

    Measured: Approximately three years

  2. Clinical Benefit Rate (CBR) (Phase 1 and Phase 2)

    To determine the CBR of repotrectinib (TPX-0005) (Phase 1 and Phase 2)

    Measured: Approximately three years

  3. Time to response (TTR) (Phase 1 and Phase 2)

    To determine the TTR of reprotrectinib (TPX-005) (Phase 1 and Phase 2)

    Measured: Approximately three years

  4. Duration of response (DOR) (Phase 1 and Phase 2)

    To determine the DOR of repotrectinib (TPX-0005) (Phase 1 and Phase 2)

    Measured: Approximately three years

  5. Intracranial objective response rate (IC-ORR) (Phase 1 and Phase 2)

    To determine the IC-ORR of repotrectinib in subjects with measurable brain metastases (TPX-005) (Phase 1 and Phase 2)

    Measured: Approximately three years

  6. Central Nervous System Progression-Free Survival (CNS-PFS) (Phase 2)

    CNS-PFS in subjects with measurable brain metastases (Phase 2)

    Measured: Approximately three years

  7. Progression-free survival (PFS) (Phase 2)

    To determine the PFS (Phase 2)

    Measured: Approximately three years

  8. Overall survival (OS) (Phase 2)

    To determine the OS (Phase 2)

    Measured: Approximately three years

  9. Maximum concentration of repotrectinib in plasma (Cmax)

    To determine the Cmax

    Measured: Pre-dose and up to 24 hours post-dose on Day 1 and Day 15 in Cycle 1 (each cycle is 28 days)

  10. Area under the concentration versus time curve of repotrectinib in plasma (AUC)

    To determine the AUC

    Measured: Pre-dose and up to 24 hours post-dose on Day 1 and Day 15 in Cycle 1 (each cycle is 28 days)

  11. Number of participants with laboratory abnormalities

    Measured: Approximately three years

  12. Number of Participants with Adverse events

    Measured: Approximately three years

Timeline

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

  1. First posted19 Sep 2019
  2. Study start12 Mar 2020
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Sep 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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04094610
Sponsor's protocol ID
CA127-1029
Other IDs
CA127-1029, TPX-0005-07, 2023-506464-14, 2023
Status last verified
Sep 2026
First submitted
12 Sep 2019
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Expanded access
Available

Publications

  • Wachter F, Al-Ibraheemi A, Trissal MC, Hollowell M, DuBois SG, Collins NB, Church AJ, Janeway KA. Molecular Characterization of Inflammatory Tumors Facilitates Initiation of Effective Therapy. Pediatrics. 2021 Dec 1;148(6):e2021050990. doi: 10.1542/peds.2021-050990.

    PubMed 34814185

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Oral repotrectinib (TPX-0005) in people with Locally Advanced Solid Tumors and Metastatic Solid Tumors, run by Turning Point Therapeutics, Inc. at 68 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 11 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 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 68 sites in United States, Spain, France, United Kingdom, Australia and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

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 BMS Clinical Trials Contact Center www.BMSClinicalTrials.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose limiting toxicities (DLTs) (Phase 1) (time frame: Within 28 days of the first repotrectinib dose). The study lists 3 primary outcomes in all. 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 NCT04094610, 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 25 Sep 2026.

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