MelanomaNCT02700763
[18F]Dabrafenib Molecular Imaging in Melanoma Brain Metastasis
A study testing [18F]dabrafenib molecular imaging in people with Melanoma, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
In this feasibility study, [18F]dabrafenib will be used as radioactive tracer. All patients in this study are diagnosed with advanced melanoma with evidence of brain metastases and are eligible for treatment with dabrafenib, a specific V600-mutated BRAF inhibitor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- [18F]dabrafenib molecular imaging
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteNetherlands
- Study dates
- 6 Dec 2016to Apr 2020
- Phase
- Interventional
- 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
- Has signed informed consent.
- Age >=18 years of age.
- Histologically confirmed cutaneous metastatic melanoma (Stage IV), including confirmed brain metastases.
- BRAF mutation-positive (V600 E/K) melanoma as determined by standardized genetic testing.
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Eligible for treatment with dabrafenib. Specific information regarding warnings, precautions, contraindications, adverse events, and other pertinent information on the study treatment that may impact subject eligibility is provided in the summary of product characteristics (SPC) for Tafinlar.
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- No contraindication for performing a CT scan.
- No contraindications for performing an MRI scan of the brain.
- Able to swallow and retain oral medication.
- Women with child-bearing potential and men with reproductive potential must be willing to practice acceptable methods of birth control, as defined in Section 5.2, from 14 days prior to randomization, throughout the treatment period and for 4 weeks after the last dose of study treatment.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
- Must have adequate organ function as defined in Table 1. Table 1 Definitions for Adequate Baseline Organ Function System Laboratory Values Hematologic ANC >= 1.2 × 109/L Hemoglobin >= 9 g/dL Platelet count >= 75 x 109/L PT/INRa and PTT <= 1.3 x ULN Hepatic Total bilirubin <= 1.5 x ULN AST and ALT <= 2.5 x ULN Renal Serum creatininec <= 1.5 mg/dL Cardial ECG QTc < 480 msec Abbreviations: ALT = alanine transaminase; ANC = absolute neutrophil count; AST = aspartate aminotransferase; ECG = electrocardiogram; INR = international normalized ratio; PT = prothrombin time; PTT = partial thromboplastin time; ULN = upper limit of normal.
- Subjects receiving anticoagulation treatment may be allowed to participate with INR established within the therapeutic range prior to randomization.
- Except subjects with known Gilbert's syndrome.
- If serum creatinine is > 1.5 mg/dL, calculate creatinine clearance using standard Cockcroft-Gault formula. Creatinine clearance must be >= 50 mL/min to be eligible.
- Women of child-bearing potential must have a negative urine or serum pregnancy test (β-HCG) within 14 days of first dose of study treatment.
Who cannot join
- Previous treatment with a BRAF or MEK inhibitor. (previous systemic treatment for melanoma with other agents is allowed).
- Previous brain surgery or radiotherapy to the brain.
- Cancer therapy (chemotherapy with delayed toxicity, extensive radiation therapy, immunotherapy, biologic therapy, vaccine therapy or major surgery) or investigational anti-cancer drugs within the last 3 weeks, or chemotherapy without delayed toxicity within the last 2 weeks, preceding the first dose of dabrafenib.
- Current use of a prohibited medication or requires any of these medications during treatment with dabrafenib as mentioned in the SPC for Tafinlar.
- Current use of oral anticoagulant therapy. NOTE: Prophylactic low-dose of low molecular weight heparin (LMWH) is permitted.
- Known immediate or delayed hypersensitivity reaction to dabrafenib or excipients.
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- Use of other investigational drugs within 28 days (or five half-lives, whichever is shorter; with a minimum of 14 days from the last dose) preceding the first dose of study treatment and during the study.
- Unresolved toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (26) grade 2 or higher from previous anti-cancer therapy, except alopecia.
- Presence of active gastrointestinal disease or other condition that will interfere significantly with the absorption of drugs. If clarification is needed as to whether a condition will significantly affect absorption of drugs, the Novartis medical monitor will be contacted.
- Presence of malignancy other than disease under study within 5 years of study enrollment, or any malignancy with confirmed activating RAS mutation. Subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.
