Intrahepatic CholangiocarcinomaPhase 2FIDES-01NCT03230318
Derazantinib in Subjects With FGFR2 Gene Fusion-, Mutation- or Amplification- Positive Inoperable or Advanced Intrahepatic Cholangiocarcinoma
A Phase 2 study testing derazantinib in people with Intrahepatic Cholangiocarcinoma and Combined Hepatocellular and Cholangiocarcinoma, run by Basilea Pharmaceutica at 41 sites in 11 countries.
Trial summary
This Phase II, open-label, single-arm study evaluated the anti-cancer activity of derazantinib in subjects with inoperable or advanced intrahepatic cholangiocarcinoma (iCCA) who received at least one prior regimen of systemic therapy. Patients received an oral once-daily total dose of 300 mg derazantinib capsules. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intrahepatic Cholangiocarcinoma, Combined Hepatocellular and Cholangiocarcinoma
- What is being tested?
- derazantinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 41 sitesin 11 countries
- Study dates
- 28 Sep 2017to 25 Oct 2022
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent granted prior to initiation of any study-specific procedures
- 18 years of age or older
- Histologically or cytologically confirmed locally advanced, inoperable, or metastatic iCCA or mixed histology tumors
- Substudy 1:
- FGFR2 fusion status based on the following assessments:
- If central laboratory was designated by Sponsor: Positive FISH test; and/or b) If non-central laboratory: i) Positive FISH or NGS test: patients were potentially enrolled and started dosing, but central confirmation was required* ii) Negative FISH or NGS test: tissue was submitted to the central laboratory designated by the Sponsor, and patients were only enrolled in case the central test was positive
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- By used standard protocols and approved by local IRB/EC, by CLIA or other similar agency.
- Substudy 2:
- FGFR2 mutation/amplification status based on local NGS testing performed or commissioned by the respective study site.
- Received at least one regimen of prior systemic therapy and then experienced documented radiographic progression
- Measurable disease by RECIST version 1.1 criteria
- ECOG performance status ≤ 1
- Adequate organ functions as indicated by the following laboratory values (based on screening visit values from the central laboratory).
- Hematological
- Hemoglobin (Hgb) ≥ 9.0 g/dL
- Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L
- Platelet count ≥ 75 x 109/L
- International normalized ratio (INR) 0.8 to upper limit of normal (ULN) or ≤ 3 for subjects who received anticoagulant therapy such as Coumadin or heparin
- Hepatic
- Total bilirubin ≤ 2 x ULN
- AST and ALT ≤ 3 ULN (≤ 5 x ULN for subjects with liver metastases)
- Albumin ≥ 2.8 g/dL
- Renal
- Serum creatinine ≤ 1.5 x ULN
- Creatinine clearance of ≥ 30 mL/min as estimated by the Cockcroft-Gault equation
- Female and male patients of child-producing potential must had agreed to avoid becoming pregnant or impregnating a partner, respectively, used double-barrier contraceptive measures, oral contraception, or had to avoid of intercourse, during the study, and until at least 120 for 90 days after the last dose of derazantinib.
- Male or female patients of child-producing potential must had agreed to comply with one of the following until at least 120 days after the last dose of derazantinib:
- Abstinence from heterosexual activity
- Using (or having their partner use) an acceptable method of contraception during heterosexual activity.
Who cannot join
- Receipt of treatment before the first dose of study drug (Cycle 1 Day 1) within an interval shorter than the following, as applicable:
- One chemotherapy or biological (e.g., antibody) cycle interval
- Five half-lives of any small-molecule investigational or licensed medicinal product
- Two weeks, for any investigational medicinal product with an unknown half-life
- Four weeks of curative radiotherapy
- Seven days of palliative radiotherapy
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- 28 days of radiotherapy
- Major surgery, locoregional therapy, or radiation therapy within four weeks of the first dose of derazantinib
- Previous treatment with any FGFR inhibitor (e.g., Balversa® [erdafitinib], Pemazyre® [pemigatinib], infigratinib, rogaratinib, futibatinib, lenvatinib, ponatinib, dovitinib, nintedanib, AZD4547, LY2784455).
