Chronic Lymphocytic LeukemiaPhase 1/2NCT03037645
Safety, PK, PD, and Antitumor Activity of Vecabrutinib (SNS-062) in B Lymphoid Cancers
A Phase 1/2 study testing SNS-062 in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Sunesis Pharmaceuticals at 11 sites in United States.
Trial summary
This is an open-label Phase 1b/2 study in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL)or non hodgkin's lymphoma (NHL) who have failed prior standard of care therapies including a BTK inhibitor where one is approved for the indication. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Lymphoplasmacytoid Lymphoma
- What is being tested?
- SNS-062
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 11 sitesUnited States
- Study dates
- 28 Apr 2017to 31 Aug 2020
- Phase
- Phase 1/2
- 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
- Eastern Cooperative Oncology Group Performance Status of ≤2.
- Confirmed malignancy with relapsed/refractory disease after ≥2 lines of standard systemic therapy including prior BTK inhibitor therapy having CLL, LPL/WM, MCL or MZL and for DLBCL-ABC and FL, after ≥2 lines of standard systemic therapy (Phase 1b). For Phase 2, CLL/SLL patients with confirmed malignancy with relapsed/refractory disease after ≥1 line of standard systemic therapy including prior BTK inhibitor therapy
- Presence of measurable disease through various assessments depending on specific cancer type.
- Current medical need for therapy of the B-lymphoid malignancy.
Who cannot join
- Active central nervous system involvement.
- History of second primary malignancy that has progressed or required systemic treatment in the past 2 years. Exceptions include: local cancers of the skin, cervix or breast cancers, non-invasive bladder cancer, hormone sensitive prostate cancer with stable PSA ≥3 months, and other localized solid tumors in situ/other low risk cancers.
- Significant cardiovascular disease or electrocardiogram (ECG) abnormalities
- Ongoing risk for bleeding due to bleeding diathesis, platelet function disorder, uncontrolled peptic ulcer disease, oral anticoagulation medications.
- Evidence of uncontrolled systemic bacterial, fungal or viral infections at the start of drug therapy.
- Demonstrated intolerance to BTK inhibitor as shown by discontinuation due to adverse effects.
- Use of a moderate or strong inhibitor or inducer of CYP3A4 within 7 days prior to start of study therapy (e.g., some antibiotics, antifungals, anticonvulsants, grapefruit).
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, 97401
MD Anderson Cancer Center
Houston, Texas, 77030
Weill Cornell Medicine
New York, New York, 10065
University of California Irvine Medical Center
Orange, California, 92868-3201
UC San Diego Moores Cancer Center
San Diego, California, 92093
Swedish Cancer Institute
Seattle, Washington, 98104
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
Texas Oncology - Tyler
Tyler, Texas, 75702
About this study
Official title: A Phase 1b/2 Dose-Escalation and Cohort-Expansion Study of the Noncovalent, Reversible Bruton's Tyrosine Kinase Inhibitor, SNS-062, in Patients With B-Lymphoid Malignancies
This is an open-label Phase 1b/2 study in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL)or non hodgkin's lymphoma (NHL) who have failed prior standard of care therapies including a BTK inhibitor where one is approved for the indication.
Read the detailed description
This study includes 2 parts: phase 1 (dose escalation) and phase 2 (cohort expansion) in patients with CLL/SLL or NHL who have failed prior standard of care therapies including a BTK inhibitor where one is approved for the indication. NHL indications include lymphoplasmacytoid lymphoma/Waldenström's macroglobulinemia (LPL/WM), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), diffuse large B-cell lymphoma of the activated B-cell subtype (DLBCL-ABC), and follicular lymphoma (FL). In Phase 1b, cohorts of 3 to 6 patients are studied at each dose level, starting with 25 mg vecabrutnib BID in oral capsule form. Following identification of the MTD and/or recommended dose, in Phase 2 only CLL/SLL patients will be enrolled to expansion cohorts to further characterize the clinical activity, safety, and pharmacology of vecabrutinib. Cycle length is 4 weeks.
