Advanced Solid Tumors (Excluding Prostate Cancer)Phase 1NCT04267939

ATR Inhibitor Elimusertib (BAY1895344) Plus Niraparib Phase 1b Study in Advanced Solid Tumors and Ovarian Cancer

A Phase 1 study testing Elimusertib (BAY1895344) and Niraparib in people with Advanced Solid Tumors (Excluding Prostate Cancer) and Ovarian Cancer, run by Bayer at 3 sites in United States.

Terminated

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced Solid Tumors (Excluding Prostate Cancer), Ovarian Cancer
What is being tested?: Elimusertib (BAY1895344) and Niraparib
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 3 sitesUnited States
Study dates: 26 Feb 2020to 1 Dec 2023
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

Participant must be ≥ 18 years of age, at the time of signing the informed consent.
Participants must have histologically confirmed diagnosis of the following indications as described below:
Dose escalation (Part A): recurrent advanced solid tumors, excluding prostate cancer, who experienced disease progression after treatment with standard of care therapy for metastatic disease.
Dose expansion (Part B): recurrent EOC, fallopian tube or primary peritoneal cancer
Sub-population 1: participants PARPi naïve and with a platinum-resistant/refractory disease (recurrence with a PFI < 6 months from last platinum-based regimen). Participants may not have had more than 3 prior therapies since the development of platinum resistance.
Sub-population 2: participants with disease progression on PARPi (including niraparib), administered as maintenance as well active line of therapy. Participants must have not received further line of therapy after disease progression on PARPi.

Show all 21Show fewer

Participants in dose escalation (Part A) of the study will need to have tumor-associated DDR deficiency and/or CCNE1 gene amplification.
-- A homozygous deletion and/or a deleterious mutation in a gene reported to be involved in DNA repair and/or sensitive to ATRi's and/or PARPi's.
Participants in dose expansion (Part B) of the study will need to have tumor associated DDR deficiency (Sub-population 1). Participants in Part B (Sub-population 2) are not enrolled based on the presence or absence of a particular biomarker.
Participants must have disease progression and measurable disease, as defined by RECIST 1.1.
Available archival tumor tissue ≤ 12 months old, otherwise a fresh baseline tumor biopsy should be obtained.
ECOG PS of 0 to 1
Life expectancy of at least 12 weeks
Adequate bone marrow function as assessed by the following laboratory tests to be conducted within 7 (±2) days before the first dose of study intervention:
Hemoglobin (Hb) ≥ 10 g/dL
Platelet count ≥ 150 x 10^9/L
Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L
Participants must have adequate organ function.
Participants must have adequate coagulation.
Adequate cardiac function per institutional normal measured by echocardiography (recommended) or cardiac MRI per institutional guidelines.
A female participant is eligible to participate if she is not pregnant (confirmed by a negative serum pregnancy test within 7 (±2) days of first study intervention), not breastfeeding, or is not a woman of childbearing potential (WOCBP). WOCBP must agree to use highly effective contraception during the intervention period and for at least 6 months (180 days) after the last dose of study intervention.

Who cannot join

Inability to swallow oral medication
Known hypersensitivity to elimusertib and/or niraparib or excipients of the preparations or any agent given in association with this study
History of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) diagnosis
Ongoing or active uncontrolled infection (bacterial, fungal, or viral; e.g. hepatitis viral) of CTCAE grade ≥ 2 that requires systemic treatment
Participants with HIV may be be ineligible depending on various parameters, but are not automatically excluded.
Immunocompromised participants (e.g. diagnosis of immunodeficiency or ongoing immunosuppressive therapy)

