Advanced Solid TumorsPhase 1NCT04049617
Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of Evixapodlin (Formerly GS-4224) in Participants With Advanced Solid Tumors
A Phase 1 study testing Evixapodlin in people with Advanced Solid Tumors, run by Gilead Sciences at 6 sites in 2 countries.
Trial summary
The primary objectives of this study are to characterize the safety and tolerability of evixapodlin (formerly GS-4224) and to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of evixapodlin in participants with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- Evixapodlin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 26 Aug 2019to 30 Mar 2021
- Phase
- Phase 1
- 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
- Dose Escalation Cohorts: Histologically or cytologically confirmed advanced malignant solid tumor that is refractory to or intolerant of all standard therapy or for which no standard therapy is available.
- Dose Expansion and 1000 mg twice a day (BID) Dose Escalation Cohorts: Individuals must have available sufficient and adequate formalin fixed tumor sample preferably from a biopsy of a tumor lesion obtained either at the time of or after the diagnosis of advanced disease has been made and from a site not previously irradiated. Alternatively, individuals must agree to have a biopsy taken prior to entering the study to provide adequate tissue. For the 1000 mg BID dose escalation cohort, individuals with melanoma, Merkel cell, microsatellite instability-high (MSI-H) cancers, and classical Hodgkin lymphoma (cHL) are not required to have archival or fresh biopsy tissue.
- Dose Escalation Biopsy Substudy and 1000 mg BID Dose Escalation Cohorts: Documented ligand 1 of programmed cell death protein 1 (PD-L1) expression in the tumor (tumor proportion score (TPS) ≥ 10% or combined positive score (CPS) ≥ 10). In the 1000 mg BID Cohort, PD-L1 expression will not be required for Merkel cell, melanoma, MSI-H cancers, and cHL.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2.
- Adequate organ function.
Who cannot join
- History or evidence of clinically significant disorder, condition, or disease that, in the opinion of the Investigator or Medical Monitor would pose a risk to individual safety or interfere with the study evaluations, procedures, or completion.
- Dose Escalation Cohorts: History of ≥ Grade 3 Adverse Events (AEs) during prior treatment with an immune checkpoint inhibitor, or history of discontinuation of treatment with an immune checkpoint inhibitor due to AEs.
- Dose Escalation 1000 mg BID and Dose Expansion Cohort: Prior treatment with an immune checkpoint inhibitor (anti-PD-1, anti-PD-L1, or anti- ligand 2 of programmed cell death protein 1 (PD-L2) antibodies).
- History of autoimmune disease (for example, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Bell's palsy, Guillain-Barré syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis).
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States3 sites
California Care Associates for Research and Excellence Inc
Encinitas, California, 92024
NEXT Oncology
San Antonio, Texas, 78229
Northwest Medical Specialties, PLLC
Tacoma, Washington, 98405
New Zealand3 sites
Auckland City Hospital
Auckland, 1023
Christchurch Clinical Studies Trust, LLC
Christchurch, 8011
Auckland Clinical Studies Ltd
Grafton, Auckland, 1010
About this study
Official title: A Phase 1b/2 Dose Escalation/Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of GS-4224 in Subjects With Advanced Solid Tumors
The primary objectives of this study are to characterize the safety and tolerability of evixapodlin (formerly GS-4224) and to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of evixapodlin in participants with advanced solid tumors.
Read the detailed description
This was a planned Phase 1/2 study. However, Phase 2 was not conducted because the study was closed due to sponsor decision prior to opening the dose expansion cohort and hence, RP2D analysis was not performed.
