Advanced Solid CancersPhase 1NCT03512340
Study of SRF231 in Patients With Advanced Solid and Hematologic Cancers
A Phase 1 study testing SRF231 in people with Advanced Solid Cancers and Hematologic Cancers, run by Surface Oncology at 3 sites in 2 countries.
Trial summary
This Phase 1/1b, open-label, first-in-human, monotherapy study will be conducted in 2 parts. Part A will consist of the SRF231 monotherapy dose-escalation portion of the study, and will enroll up to 48 patients with advanced solid tumors and hematological cancers. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Advanced Solid Cancers, Hematologic Cancers
- What is being tested?
- SRF231
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 13 Mar 2018to 29 Sep 2020
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years of age.
- Failure to respond to standard therapy, and for whom no appropriate therapies are available (based on the judgment of the Investigator).
- Histological or cytological evidence of advanced, relapsed, or refractory, solid and hematologic cancers that are not a candidate for curative therapy.
- Part B only: Patient must have demonstrated progressive disease (PD) after the most recent treatment regimen (or within 3 months prior to enrollment in the case of treatment-naïve patients).
- Washout period from the last dose of previous anticancer therapy (chemotherapy, biologic, or other investigational agent) to the initiation of study drug must be > 5 times the half-life of the agent or > 21 days (whichever is shorter).
- Note: the washout period for palliative radiotherapy is 7 days.
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- Resolution of adverse events (AEs) related to prior anticancer therapy (including immune-related AEs but excluding alopecia) to ≤ Grade 1 per NCI-CTCAE v. 4.03 or higher.
- Measurable disease per applicable disease-specific criteria for Part B only.
- Serum creatinine clearance ≥ 60 mL/min per Cockcroft-Gault formula or serum creatinine ≤ 2.0 x the upper limit of normal (ULN).
- Total bilirubin ≤ 1.5 x ULN (≤ 3 x ULN if elevated due to Gilbert's syndrome).
- Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) < 2.5 x ULN ( < 5 x ULN if liver metastasis).
- Adequate hematologic function, defined as absolute neutrophil count (ANC) ≥ 1.0 x 109/L, hemoglobin ≥ 9.0 g/dL, and platelet count ≥ 100 x 109/L.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Ejection fraction ≥ 50%, as measured by echocardiogram or multigated acquisition (MUGA) scan at Screening.
- For women of childbearing potential (WCBP): negative serum beta human chorionic gonadotropin (betahCG) pregnancy test within 1 week before first treatment (WCBP defined as a sexually mature woman who has not undergone surgical sterilization or who has not been naturally postmenopausal for at least 12 consecutive months for women > 55 years of age).
- Willingness of male and female patients who are not surgically sterile or postmenopausal to use medically acceptable methods of birth control for the duration of the study treatment, including 30 days after the last dose of SRF231. Sexually active men, and women using oral contraceptive pills, should also use barrier contraception. Azoospermic males and WCBP who are continuously not heterosexually active are exempt from contraceptive requirements. However female patients must still undergo pregnancy testing as described in this section.
- Ability to adhere to the study visit schedule and all protocol requirements.
- Signed and dated institutional review board (IRB)/independent ethics committee (IEC)-approved informed consent form before any screening procedures are performed.
Who cannot join
- Previously received an anti-CD47 antibody or SIRPalpha targeted therapy.
- High-grade lymphomas (eg, Burkitt's, lymphoblastic), plasma cell leukemia.
- History of any condition known to be associated with reduced red blood cell (RBC) lifespan (eg, thalassemia trait, glucose-6-phosphate dehydrogenase deficiency).
- History of ≥ Grade 4 allergic or anaphylactic reaction to any monoclonal antibody therapy, murine protein, or any excipient in the study drugs.
- Major surgery within 4 weeks prior to Screening.
- Symptomatic or untreated brain metastases (including leptomeningeal metastases).
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- Primary central nervous system malignancy.
- Part A only: Prior RBC or platelet transfusion < 4 weeks prior to starting SRF231.
- Prior autologous stem cell transplant ≤ 3 months prior to starting SRF231.
- Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C virus.
- Ongoing treatment with chronic immunosuppressants (eg, cyclosporine) or systemic steroids at doses used as anticancer therapy (ie, > 20 mg/day prednisone or equivalent) Note: topical, intranasal, or inhaled corticosteroids and physiologic replacement for patients with adrenal insufficiency are allowed.
- Ongoing uncontrolled systemic bacterial, fungal, or viral infections at Screening Note: oral antibiotics for a controlled infection are permitted. Patients on antimicrobial, antifungal, or antiviral prophylaxis are not specifically excluded if all other inclusion/exclusion criteria are met.
- Administration of a live vaccine within 6 weeks of first dose of study drug.
- Prior allogeneic hematopoietic cell transplant within 6 months or with clinical Graft-Versus-Host Disease.
- Previous chimeric antigen receptor (CAR)-T/T-cell receptor (TCR) cellular therapy with detectable circulating CAR-T/TCR cells.
- History of autoimmune hemolytic anemia, autoimmune thrombocytopenia, atypical hemolytic uremic syndrome, or thrombotic thrombocytopenic purpura.
- Baseline QT interval corrected with Fridericia's method (QTcF) > 480 ms. Note: criterion does not apply to patients with a right or left bundle branch block.
- Female patients who are pregnant or breastfeeding.
- Concurrent active malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix.
- History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months prior to Screening.
- Unstable or severe uncontrolled medical condition (eg, unstable cardiac function, unstable pulmonary condition including pneumonitis and/or interstitial lung disease, uncontrolled diabetes) or any important medical illness or abnormal laboratory finding that would, in the Investigator's judgment, increase the risk to the patient associated with his or her participation in the study.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Research Site 002
New York, New York, 10065
Research Site 001
San Antonio, Texas, 78229
About this study
Official title: A Phase 1 Study of SRF231 in Patients With Advanced Solid and Hematologic Cancers
This Phase 1/1b, open-label, first-in-human, monotherapy study will be conducted in 2 parts. Part A will consist of the SRF231 monotherapy dose-escalation portion of the study, and will enroll up to 48 patients with advanced solid tumors and hematological cancers. Part B will include monotherapy expansion cohorts in advanced solid and hematologic cancers to further examine SRF231 as monotherapy (100 patients total).
Read the detailed description
This first-in-human study is designed to evaluate the safety and tolerability of SRF231 as a monotherapy via dose escalation (Part A), and to determine the dose(s) of SRF231 to be further examined in expansion cohorts as monotherapy. The preliminary clinical activity of SRF231 administered as monotherapy will be characterized, along with pharmacokinetics (PK) and pharmacodynamics. In Part B, the safety and tolerability of SRF231 as monotherapy will be evaluated in select patient cohorts of advanced cancers and evaluate clinical activity. The study also is designed to examine the effect of SRF231 monotherapy on peripheral blood immune cell subsets, peripheral blood gene expression, and serum biomarkers
- Conditions
- Advanced Solid Cancers, Hematologic Cancers
- Being tested
- SRF231
- Keywords
- CD47, SiRP α, tumor microenvironment, macrophage, solid tumor, Phase 1, safety, efficacy, hematologic malignancies, SRF231
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SRF231Drug
SRF231 specifically blocks the interaction between CD47 and signal regulatory protein alpha and acts as a potent enhancer of human tumor cell phagocytosis.
| Study group | Role | What they receive |
|---|---|---|
| Part A | Experimental | Part A will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of SRF231 as a monotherapy in patients with advanced solid tumors and lymphoma/Chronic lymphocytic leukemia. Receives: Drug: SRF231 |
| Part B Cohort 1 | Experimental | Depending upon the results from Part A of the study and the decision from the Safety Review Committee, 1 or 2 doses or dosing frequencies of SRF231 in select advanced solid and hematologic malignancies. Receives: Drug: SRF231 |
What is being measured
The primary outcome is the main question the study is designed to answer.
[Part A] Dose-limiting toxicity (DLT)
The number of patients in Part A who experienced a DLT during Cycle 1 or completed at least 75% of the prescribed Cycle 1 SRF231 dose will be used to assess tolerability and determine the appropriate dose for Part B.
