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Urothelial CancerPhase 2NCT02365597

An Efficacy and Safety Study of Erdafitinib (JNJ-42756493) in Participants With Urothelial Cancer

A Phase 2 study testing Erdafitinib, Midazolam and Metformin in people with Urothelial Cancer, run by Janssen Research & Development, LLC at 105 sites in 15 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 purpose of this study is to evaluate the objective response rate (complete response [CR]+ partial response [PR]) of the selected dose regimen in participants with metastatic or surgically unresectable urothelial cancers that harbor specific FGFR genomic alterations. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Urothelial Cancer
What is being tested?
Erdafitinib, Midazolam and Metformin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
239 participants
Where
105 sitesin 15 countries
Study dates
22 Apr 2015to 31 Mar 2027
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

  • Must have histologic demonstration of metastatic or surgically unresectable urothelial cancer. Minor components of variant histology such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable
  • Must have measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) at baseline
  • Must have an Eastern Cooperative Oncology Group (ECOG) performance status score 0, 1, or 2
  • Must have adequate bone marrow, liver, and renal function as described in protocol
  • Negative pregnancy test (urine or serum beta human chorionic gonadotropin [b-hCG]) at Screening for women of child bearing potential who are sexually active
  • Must have shown disease progression according to RECIST, version 1.1, following prior chemotherapy for metastatic or surgically unresectable urothelial cancer. Participants who received neoadjuvant or adjuvant chemotherapy and showed disease recurrence or progression according to RECIST, version 1.1, within 12 months of the last dose are considered to have received chemotherapy in the metastatic setting. These participants will be referred to as chemo-refractory participants. (Participants who have shown disease progression according to RECIST, version 1.1 following prior treatment with anti-Programmed death-ligand 1 (anti PDL1/PD1) antibodies are also eligible) For DDI substudy
  • Disease progression following prior chemotherapy for metastatic or surgically unresectable urothelial cancer. Participants who received neoadjuvant or adjuvant chemotherapy and showed disease recurrence or progression within 12 months of the last dose are considered to have received chemotherapy in the metastatic setting

Who cannot join

  • Received chemotherapy, targeted therapies, definitive radiotherapy, or treatment with an investigational anticancer agent within 2 weeks (in the case of nitrosoureas and mitomycin C, within 6 weeks; in the case of immunotherapy, within 4 weeks) before the first administration of study drug. Localized palliative radiation therapy (but should not include radiation to target lesions) and ongoing bisphosphonates and denosumab, are permitted
  • Has persistent phosphate level greater than upper limit of normal (ULN) during screening (within 14 days of treatment and prior to Cycle 1 Day 1) and despite medical management
  • Has a history of or current uncontrolled cardiovascular disease
  • Females who are pregnant, breast-feeding, or planning to become pregnant within 3 months after the last dose of study drug and males ho plan to father a child while enrolled in this study or within 5 months after the last dose of study drug
  • Has not recovered from reversible toxicity of prior anticancer therapy (except toxicities which are not clinically significant such as alopecia, skin discoloration, or Grade 1 neuropathy)

Trial locations and contacts

105 sites in 15 countries.