- Conditions
- Advanced Solid Tumors
- Being tested
- Evixapodlin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvixapodlinDrug
Also called GS-4224
Tablets administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Evixapodlin 400 mg (Phase 1) | Experimental | Participants will receive Evixapodlin 400 mg once daily for 21 days of each cycle. Receives: Drug: Evixapodlin |
| Cohort 2: Evixapodlin 700 mg (Phase 1) | Experimental | Participants will receive Evixapodlin 700 mg once daily for 21 days of each cycle. Receives: Drug: Evixapodlin |
| Cohort 3: Evixapodlin 1000 mg (Phase 1) | Experimental | Participants will receive Evixapodlin 1000 mg once daily for 21 days of each cycle. Receives: Drug: Evixapodlin |
| Cohort 4: Evixapodlin 1500 mg (Phase 1) | Experimental | Participants will receive Evixapodlin 1500 mg once daily for 21 days of each cycle. Receives: Drug: Evixapodlin |
| Cohort 5: Evixapodlin 1000 mg (Phase 1) | Experimental | Participants are planned to receive Evixapodlin 1000 mg twice daily (BID) for 21 days of each cycle. Receives: Drug: Evixapodlin |
| Cohort 1 Substudy: Evixapodlin 400 mg (Phase 1) | Experimental | Participants will receive Evixapodlin 400 mg once daily for 21 days of each cycle. Receives: Drug: Evixapodlin |
| Cohort 2 Substudy: Evixapodlin 700 mg (Phase 1) | Experimental | Participants are planned to receive Evixapodlin 700 mg once daily for 21 days of each cycle. Receives: Drug: Evixapodlin |
| Cohort 3 Substudy: Evixapodlin 1000 mg (Phase 1) | Experimental | Participants will receive Evixapodlin 1000 mg once daily for 21 days of each cycle. Receives: Drug: Evixapodlin |
| Dose Expansion (Phase 2) | Experimental | Dose expansion is planned to begin when the recommended Phase 2 dose (RP2D) will be determined. Receives: Drug: Evixapodlin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Dose Limiting Toxicities (DLTs) During the Dose Escalation Phase
A DLT was any toxicity defined as follows excluding toxicities clearly related to disease progression or disease-related processes occurring during the DLT assessment window (Day 1 through Day 21):
- Grade ≥ 4 neutropenia
- Grade ≥ 3 neutropenia with fever
- Grade ≥ 3 thrombocytopenia
- Grade ≥ 2 bleeding
- Grade ≥ 3 anemia
- Grade ≥ 3 or higher non-hematologic toxicity (excluding Grade 3 nausea or emesis or Grade 3 diarrhea)
- Grade ≥ 2 non-hematologic treatment-emergent adverse event that in the opinion of the investigator is of potential clinical significance
- Treatment interruption of ≥ 7 days due to unresolved toxicity
- Any toxicity event that precludes further administration of evixapodlin
- Any Grade 3 or Grade 4 elevation in aspartate aminotransferase (AST) or alanine aminotransferase (ALT) associated with a Grade 2 elevation in bilirubin lasting ≥ 7 days
- An immune-related adverse event (irAE) for which immunotherapy should be permanently discontinued
Measured: Day 1 through Day 21
Secondary outcomes (6)
Pharmacokinetic (PK) Parameter: AUCtau of Evixapodlin During the Dose Escalation Phase
AUCtau was defined as area under the concentration-time curve from time zero to the end of the dosing interval.
Measured: Intensive PK: Predose, 0.5, 1, 1.5, 2.5, 4, 6, 24 hours (h) postdose (400-1500 once daily [QD] mg cohorts) on Cycle (C) 1 Day (D) 1 & D15
PK Parameter: Cmax of Evixapodlin During the Dose Escalation Phase
Cmax was defined as the maximum observed drug concentration.
Measured: Intensive PK: Predose, 0.5, 1, 1.5, 2.5, 4, 6, 24 h postdose (400-1500 QD mg cohorts) on C1D1 & D15
PK Parameter: Ctrough of Evixapodlin During the Dose Escalation Phase
Ctrough is defined as the observed concentration at the end of the dosing interval.
Measured: Intensive PK: Predose, 0.5, 1, 1.5, 2.5, 4, 6, 24 h postdose (400-1500 QD mg cohorts) on C1D1 & D15
PK Parameter: Tmax of Evixapodlin During the Dose Escalation Phase
Tmax is defined as the time to maximum observed concentration.
Measured: Intensive PK: Predose, 0.5, 1, 1.5, 2.5, 4, 6, 24 h postdose (400-1500 QD mg cohorts) on C1D1 & D15
Percentage of Participants Experiencing ≥ Grade 3 Treatment-Emergent Adverse Events During the Dose Expansion Phase
Measured: First dose date through end of treatment plus 30 days, approximately 5 years
Percentage of Participants Experiencing ≥ Grade 3 Treatment-Emergent Laboratory Abnormalities During the Dose Expansion Phase
Measured: First dose date through end of treatment plus 30 days, approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start26 Aug 2019
- Primary completion30 Mar 2021
- Study completion30 Mar 2021
Why it stopped: Gilead decision to terminate
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 Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04049617
- Sponsor's protocol ID
- GS-US-494-5484
- Other IDs
- 2019-004605-27, 2019
- Status last verified
- Sep 2022
- First submitted
- 31 Jul 2019
- Last updated
- 6 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Odegard JM, Othman AA, Lin KW, Wang AY, Nazareno J, Yoon OK, Ling J, Lad L, Dunbar PR, Thai D, Ang E, Waldron N, Deva S. Oral PD-L1 inhibitor GS-4224 selectively engages PD-L1 high cells and elicits pharmacodynamic responses in patients with advanced solid tumors. J Immunother Cancer. 2024 Apr 11;12(4):e008547. doi: 10.1136/jitc-2023-008547.