Measured: Through 24 months with 21 day drug treatment cycles
[Part A] Non-tolerated Dose (NTD)
For Part A, the NTD is the dose level at which 2 or more patients experience a DLT in the first cycle of treatment.
Measured: Through 24 months with 21 day drug treatment cycles
[Part A] Maximum tolerated Dose (MTD)
For Part A, the MTD is defined as the dose level immediately below the non-tolerated dose (NTD). A total of 6 patients must be treated at a dose level for it to be considered the MTD.
Measured: Through 24 months with 21 day drug treatment cycles
[Parts A and B] Safety Analysis: summarizing adverse events (AEs) and will be based on treatment-emergent AEs (TEAEs)
Safety and tolerability of SRF231 monotherapy will be assessed by summarizing adverse events (AEs) and will be based on treatment-emergent AEs (TEAEs). A TEAE is an AE that emerges or worsens in the period from the first dose of study treatment to 30 days after the last dose of study drug assessed by per CTCAE version 4.03 or higher.
Measured: Through 24 months with 21 day drug treatment cycles
Secondary outcomes (11)
[Parts A and B] Maximum serum concentration (Cmax) of SRF231
Cmax in serum for all patients who receive at least one dose of SRF231 and had at least one measurable concentration based on the actual sample collection times determined using standard noncompartmental methods.
Measured: Up to 24 months
[Parts A and B] Time to maximum serum concentration (tmax) of SRF231
Tmax in serum for all patients who receive at least one dose of SRF231 and had at least one measurable concentration based on the actual sample collection times determined using standard noncompartmental methods.
Measured: Up to 24 months
[Parts A and B] Area under the serum concentration-time curve from time zero to the last quantifiable time point (AUC 0-last) of SRF231
AUC 0-last for all patients who receive at least one dose of SRF231 and had at least one measurable concentration based on the actual sample collection times determined using standard noncompartmental methods
Measured: Up to 24 months
[Parts A and B] Area under the serum concentration-time curve from time zero extrapolated to infinity (AUC 0-INF) of SRF231
AUC 0-INF for all patients who receive at least one dose of SRF231 and had at least one measurable concentration based on the actual sample collection times determined using standard noncompartmental methods.
Measured: Up to 24 months
[Parts A and B] Terminal elimination half-life (t1/2) of SRF231
T1/2 for all patients who receive at least one dose of SRF231 and had at least one measurable concentration based on the actual sample collection times determined using standard noncompartmental methods.
Measured: Up to 24 months
[Parts A and B] Pharmacodynamics of SRF231 via receptor occupancy
Blood samples will be collected from all patients at multiple time points for analysis of CD47 receptor occupancy by SRF231. PD analyses will be descriptive and summary tabulations may be produced.
Measured: Up to 24 months
[Parts A and B] Anti-Drug Antibodies (ADAs). Time Frame: Up to 24 months
Determine the incidence of ADAs in all patients who receive at least one dose of SRF231 and had at least one measurable sample.
Measured: Up to 24 months
[Part B] Overall Response Rate (ORR) including the best response of complete response (CR) or partial response (PR)
ORR will be estimated by the percentage of patients achieving a best overall response of CR or PR using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, International Working Group Lugano Criteria (IWG Lugano) or other tumor-appropriate response criteria.
Measured: Up to 24 months
[Part B] Duration of Response (DOR) including time from the first documented to response to documented disease progression
DoR defined as the time from first documented response to documented disease progression using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, International Working Group Lugano Criteria (IWG Lugano) or other tumor-appropriate response criteria will be summarized.
Measured: Up to 24 months
[Part B] Disease Control Rate (DCR) as the percentage of patients with CR, PR, or stable disease (SD)
DCR defined as the percentage of patients with CR, PR or SD determined using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, International Working Group Lugano Criteria (IWG Lugano) or other tumor-appropriate response criteria will be summarized.