105 sites in 15 countries

United States25 sites

  • Study site

    Aurora, Colorado

  • Study site

    Charlotte, North Carolina

  • Study site

    Chicago, Illinois

  • Study site

    Dallas, Texas

  • Study site

    Denton, Texas

  • Study site

    Hampton, Virginia

  • Study site

    Hershey, Pennsylvania

  • Study site

    Houston, Texas

  • Study site

    Iowa City, Iowa

  • Study site

    Las Vegas, Nevada

  • Study site

    Los Angeles, California

  • Study site

    Louisville, Kentucky

  • Study site

    Medford, Oregon

  • Study site

    Minneapolis, Minnesota

  • Study site

    Myrtle Beach, South Carolina

  • Study site

    Nashville, Tennessee

  • Study site

    New York, New York

  • Study site

    Omaha, Nebraska

  • Study site

    Orange, California

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    Sacramento, California

  • Study site

    Sedona, Arizona

  • Study site

    Stanford, California

  • Study site

    Tualatin, Oregon

  • Study site

    Washington D.C., District of Columbia

Other trials in United States

Germany14 sites

  • Study site

    Berlin

  • Study site

    Erlangen

  • Study site

    Essen

  • Study site

    Freiburg im Breisgau

  • Study site

    Göttingen

  • Study site

    Greifswald

  • Study site

    Hamburg

  • Study site

    Hanover

  • Study site

    Heidelberg

  • Study site

    München

  • Study site

    Münster

  • Study site

    Regensburg

  • Study site

    Straubing

  • Study site

    Weiden/Opf

Other trials in Germany

France11 sites

  • Study site

    Angers

  • Study site

    Bordeaux

  • Study site

    Caen Cédex 05

  • Study site

    Dijon

  • Study site

    Lyon

  • Study site

    Nice

  • Study site

    Nîmes

  • Study site

    Paris

  • Study site

    Saint-Herblain

  • Study site

    Suresnes

  • Study site

    Villejuif

Other trials in France

Spain10 sites

  • Study site

    Badalona

  • Study site

    Barcelona

  • Study site

    Madrid

  • Study site

    Málaga

  • Study site

    Pamplona

  • Study site

    Sabadell

  • Study site

    Santander

  • Study site

    Santiago de Compostela

  • Study site

    Seville

  • Study site

    Valencia

Other trials in Spain

United Kingdom7 sites

  • Study site

    Blackburn

  • Study site

    Dundee

  • Study site

    Essex

  • Study site

    London

  • Study site

    Metropolitan Borough of Wirral

  • Study site

    Plymouth

  • Study site

    Sutton

Other trials in United Kingdom

Israel6 sites

  • Study site

    Beer Yaakov

  • Study site

    Beersheba

  • Study site

    Haifa

  • Study site

    Kfar Saba

  • Study site

    Petah Tikva

  • Study site

    Tel Aviv

Other trials in Israel

Russia6 sites

  • Study site

    Barnaul

  • Study site

    Moscow

  • Study site

    Omsk

  • Study site

    Pyatigorsk

  • Study site

    Saint Petersburg

  • Study site

    Ufa

Other trials in Russia

Belgium5 sites

  • Study site

    Aalst

  • Study site

    Brussels

  • Study site

    Charleroi

  • Study site

    Ghent

  • Study site

    Wilrijk

Other trials in Belgium

India4 sites

  • Study site

    Bangalore

  • Study site

    Kolkata

  • Study site

    Mira Road (East)

  • Study site

    Nadiād

Other trials in India

Romania4 sites

  • Study site

    Bucharest

  • Study site

    Cluj-Napoca

  • Study site

    Craiova

  • Study site

    Iași

Other trials in Romania

South Korea4 sites

  • Study site

    Daejeon

  • Study site

    Goyang-si

  • Study site

    Incheon

  • Study site

    Seoul

Other trials in South Korea

Taiwan4 sites

  • Study site

    Taichung

  • Study site

    Tainan

  • Study site

    Taipei

  • Study site

    Taoyuan

Other trials in Taiwan

Austria3 sites

  • Study site

    Graz

  • Study site

    Linz

  • Study site

    Vienna

Other trials in Austria

Moldova1 site

  • Study site

    Chisinau

Other trials in Moldova

Turkey (Türkiye)1 site

  • Study site

    Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: A Phase 2, Two-arm Multicenter, Open-Label Study to Determine the Efficacy and the Safety of Two Different Dose Regimens of a Pan-FGFR Tyrosine Kinase Inhibitor JNJ-42756493 in Subjects With Metastatic or Surgically Unresectable Urothelial Cancer With FGFR Genomic Alterations

The purpose of this study is to evaluate the objective response rate (complete response [CR]+ partial response [PR]) of the selected dose regimen in participants with metastatic or surgically unresectable urothelial cancers that harbor specific FGFR genomic alterations.

