Acute Myeloid LeukemiaPhase 1/2NCT02416908
Study of CLAG + Selinexor in Relapsed or Refractory Acute Myeloid Leukemia
A Phase 1/2 study testing Selinexor, Cladribine and G-CSF in people with Acute Myeloid Leukemia, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Selinexor has shown single-agent activity in a current phase I study enrolling patients with relapsed/refractory AML with durable complete remissions (CR), complete remissions with incomplete hematologic recovery (CRi), partial remissions (PR), and stable disease (SD) observed. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Selinexor, Cladribine and G-CSF
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2015to 21 Jun 2019
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed AML (defined using WHO criteria) with one of the following:
- Primary refractory disease following ≤ 2 cycles of induction chemotherapy, or
- First relapse with no prior unsuccessful salvage chemotherapy, or
- Relapsed or refractory to hypomethylating agent, defined as a lack of response, disease progression, loss of response, or intolerance as deemed by the study investigator
- Age between 18 and 70 years old.
- ECOG performance status ≤ 3
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- Adequate organ function as defined below:
- AST(SGOT), ALT(SGPT), total bilirubin ≤ 2 x IULN except when in the opinion of treating physician is due to direct involvement of leukemia (eg. hepatic infiltration or biliary obstruction due to leukemia) or Gilbert's disease
- Creatinine clearance >50 ml/min, calculated using the formula of Cockroft and Gault: (140-Age) x Mass (kg) / (72 x Creatinine mg/dL); multiply by 0.85 if female.
- Left ventricular ejection fraction of ≥ 40% by MUGA scan or echocardiogram
- To ensure that no patient will receive a dose of selinexor >70mg/m^2, body surface area (BSA) calculated by Dubois method must be >1.43 m^2
- Patients should not become pregnant or father a baby while on this study because the drugs in this study can affect an unborn baby. Women should not breastfeed a baby while on this study. It is important patients understand the need to use birth control while on this study. It is not anticipated that female patients enrolling in this study will be able to conceive. However, in the rare event that this is possible, female patients of child-bearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening, and male patients must use an effective barrier method of contraception if sexually active with a female of child-bearing potential. Acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or post-menopausal. For both male and female patients, effective methods of contraception must be used throughout the study and for three months following the last dose.
- Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
Who cannot join
- Acute promyelocytic leukemia (AML with t(15;17)(q22;q11) and variants).
- Previous treatment with CLAG or other chemotherapy regimen containing both cladribine and cytarabine.
- Colony stimulating factors within 2 weeks of study.
- Active graft versus host disease (GVHD) after allogeneic stem cell transplantation. At least 2 months must have elapsed since completion of an allogeneic stem cell transplantation.
- Less than 2 weeks from the completion of any previous cytotoxic chemotherapy (with the exception of hydroxyurea).
- Concurrent active malignancy under treatment except prostate or breast cancer undergoing treatment with hormonal therapy.
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- Treatment with any investigational agent within three weeks prior to first dose in this study.
- Active CNS involvement with leukemia.
- Unstable cardiovascular function:
- symptomatic ischemia, or
- uncontrolled clinically significant conduction abnormalities (i.e. ventricular tachycardia on antiarrhythmics are excluded and 1st degree AV block or asymptomatic LAFB/RBBB will not be excluded), or
- congestive heart failure (CHF) of NYHA class ≥3, or
- myocardial infarction (MI) within 3 months
- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to KPT-330 or other agents used in the study.
- Uncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose. Infections controlled on concurrent anti-microbial agents are acceptable, and anti-microbial prophylaxis per institutional guidelines is acceptable.
- Any medical condition which, in the investigator's opinion, could compromise the patient's safety.
- Pregnant and/or breastfeeding. Patient must have a negative urine pregnancy test within 5 days of study entry.
- Unable to swallow tablets, or diagnosed malabsorption syndrome, or any other disease significantly affecting gastrointestinal function.
- Known active hepatitis B virus (HBV) or C virus (HCV) infection; or known to be positive for HCV ribonucleic acid (RNA) or HBsAg (HBV surface antigen).
- Known human immunodeficiency virus (HIV) infection.