- Conditions
- Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Lymphoplasmacytoid Lymphoma, Mantle-Cell Lymphoma, Waldenstrom Macroglobulinemia, Diffuse Large B Cell Lymphoma
- Being tested
- SNS-062
- Keywords
- CLL, hematological diseases, relapsed, cancer, malignancy, SNS-062, B-lymphoid, chronic lymphocytic leukemia, small lymphocytic lymphoma, lymphoplasmacytoid lymphoma, Waldenström's macrogloulinemia, mantle cell lymphoma, SLL, LPL, WM, MCL, refractory, DLBCL-ABC, DLBCL, follicular lymphoma
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Waldenstrom Macroglobulinemia, Lymphoma, Mantle-Cell, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular, Lymphoma, B-Cell, Marginal Zone, Hematologic Diseases, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNS-062Drug
SNS-062 will be orally administered twice daily and available in capsules containing either 25 mg or 100 mg of active ingredient.
| Study group | Role | What they receive |
|---|---|---|
| Dose escalating cohorts of SNS-062 | Experimental | Sequential groups, 25, 50, 100, 200, 300, 400 and 500 mg twice daily to determine maximum tolerated dose and recommended dose (RD) in the treatment of various hematological cancers followed by expansion of the recommended dose cohort in Phase 2 of the study treating hematological cancers. Receives: Drug: SNS-062 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose and/or Recommended dose of SNS-062 (Phase 1b)
To determine the Maximum Tolerated Dose (MTD) and/or Recommended Dose (RD)within the tested SNS-062 dose range. The MTD is the highest tested dose level at which ≥6 subjects have been treated and which is associated with a Cycle 1 dose limiting toxicity (DLT) in <33% of the subjects. The RD may be the MTD or may be a lower dose.
Measured: Up to approximately 21 months
Objective Response Rate (ORR) (Phase 2)
Phase 2 portion of study measuring ORR and corresponding 90% confidence intervals by cohort. ORR will be defined by disease subtype as the proportion of subjects who achieve CLL/SLL: a CR, CRi, or PR.
Measured: Up to approximately 36 months
Secondary outcomes (11)
Safety as assessed through reported AEs, SAEs, DLTs and abnormal lab findings (Phase 1b and Phase 2)
Type, severity, timing of onset, duration, and relationship to study drug of any TEAEs or abnormalities of laboratory tests, SAEs, DLTs, or AEs leading to study discontinuation.
Measured: Up to approximately 36 months
Characterization of Pharmacokinetics (AUC) (Phase 1b and Phase 2)
Area Under the Curve (AUC)
Measured: Up to approximately 36 months
Characterization of Pharmacokinetics (Cmin,ss) (Phase 1b and Phase 2)
Minimum Plasma Concentration During Dosing Interval at Steady-State (Cmin,ss)
Measured: Up to approximately 36 months
Characterization of Pharmacokinetics (Cmax) (Phase 1b and Phase 2)
Maximum Plasma Concentration (Cmax)
Measured: Up to approximately 36 months
Characterization of Pharmacokinetics (Tmax) (Phase 1b and Phase 2)
Time of Maximum Plasma Concentration (Tmax)
Measured: Up to approximately 36 months
Preliminary evidence of anti-tumor activity, in terms of Time to Response (TTR) as assessed by the Investigator. (Phase 2)
Measure of Time to Response (TTR) as evaluated by standard response and progression criteria for CLL/SLL.
Measured: Up to approximately 36 months
Preliminary evidence of anti-tumor activity, in terms of Duration of Response (DOR) as assessed by the Investigator. (Phase 2)
Measure of Duration of Response (DOR) as evaluated by standard response and progression criteria for CLL/SLL.
Measured: Up to approximately 36 months
Preliminary evidence of anti-tumor activity, in terms of Response Rate (RR) as assessed by the Investigator. (Phase 2)
Measure of Response Rate (RR) as evaluated by standard response and progression criteria for CLL/SLL.
Measured: Up to approximately 36 months
Preliminary evidence of anti-tumor activity, in terms of Disease Control Rate (DCR) as assessed by the Investigator. (Phase 2)
Measure of Disease Control Rate (DCR) as evaluated by standard response and progression criteria for CLL/SLL.
Measured: Up to approximately 36 months
Preliminary evidence of anti-tumor activity, in terms of Progression-Free Survival (PFS) as assessed by the Investigator. (Phase 2)
Measure of Progression-Free Survival (PFS) as evaluated by standard response and progression criteria for CLL/SLL.
Measured: Up to approximately 36 months
Preliminary evidence of anti-tumor activity, in terms of Overall Survival (OS) as assessed by the Investigator. (Phase 2)
Measure of Overall Survival (OS) as evaluated by standard response and progression criteria for CLL/SLL.
Measured: Up to approximately 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study start28 Apr 2017
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Why it stopped: Phase 1b portion completed. Sponsor decided not to proceed with P2 portion of study. Vecabrutinib was very well tolerated, there was insufficient evidence of activity at the doses tested in the Phase 1b to advance to Phase 2.
