NeoplasmsPhase 1NCT03573310
A Study of JNJ-64619178, an Inhibitor of PRMT5 in Participants With Advanced Solid Tumors, NHL, and Lower Risk MDS
A Phase 1 study testing JNJ-64619178 in people with Neoplasms and Solid Tumor, Adult, run by Janssen Research & Development, LLC at 18 sites in 5 countries.
Trial summary
The purpose of the study is to identify the maximum tolerated dose (MTD) of JNJ-64619178 in participants with relapsed/refractory B cell non-Hodgkin lymphoma (NHL) or advanced solid tumors and also to identify the recommended Phase 2 dose(s) (RP2Ds) of JNJ-64619178 for NHL and advanced solid tumors (Part 1) and to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Solid Tumor, Adult, Non-Hodgkin Lymphoma
- What is being tested?
- JNJ-64619178
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 18 sitesin 5 countries
- Study dates
- 13 Jul 2018to 25 Sep 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- B cell non-Hodgkin lymphoma (NHL) or solid tumors, or lower risk MDS
- At least 1 measurable site of disease for B cell-NHL and solid tumors
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Adequate organ function
- Women of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) at screening and prior to the first dose of study drug. Women must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 90 days after receiving the last dose of study drug
Who cannot join
- History of, or known, central nervous system (CNS) involvement
- Prior solid organ transplantation
- Either of the following: a) Received an autologous stem cell transplant less than or equal (<=) 9 months before the first dose of study drug B) Prior treatment with allogenic stem cell transplant
- History of malignancy (other than the disease under study) within 3 years before the first administration of study drug. Exceptions include squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years
- Known allergies, hypersensitivity, or intolerance to JNJ-64619178 or its excipient
Trial locations and contacts
18 sites in 5 countries.
18 sites in 5 countries
Spain6 sites
Hosp. Univ. Germans Trias I Pujol
Badalona, 08916
Hosp Univ Vall D Hebron
Barcelona, 08035
Hosp Univ Fund Jimenez Diaz
Madrid, 28040
Clinica Univ. de Navarra
Pamplona, 31008
Hosp Clinico Univ de Salamanca
Salamanca, 37007
Hosp. Virgen Del Rocio
Seville, 41013
United States4 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Ohio State University
Columbus, Ohio, 43210
University of Texas, MD Anderson Cancer Center
Houston, Texas, 77030
Florida Specialist and Cancer Institute
Sarasota, Florida, 34232
Germany3 sites
Universitaetsklinikum Duesseldorf
Düsseldorf, 40225
Goethe Universität Frankfurt
Frankfurt am Main, 60590
Universitaetsklinikum Leipzig
Leipzig, 04103
Israel3 sites
Carmel Medical Center
Haifa, 34362
Hadassah Medical Center
Jerusalem, 9112001
Tel Aviv Sourasky MC
Tel Aviv, 6423906
Canada2 sites
Princess Margaret Cancer Centre University Health Network
Toronto, Ontario, M5G1Z5
St. Paul's Hospital
Vancouver, British Columbia, V6E 1M7
About this study
Official title: A Phase 1, First-in-Human, Open-Label Study of the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-64619178, an Inhibitor of Protein Arginine Methyltransferase 5 (PRMT5) in Subjects With Advanced Cancers
The purpose of the study is to identify the maximum tolerated dose (MTD) of JNJ-64619178 in participants with relapsed/refractory B cell non-Hodgkin lymphoma (NHL) or advanced solid tumors and also to identify the recommended Phase 2 dose(s) (RP2Ds) of JNJ-64619178 for NHL and advanced solid tumors (Part 1) and to confirm the tolerability of JNJ-64619178 in participants with lower risk myelodysplastic syndromes (MDS) (Part 2).
Read the detailed description
The study is designed to determine the maximum tolerated dose (MTD) of JNJ-64619178, and to select a dose(s) and regimen(s) that may be used in future clinical development. Study evaluations will include safety, pharmacokinetics, biomarkers and efficacy evaluations (Disease Assessments). Adverse events will be evaluated throughout the study. The study is divided into 4 periods: a screening phase, a pharmacokinetic run-in phase, a treatment phase, and a post treatment follow-up phase. An end-of-treatment visit will be completed less than or equal (<=) 30 days (+7 days) after the last dose of study drug or prior to the start of a new anticancer therapy, whichever comes first.