- Serious psychiatric or medical conditions that could interfere with treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: An Investigator Sponsored Phase I/II Study of CLAG + Selinexor in Relapsed or Refractory Acute Myeloid Leukemia
Selinexor has shown single-agent activity in a current phase I study enrolling patients with relapsed/refractory AML with durable complete remissions (CR), complete remissions with incomplete hematologic recovery (CRi), partial remissions (PR), and stable disease (SD) observed. Furthermore, common toxicities included nausea, fatigue, and anorexia and were manageable with supportive care agents. Additionally, CLAG chemotherapy has proven activity in relapsed and refractory AML, and has been shown to be a relatively well tolerated regimen without significant non-hematologic toxicity. Given the established role of CLAG chemotherapy, the single agent activity of selinexor, and their non-overlapping toxicities, the investigators propose a phase I/II open label study of selinexor in combination with CLAG for the treatment of patients with relapsed/refractory AML.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Selinexor, Cladribine, G-CSF, Cytarabine, Bone marrow biopsy
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SelinexorDrug
Also called KPT-330
CladribineDrug
Also called Leustatin®, 2-CdA, 2-Chloro-2'-deoxyadenosine, CdA
G-CSFDrug
Also called Plerixafor, Mozobil®
CytarabineDrug
Also called Cytosar-U ®, 1-β-Arabinofuranosylcytosine, Cytosine arabinoside, Ara-C
Bone marrow biopsyProcedure or surgery
Also called Bone marrow aspirate
| Study group | Role | What they receive |
|---|---|---|
| Phase I Schedule A (selinexor) | Experimental | * Selinexor will be dosed on Days 1, 5, 10, and 12 of the 28-day cycle. All doses will be 60 mg each PO.
* Single agent selinexor maintenance may be given at 60 mg on Days 1, 8, 15, and 22 (4 doses per 28 day cycle).
* Cladribine will be given 5 mg/m^2/day IV once daily on Days 4-8.
* G-CSF will be given 300 mcg SC once daily on Days 3-8.
* Cytarabine will be given 2000 mg/m^2/day IV once daily on Days 4-8.
* Bone marrow biopsy will be performed at baseline, Day 3, at time of hematopoietic recovery, and as clinically indicated to assess treatment response. Receives: Drug: Selinexor; Drug: Cladribine; Drug: G-CSF; Drug: Cytarabine; Procedure: Bone marrow biopsy |
| Phase I Schedule B (selinexor) | Experimental | * Selinexor will be dosed on Days 1, 5, 10, 12, 17, and 19 of the 28-day cycle. All doses will be 60 mg each PO.
* Single agent selinexor maintenance may be given at 60 mg on Days 1, 8, 15, and 22 (4 doses per 28 day cycle).
* Cladribine will be given 5 mg/m^2/day IV once daily on Days 4-8.
* G-CSF will be given 300 mcg SC once daily on Days 3-8.
* Cytarabine will be given 2000 mg/m^2/day IV once daily on Days 4-8.
* Bone marrow biopsy will be performed at baseline, Day 3, at time of hematopoietic recovery, and as clinically indicated to assess treatment response. Receives: Drug: Selinexor; Drug: Cladribine; Drug: G-CSF; Drug: Cytarabine; Procedure: Bone marrow biopsy |
| Phase II (selinexor) | Experimental | * Selinexor will be given at the schedule as determined in Phase 1.
* Single agent selinexor maintenance may be given at 60 mg on Days 1, 8, 15, and 22 (4 doses per 28 day cycle).
* Cladribine will be given 5 mg/m^2/day IV once daily on Days 4-8.
* G-CSF will be given 300 mcg SC once daily on Days 3-8.
* Cytarabine will be given 2000 mg/m^2/day IV once daily on Days 4-8.
* Bone marrow biopsy will be performed at baseline, Day 3, at time of hematopoietic recovery, and as clinically indicated to assess treatment response. Receives: Drug: Selinexor; Drug: Cladribine; Drug: G-CSF; Drug: Cytarabine; Procedure: Bone marrow biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of Treatment as Measured by Incidence of Grade 3-4 Adverse Events Occurring in >5% of Participants
-All adverse events will be classified using the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Measured: From start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever came first (41 days)
Complete Remission Rate (CR + CRi)
- Morphologic complete remission (CR): neutrophil count > 1.0 x 109 /L, platelet count ≥ 100 x 109/L, < 5% bone marrow blasts by morphologic review, no Auer rods, no evidence of extramedullary disease. (No requirements for marrow cellularity, hemoglobin concentration).
- Morphologic complete remission with incomplete blood count recovery (CRi): same as CR but ANC may be <1000/mcl or platelet count <100,000/mcl
- Participants in the phase I portion of the study, treated at the MTD will count towards the phase II accrual goal for evaluation of the primary endpoint.
Measured: Median follow-up of 34 days
Secondary outcomes (7)
Time to Platelet Engraftment
-Time to platelet engraftment: Defined as the date of the first dose of study drug to the date that the platelet count is >100,000/mm^3 in the absence of platelet transfusions.