- Patients who were unable or unwilling to swallow the complete daily dose of derazantinib capsules
- Clinically unstable central nervous system (CNS) metastases (to be eligible, subjects must had stable disease ≥ 3 months, confirmed by magnetic resonance imaging (MRI) or computed tomography (CT) scan, and/or had CNS metastases well controlled by low-dose steroids, anti-epileptics, or other symptom-relieving medications)
- Evidence of clinically significant corneal or retinal disorder which was likely to increase the risk of eye toxicity, including but not limited to bullous/band keratopathy, keratoconjunctivitis (unless keratoconjunctivitis sicca), corneal abrasion, inflammation/ulceration, confirmed by ophthalmologic examination.
- Uncontrolled or active hepatobiliary disorders, untreated or ongoing complications after laparoscopic procedures or stent placement, including but not limited to active cholangitis, biloma or abscess (to be eligible, the subjects had to be treated and disorders/complications should had been resolved within 2 weeks prior to the first dose of derazantinib)
- History of significant cardiac disorders:
- Myocardial infarction (MI) or congestive heart failure defined as Class II to IV per the New York Heart Association (NYHA) classification within 6 months of the first dose of derazantinib (MI that occurred > 6 months prior to the first dose of derazantinib was permitted)
- QTcF >450 msec (males or females)
- Serum electrolyte abnormalities defined as follows:
- Hyperphosphataemia: Serum phosphate > institutional ULN
- Hyperkalemia: > 6.0 mmol/L
- Hypokalemia: < 3.0 mmol/L
- Hypercalcemia: corrected serum calcium < 1.75 mmol/L (< 7.0 mg/dL)
- Hypocalcemia: corrected serum calcium > 3.1 mmol/L (> 12.5 mg/dL)
- Hypomagnesemia: < 0.4 mmol/L (< 0.9 mg/dL)
- Significant gastrointestinal disorder(s) that could had, in the opinion of the Investigator, interfered with the absorption, metabolism, or excretion of derazantinib (e.g., Crohn's disease, ulcerative colitis, extensive gastric resection)
- History of additional malignancy that was progressing or required active treatment. Exceptions included basal cell carcinoma of the skin, squamous cell carcinoma of the skin that had undergone potentially curative therapy, and in situ cervical cancer.
- Uncontrolled illness not related to cancer, including but not limited to:
- Psychiatric illness/substance abuse/social situation that would limit compliance with study requirements
- Known uncontrolled human immunodeficiency virus (HIV) infection
- Severe bacterial, fungal, viral and/or parasitic infections on therapeutic oral or IV medication at the time of first dose of study drug administration
- Blood or albumin transfusion within 5 days of the blood draw which has been used to confirm eligibility
- Pregnant or breast feeding
- Known hypsersensitivity to derazantinib, or to any of the study drug excipients (starch, lactose, crospovidone, magnesium stearate)
Trial locations and contacts
41 sites in 11 countries.