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 Chronic Lymphocytic LeukemiaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunesis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gary Acton, MD, Study director, Sunesis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03037645
- Sponsor's protocol ID
- 062-HEM-102
- Status last verified
- Oct 2020
- First submitted
- 25 Jan 2017
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kipps TJ. Mining the Microenvironment for Therapeutic Targets in Chronic Lymphocytic Leukemia. Cancer J. 2021 Jul-Aug 01;27(4):306-313. doi: 10.1097/PPO.0000000000000536.
PubMed 34398557
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2 Dose-Escalation and Cohort-Expansion Study of the Noncovalent, Reversible Bruton's Tyrosine Kinase Inhibitor, SNS-062, in Patients With B-Lymphoid Malignancies
- ClinicalTrials.gov ID
- NCT03037645
- Acronym / sponsor ID
- 062-HEM-102
- Conditions
- Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Lymphoplasmacytoid Lymphoma, Mantle-Cell Lymphoma, Waldenstrom Macroglobulinemia, Diffuse Large B Cell Lymphoma
- Keywords
- CLL, hematological diseases, relapsed, cancer, malignancy, SNS-062, B-lymphoid, chronic lymphocytic leukemia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Phase 1b portion completed. Sponsor decided not to proceed with P2 portion of study. Vecabrutinib was very well tolerated, there was insufficient evidence of activity at the doses tested in the Phase 1b to advance to Phase 2.
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Sunesis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 28 Apr 2017 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 31 Jan 2017 (estimated)
- 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 is an open-label Phase 1b/2 study in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL)or non hodgkin's lymphoma (NHL) who have failed prior standard of care therapies including a BTK inhibitor where one is approved for the indication.
Detailed description
This study includes 2 parts: phase 1 (dose escalation) and phase 2 (cohort expansion) in patients with CLL/SLL or NHL who have failed prior standard of care therapies including a BTK inhibitor where one is approved for the indication. NHL indications include lymphoplasmacytoid lymphoma/Waldenström's macroglobulinemia (LPL/WM), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), diffuse large B-cell lymphoma of the activated B-cell subtype (DLBCL-ABC), and follicular lymphoma (FL). In Phase 1b, cohorts of 3 to 6 patients are studied at each dose level, starting with 25 mg vecabrutnib BID in oral capsule form. Following identification of the MTD and/or recommended dose, in Phase 2 only CLL/SLL patients will be enrolled to expansion cohorts to further characterize the clinical activity, safety, and pharmacology of vecabrutinib. Cycle length is 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose escalating cohorts of SNS-062 | Experimental | Drug: SNS-062Sequential groups, 25, 50, 100, 200, 300, 400 and 500 mg twice daily to determine maximum tolerated dose and recommended dose (RD) in the treatment of various hematological cancers followed by expansion of the recommended dose cohort in Phase 2 of the study treating hematological cancers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Eastern Cooperative Oncology Group Performance Status of ≤2.
- Confirmed malignancy with relapsed/refractory disease after ≥2 lines of standard systemic therapy including prior BTK inhibitor therapy having CLL, LPL/WM, MCL or MZL and for DLBCL-ABC and FL, after ≥2 lines of standard systemic therapy (Phase 1b). For Phase 2, CLL/SLL patients with confirmed malignancy with relapsed/refractory disease after ≥1 line of standard systemic therapy including prior BTK inhibitor therapy
- Presence of measurable disease through various assessments depending on specific cancer type.
- Current medical need for therapy of the B-lymphoid malignancy.
Key exclusion criteria (7 listed)
- Active central nervous system involvement.
- History of second primary malignancy that has progressed or required systemic treatment in the past 2 years. Exceptions include: local cancers of the skin, cervix or breast cancers, non-invasive bladder cancer, hormone sensitive prostate cancer with stable PSA ≥3 months, and other localized solid tumors in situ/other low risk cancers.
- Significant cardiovascular disease or electrocardiogram (ECG) abnormalities
- Ongoing risk for bleeding due to bleeding diathesis, platelet function disorder, uncontrolled peptic ulcer disease, oral anticoagulation medications.
- Evidence of uncontrolled systemic bacterial, fungal or viral infections at the start of drug therapy.
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 |
|---|---|---|
| SNS-062SNS-062 will be orally administered twice daily and available in capsules containing either 25 mg or 100 mg of active ingredient. | Drug | Dose escalating cohorts of SNS-062 |
Primary outcome
Maximum tolerated dose and/or Recommended dose of SNS-062 (Phase 1b)
Time frame: Up to approximately 21 months
To determine the Maximum Tolerated Dose (MTD) and/or Recommended Dose (RD)within the tested SNS-062 dose range. The MTD is the highest tested dose level at which ≥6 subjects have been treated and which is associated with a Cycle 1 dose limiting toxicity (DLT) in <33% of the subjects. The RD may be the MTD or may be a lower dose.