Read the detailed description

This is a multicenter, open-label study (participants will know the identity of study drugs administered) to evaluate the efficacy and safety of erdafitinib in participants with urothelial cancer. The study comprises a 30-days Screening Phase, a Treatment Phase comprised of 28-day treatment cycles that will continue until disease progression or unacceptable toxicity occurs in a long-term extension (LTE) phase, and a post-treatment Follow-up Phase that will extend from the End-of-Treatment Visit until the participant has died, withdraws consent, is lost to follow-up, or the end of the study, whichever comes first. The end of study is defined as the date when all participants have completed the study treatment (Regimens 1 to 3) and all participants enrolled under the drug-drug interaction (DDI) substudy are no longer receiving treatment with erdafitinib. The purpose of DDI sub-study is to evaluate the interaction of repeated doses of erdafitinib with a sensitive cytochrome 450 (CYP) 3A substrate (midazolam) and with an organic cation transporter 2 (OCT2) probe substrate (metformin). Safety will be monitored throughout the study.

Being tested
Erdafitinib, Midazolam, Metformin
Keywords
Urothelial Cancer, JNJ-42756493, Erdafitinib, Tyrosine Kinase Inhibitor

What participants receive

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

  • ErdafitinibDrug

    Also called JNJ-42756493

    8 mg orally once daily for 28 days on a 28 day cycle.

  • MidazolamDrug

    Participants who enrolled in DDI substudy will receive pretreatment with single dose of midazolam on Day -2 and single dose of midazolam on Day 13.

  • MetforminDrug

    Participants who enrolled in DDI substudy will receive pretreatment with single dose of metformin on Day -1 and single dose of metformin on Day 14.

Study groups in NCT02365597
Study groupRoleWhat they receive
Erdafitinib (8 milligram)ExperimentalPrior to interim analysis 1 (IA1), there were 2 treatment regimens: Regimen 1 (10 milligram [mg] once daily, 7 days on/7 days off); and Regimen 2 (6 mg once daily for 28 days). Following IA1, Regimen 1 is closed for further enrollment and starting dose of Regimen 2 is increased to 8 mg once daily for 28 days on a 28-day cycle (referred to as Regimen 3). Participants who enrolled in DDI substudy will receive pretreatment with single doses of midazolam (Day -2) and metformin (Day -1). Participants enrolled in DDI substudy will receive 8 mg erdafitinib treatment from Day 1 to Day 15, single doses of midazolam 2.5 mg (Day 13) and metformin 1000 mg (Day 14) and erdafitinib treatment will continued until disease progression. Participants who completed the DDI substudy and continue to benefit from erdafitinib treatment, will continue to receive erdafitinib in long-term extension (LTE) phase.
Receives: Drug: Erdafitinib; Drug: Midazolam; Drug: Metformin

What is being measured

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

  1. Main Study: Percentage of Participants With Best (Overall) Objective Response

    Percentage of participants with best (overall) objective response were reported. Best objective response is defined as the best (overall) objective response a participants achieved during the study in the order of complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), where CR and PR were confirmed as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. As per RECIST version 1.1, CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must had reduction in the short axis to less than (<) 10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Responders are participants with BOR of CR or PR.

    Measured: From Cycle 1 Day 1 up to 6 years 2 months

  2. Drug-Drug Interaction (DDI) Substudy: Maximum Observed Plasma Concentration (Cmax) of Midazolam Alone or in Combination With Erdafitinib

    Cmax is the maximum observed plasma concentration of midazolam alone or in combination with erdafitinib.

    Measured: Cycle 1 Day -2 (predose) up to Day 13 post dose

  3. Drug-Drug Interaction (DDI) Substudy: Maximum Observed Plasma Concentration (Cmax) of 1-OH-Midazolam (Midazolam Metabolite) Alone or in Combination With Erdafitinib

    Cmax is the maximum observed plasma concentration of 1-OH-Midazolam (midazolam metabolite) alone or in combination with erdafitinib.

    Measured: Cycle 1 Day -2 (predose) up to Day 13 post dose (each cycle length=28 days)

  4. Drug-Drug Interaction (DDI) Substudy: Maximum Observed Plasma Concentration (Cmax) of Metformin Alone or in Combination With Erdafitinib

    Cmax is the maximum observed plasma concentration of metformin alone or in combination with erdafitinib

    Measured: Cycle 1 Day -1 (predose) up to Day 14 post dose (each cycle length=28 days)

  5. Drug-Drug Interaction (DDI) Substudy: Time to Reach the Maximum Observed Plasma Concentration (Tmax) of Midazolam Alone or in Combination With Erdafitinib

    Tmax is the time to reach the maximum observed plasma concentration of midazolam alone or in combination with erdafitinib.