Measured: Up to 24 months
[Part B] Progression Free Survival as the time from first treatment to death or documented disease progression
PFS defined as the time from the first treatment on study to death or documented disease progression using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, International Working Group Lugano Criteria (IWG Lugano) or other tumor-appropriate response criteria will be summarized.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2018
- Study start13 Mar 2018
- Primary completion15 Sep 2020
- Study completion29 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid CancersStudies of the same condition, open and under way.
- 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
- Parallel groups
- Model description
- This Phase 1/1b, open-label, first-in-human, monotherapy study will be conducted in 2 parts. Part A will consist of the SRF231 monotherapy dose-escalation portion of the study, and will enroll up to 48 patients with advanced solid tumors and lymphoma/CLL. Part B will include 5 monotherapy expansion cohorts: in advance solid and hematologic cancers (100 patients total).
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Surface Oncology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Ross, MD, Study chair, Surface Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03512340
- Sponsor's protocol ID
- SRF231-101
- Status last verified
- Oct 2020
- First submitted
- 13 Mar 2018
- Last updated
- 20 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of SRF231 in Patients With Advanced Solid and Hematologic Cancers
- ClinicalTrials.gov ID
- NCT03512340
- Acronym / sponsor ID
- SRF231-101
- Conditions
- Advanced Solid Cancers, Hematologic Cancers
- Keywords
- CD47, SiRP α, tumor microenvironment, macrophage, solid tumor, Phase 1, safety, efficacy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Surface OncologyIndustry (pharma, biotech, devices)
- Study start
- 13 Mar 2018 (actual)
- Primary completion
- 15 Sep 2020 (actual)
- Study completion
- 29 Sep 2020 (actual)
- First posted
- 30 Apr 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.
This Phase 1/1b, open-label, first-in-human, monotherapy study will be conducted in 2 parts. Part A will consist of the SRF231 monotherapy dose-escalation portion of the study, and will enroll up to 48 patients with advanced solid tumors and hematological cancers. Part B will include monotherapy expansion cohorts in advanced solid and hematologic cancers to further examine SRF231 as monotherapy (100 patients total).
Detailed description
This first-in-human study is designed to evaluate the safety and tolerability of SRF231 as a monotherapy via dose escalation (Part A), and to determine the dose(s) of SRF231 to be further examined in expansion cohorts as monotherapy. The preliminary clinical activity of SRF231 administered as monotherapy will be characterized, along with pharmacokinetics (PK) and pharmacodynamics. In Part B, the safety and tolerability of SRF231 as monotherapy will be evaluated in select patient cohorts of advanced cancers and evaluate clinical activity. The study also is designed to examine the effect of SRF231 monotherapy on peripheral blood immune cell subsets, peripheral blood gene expression, and serum biomarkers
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This Phase 1/1b, open-label, first-in-human, monotherapy study will be conducted in 2 parts. Part A will consist of the SRF231 monotherapy dose-escalation portion of the study, and will enroll up to 48 patients with advanced solid tumors and lymphoma/CLL. Part B will include 5 monotherapy expansion cohorts: in advance solid and hematologic cancers (100 patients total).
| Arm | Type | Receives |
|---|---|---|
| Part A | Experimental | Drug: SRF231Part A will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of SRF231 as a monotherapy in patients with advanced solid tumors and lymphoma/Chronic lymphocytic leukemia. |
| Part B Cohort 1 | Experimental | Drug: SRF231Depending upon the results from Part A of the study and the decision from the Safety Review Committee, 1 or 2 doses or dosing frequencies of SRF231 in select advanced solid and hematologic malignancies. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- ≥18 years of age.
- Failure to respond to standard therapy, and for whom no appropriate therapies are available (based on the judgment of the Investigator).
- Histological or cytological evidence of advanced, relapsed, or refractory, solid and hematologic cancers that are not a candidate for curative therapy.
- Part B only: Patient must have demonstrated progressive disease (PD) after the most recent treatment regimen (or within 3 months prior to enrollment in the case of treatment-naïve patients).
- Washout period from the last dose of previous anticancer therapy (chemotherapy, biologic, or other investigational agent) to the initiation of study drug must be > 5 times the half-life of the agent or > 21 days (whichever is shorter).