Measured: 56 days
Time to Neutrophil Engraftment
-Time to neutrophil engraftment: Defined as the date of the first dose of study drug to the date that the absolute neutrophil count is >1,000/mm3
Measured: Up to 2 years
Event-free Survival
Event-free survival (EFS): Defined as the interval from the date of first dose of study drug to date of treatment failure including progressive disease, recurrence, or discontinuation for any reason (including toxicity, patient preference, initiation of new treatment without documented progression, or death due to any cause).
Measured: Up to 2 years (median follow-up of 307 days)
Duration of Remission
-Duration of remission (DOR): Defined as the interval from the date complete remission is documented to the date of recurrence.
Measured: Up to 2 years
Relapse-free Survival
Relapse-free survival (RFS): For patients achieving a complete remission, defined as the interval from the date of first documentation of a leukemia free state to date of recurrence or death due to any cause.
Measured: Median follow-up of 307 days
Overall Survival
Overall survival (OS): Defined as the date of first dose of study drug to the date of death from any cause. OS will be evaluated at 3 month intervals for at least 12 months and up to a maximum of 2 years.
Measured: Up to 2 years (median follow-up of 307 days)
Number of Participants Who Were Able to Undergo Hematopoietic Stem Cell Transplantation
Allogeneic stem cell transplant utilization: the number of patients proceeding to allogeneic transplant within 2 months following end of study without any additional salvage therapy following study treatment.
Measured: Up to 2 years (median follow-up of 307 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2015 (estimated)
- Study start16 Jun 2015
- Primary completion21 Jun 2019
- Study completion21 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Karyopharm Therapeutics Inc
- Responsible party
- Sponsor
- Investigators
- Geoffrey Uy, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02416908
- Sponsor's protocol ID
- 201505084
- Status last verified
- Mar 2020
- First submitted
- 30 Mar 2015
- Last updated
- 13 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigator Sponsored Phase I/II Study of CLAG + Selinexor in Relapsed or Refractory Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT02416908
- Acronym / sponsor ID
- 201505084
- Conditions
- Acute Myeloid Leukemia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Karyopharm Therapeutics Inc
- Study start
- 16 Jun 2015 (actual)
- Primary completion
- 21 Jun 2019 (actual)
- Study completion
- 21 Jun 2019 (actual)
- First posted
- 15 Apr 2015 (estimated)
- Results
- Posted 13 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Selinexor has shown single-agent activity in a current phase I study enrolling patients with relapsed/refractory AML with durable complete remissions (CR), complete remissions with incomplete hematologic recovery (CRi), partial remissions (PR), and stable disease (SD) observed. Furthermore, common toxicities included nausea, fatigue, and anorexia and were manageable with supportive care agents. Additionally, CLAG chemotherapy has proven activity in relapsed and refractory AML, and has been shown to be a relatively well tolerated regimen without significant non-hematologic toxicity. Given the established role of CLAG chemotherapy, the single agent activity of selinexor, and their non-overlapping toxicities, the investigators propose a phase I/II open label study of selinexor in combination with CLAG for the treatment of patients with relapsed/refractory AML.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase I Schedule A (selinexor) | Experimental | Drug: Selinexor, Drug: Cladribine, Drug: G-CSF, Drug: Cytarabine, Procedure: Bone marrow biopsy* Selinexor will be dosed on Days 1, 5, 10, and 12 of the 28-day cycle. All doses will be 60 mg each PO. * Single agent selinexor maintenance may be given at 60 mg on Days 1, 8, 15, and 22 (4 doses per 28 day cycle). * Cladribine will be given 5 mg/m^2/day IV once daily on Days 4-8. * G-CSF will be given 300 mcg SC once daily on Days 3-8. * Cytarabine will be given 2000 mg/m^2/day IV once daily on Days 4-8. * Bone marrow biopsy will be performed at baseline, Day 3, at time of hematopoietic recovery, and as clinically indicated to assess treatment response. |
| Phase I Schedule B (selinexor) | Experimental | Drug: Selinexor, Drug: Cladribine, Drug: G-CSF, Drug: Cytarabine, Procedure: Bone marrow biopsy* Selinexor will be dosed on Days 1, 5, 10, 12, 17, and 19 of the 28-day cycle. All doses will be 60 mg each PO. * Single agent selinexor maintenance may be given at 60 mg on Days 1, 8, 15, and 22 (4 doses per 28 day cycle). * Cladribine will be given 5 mg/m^2/day IV once daily on Days 4-8. * G-CSF will be given 300 mcg SC once daily on Days 3-8. * Cytarabine will be given 2000 mg/m^2/day IV once daily on Days 4-8. * Bone marrow biopsy will be performed at baseline, Day 3, at time of hematopoietic recovery, and as clinically indicated to assess treatment response. |
| Phase II (selinexor) | Experimental | Drug: Selinexor, Drug: Cladribine, Drug: G-CSF, Drug: Cytarabine, Procedure: Bone marrow biopsy* Selinexor will be given at the schedule as determined in Phase 1. * Single agent selinexor maintenance may be given at 60 mg on Days 1, 8, 15, and 22 (4 doses per 28 day cycle). * Cladribine will be given 5 mg/m^2/day IV once daily on Days 4-8. * G-CSF will be given 300 mcg SC once daily on Days 3-8. * Cytarabine will be given 2000 mg/m^2/day IV once daily on Days 4-8. * Bone marrow biopsy will be performed at baseline, Day 3, at time of hematopoietic recovery, and as clinically indicated to assess treatment response. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically confirmed AML (defined using WHO criteria) with one of the following:
- Age between 18 and 70 years old.