    Measured: Cycle 1 Day -2 (predose) up to Day 13 post dose (each cycle length=28 days)

  6. Drug-Drug Interaction (DDI) Substudy: Time to Reach the Maximum Observed Plasma Concentration (Tmax) of 1-OH-Midazolam (Midazolam Metabolite) Alone or in Combination With Erdafitinib

    Tmax is the time to reach the maximum observed plasma concentration of 1-OH-Midazolam alone or in combination with erdafitinib.

    Measured: Cycle 1 Day -2 (predose) up to Day 13 post dose (each cycle length=28 days)

  7. Drug-Drug Interaction (DDI) Substudy: Time to Reach the Maximum Observed Plasma Concentration (Tmax) of Metformin Alone or in Combination With Erdafitinib

    Tmax is the time to reach maximum observed plasma concentration of metformin alone or in combination with erdafitinib

    Measured: Cycle 1 Day -1 (predose) up to Day 14 post dose (each cycle length=28 days)

  8. Drug-Drug Interaction (DDI) Substudy: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUC[0-last]) of Midazolam Alone or in Combination With Erdafitinib

    AUC(0-last) is the area under the plasma concentration versus time curve from time 0 to the time of the last measurable concentration of midazolam alone or in combination with erdafitinib.

    Measured: Cycle 1 Day -2 (predose) up to Day 13 post dose (each cycle length=28 days)

  9. Drug-Drug Interaction (DDI) Substudy: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUC[0-last]) of 1-OH-Midazolam (Midazolam Metabolite) Alone or in Combination With Erdafitinib

    AUC(0-last) is the area under the plasma concentration versus time curve from time 0 to the time of the last measurable concentration of 1-OH-Midazolam alone or in combination with erdafitinib.

    Measured: Cycle 1 Day -2 (predose) up to Day 13 post dose (each cycle length=28 days)

  10. Drug-Drug Interaction (DDI) Substudy: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUC[0-last]) of Metformin Alone or in Combination With Erdafitinib

    AUC(0-last) is the area under the plasma concentration versus time curve from time 0 to the time of the last measurable concentration of metformin alone or in combination with erdafitinib.

    Measured: Cycle 1 Day -1 (predose) up to Day 14 post dose (each cycle length=28 days)

  11. Drug-Drug Interaction (DDI) Substudy: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Infinite Time (AUC[0-Infinity]) of Midazolam Alone or in Combination With Erdafitinib

    AUC(0-Infinity) is the area under the plasma concentration versus time curve from time 0 to the infinite time of midazolam alone or in combination with erdafitinib.

    Measured: Cycle 1 Day -2 (predose) up to Day 13 post dose (each cycle length=28 days)

  12. Drug-Drug Interaction (DDI) Substudy: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Infinite Time (AUC[0-Infinity]) of 1-OH-Midazolam (Midazolam Metabolite) Alone or in Combination With Erdafitinib

    AUC(0-Infinity) is the area under the plasma concentration versus time curve from time 0 to the infinite time of 1-OH-Midazolam alone or in combination with erdafitinib.

    Measured: Cycle 1 Day -2 (predose) up to Day 13 post dose (each cycle length=28 days)

  13. Drug-Drug Interaction (DDI) Substudy: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Infinite Time (AUC[0-Infinity]) of Metformin Alone or in Combination With Erdafitinib

    AUC(0-Infinity) is the area under the plasma concentration versus time curve from time 0 to the infinite time of metformin alone or in combination with erdafitinib

    Measured: Cycle 1 Day -1 (predose) up to Day 14 post dose (each cycle length=28 days)

Secondary outcomes (6)

  1. Main Study: Progression-free Survival (PFS)

    Progression-free survival is defined as the duration from the date of the first dose of study drug until the date of first documented evidence of progressive disease (or relapse for participants who experience CR during the study) or death due to any cause, whichever occurs first, regardless of the use of subsequent anticancer therapy. As per RECIST version 1.1, CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must had reduction in the short axis to less than (<) 10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

    Measured: From screening up to 6 years 2 months

  2. Main Study: Duration of Response (DoR)

    DOR is defined as the time (in months) from the date of first observation of response (PR or CR) to the date of the first observation of progression or date of death, whatever the cause based on the RECIST version 1.1. CR: disappearance of all target and non-target lesions. All pathological (whether target or non-target) must have a reduction in their short axis <10 mm. PR: at least a 30% decrease in the SOD of target lesions, taking as reference the baseline sum diameters. PD was defined as at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.