- Being tested
- JNJ-64619178
- Keywords
- Lower risk MDS, Low risk MDS, Lower-risk MDS, Low-risk MDS, Intermediate 1 risk MDS, Intermediate-1 risk MDS
- Medical subject headings
- Neoplasms, Lymphoma, Non-Hodgkin, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-64619178Drug
JNJ-64619178 capsules to be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Dose escalation and RP2D Selection | Experimental | Participants with solid tumors or non-Hodgkin lymphoma (NHL) will receive JNJ-64619178 orally as per the assigned sequential cohorts and doses will be escalated based on the review of all available data including, but not limited to, pharmacokinetic, pharmacodynamic, safety, and clinical activity. One or more recommended Phase 2 dose(s) (RP2Ds) may be determined for further exploration. Receives: Drug: JNJ-64619178 |
| Part 2:Dose Confirmation and Expansion | Experimental | Participants with myelodysplastic syndromes (MDS) will receive JNJ-64619178 at a dose less than or equal to the RP2D selected in Part 1 for 24 weeks, or longer if there is evidence of clinical benefit. The dose level of JNJ-64619178 may be adjusted based on observed toxicities. Receives: Drug: JNJ-64619178 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1 and Part 2: Number of Participants with Dose-limiting Toxicities (DLTs)
DLTs are defined as certain non-hematologic and hematologic toxicities of Grade 3 or higher.
Measured: Approximately 3 years
Secondary outcomes (19)
Part 1 and Part 2: Number of Participants with Adverse Events (AE)
AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship.
Measured: Approximately 3 years
Part 1 and Part 2: Number of Participants with AE by Severity
Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE). Severity scale ranges from Grade 1 (Mild) to Grade 4 (Life-threatening). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.
Measured: Approximately 3 years
Part 1 and Part 2: Number of Participants with Abnormal Vital Signs
Number of participants with abnormality in vital signs (temperature, pulse/heart rate, and blood pressure) will be reported.
Measured: Approximately 3 years
Part 1 and Part 2: Number of Participants with Laboratory Abnormalities
Number of participants with laboratory abnormalities (serum chemistry, hematology, and coagulation, and disease-related laboratory abnormalities) will be reported.
Measured: Approximately 3 years
Part 1 and Part 2: Number of Participants with Electrocardiogram (ECG) Abnormalities
Number of participants with electrocardiogram(ECG) abnormalities will be reported.
Measured: Approximately 3 years
Part 1 and Part 2: Maximum Plasma Concentration (Cmax) of JNJ-64619178
Cmax is the maximum observed plasma concentration.
Measured: Approximately 3 years
Part 1 and Part 2: Area Under the Plasma Concentration Versus Time Curve From Time Zero to End of Dosing Interval (AUCtau)
AUCtau is the measure of the plasma drug concentration from time zero to end of dosing interval.
Measured: Approximately 3 years
Part 1 and Part 2: Minimum Plasma Concentration (Cmin)
Cmin is the minimum observed plasma concentration.
Measured: Approximately 3 years
Part 1 and Part 2: Plasma Decay Half-Life (t1/2)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Measured: Approximately 3 years
Part 1 and Part 2: Volume of Distribution at Steady-State Influenced by the Fraction Absorbed (Vss/F)
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady state which is estimated by (D/AUC[0-infinity])* (AUMC[0-infinity])/(AUC[0-infinity]) where D is the dose of study drug, AUMC(0-infinity) is the area under the first moment curve extrapolated to infinity and AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time. All these parameters will be assessed as influenced by the fraction absorbed.
Measured: Approximately 3 years
Part 1 and Part 2: Apparent Total Systemic Clearance of Drug (CL/F) after Extravascular Administration
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Measured: Approximately 3 years
Part 1 and Part 2: Accumulation Index (RA)
Accumulation Index (RA) is calculated as AUC (0-24) value at steady state divided by AUC (0-24) value after first dose.
Measured: Approximately 3 years
Part 1 and Part 2: Plasma Concentration of Symmetric Dimethyl-Arginine (SDMA)
Plasma concentration of symmetric dimethyl-arginine (SDMA) will be evaluated.
Measured: Approximately 3 years
Part 1: Percentage of Participants with B cell non-Hodgkin lymphoma (NHL) Showing Overall Response of Partial Response (PR) or Better
Overall response rate (ORR) is defined as the percentage of participants who have a PR or better. Per Lugano classification, PR is defined as greater than or equal (>=) 50 percent (%) decrease in size of target lesions.
Measured: Approximately 3 years
Part 1: Percentage of Participants with Solid Tumors Showing Overall Response of PR or Better
Overall response rate (ORR) is defined as the percentage of participants who have a PR or better. PR criteria in solid tumors (RECIST) is >= 30 percent (%) decrease in the sum of the diameters of all index lesions compared with baseline in 2 observations at least 4 weeks apart, in absence of new lesions or unequivocal progression of non-index lesions.