- Leptomeningeal metastases, brain metastases, or metastases causing spinal cord compression that are symptomatic or not stable for >=4 weeks or requiring corticosteroids. Subjects on a stable dose of corticosteroids >1 month or who have been off of corticosteroids for at least 2 weeks can be enrolled with approval of the Novartis medical monitor.
- A history or evidence of cardiovascular risk including any of the following:
- A QT interval corrected for heart rate using the Bazett's formula >=480 msec;
- A history or evidence of current clinically significant uncontrolled arrhythmias;
- A history of acute coronary syndromes (including myocardial infarction or unstable angina), coronary angioplasty, or stenting within 6 months prior to randomization
- A history or evidence of current >=Class II congestive heart failure as defined by the New York Heart Association (NYHA) guidelines.
- Abnormal cardiac valve morphology (≥grade 2) documented by echocardiogram (subjects with grade 1 abnormalities [i.e., mild regurgitation/stenosis] can be entered on study). Subjects with moderate valvular thickening should not be entered on study.
- Patients with intra-cardiac defibrillators.
- A history of Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection (subjects with laboratory evidence of cleared HBV and/or HCV will be permitted).
- Any serious or unstable pre-existing medical conditions (i.e, diabetes mellitus, hypertension, etc), psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol; or unwillingness or inability to follow the procedures required in the protocol.
- Altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent, unless a legally acceptable representative could provide informed consent.
- Pregnant or nursing females.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PET Imaging of [18F]Dabrafenib Distribution and Kinetics in Brain Metastasis in Patients With BRAF Positive Metastastic Melanoma. A Feasibility Study.
In this feasibility study, [18F]dabrafenib will be used as radioactive tracer. All patients in this study are diagnosed with advanced melanoma with evidence of brain metastases and are eligible for treatment with dabrafenib, a specific V600-mutated BRAF inhibitor. Patients will undergo a dynamic PET scan of the brain to determine [18F]dabrafenib distribution and kinetics in brain metastases. In addition, a static total body PET scan will be performed to visualize whole body distribution and tracer uptake.
Read the detailed description
Rationale: Dabrafenib is an oral protein tyrosine kinase inhibitor which specifically targets mutated BRAF protein. It is used in the treatment of metastatic melanoma with evidence of a BRAF V600 mutation in genomic material. However, in this group of patients often a heterogenic response to treatment is seen. Heterogeneity in drug accumulation in the tumor could be responsible for the observed differences in treatment response between lesions and between patients. Besides poor tumor accumulation of the drug, heterogeneous expression of the drug target, B-Raf protein, between patients and between lesions within a single patient could account for heterogeneity in treatment response.
PET imaging with radioactively labeled carrier-added [18F]dabrafenib (low specific activity) as the tracer might be a useful tool to show the distribution pattern and kinetics of the native drug; in particular PET can be used to determine if dabrafenib can cross the blood-brain barrier (BBB) and accumulate in brain metastases.
Since the behavior of [18F]dabrafenib in patients is hitherto unknown, first a feasibility study is needed. In this feasibility study, we will use low specific activity [18F]dabrafenib, for which a labeling procedure has already been developed, to determine the whole body distribution and kinetics in brain metastases in metastatic BRAF V600 mutation positive melanoma patients.
Study design: This study is a feasibility study for the use of [18F]dabrafenib as a PET tracer, in 10 patients. Patients who will be eligible for this study are at least 18 years of age. They are all diagnosed with metastatic melanoma with presence of metastasis to the brain and should have a positive BRAF V600 mutation status. In addition, patients should be naïve to treatment with a BRAF or MEK inhibitor.