PubMed 38604815
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2 Dose Escalation/Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of GS-4224 in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04049617
- Acronym / sponsor ID
- GS-US-494-5484
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Gilead decision to terminate
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 26 Aug 2019 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 8 Aug 2019 (actual)
- Results
- Posted 10 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objectives of this study are to characterize the safety and tolerability of evixapodlin (formerly GS-4224) and to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of evixapodlin in participants with advanced solid tumors.
Detailed description
This was a planned Phase 1/2 study. However, Phase 2 was not conducted because the study was closed due to sponsor decision prior to opening the dose expansion cohort and hence, RP2D analysis was not performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Evixapodlin 400 mg (Phase 1) | Experimental | Drug: EvixapodlinParticipants will receive Evixapodlin 400 mg once daily for 21 days of each cycle. |
| Cohort 2: Evixapodlin 700 mg (Phase 1) | Experimental | Drug: EvixapodlinParticipants will receive Evixapodlin 700 mg once daily for 21 days of each cycle. |
| Cohort 3: Evixapodlin 1000 mg (Phase 1) | Experimental | Drug: EvixapodlinParticipants will receive Evixapodlin 1000 mg once daily for 21 days of each cycle. |
| Cohort 4: Evixapodlin 1500 mg (Phase 1) | Experimental | Drug: EvixapodlinParticipants will receive Evixapodlin 1500 mg once daily for 21 days of each cycle. |
| Cohort 5: Evixapodlin 1000 mg (Phase 1) | Experimental | Drug: EvixapodlinParticipants are planned to receive Evixapodlin 1000 mg twice daily (BID) for 21 days of each cycle. |
| Cohort 1 Substudy: Evixapodlin 400 mg (Phase 1) | Experimental | Drug: EvixapodlinParticipants will receive Evixapodlin 400 mg once daily for 21 days of each cycle. |
| Cohort 2 Substudy: Evixapodlin 700 mg (Phase 1) | Experimental | Drug: EvixapodlinParticipants are planned to receive Evixapodlin 700 mg once daily for 21 days of each cycle. |
| Cohort 3 Substudy: Evixapodlin 1000 mg (Phase 1) | Experimental | Drug: EvixapodlinParticipants will receive Evixapodlin 1000 mg once daily for 21 days of each cycle. |
| Dose Expansion (Phase 2) | Experimental | Drug: EvixapodlinDose expansion is planned to begin when the recommended Phase 2 dose (RP2D) will be determined. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Dose Escalation Cohorts: Histologically or cytologically confirmed advanced malignant solid tumor that is refractory to or intolerant of all standard therapy or for which no standard therapy is available.
- Dose Expansion and 1000 mg twice a day (BID) Dose Escalation Cohorts: Individuals must have available sufficient and adequate formalin fixed tumor sample preferably from a biopsy of a tumor lesion obtained either at the time of or after the diagnosis of advanced disease has been made and from a site not previously irradiated. Alternatively, individuals must agree to have a biopsy taken prior to entering the study to provide adequate tissue. For the 1000 mg BID dose escalation cohort, individuals with melanoma, Merkel cell, microsatellite instability-high (MSI-H) cancers, and classical Hodgkin lymphoma (cHL) are not required to have archival or fresh biopsy tissue.
- Dose Escalation Biopsy Substudy and 1000 mg BID Dose Escalation Cohorts: Documented ligand 1 of programmed cell death protein 1 (PD-L1) expression in the tumor (tumor proportion score (TPS) ≥ 10% or combined positive score (CPS) ≥ 10). In the 1000 mg BID Cohort, PD-L1 expression will not be required for Merkel cell, melanoma, MSI-H cancers, and cHL.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2.
- Adequate organ function.
Key exclusion criteria (5 listed)
- History or evidence of clinically significant disorder, condition, or disease that, in the opinion of the Investigator or Medical Monitor would pose a risk to individual safety or interfere with the study evaluations, procedures, or completion.
- Dose Escalation Cohorts: History of ≥ Grade 3 Adverse Events (AEs) during prior treatment with an immune checkpoint inhibitor, or history of discontinuation of treatment with an immune checkpoint inhibitor due to AEs.
- Dose Escalation 1000 mg BID and Dose Expansion Cohort: Prior treatment with an immune checkpoint inhibitor (anti-PD-1, anti-PD-L1, or anti- ligand 2 of programmed cell death protein 1 (PD-L2) antibodies).