41 sites in 11 countries
United States11 sites
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322
The University of Texas Southwestern Medical Center
Dallas, Texas, 75390
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Mayo Clinic
Jacksonville, Florida, 32224
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
Memorial Sloan Kettering Cancer Center - Sidney Kimmel Center for Prostate and Urologic Cancers
New York, New York, 10065-6800
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mayo Clinic
Phoenix, Arizona, 85054
Mayo Clinic
Rochester, Minnesota, 55905
University of Washington Medical Center
Seattle, Washington, 98109
Moffitt Cancer Center
Tampa, Florida, 33612-9416
Italy6 sites
Sant'Orsola-Malpighi Hospital, University of Bologna
Bologna, 40138
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133
Ospedale San Gerardo
Monza, 20900
Istituto Oncologico Veneto - IRCCS
Padova, 35128
Azienda Ospedaliero-Universitaria Pisana
Pisa, 56126
Humanitas Cancer Center, Istituto Clinico Humanitas IRCCS
Rozzano, 20089
Germany5 sites
Universitätsklinikum Frankfurt
Frankfurt am Main, 60590
Universitätsklinikum Hamburg-Eppendorf (UKE)
Hamburg, 20246
Medizinische Hochschule Hannover (MHH)
Hanover, 30625
Universitätsklinikum des Saarlandes
Homburg, 66421
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, 55131
Spain4 sites
Vall d'Hebrón University Hospital
Barcelona, 08035
Catalan Institute of Oncology
Barcelona, 08908
Hospital General Universitario Gregorio Marañón
Madrid, 28007
Hospital Universitario 12 de Octubre
Madrid, 28041
Belgium3 sites
Hôpital Erasme
Brussels, 1070
Cliniques Universitaires Saint-Luc
Brussels, 1200
Antwerp University Hospital
Edegem, 2650
South Korea3 sites
Seoul National University Hospital
Seoul, 3080
Samsung Medical Center
Seoul, 6351
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 6591
United Kingdom3 sites
University College London Hospitals NHS Foundation Trust
Euston, NW1 2BU
Beatson West of Scotland Cancer Centre
Glasgow, G120YN
The Royal Marsden
Sutton, SM2 5PT
Canada2 sites
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
France2 sites
CHU Grenoble Alpes
La Tronche, 38700
Gustave Roussy
Villejuif, 94805
About this study
Official title: A Pivotal Study of Derazantinib in Patients With Inoperable or Advanced Intrahepatic Cholangiocarcinoma and FGFR2 Gene Fusions or FGFR2 Gene Mutations or Amplifications
This Phase II, open-label, single-arm study evaluated the anti-cancer activity of derazantinib in subjects with inoperable or advanced intrahepatic cholangiocarcinoma (iCCA) who received at least one prior regimen of systemic therapy. Patients received an oral once-daily total dose of 300 mg derazantinib capsules.
Read the detailed description
This was a multi-center, open-label, single arm study which evaluated the anti-cancer activity of derazantinib in adult patients with inoperable or advanced iCCA in the following study population:
Patients with inoperable or advanced iCCA and with fibroblast growth factor receptor 2 (FGFR2) fusions (Substudy 1) or FGFR2 mutations/amplifications (Substudy 2), treated with at least one prior regimen of systemic therapy.
Derazantinib was supplied as 100 mg capsules. A dose of 300 mg once-daily (three capsules of 100 mg each) of derazantinib was administered orally to patients, 1 hour before, or 2 hours after, a meal.
- Being tested
- derazantinib
- Keywords
- iCCA, intrahepatic cholangiocarcinoma, FGFR2 gene fusion or FGFR2 gene mutation or amplification, biliary cancer, bile duct cancer, FGFR2 gene rearrangement, liver cancer, targeted therapy, combined hepatocellular and cholangiocarcinoma, cHCC-CCA, derazantinib
- Medical subject headings
- Cholangiocarcinoma, Liver Neoplasms, Biliary Tract Neoplasms, Bile Duct Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
derazantinibDrug
Derazantinib was administered orally at 300 mg once daily
| Study group | Role | What they receive |
|---|---|---|
| derazantinib | Experimental | Oral administration Receives: Drug: derazantinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Substudy 1: Objective Response Rate (ORR)
ORR was defined as the proportion of patients who achieved a confirmed clinical response (CR) or partial response (PR) by blinded independent central review using the internationally recognized criteria for the radiological assessment in tumor response of solid tumors (RECIST) Version 1.1
Measured: From first dose and up to 54 months
Substudy 2: Progression Free Survival at 3 Months (PFS 3)
PFS3 was defined as the proportion of patients who have progression-free survival at 3 months from the first date of receiving study drug as assessed by survival status and blinded independent central review as per RECIST 1.1.
Measured: From first dose and up to 3 months
Secondary outcomes (5)
PFS
PFS was calculated from the first date of receiving study drug until radiographic disease progression by blinded independent central review or death.