Interventions: A [18F]dabrafenib PET/CT scan and an MRI scan of the brain will be performed at baseline, 7 days or less before the start of treatment with oral dabrafenib. CT and MRI are part of the regular care. The PET procedure commence with the injection of approximately 200 MBq [18F]dabrafenib, which is followed by a 60 minutes dynamic PET scan of the brain and thereafter a total-body PET scan (toe to head). During the dynamic PET scan of the brain, arterial blood sampling and analysis of plasma metabolites will be performed. Treatment response will be monitored as part of the regular treatment (CT for thorax/abdomen and MRI for brain) after 4 weeks. In addition, a single venous blood sample will be collected for isolation of circulating tumor DNA. Immunohistochemical staining for mutated B-raf protein will be performed on tumor tissue, either derived from a fresh biopsy or from a preexisting tumor specimen.
Nature and extent of burden and risk associated with participation, benefit and group relatedness: Patients who will participate in this study will receive a dynamic PET/CT scan of the brain, a static total-body PET/CT scan and an MRI scan of the brain at baseline. After 4 weeks they receive a CT scan of chest and abdomen and a MRI scan of the brain. All CT and MRI scans are part of regular care. The PET/CT scan, which is a study procedure, carries a radiation burden of 4.1 mSv. This constitutes an intermediate risk, based on criteria of the International Commission on Radiological Protection. For the purpose of pharmacokinetic modeling, an arterial catheter will be placed which is an invasive procedure. Expected adverse events will be identical to that of unlabeled dabrafenib. Patients do not directly benefit from the study, but their participation helps to get more insights in the pharmacokinetics of dabrafenib and its role in the treatment of brain metastases.
- Conditions
- Melanoma
- Being tested
- [18F]dabrafenib molecular imaging
- Keywords
- Brain metastasis
- Medical subject headings
- Melanoma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]dabrafenib molecular imagingOther
A [18F]dabrafenib dynamic PET scan of the brain (60 minutes) and static total body PET scan will be performed at baseline.
| Study group | Role | What they receive |
|---|---|---|
| [18F]dabrafenib molecular imaging | Experimental | A [18F]dabrafenib PET scan will be performed at baseline (7 days or less before the start of treatment with oral dabrafenib). Receives: Other: [18F]dabrafenib molecular imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute uptake of [18F]dabrafenib
Determination of the absolute uptake (Standard uptake value (SUV)) and kinetics (time-activity curves, volume of distribution) of [18F]dabrafenib in normal brain and brain metastasis.
Measured: 60 minutes
Secondary outcomes (7)
Heterogeneity of [18F]dabrafenib uptake of tumor lesions and kinetics in the brain
Analysis of heterogeneity in [18F]dabrafenib accumulation and kinetics between lesions within one organ (brain; intra-patient heterogeneity).
Measured: Baseline
Intra-patient heterogeneity in [18F]dabrafenib uptake of tumor lesions
Analysis of heterogeneity in [18F]dabrafenib accumulation between lesions in different organs including brain metastases (total body imaging; intra-patient heterogeneity).
Measured: Baseline
Inter-patient heterogeneity in [18F]dabrafenib uptake of tumor lesions
Analysis of heterogeneity in [18F]dabrafenib accumulation between all lesions in different patients (Inter-patient heterogeneity).
Measured: baseline
Correlation of [18F]dabrafenib uptake with response to dabrafenib treatment of tumor lesions
Correlation of accumulation of [18F]dabrafenib in melanoma metastasis with response to treatment according to the RECIST criteria (response evaluation with MRI brain and CT of chest and abdomen after 4 weeks).
Measured: 4 weeks
Correlation between absolute tumor tracer uptake of [18F]dabrafenib and immunohistochemical staining with VE1 mAb (anti V600-mutated BRAF).
Correlation between absolute tumor tracer uptake of [18F]dabrafenib and positive immunohistochemical staining using specific MAB's against mutated B-Raf protein.
Measured: Baseline
Correlation between absolute tumor tracer uptake of [18F]dabrafenib and BRAF V600 mutation load as maesured in circulating tumor DNA (ctDNA).
Correlation between absolute tumor tracer uptake of [18F]dabrafenib and BRAF V600 mutation load in ctDNA as measured by quantitative PCR.
Measured: Baseline
Comparison between direct DNA sequencing and Droplet Digital Polymerase Chain Reaction (ddPCR) for BRAF mutation detection.