- ECOG performance status ≤ 3
- Adequate organ function as defined below:
- To ensure that no patient will receive a dose of selinexor >70mg/m^2, body surface area (BSA) calculated by Dubois method must be >1.43 m^2
Key exclusion criteria (21 listed)
- Acute promyelocytic leukemia (AML with t(15;17)(q22;q11) and variants).
- Previous treatment with CLAG or other chemotherapy regimen containing both cladribine and cytarabine.
- Colony stimulating factors within 2 weeks of study.
- Active graft versus host disease (GVHD) after allogeneic stem cell transplantation. At least 2 months must have elapsed since completion of an allogeneic stem cell transplantation.
- Less than 2 weeks from the completion of any previous cytotoxic chemotherapy (with the exception of hydroxyurea).
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 |
|---|---|---|
| SelinexorAlso: KPT-330 | Drug | Phase I Schedule A (selinexor), Phase I Schedule B (selinexor), Phase II (selinexor) |
| CladribineAlso: Leustatin®, 2-CdA, 2-Chloro-2'-deoxyadenosine, CdA | Drug | Phase I Schedule A (selinexor), Phase I Schedule B (selinexor), Phase II (selinexor) |
| G-CSFAlso: Plerixafor, Mozobil® | Drug | Phase I Schedule A (selinexor), Phase I Schedule B (selinexor), Phase II (selinexor) |
| CytarabineAlso: Cytosar-U ®, 1-β-Arabinofuranosylcytosine, Cytosine arabinoside, Ara-C | Drug | Phase I Schedule A (selinexor), Phase I Schedule B (selinexor), Phase II (selinexor) |
| Bone marrow biopsyAlso: Bone marrow aspirate | Procedure or surgery | Phase I Schedule A (selinexor), Phase I Schedule B (selinexor), Phase II (selinexor) |
Primary outcome
Safety and Tolerability of Treatment as Measured by Incidence of Grade 3-4 Adverse Events Occurring in >5% of Participants
Time frame: From start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever came first (41 days)
-All adverse events will be classified using the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Complete Remission Rate (CR + CRi)
Time frame: Median follow-up of 34 days
* Morphologic complete remission (CR): neutrophil count > 1.0 x 109 /L, platelet count ≥ 100 x 109/L, < 5% bone marrow blasts by morphologic review, no Auer rods, no evidence of extramedullary disease. (No requirements for marrow cellularity, hemoglobin concentration). * Morphologic complete remission with incomplete blood count recovery (CRi): same as CR but ANC may be <1000/mcl or platelet count <100,000/mcl * Participants in the phase I portion of the study, treated at the MTD will count towards the phase II accrual goal for evaluation of the primary endpoint.
7 secondary outcomes
Time to Platelet Engraftment
Time frame: 56 days
Time to Neutrophil Engraftment
Time frame: Up to 2 years
Event-free Survival
Time frame: Up to 2 years (median follow-up of 307 days)
Duration of Remission
Time frame: Up to 2 years
Relapse-free Survival
Time frame: Median follow-up of 307 days
Overall Survival
Time frame: Up to 2 years (median follow-up of 307 days)
Number of Participants Who Were Able to Undergo Hematopoietic Stem Cell Transplantation
Time frame: Up to 2 years (median follow-up of 307 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- 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.
Geoffrey Uy, M.D. principal investigator
Washington University School of Medicine
1 site 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 Selinexor, Cladribine and G-CSF in people with Acute Myeloid Leukemia, run by Washington University School of Medicine at 1 site 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 13 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 13 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 13 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability of Treatment as Measured by Incidence of Grade 3-4 Adverse Events Occurring in >5% of Participants (time frame: From start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever came first (41 days)). 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?
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 13 Mar 2020; AzTrials last refreshed its copy on 7 Nov 2026.