Show all 15Show fewer

Pleural effusion or ascites that causes respiratory compromise (CTCAE grade ≥ 2 dyspnea)
Active HBV or HCV infection that requires treatment.
Moderate or severe hepatic impairment, i.e. Child Pugh Class B or C
Participants with significant cardiovascular disease and/or relevant findings meeting the below criteria are excluded:
History of cardiac disease: congestive heart failure NYHA class > II, unstable angina (angina symptoms at rest), new-onset angina (within the past 6 months before study entry), myocardial infarction within the past 6 months before study entry, or cardiac arrhythmias requiring anti-arrhythmic therapy (beta-blockers, calcium channel blockers, and digoxin are permitted).
Clinically relevant findings in the ECG such as a second- or third-degree atrioventricular block, prolongation of the QRS complex ≥ 120 ms, or prolongation of the of the QTc interval (Fridericia) over 450 ms unless agreed otherwise between the investigator and the sponsor's medically responsible person. QTc > 450 ms detected in 2 or more time points within a 24-hour period are excluded.
Clinically significant arterial hypertension despite optimal medical management (per investigator´s opinion). Clinically significant hypertension defined as systolic blood pressure above 150 mmHg and/or diastolic blood pressure above 90 mmHg, despite optimal medical management. For participants taking antihypertensive medication, blood pressure should be stable/ controlled for more than 7 days before first dose of study medication.
Previous treatment with an ATR Inhibitor
Participants in Part A and Part B (Sub-population 2): Previous treatment with known or putative PARPi, if discontinued for CTCAE grade ≥ 3 AEs or CTCAE grade ≥ 3 hypersensitivity to PARPi. Participants in Part B Sub-population 1 must not have received prior PARPi treatment.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065

Other trials in United States

About this study

Official title: An Open-label Phase 1b Study to Determine the Maximum Tolerated and/or Recommended Phase 2 Dose of the ATR Inhibitor Elimusertib (BAY 1895344) in Combination With PARP Inhibitor Niraparib, in Participants With Recurrent Advanced Solid Tumors and Ovarian Cancer

The purpose of the study is to test how well patients with advanced solid tumors and ovarian cancer respond to treatment with elimusertib in combination with niraparib. In addition researchers want to find for patients the optimal dose of elimusertib in combination with niraparib, how the drug is tolerated and the way the body absorbs, distributes and discharges the drug. The study medication elimusertib works by blocking a substance produced by the body (ATR Kinase) which is important for the growth of tumor cells. Niraparib works by blocking a substance produced by the body (PARP enzymes) in a way that tumor cells can be killed, or made more susceptible to chemotherapy.

Conditions: Advanced Solid Tumors (Excluding Prostate Cancer), Ovarian Cancer
Being tested: Elimusertib (BAY1895344), Niraparib
Medical subject headings: Ovarian Neoplasms

What participants receive

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

Elimusertib (BAY1895344)Drug
Elimusertib will be administered in 28-day cycles.
NiraparibDrug
Niraparib will be administered in 28-day cycles.

Study groups in NCT04267939
Study group	Role	What they receive
Dose escalation of elimusertib_Part A.1	Experimental	Dose escalation will initiate with Part A.1 in which niraparib is used at a lower fixed dose. Receives: Drug: Elimusertib (BAY1895344); Drug: Niraparib
Dose escalation of elimusertib_Part A.2	Experimental	If the starting dose level in Part A.1 is tolerated, dose escalation in Part A.2 may be initiated on an optional basis. In Part A.2, niraparib is used at a higher fixed dose. Receives: Drug: Elimusertib (BAY1895344); Drug: Niraparib
Dose expansion_sub-population 1_lower dose of niraparib	Experimental	MTDs and/or candidate RP2Ds for elimusertib used in combination with niraparib at a lower fixed dose. MTD: Maximum tolerated dose. RP2D: Recommended phase 2 dose. Receives: Drug: Elimusertib (BAY1895344); Drug: Niraparib
Dose expansion_sub-population 2_lower dose of niraparib	Experimental	MTDs and/or candidate RP2Ds for elimusertib used in combination with niraparib at a lower fixed dose. Receives: Drug: Elimusertib (BAY1895344); Drug: Niraparib
Dose expansion_sub-population 1_higher dose of niraparib	Experimental	MTDs and/or candidate RP2Ds for elimusertib used in combination with niraparib at a higher fixed dose. Receives: Drug: Elimusertib (BAY1895344); Drug: Niraparib
Dose expansion_sub-population 2_higher dose of niraparib	Experimental	MTDs and/or candidate RP2Ds for elimusertib used in combination with niraparib at a higher fixed dose. Receives: Drug: Elimusertib (BAY1895344); Drug: Niraparib