Correlation between BRAF mutation status as determined by direct DNA sequencing using tumor tissue samples (golden standard) and ddPCR using ctDNA.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2016 (estimated)
- Study start6 Dec 2016
- Primary completionApr 2020
- Study completionApr 2020
Why it stopped: Due to the very low inlcusion rate and the current COVID-19 pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Geke AP Hospers, MD, PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02700763
- Sponsor's protocol ID
- 201600134
- Status last verified
- May 2024
- First submitted
- 1 Mar 2016
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET Imaging of [18F]Dabrafenib Distribution and Kinetics in Brain Metastasis in Patients With BRAF Positive Metastastic Melanoma. A Feasibility Study.
- ClinicalTrials.gov ID
- NCT02700763
- Acronym / sponsor ID
- 201600134
- Conditions
- Melanoma
- Keywords
- Brain metastasis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the very low inlcusion rate and the current COVID-19 pandemic.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 6 Dec 2016 (actual)
- Primary completion
- Apr 2020 (actual)
- Study completion
- Apr 2020 (actual)
- First posted
- 7 Mar 2016 (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.
In this feasibility study, [18F]dabrafenib will be used as radioactive tracer. All patients in this study are diagnosed with advanced melanoma with evidence of brain metastases and are eligible for treatment with dabrafenib, a specific V600-mutated BRAF inhibitor. Patients will undergo a dynamic PET scan of the brain to determine [18F]dabrafenib distribution and kinetics in brain metastases. In addition, a static total body PET scan will be performed to visualize whole body distribution and tracer uptake.
Detailed description
Rationale: Dabrafenib is an oral protein tyrosine kinase inhibitor which specifically targets mutated BRAF protein. It is used in the treatment of metastatic melanoma with evidence of a BRAF V600 mutation in genomic material. However, in this group of patients often a heterogenic response to treatment is seen. Heterogeneity in drug accumulation in the tumor could be responsible for the observed differences in treatment response between lesions and between patients. Besides poor tumor accumulation of the drug, heterogeneous expression of the drug target, B-Raf protein, between patients and between lesions within a single patient could account for heterogeneity in treatment response.
PET imaging with radioactively labeled carrier-added [18F]dabrafenib (low specific activity) as the tracer might be a useful tool to show the distribution pattern and kinetics of the native drug; in particular PET can be used to determine if dabrafenib can cross the blood-brain barrier (BBB) and accumulate in brain metastases.
Since the behavior of [18F]dabrafenib in patients is hitherto unknown, first a feasibility study is needed. In this feasibility study, we will use low specific activity [18F]dabrafenib, for which a labeling procedure has already been developed, to determine the whole body distribution and kinetics in brain metastases in metastatic BRAF V600 mutation positive melanoma patients.
Study design: This study is a feasibility study for the use of [18F]dabrafenib as a PET tracer, in 10 patients. Patients who will be eligible for this study are at least 18 years of age. They are all diagnosed with metastatic melanoma with presence of metastasis to the brain and should have a positive BRAF V600 mutation status. In addition, patients should be naïve to treatment with a BRAF or MEK inhibitor.
Interventions: A [18F]dabrafenib PET/CT scan and an MRI scan of the brain will be performed at baseline, 7 days or less before the start of treatment with oral dabrafenib. CT and MRI are part of the regular care. The PET procedure commence with the injection of approximately 200 MBq [18F]dabrafenib, which is followed by a 60 minutes dynamic PET scan of the brain and thereafter a total-body PET scan (toe to head). During the dynamic PET scan of the brain, arterial blood sampling and analysis of plasma metabolites will be performed. Treatment response will be monitored as part of the regular treatment (CT for thorax/abdomen and MRI for brain) after 4 weeks. In addition, a single venous blood sample will be collected for isolation of circulating tumor DNA. Immunohistochemical staining for mutated B-raf protein will be performed on tumor tissue, either derived from a fresh biopsy or from a preexisting tumor specimen.