Measured: From first dose and up to 54 months
Overall Survival (OS)
OS was calculated from the first date of receiving study drug until death
Measured: From first dose and up to 54 months
Duration of Response (DoR)
DoR was calculated from the first date of documented tumor response to disease progression by blinded independent central review per RECIST version 1.1 DoR was derived only for patients who have the best overall response of CR or PR
Measured: From first dose and up to 54 months
Substudy 2: Objective Response Rate
ORR was defined as the proportion of patients who achieved a confirmed clinical response (CR) or partial response (PR) by blinded independent central review using the internationally recognized criteria for the radiological assessment in tumor response of solid tumors (RECIST) Version 1.1
Measured: From first dose and up to 54 months
Number of Patients With Grade 3-5 Treatment-emergent Adverse Events (TEAEs)
Number of patients experiencing TEAE of Grade 3 to 5 according to Common Terminology Criteria for Adverse Events (CTCAE)
Measured: TEAEs were defined as all events occurring after drug treatment began and up to 30 days after last study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2017
- Study start28 Sep 2017
- Primary completion25 Oct 2022
- Study completion25 Oct 2022
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intrahepatic CholangiocarcinomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Basilea Pharmaceutica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Manuel Häckl, MD, Study director, Basilea Pharmaceutica International Ltd, Allschwil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03230318
- Sponsor's protocol ID
- DZB-CS-301
- Other IDs
- ARQ 087-301
- Acronym
- FIDES-01
- Status last verified
- Nov 2023
- First submitted
- 24 Jul 2017
- Last updated
- 19 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
- Expanded access
- Available
Publications
Mazzaferro V, El-Rayes BF, Droz Dit Busset M, Cotsoglou C, Harris WP, Damjanov N, Masi G, Rimassa L, Personeni N, Braiteh F, Zagonel V, Papadopoulos KP, Hall T, Wang Y, Schwartz B, Kazakin J, Bhoori S, de Braud F, Shaib WL. Derazantinib (ARQ 087) in advanced or inoperable FGFR2 gene fusion-positive intrahepatic cholangiocarcinoma. Br J Cancer. 2019 Jan;120(2):165-171. doi: 10.1038/s41416-018-0334-0. Epub 2018 Nov 13.
PubMed 30420614
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pivotal Study of Derazantinib in Patients With Inoperable or Advanced Intrahepatic Cholangiocarcinoma and FGFR2 Gene Fusions or FGFR2 Gene Mutations or Amplifications
- ClinicalTrials.gov ID
- NCT03230318
- Acronym / sponsor ID
- FIDES-01 / DZB-CS-301
- Keywords
- iCCA, intrahepatic cholangiocarcinoma, FGFR2 gene fusion or FGFR2 gene mutation or amplification, biliary cancer, bile duct cancer, FGFR2 gene rearrangement, liver cancer, targeted therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Basilea PharmaceuticaIndustry (pharma, biotech, devices)
- Study start
- 28 Sep 2017 (actual)
- Primary completion
- 25 Oct 2022 (actual)
- Study completion
- 25 Oct 2022 (actual)
- First posted
- 26 Jul 2017 (actual)
- Results
- Posted 19 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase II, open-label, single-arm study evaluated the anti-cancer activity of derazantinib in subjects with inoperable or advanced intrahepatic cholangiocarcinoma (iCCA) who received at least one prior regimen of systemic therapy. Patients received an oral once-daily total dose of 300 mg derazantinib capsules.
Detailed description
This was a multi-center, open-label, single arm study which evaluated the anti-cancer activity of derazantinib in adult patients with inoperable or advanced iCCA in the following study population:
Patients with inoperable or advanced iCCA and with fibroblast growth factor receptor 2 (FGFR2) fusions (Substudy 1) or FGFR2 mutations/amplifications (Substudy 2), treated with at least one prior regimen of systemic therapy.