What is being measured

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

Incidence of treatment emergent adverse events (TEAEs)
Measured: Up to 30 days after the last administration of study intervention
Severity of treatment emergent adverse events (TEAEs)
Measured: Up to 30 days after the last administration of study intervention
Incidence of treatment emergent serious adverse events (TESAEs)
Measured: Up to 30 days after the last administration of study intervention
Severity of treatment emergent serious adverse events (TESAEs)
Measured: Up to 30 days after the last administration of study intervention
Maximum tolerated dose (MTD): Frequency of Dose Limiting Toxicities (DLTs) at each dose level during the DLT observation period for Cycle 1
Measured: Cycle 1, 28 days after first administration of study intervention
Recommended Phase II dose (RP2D) of elimusertib
Measured: Up to 30 days after last administration of study Intervention

Secondary outcomes (10)

Incidence of participants with complete response (CR)
Measured: At baseline and at the start of every 2nd cycle (each cycle is 28 days) starting with Cycle 3, and at the start of every 4th cycle after Cycle 11 up to 24 months.
Incidence of participants with partial response (PR)
Measured: At baseline and at the start of every 2nd cycle (each cycle is 28 days) starting with Cycle 3, and at the start of every 4th cycle after Cycle 11 up to 24 months.
Incidence of participants with stable disease (SD)
Measured: At baseline and at the start of every 2nd cycle (each cycle is 28 days) starting with Cycle 3, and at the start of every 4th cycle after Cycle 11 up to 24 months.
Incidence of participants with progressive disease (PD)
Measured: At baseline and at the start of every 2nd cycle (each cycle is 28 days) starting with Cycle 3, and at the start of every 4th cycle after Cycle 11 up to 24 months.
Objective response rate (ORR)
Measured: At baseline and at the start of every 2nd cycle (each cycle is 28 days) starting with Cycle 3, and at the start of every 4th cycle after Cycle 11 up to 24 months.
Disease control rate (DCR)
Measured: At baseline and at the start of every 2nd cycle (each cycle is 28 days) starting with Cycle 3, and at the start of every 4th cycle after Cycle 11 up to 24 months.
Cmax (Maximal plasma exposure) of elimusertib after single dose administration
Measured: Cycle 1 Day 5 and Cycle 1 Day 21, each cycle is 28 days.
AUC(0-8) of elimusertib after single dose administration
Measured: Cycle 1 Day 5 and Cycle 1 Day 21, each cycle is 28 days.
Cmax,md of elimusertib after multiple dose administration
Measured: Cycle 1 Day 5 and Cycle 1 Day 21, each cycle is 28 days.
AUC(0-8)md of elimusertib after multiple dose administration
AUC: Area under the curve
Measured: Cycle 1 Day 5 and Cycle 1 Day 21, each cycle is 28 days.

Timeline

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

26 Feb 20201 Dec 2023

First posted13 Feb 2020
Study start26 Feb 2020
Primary completion1 Dec 2023
Study completion1 Dec 2023

Why it stopped: There was no anticipated benefit of the experimental combination as tested over available standard therapies; therefore Sponsor has decided to terminate the investigation.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Advanced Solid Tumors (Excluding Prostate Cancer)Studies of the same condition, open and under way.
More trials run by BayerThe 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: Other
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04267939
Sponsor's protocol ID: 18595
Other IDs: 2018-003930-34, 2018
Status last verified: Dec 2023
First submitted: 11 Feb 2020
Last updated: 21 Dec 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Publications

Smith G, Alholm Z, Coleman RL, Monk BJ. DNA Damage Repair Inhibitors-Combination Therapies. Cancer J. 2021 Nov-Dec 01;27(6):501-505. doi: 10.1097/PPO.0000000000000561.
PubMed 34904813