Nature and extent of burden and risk associated with participation, benefit and group relatedness: Patients who will participate in this study will receive a dynamic PET/CT scan of the brain, a static total-body PET/CT scan and an MRI scan of the brain at baseline. After 4 weeks they receive a CT scan of chest and abdomen and a MRI scan of the brain. All CT and MRI scans are part of regular care. The PET/CT scan, which is a study procedure, carries a radiation burden of 4.1 mSv. This constitutes an intermediate risk, based on criteria of the International Commission on Radiological Protection. For the purpose of pharmacokinetic modeling, an arterial catheter will be placed which is an invasive procedure. Expected adverse events will be identical to that of unlabeled dabrafenib. Patients do not directly benefit from the study, but their participation helps to get more insights in the pharmacokinetics of dabrafenib and its role in the treatment of brain metastases.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [18F]dabrafenib molecular imaging | Experimental | Other: [18F]dabrafenib molecular imagingA [18F]dabrafenib PET scan will be performed at baseline (7 days or less before the start of treatment with oral dabrafenib). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Has signed informed consent.
- Age >=18 years of age.
- Histologically confirmed cutaneous metastatic melanoma (Stage IV), including confirmed brain metastases.
- BRAF mutation-positive (V600 E/K) melanoma as determined by standardized genetic testing.
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Key exclusion criteria (22 listed)
- Previous treatment with a BRAF or MEK inhibitor. (previous systemic treatment for melanoma with other agents is allowed).
- Previous brain surgery or radiotherapy to the brain.
- Cancer therapy (chemotherapy with delayed toxicity, extensive radiation therapy, immunotherapy, biologic therapy, vaccine therapy or major surgery) or investigational anti-cancer drugs within the last 3 weeks, or chemotherapy without delayed toxicity within the last 2 weeks, preceding the first dose of dabrafenib.
- Current use of a prohibited medication or requires any of these medications during treatment with dabrafenib as mentioned in the SPC for Tafinlar.
- Current use of oral anticoagulant therapy. NOTE: Prophylactic low-dose of low molecular weight heparin (LMWH) is permitted.
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 |
|---|---|---|
| [18F]dabrafenib molecular imagingA [18F]dabrafenib dynamic PET scan of the brain (60 minutes) and static total body PET scan will be performed at baseline. | Other | [18F]dabrafenib molecular imaging |
Primary outcome
Absolute uptake of [18F]dabrafenib
Time frame: 60 minutes
Determination of the absolute uptake (Standard uptake value (SUV)) and kinetics (time-activity curves, volume of distribution) of [18F]dabrafenib in normal brain and brain metastasis.
7 secondary outcomes
Heterogeneity of [18F]dabrafenib uptake of tumor lesions and kinetics in the brain
Time frame: Baseline
Intra-patient heterogeneity in [18F]dabrafenib uptake of tumor lesions
Time frame: Baseline
Inter-patient heterogeneity in [18F]dabrafenib uptake of tumor lesions
Time frame: baseline
Correlation of [18F]dabrafenib uptake with response to dabrafenib treatment of tumor lesions
Time frame: 4 weeks
Correlation between absolute tumor tracer uptake of [18F]dabrafenib and immunohistochemical staining with VE1 mAb (anti V600-mutated BRAF).
Time frame: Baseline
Correlation between absolute tumor tracer uptake of [18F]dabrafenib and BRAF V600 mutation load as maesured in circulating tumor DNA (ctDNA).
Time frame: Baseline
Comparison between direct DNA sequencing and Droplet Digital Polymerase Chain Reaction (ddPCR) for BRAF mutation detection.
Time frame: Baseline
Results and safety
The study was stopped early (reason given: Due to the very low inlcusion rate and the current COVID-19 pandemic.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
- 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.
Geke AP Hospers, MD, PhD principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing [18F]dabrafenib molecular imaging in people with Melanoma, run by University Medical Center Groningen at 1 site in Netherlands.
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 16 inclusion and 22 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 6 May 2024. 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 Netherlands. 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.
Are results available for this study?
The study was stopped early (reason given: Due to the very low inlcusion rate and the current COVID-19 pandemic.). 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?
Absolute uptake of [18F]dabrafenib (time frame: 60 minutes). 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 6 May 2024; AzTrials last refreshed its copy on 7 Nov 2026.