Measured: Approximately 3 years
Part 1: Duration of Response
Duration of response (DOR) will be calculated from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease (PD), as defined in the disease-specific response criteria, or death due to any cause, whichever occurs first. PD (per RECIST 1.1) defined as at least 20% increase in the sum of the longest diameters of index lesions or unequivocal progression of non-index lesions. Per Lugano classification, PD: target lesions larger; clear progression of non-target lesions; or new tumor lesions; new or recurrent bone marrow involvement; splenomegaly + 2 centimeter (cm) or +50%.
Measured: Approximately 3 years
Part 1: Clinical Benefit Rate
Clinical benefit rate is defined as percentage of participants who have a complete response (CR), PR and sustained stable disease of 12 weeks or more. Sustained stable disease of 12 weeks or more is defined as participants with stable disease assessment maintained for about 12 weeks or longer from baseline. Per Lugano classification CR is defined as no detectable disease by computed tomography (CT) or positron emission tomography (PET)/CT scan. Evaluation criteria as per RECIST 1.1 for CR is defined as disappearance of all lesions in 2 consecutive observations not less than 4 weeks apart.
Measured: Approximately 3 years
Part 2: Red Blood Cell (RBC) Transfusion Independence (TI) Rate
Percentage of participants with TI, defined as being without any transfusion during any consecutive 8 weeks (56 days) between the first dose of study drug and treatment discontinuation.
Measured: Approximately 3 years
Part 2: Overall Improvement Rate
Overall improvement rate is defined as the percentage of participants achieving complete remission (bone marrow: less than or equal to (<=)5% myeloblasts with normal maturation of all cell lines; Peripheral blood: hemoglobin >=11 gram per deciliter (g/dL); platelets >=100*109/liter(L); neutrophils >=1.0*109/L; blasts, 0%), partial remission (All complete remission criteria if abnormal before treatment except: Bone marrow blasts decreased by >=50% over pretreatment but still >5% Cellularity and morphology not relevant), or hematologic improvement (HI) (Erythroid response [pretreatment, <11 g/dL]; Platelet response (pretreatment, <100*10^9/L); Neutrophil response (pretreatment, <1*10^9/L); Progression or relapse after HI) according to modified International Working Group (IWG) criteria.
Measured: Approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2018
- Study start13 Jul 2018
- Primary completion25 Sep 2025
- Study completion25 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03573310
- Sponsor's protocol ID
- CR108485
- Other IDs
- 64619178EDI1001, 2018-000067-87, 2024-515254-24-00, 2018
- Status last verified
- Dec 2025
- First submitted
- 20 Jun 2018
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, First-in-Human, Open-Label Study of the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-64619178, an Inhibitor of Protein Arginine Methyltransferase 5 (PRMT5) in Subjects With Advanced Cancers
- ClinicalTrials.gov ID
- NCT03573310
- Acronym / sponsor ID
- CR108485
- Keywords
- Lower risk MDS, Low risk MDS, Lower-risk MDS, Low-risk MDS, Intermediate 1 risk MDS, Intermediate-1 risk MDS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 13 Jul 2018 (actual)
- Primary completion
- 25 Sep 2025 (actual)
- Study completion
- 25 Sep 2025 (actual)
- First posted
- 29 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to identify the maximum tolerated dose (MTD) of JNJ-64619178 in participants with relapsed/refractory B cell non-Hodgkin lymphoma (NHL) or advanced solid tumors and also to identify the recommended Phase 2 dose(s) (RP2Ds) of JNJ-64619178 for NHL and advanced solid tumors (Part 1) and to confirm the tolerability of JNJ-64619178 in participants with lower risk myelodysplastic syndromes (MDS) (Part 2).