    Measured: From screening up to 6 years 2 months

  3. Main Study: Overall Survival

    Overall survival is defined as the time from the date of first dose of study drug to the date of the participant's death from any cause.

    Measured: From screening up to 6 years 2 months

  4. Main Study: Percentage of Participants With Treatment-emergent Adverse Event (TEAEs)

    Percentage of participants with TEAEs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are those events that occurred from first dose date through 30 days after last dose date, or day before subsequent anticancer therapy, whichever occurs first.

    Measured: From Day 1 up to 6 years 2 months

  5. Main Study: Plasma Concentration of Erdafitinib at 2 Hours (C2h)

    C2h is the plasma concentration of erdafitinib at 2 hours.

    Measured: Cycle 1 Days 1 and 21: Pre-dose up to 2 hours post-dose (each cycle length=28 days)

  6. Main Study: Plasma Concentration of Erdafitinib at 4 Hours (C4h)

    C4h is the plasma concentration of erdafitinib at 4 hours.

    Measured: Cycle 1 Days 1 and 21: Pre-dose up to 4 hours post-dose (each cycle length=28 days)

Timeline

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

  1. First posted19 Feb 2015 (estimated)
  2. Study start22 Apr 2015
  3. Primary completion15 Sep 2022
  4. Study completion31 Mar 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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
239 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02365597
Sponsor's protocol ID
CR105065
Other IDs
42756493BLC2001, 2014-002408-26, 2023-510273-34-00, 2023, 2014
Status last verified
Sep 2026
First submitted
29 Jan 2015
Last updated
25 Sep 2026
Data monitoring committee
Yes
FDA-regulated device
No
Expanded access
Available

Publications

  • Siefker-Radtke AO, Necchi A, Park SH, Garcia-Donas J, Huddart RA, Burgess EF, Fleming MT, Rezazadeh Kalebasty A, Mellado B, Varlamov S, Joshi M, Duran I, Tagawa ST, Zakharia Y, Akapame S, Santiago-Walker AE, Monga M, O'Hagan A, Loriot Y; BLC2001 Study Group. Efficacy and safety of erdafitinib in patients with locally advanced or metastatic urothelial carcinoma: long-term follow-up of a phase 2 study. Lancet Oncol. 2022 Feb;23(2):248-258. doi: 10.1016/S1470-2045(21)00660-4. Epub 2022 Jan 11.

    PubMed 35030333

  • Dosne AG, Valade E, Goeyvaerts N, De Porre P, Avadhani A, O'Hagan A, Li LY, Ouellet D, Perez Ruixo JJ. Exposure-response analyses of erdafitinib in patients with locally advanced or metastatic urothelial carcinoma. Cancer Chemother Pharmacol. 2022 Feb;89(2):151-164. doi: 10.1007/s00280-021-04381-4. Epub 2022 Jan 3.

    PubMed 34977972

  • Loriot Y, Necchi A, Park SH, Garcia-Donas J, Huddart R, Burgess E, Fleming M, Rezazadeh A, Mellado B, Varlamov S, Joshi M, Duran I, Tagawa ST, Zakharia Y, Zhong B, Stuyckens K, Santiago-Walker A, De Porre P, O'Hagan A, Avadhani A, Siefker-Radtke AO; BLC2001 Study Group. Erdafitinib in Locally Advanced or Metastatic Urothelial Carcinoma. N Engl J Med. 2019 Jul 25;381(4):338-348. doi: 10.1056/NEJMoa1817323.

    PubMed 31340094

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Erdafitinib, Midazolam and Metformin in people with Urothelial Cancer, run by Janssen Research & Development, LLC at 105 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 7 inclusion and 5 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 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 105 sites in United States, Germany, France, Spain, United Kingdom 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 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 10 Oct 2023). 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?

Main Study: Percentage of Participants With Best (Overall) Objective Response (time frame: From Cycle 1 Day 1 up to 6 years 2 months). The study lists 13 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 NCT02365597, which also lists 3 linked publications.

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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