Derazantinib was supplied as 100 mg capsules. A dose of 300 mg once-daily (three capsules of 100 mg each) of derazantinib was administered orally to patients, 1 hour before, or 2 hours after, a meal.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| derazantinib | Experimental | Drug: derazantinibOral administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Signed written informed consent granted prior to initiation of any study-specific procedures
- 18 years of age or older
- Histologically or cytologically confirmed locally advanced, inoperable, or metastatic iCCA or mixed histology tumors
- Substudy 1:
- By used standard protocols and approved by local IRB/EC, by CLIA or other similar agency.
Key exclusion criteria (32 listed)
- Receipt of treatment before the first dose of study drug (Cycle 1 Day 1) within an interval shorter than the following, as applicable:
- Major surgery, locoregional therapy, or radiation therapy within four weeks of the first dose of derazantinib
- Previous treatment with any FGFR inhibitor (e.g., Balversa® [erdafitinib], Pemazyre® [pemigatinib], infigratinib, rogaratinib, futibatinib, lenvatinib, ponatinib, dovitinib, nintedanib, AZD4547, LY2784455).
- Patients who were unable or unwilling to swallow the complete daily dose of derazantinib capsules
- Clinically unstable central nervous system (CNS) metastases (to be eligible, subjects must had stable disease ≥ 3 months, confirmed by magnetic resonance imaging (MRI) or computed tomography (CT) scan, and/or had CNS metastases well controlled by low-dose steroids, anti-epileptics, or other symptom-relieving medications)
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 |
|---|---|---|
| derazantinibDerazantinib was administered orally at 300 mg once daily | Drug | derazantinib |
Primary outcome
Substudy 1: Objective Response Rate (ORR)
Time frame: From first dose and up to 54 months
ORR was defined as the proportion of patients who achieved a confirmed clinical response (CR) or partial response (PR) by blinded independent central review using the internationally recognized criteria for the radiological assessment in tumor response of solid tumors (RECIST) Version 1.1
Substudy 2: Progression Free Survival at 3 Months (PFS 3)
Time frame: From first dose and up to 3 months
PFS3 was defined as the proportion of patients who have progression-free survival at 3 months from the first date of receiving study drug as assessed by survival status and blinded independent central review as per RECIST 1.1.
5 secondary outcomes
PFS
Time frame: From first dose and up to 54 months
Overall Survival (OS)
Time frame: From first dose and up to 54 months
Duration of Response (DoR)
Time frame: From first dose and up to 54 months
Substudy 2: Objective Response Rate
Time frame: From first dose and up to 54 months
Number of Patients With Grade 3-5 Treatment-emergent Adverse Events (TEAEs)
Time frame: TEAEs were defined as all events occurring after drug treatment began and up to 30 days after last study drug administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30420614Mazzaferro V, El-Rayes BF, Droz Dit Busset M, Cotsoglou C, Harris WP, Damjanov N, Masi G, Rimassa L, Personeni N, Braiteh F, Zagonel V, Papadopoulos KP, Hall T, Wang Y, Schwartz B, Kazakin J, Bhoori S, de Braud F, Shaib WL. Derazantinib (ARQ 087) in advanced or inoperable FGFR2 gene fusion-positive intrahepatic cholangiocarcinoma. Br J Cancer. 2019 Jan;120(2):165-171. doi: 10.1038/s41416-018-0334-0. Epub 2018 Nov 13.
- 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.
Manuel Häckl, MD study director
Basilea Pharmaceutica International Ltd, Allschwil
41 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing derazantinib in people with Intrahepatic Cholangiocarcinoma and Combined Hepatocellular and Cholangiocarcinoma, run by Basilea Pharmaceutica at 41 sites in 11 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 29 inclusion and 32 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 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States, Italy, Germany, Spain, Belgium and 6 more countries. 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 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 19 Dec 2023). 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?
Substudy 1: Objective Response Rate (ORR) (time frame: From first dose and up to 54 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 NCT03230318, 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 Dec 2023.