Objective Response Rate (ORR) (Phase 2)
Time frame: Up to approximately 36 months
Phase 2 portion of study measuring ORR and corresponding 90% confidence intervals by cohort. ORR will be defined by disease subtype as the proportion of subjects who achieve CLL/SLL: a CR, CRi, or PR.
11 secondary outcomes
Safety as assessed through reported AEs, SAEs, DLTs and abnormal lab findings (Phase 1b and Phase 2)
Time frame: Up to approximately 36 months
Characterization of Pharmacokinetics (AUC) (Phase 1b and Phase 2)
Time frame: Up to approximately 36 months
Characterization of Pharmacokinetics (Cmin,ss) (Phase 1b and Phase 2)
Time frame: Up to approximately 36 months
Characterization of Pharmacokinetics (Cmax) (Phase 1b and Phase 2)
Time frame: Up to approximately 36 months
Characterization of Pharmacokinetics (Tmax) (Phase 1b and Phase 2)
Time frame: Up to approximately 36 months
Preliminary evidence of anti-tumor activity, in terms of Time to Response (TTR) as assessed by the Investigator. (Phase 2)
Time frame: Up to approximately 36 months
Preliminary evidence of anti-tumor activity, in terms of Duration of Response (DOR) as assessed by the Investigator. (Phase 2)
Time frame: Up to approximately 36 months
Preliminary evidence of anti-tumor activity, in terms of Response Rate (RR) as assessed by the Investigator. (Phase 2)
Time frame: Up to approximately 36 months
Preliminary evidence of anti-tumor activity, in terms of Disease Control Rate (DCR) as assessed by the Investigator. (Phase 2)
Time frame: Up to approximately 36 months
Preliminary evidence of anti-tumor activity, in terms of Progression-Free Survival (PFS) as assessed by the Investigator. (Phase 2)
Time frame: Up to approximately 36 months
Preliminary evidence of anti-tumor activity, in terms of Overall Survival (OS) as assessed by the Investigator. (Phase 2)
Time frame: Up to approximately 36 months
Results and safety
The study was stopped early (reason given: Phase 1b portion completed. Sponsor decided not to proceed with P2 portion of study. Vecabrutinib was very well tolerated, there was insufficient evidence of activity at the doses tested in the Phase 1b to advance to Phase 2.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Derived from this study: PubMed 34398557Kipps TJ. Mining the Microenvironment for Therapeutic Targets in Chronic Lymphocytic Leukemia. Cancer J. 2021 Jul-Aug 01;27(4):306-313. doi: 10.1097/PPO.0000000000000536.
- Individual participant dataSharing planned: No
Related trials for Chronic Lymphocytic Leukemia
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Not yet recruitingPhase 2
Nemtabrutinib for Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Leukemia (SLL) Refractory to Covalent Bruton Tyrosine Kinase Inhibitor or Pirtobrutinib and Previously Treated With a BCL2 Inhibitor
Chronic Lymphocytic Leukemia, Small Lymphocytic Leukemia
RecruitingObservational study
Natural History Study of Monoclonal B Cell Lymphocytosis (MBL), Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Lymphoplasmacytic Lymphoma (LPL)/Waldenstrom Macroglobulinemia (WM), and Splenic Marginal Zone Lymphoma (SMZL)
Waldenstrom Macroglobulinemia, Lymphoplasmacytic Lymphoma
RecruitingPhase 3
A Study of Nemtabrutinib Plus Venetoclax vs Venetoclax + Rituximab (VR) in Second-line (2L) + Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) (MK-1026-010/BELLWAVE-010).
Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Chronic Lymphocytic
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.
Gary Acton, MD study director
Sunesis Pharmaceuticals
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SNS-062 in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Sunesis Pharmaceuticals at 11 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 4 inclusion and 7 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 19 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 11 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Phase 1b portion completed. Sponsor decided not to proceed with P2 portion of study. Vecabrutinib was very well tolerated, there was insufficient evidence of activity at the doses tested in the Phase 1b to advance to Phase 2.). Results are not available in the source record.
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?
Maximum tolerated dose and/or Recommended dose of SNS-062 (Phase 1b) (time frame: Up to approximately 21 months). The study lists 2 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 NCT03037645, 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 19 Oct 2020.