Detailed description
The study is designed to determine the maximum tolerated dose (MTD) of JNJ-64619178, and to select a dose(s) and regimen(s) that may be used in future clinical development. Study evaluations will include safety, pharmacokinetics, biomarkers and efficacy evaluations (Disease Assessments). Adverse events will be evaluated throughout the study. The study is divided into 4 periods: a screening phase, a pharmacokinetic run-in phase, a treatment phase, and a post treatment follow-up phase. An end-of-treatment visit will be completed less than or equal (<=) 30 days (+7 days) after the last dose of study drug or prior to the start of a new anticancer therapy, whichever comes first.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1: Dose escalation and RP2D Selection | Experimental | Drug: JNJ-64619178Participants with solid tumors or non-Hodgkin lymphoma (NHL) will receive JNJ-64619178 orally as per the assigned sequential cohorts and doses will be escalated based on the review of all available data including, but not limited to, pharmacokinetic, pharmacodynamic, safety, and clinical activity. One or more recommended Phase 2 dose(s) (RP2Ds) may be determined for further exploration. |
| Part 2:Dose Confirmation and Expansion | Experimental | Drug: JNJ-64619178Participants with myelodysplastic syndromes (MDS) will receive JNJ-64619178 at a dose less than or equal to the RP2D selected in Part 1 for 24 weeks, or longer if there is evidence of clinical benefit. The dose level of JNJ-64619178 may be adjusted based on observed toxicities. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- B cell non-Hodgkin lymphoma (NHL) or solid tumors, or lower risk MDS
- At least 1 measurable site of disease for B cell-NHL and solid tumors
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Adequate organ function
- Women of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) at screening and prior to the first dose of study drug. Women must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 90 days after receiving the last dose of study drug
Key exclusion criteria (5 listed)
- History of, or known, central nervous system (CNS) involvement
- Prior solid organ transplantation
- Either of the following: a) Received an autologous stem cell transplant less than or equal (<=) 9 months before the first dose of study drug B) Prior treatment with allogenic stem cell transplant
- History of malignancy (other than the disease under study) within 3 years before the first administration of study drug. Exceptions include squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years
- Known allergies, hypersensitivity, or intolerance to JNJ-64619178 or its excipient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JNJ-64619178JNJ-64619178 capsules to be administered orally. | Drug | Part 1: Dose escalation and RP2D Selection, Part 2:Dose Confirmation and Expansion |
Primary outcome
Part 1 and Part 2: Number of Participants with Dose-limiting Toxicities (DLTs)
Time frame: Approximately 3 years
DLTs are defined as certain non-hematologic and hematologic toxicities of Grade 3 or higher.
19 secondary outcomes
Part 1 and Part 2: Number of Participants with Adverse Events (AE)
Time frame: Approximately 3 years
Part 1 and Part 2: Number of Participants with AE by Severity
Time frame: Approximately 3 years
Part 1 and Part 2: Number of Participants with Abnormal Vital Signs
Time frame: Approximately 3 years
Part 1 and Part 2: Number of Participants with Laboratory Abnormalities
Time frame: Approximately 3 years
Part 1 and Part 2: Number of Participants with Electrocardiogram (ECG) Abnormalities
Time frame: Approximately 3 years
Part 1 and Part 2: Maximum Plasma Concentration (Cmax) of JNJ-64619178
Time frame: Approximately 3 years
Part 1 and Part 2: Area Under the Plasma Concentration Versus Time Curve From Time Zero to End of Dosing Interval (AUCtau)
Time frame: Approximately 3 years
Part 1 and Part 2: Minimum Plasma Concentration (Cmin)
Time frame: Approximately 3 years
Part 1 and Part 2: Plasma Decay Half-Life (t1/2)
Time frame: Approximately 3 years
Part 1 and Part 2: Volume of Distribution at Steady-State Influenced by the Fraction Absorbed (Vss/F)
Time frame: Approximately 3 years
Part 1 and Part 2: Apparent Total Systemic Clearance of Drug (CL/F) after Extravascular Administration
Time frame: Approximately 3 years
Part 1 and Part 2: Accumulation Index (RA)
Time frame: Approximately 3 years
Part 1 and Part 2: Plasma Concentration of Symmetric Dimethyl-Arginine (SDMA)
Time frame: Approximately 3 years
Part 1: Percentage of Participants with B cell non-Hodgkin lymphoma (NHL) Showing Overall Response of Partial Response (PR) or Better
Time frame: Approximately 3 years
Part 1: Percentage of Participants with Solid Tumors Showing Overall Response of PR or Better
Time frame: Approximately 3 years
Part 1: Duration of Response
Time frame: Approximately 3 years
Part 1: Clinical Benefit Rate
Time frame: Approximately 3 years
Part 2: Red Blood Cell (RBC) Transfusion Independence (TI) Rate
Time frame: Approximately 3 years
Part 2: Overall Improvement Rate
Time frame: Approximately 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
18 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JNJ-64619178 in people with Neoplasms and Solid Tumor, Adult, run by Janssen Research & Development, LLC at 18 sites in 5 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 5 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: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Spain, United States, Germany, Israel, Canada. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Part 1 and Part 2: Number of Participants with Dose-limiting Toxicities (DLTs) (time frame: Approximately 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.