Study at a glance

From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label Phase 1b Study to Determine the Maximum Tolerated and/or Recommended Phase 2 Dose of the ATR Inhibitor Elimusertib (BAY 1895344) in Combination With PARP Inhibitor Niraparib, in Participants With Recurrent Advanced Solid Tumors and Ovarian Cancer
ClinicalTrials.gov ID: NCT04267939
Acronym / sponsor ID: 18595
Conditions: Advanced Solid Tumors (Excluding Prostate Cancer), Ovarian Cancer
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: There was no anticipated benefit of the experimental combination as tested over available standard therapies; therefore Sponsor has decided to terminate the investigation.
Enrolment: 14 participants (actual)
Lead sponsor: BayerIndustry (pharma, biotech, devices)
Collaborators: GlaxoSmithKline
Study start: 26 Feb 2020 (actual)
Primary completion: 1 Dec 2023 (actual)
Study completion: 1 Dec 2023 (actual)
First posted: 13 Feb 2020 (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.

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Dose escalation of elimusertib_Part A.1	Experimental	Drug: Elimusertib (BAY1895344), Drug: NiraparibDose escalation will initiate with Part A.1 in which niraparib is used at a lower fixed dose.
Dose escalation of elimusertib_Part A.2	Experimental	Drug: Elimusertib (BAY1895344), Drug: NiraparibIf the starting dose level in Part A.1 is tolerated, dose escalation in Part A.2 may be initiated on an optional basis. In Part A.2, niraparib is used at a higher fixed dose.
Dose expansion_sub-population 1_lower dose of niraparib	Experimental	Drug: Elimusertib (BAY1895344), Drug: NiraparibMTDs and/or candidate RP2Ds for elimusertib used in combination with niraparib at a lower fixed dose. MTD: Maximum tolerated dose. RP2D: Recommended phase 2 dose.
Dose expansion_sub-population 2_lower dose of niraparib	Experimental	Drug: Elimusertib (BAY1895344), Drug: NiraparibMTDs and/or candidate RP2Ds for elimusertib used in combination with niraparib at a lower fixed dose.
Dose expansion_sub-population 1_higher dose of niraparib	Experimental	Drug: Elimusertib (BAY1895344), Drug: NiraparibMTDs and/or candidate RP2Ds for elimusertib used in combination with niraparib at a higher fixed dose.
Dose expansion_sub-population 2_higher dose of niraparib	Experimental	Drug: Elimusertib (BAY1895344), Drug: NiraparibMTDs and/or candidate RP2Ds for elimusertib used in combination with niraparib at a higher fixed dose.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (21 listed)

Participant must be ≥ 18 years of age, at the time of signing the informed consent.
Participants must have histologically confirmed diagnosis of the following indications as described below:
Participants in dose escalation (Part A) of the study will need to have tumor-associated DDR deficiency and/or CCNE1 gene amplification.
-- A homozygous deletion and/or a deleterious mutation in a gene reported to be involved in DNA repair and/or sensitive to ATRi's and/or PARPi's.
Participants in dose expansion (Part B) of the study will need to have tumor associated DDR deficiency (Sub-population 1). Participants in Part B (Sub-population 2) are not enrolled based on the presence or absence of a particular biomarker.

Key exclusion criteria (15 listed)

Inability to swallow oral medication
Known hypersensitivity to elimusertib and/or niraparib or excipients of the preparations or any agent given in association with this study
History of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) diagnosis
Ongoing or active uncontrolled infection (bacterial, fungal, or viral; e.g. hepatitis viral) of CTCAE grade ≥ 2 that requires systemic treatment
Participants with HIV may be be ineligible depending on various parameters, but are not automatically excluded.