- History of autoimmune disease (for example, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Bell's palsy, Guillain-Barré syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis).
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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 |
|---|---|---|
| EvixapodlinAlso: GS-4224Tablets administered orally. | Drug | Cohort 1 Substudy: Evixapodlin 400 mg (Phase 1), Cohort 1: Evixapodlin 400 mg (Phase 1), Cohort 2 Substudy: Evixapodlin 700 mg (Phase 1), Cohort 2: Evixapodlin 700 mg (Phase 1), Cohort 3 Substudy: Evixapodlin 1000 mg (Phase 1), Cohort 3: Evixapodlin 1000 mg (Phase 1), Cohort 4: Evixapodlin 1500 mg (Phase 1), Cohort 5: Evixapodlin 1000 mg (Phase 1), Dose Expansion (Phase 2) |
Primary outcome
Number of Participants Experiencing Dose Limiting Toxicities (DLTs) During the Dose Escalation Phase
Time frame: Day 1 through Day 21
A DLT was any toxicity defined as follows excluding toxicities clearly related to disease progression or disease-related processes occurring during the DLT assessment window (Day 1 through Day 21): * Grade ≥ 4 neutropenia * Grade ≥ 3 neutropenia with fever * Grade ≥ 3 thrombocytopenia * Grade ≥ 2 bleeding * Grade ≥ 3 anemia * Grade ≥ 3 or higher non-hematologic toxicity (excluding Grade 3 nausea or emesis or Grade 3 diarrhea) * Grade ≥ 2 non-hematologic treatment-emergent adverse event that in the opinion of the investigator is of potential clinical significance * Treatment interruption of ≥ 7 days due to unresolved toxicity * Any toxicity event that precludes further administration of evixapodlin * Any Grade 3 or Grade 4 elevation in aspartate aminotransferase (AST) or alanine aminotransferase (ALT) associated with a Grade 2 elevation in bilirubin lasting ≥ 7 days * An immune-related adverse event (irAE) for which immunotherapy should be permanently discontinued
6 secondary outcomes
Pharmacokinetic (PK) Parameter: AUCtau of Evixapodlin During the Dose Escalation Phase
Time frame: Intensive PK: Predose, 0.5, 1, 1.5, 2.5, 4, 6, 24 hours (h) postdose (400-1500 once daily [QD] mg cohorts) on Cycle (C) 1 Day (D) 1 & D15
PK Parameter: Cmax of Evixapodlin During the Dose Escalation Phase
Time frame: Intensive PK: Predose, 0.5, 1, 1.5, 2.5, 4, 6, 24 h postdose (400-1500 QD mg cohorts) on C1D1 & D15
PK Parameter: Ctrough of Evixapodlin During the Dose Escalation Phase
Time frame: Intensive PK: Predose, 0.5, 1, 1.5, 2.5, 4, 6, 24 h postdose (400-1500 QD mg cohorts) on C1D1 & D15
PK Parameter: Tmax of Evixapodlin During the Dose Escalation Phase
Time frame: Intensive PK: Predose, 0.5, 1, 1.5, 2.5, 4, 6, 24 h postdose (400-1500 QD mg cohorts) on C1D1 & D15
Percentage of Participants Experiencing ≥ Grade 3 Treatment-Emergent Adverse Events During the Dose Expansion Phase
Time frame: First dose date through end of treatment plus 30 days, approximately 5 years
Percentage of Participants Experiencing ≥ Grade 3 Treatment-Emergent Laboratory Abnormalities During the Dose Expansion Phase
Time frame: First dose date through end of treatment plus 30 days, approximately 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38604815Odegard JM, Othman AA, Lin KW, Wang AY, Nazareno J, Yoon OK, Ling J, Lad L, Dunbar PR, Thai D, Ang E, Waldron N, Deva S. Oral PD-L1 inhibitor GS-4224 selectively engages PD-L1 high cells and elicits pharmacodynamic responses in patients with advanced solid tumors. J Immunother Cancer. 2024 Apr 11;12(4):e008547. doi: 10.1136/jitc-2023-008547.
- 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.
Gilead Study Director study director
Gilead Sciences
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Evixapodlin in people with Advanced Solid Tumors, run by Gilead Sciences at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 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 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Aug 2022). 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?
Number of Participants Experiencing Dose Limiting Toxicities (DLTs) During the Dose Escalation Phase (time frame: Day 1 through Day 21). 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 NCT04049617, 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 6 Oct 2022.