Key exclusion criteria (21 listed)
- Previously received an anti-CD47 antibody or SIRPalpha targeted therapy.
- High-grade lymphomas (eg, Burkitt's, lymphoblastic), plasma cell leukemia.
- History of any condition known to be associated with reduced red blood cell (RBC) lifespan (eg, thalassemia trait, glucose-6-phosphate dehydrogenase deficiency).
- History of ≥ Grade 4 allergic or anaphylactic reaction to any monoclonal antibody therapy, murine protein, or any excipient in the study drugs.
- Major surgery within 4 weeks prior to Screening.
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 |
|---|---|---|
| SRF231SRF231 specifically blocks the interaction between CD47 and signal regulatory protein alpha and acts as a potent enhancer of human tumor cell phagocytosis. | Drug | Part A, Part B Cohort 1 |
Primary outcome
[Part A] Dose-limiting toxicity (DLT)
Time frame: Through 24 months with 21 day drug treatment cycles
The number of patients in Part A who experienced a DLT during Cycle 1 or completed at least 75% of the prescribed Cycle 1 SRF231 dose will be used to assess tolerability and determine the appropriate dose for Part B.
[Part A] Non-tolerated Dose (NTD)
Time frame: Through 24 months with 21 day drug treatment cycles
For Part A, the NTD is the dose level at which 2 or more patients experience a DLT in the first cycle of treatment.
[Part A] Maximum tolerated Dose (MTD)
Time frame: Through 24 months with 21 day drug treatment cycles
For Part A, the MTD is defined as the dose level immediately below the non-tolerated dose (NTD). A total of 6 patients must be treated at a dose level for it to be considered the MTD.
[Parts A and B] Safety Analysis: summarizing adverse events (AEs) and will be based on treatment-emergent AEs (TEAEs)
Time frame: Through 24 months with 21 day drug treatment cycles
Safety and tolerability of SRF231 monotherapy will be assessed by summarizing adverse events (AEs) and will be based on treatment-emergent AEs (TEAEs). A TEAE is an AE that emerges or worsens in the period from the first dose of study treatment to 30 days after the last dose of study drug assessed by per CTCAE version 4.03 or higher.
11 secondary outcomes
[Parts A and B] Maximum serum concentration (Cmax) of SRF231
Time frame: Up to 24 months
[Parts A and B] Time to maximum serum concentration (tmax) of SRF231
Time frame: Up to 24 months
[Parts A and B] Area under the serum concentration-time curve from time zero to the last quantifiable time point (AUC 0-last) of SRF231
Time frame: Up to 24 months
[Parts A and B] Area under the serum concentration-time curve from time zero extrapolated to infinity (AUC 0-INF) of SRF231
Time frame: Up to 24 months
[Parts A and B] Terminal elimination half-life (t1/2) of SRF231
Time frame: Up to 24 months
[Parts A and B] Pharmacodynamics of SRF231 via receptor occupancy
Time frame: Up to 24 months
[Parts A and B] Anti-Drug Antibodies (ADAs). Time Frame: Up to 24 months
Time frame: Up to 24 months
[Part B] Overall Response Rate (ORR) including the best response of complete response (CR) or partial response (PR)
Time frame: Up to 24 months
[Part B] Duration of Response (DOR) including time from the first documented to response to documented disease progression
Time frame: Up to 24 months
[Part B] Disease Control Rate (DCR) as the percentage of patients with CR, PR, or stable disease (SD)
Time frame: Up to 24 months
[Part B] Progression Free Survival as the time from first treatment to death or documented disease progression
Time frame: Up to 24 months
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 20 Oct 2020.
- Individual participant dataSharing planned: No
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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.
Robert Ross, MD study chair
Surface Oncology
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SRF231 in people with Advanced Solid Cancers and Hematologic Cancers, run by Surface Oncology at 3 sites in 2 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 18 inclusion and 21 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 20 Oct 2020. 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, 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 A] Dose-limiting toxicity (DLT) (time frame: Through 24 months with 21 day drug treatment cycles). The study lists 4 primary outcomes in all. 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 20 Oct 2020.