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
Elimusertib (BAY1895344)Elimusertib will be administered in 28-day cycles.	Drug	Dose escalation of elimusertib_Part A.1, Dose escalation of elimusertib_Part A.2, Dose expansion_sub-population 1_higher dose of niraparib, Dose expansion_sub-population 1_lower dose of niraparib, Dose expansion_sub-population 2_higher dose of niraparib, Dose expansion_sub-population 2_lower dose of niraparib
NiraparibNiraparib will be administered in 28-day cycles.	Drug	Dose escalation of elimusertib_Part A.1, Dose escalation of elimusertib_Part A.2, Dose expansion_sub-population 1_higher dose of niraparib, Dose expansion_sub-population 1_lower dose of niraparib, Dose expansion_sub-population 2_higher dose of niraparib, Dose expansion_sub-population 2_lower dose of niraparib

Primary outcome

Incidence of treatment emergent adverse events (TEAEs)
Time frame: Up to 30 days after the last administration of study intervention
Severity of treatment emergent adverse events (TEAEs)
Time frame: Up to 30 days after the last administration of study intervention
Incidence of treatment emergent serious adverse events (TESAEs)
Time frame: Up to 30 days after the last administration of study intervention
Severity of treatment emergent serious adverse events (TESAEs)
Time frame: Up to 30 days after the last administration of study intervention
Maximum tolerated dose (MTD): Frequency of Dose Limiting Toxicities (DLTs) at each dose level during the DLT observation period for Cycle 1
Time frame: Cycle 1, 28 days after first administration of study intervention
Recommended Phase II dose (RP2D) of elimusertib
Time frame: Up to 30 days after last administration of study Intervention

10 secondary outcomes

Incidence of participants with complete response (CR)
Time frame: At baseline and at the start of every 2nd cycle (each cycle is 28 days) starting with Cycle 3, and at the start of every 4th cycle after Cycle 11 up to 24 months.
Incidence of participants with partial response (PR)
Time frame: At baseline and at the start of every 2nd cycle (each cycle is 28 days) starting with Cycle 3, and at the start of every 4th cycle after Cycle 11 up to 24 months.
Incidence of participants with stable disease (SD)
Time frame: At baseline and at the start of every 2nd cycle (each cycle is 28 days) starting with Cycle 3, and at the start of every 4th cycle after Cycle 11 up to 24 months.
Incidence of participants with progressive disease (PD)
Time frame: At baseline and at the start of every 2nd cycle (each cycle is 28 days) starting with Cycle 3, and at the start of every 4th cycle after Cycle 11 up to 24 months.
Objective response rate (ORR)
Time frame: At baseline and at the start of every 2nd cycle (each cycle is 28 days) starting with Cycle 3, and at the start of every 4th cycle after Cycle 11 up to 24 months.
Disease control rate (DCR)
Time frame: At baseline and at the start of every 2nd cycle (each cycle is 28 days) starting with Cycle 3, and at the start of every 4th cycle after Cycle 11 up to 24 months.
Cmax (Maximal plasma exposure) of elimusertib after single dose administration
Time frame: Cycle 1 Day 5 and Cycle 1 Day 21, each cycle is 28 days.
AUC(0-8) of elimusertib after single dose administration
Time frame: Cycle 1 Day 5 and Cycle 1 Day 21, each cycle is 28 days.
Cmax,md of elimusertib after multiple dose administration
Time frame: Cycle 1 Day 5 and Cycle 1 Day 21, each cycle is 28 days.
AUC(0-8)md of elimusertib after multiple dose administration
Time frame: Cycle 1 Day 5 and Cycle 1 Day 21, each cycle is 28 days.

Results and safety

The study was stopped early (reason given: There was no anticipated benefit of the experimental combination as tested over available standard therapies; therefore Sponsor has decided to terminate the investigation.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
Derived from this study: PubMed 34904813Smith G, Alholm Z, Coleman RL, Monk BJ. DNA Damage Repair Inhibitors-Combination Therapies. Cancer J. 2021 Nov-Dec 01;27(6):501-505. doi: 10.1097/PPO.0000000000000561.
Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

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.

Bayer Study Director study director

Bayer

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Elimusertib (BAY1895344) and Niraparib in people with Advanced Solid Tumors (Excluding Prostate Cancer) and Ovarian Cancer, run by Bayer at 3 sites in United States.

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 21 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: stopped early, as of the sponsor's last update on 21 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. 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?

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?

Incidence of treatment emergent adverse events (TEAEs) (time frame: Up to 30 days after the last administration of study intervention). The study lists 6 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 NCT04267939, 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 21 Dec 2023.