Small Cell Lung CancerPhase 2NCT02735980

A Study of Prexasertib (LY2606368) in Participants With Extensive Stage Disease Small Cell Lung Cancer

A Phase 2 study testing Prexasertib in people with Small Cell Lung Cancer, run by Eli Lilly and Company at 41 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the safety and efficacy of prexasertib when given to participants with extensive stage disease small cell lung cancer (ED-SCLC). The study will evaluate how the body processes the drug and how the drug affects the body. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Small Cell Lung Cancer
What is being tested?: Prexasertib
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 133 participants
Where: 41 sitesin 10 countries
Study dates: 11 May 2016to 12 Feb 2019
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

Have ED-SCLC and have received a prior platinum-based regimen
Participants in Cohort 1 and in the addendum must have had an objective response to prior platinum-based therapy with subsequent progression ≥90 days after the last dose of platinum
Participants in Cohort 2 must have either not had an objective response to prior platinum based therapy or had progression <90 days after the last dose of platinum
Have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group scale

Who cannot join

Have received more than 2 prior therapies for ED-SCLC (including immunotherapy, targeted therapies, or chemotherapy)
Have symptomatic central nervous system (CNS) malignancy or metastasis. Asymptomatic participants with treated CNS metastases are eligible for this study if they are not currently receiving corticosteroids to treat CNS metastases
Have previously completed or withdrawn from this study or any other study investigating prexasertib or a checkpoint kinase I (CHK1) inhibitor or have shown hypersensitivity to any of the components of the prexasertib formulation
Have a serious cardiac condition

Trial locations and contacts

41 sites in 10 countries.

Country

City, postcode or hospital

41 sites in 10 countries

United States14 sites

Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, 37404
Massachusetts General Hospital
Danvers, Massachusetts, 01923
Highlands Oncology Group
Fayetteville, Arkansas, 72703
Florida Cancer Specialists
Fort Myers, Florida, 33908
The Center for Cancer and Blood Disorders
Fort Worth, Texas, 76104
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756-0001
Sarah Cannon Cancer Center
Nashville, Tennessee, 37203
Tennessee Oncology PLLC
Nashville, Tennessee, 37203
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-6307
Yale University School of Medicine
New Haven, Connecticut, 06520
Washington University Medical Center
St Louis, Missouri, 63110
Florida Cancer Specialists and Research Institute
St. Petersburg, Florida, 33705
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007

Other trials in United States

Turkey (Türkiye)5 sites

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Antalya, 07059
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Edirne
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Istanbul, 34098
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Izmir, 35100
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Kayseri, 38039

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France4 sites

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Besançon, 25030
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Lille, 59037
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Montpellier, 34070
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Vantoux, 57070

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Greece3 sites

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Athens, 11527
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Heraklion, 71110
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Pátrai, 26504

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Netherlands3 sites

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Amsterdam, 1066 CX
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Breda, 4818 CK
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Zwolle, 8025 AB

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Spain3 sites

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Barcelona, 08035
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Madrid, 28034
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Zaragoza, 50009

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Ukraine3 sites

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Dnipropetrovsk, 49102
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Kharkiv, 61070
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Sumy, 40005

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United Kingdom3 sites

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Headington, OX3 7LJ
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Leicester, LE1 5WN
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Sheffield, S10 2SJ

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South Korea2 sites

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Seoul, 06351
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Seoul, 120-792

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Germany1 site

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Halle, 06120

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About this study

Official title: A Phase 2 Study of LY2606368 in Patients With Extensive Stage Disease Small Cell Lung Cancer

Conditions: Small Cell Lung Cancer
Being tested: Prexasertib
Keywords: SCLC, LY2606368, CHK1
Medical subject headings: Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PrexasertibDrug
Also called LY2606368
Administered IV

Study groups in NCT02735980
Study group	Role	What they receive
Prexasertib (Platinum Sensitive Disease)	Experimental	105 mg/m^2 Intravenous (IV) prexasertib administered of every 14 days with extensive stage disease small cell lung cancer (ED-SCLC) who had platinum-sensitive disease (has prior platinum based therapy with subsequent progression greater or less than 90 days after last dose of platinum based therapy). Receives: Drug: Prexasertib
Prexasertib (Platinum Resistant Disease)	Experimental	105 mg/m^2 IV prexasertib administered of every 14 days with extensive stage disease small cell lung cancer (ED-SCLC) who had resistant/refractory disease (did not have an objective response to platinum-based therapy or had progression greater than 90 days after the last dose of platinum). Receives: Drug: Prexasertib
Prexasertib Exploratory Addendum (Platinum Sensitive Disease)	Experimental	40 mg/m^2 IV prexasertib Day 1, 2, and Day 3 of a 14 day cycle in participants with ED-SCLC platinum sensitive disease. Receives: Drug: Prexasertib

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])
ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions
Measured: Baseline to 10 months

Secondary outcomes (9)

Pharmacokinetics(PK): Maximum Concentration (Cmax) of Prexasertib Cohort 1 and Cohort 2
Pharmacokinetics(PK): Maximum Concentration of Prexasertib. The same dose was administered to Cohort 1 and Cohort 2 and were combined for analysis.
Measured: Cycle 1,3, 5, and 7: Day 1, Day 2 and Day 3- Prior to start of infusion, end of infusion plus 10 minutes, Day 8: anytime
Pharmacokinetics(PK): Maximum Concentration of Prexasertib Cohort 3 (40 mg/m^2, Protocol Addenda)
Pharmacokinetics(PK): Maximum Concentration of Prexasertib
Measured: Cycle 1,3, 5, and 7: Day 1, Day 2 and Day 3- Prior to start of infusion, end of infusion plus 10 minutes, Day 8: anytime
Pharmacokinetics: Area Under the Concentration Curve of Prexasertib
Pharmacokinetics: Area Under the Concentration Curve of Prexasertib
Measured: Cycle 1,3, 5, and 7: Day 1, Day 2 and Day 3- Prior to start of infusion, end of infusion plus 10 minutes, Day 8: anytime
Disease Control Rate: Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD)
Disease control rate (DCR) is defined as the percentage of participants achieving a best overall response of CR, PR, or SD as determined by RECIST 1.1. CR is defined as a disappearance of all target lesions and any pathological lymph nodes must have reduction in short axis to <10 mm and normalization of tumor marker results; PR is defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters; SD is defined as neither sufficient shrinking to qualify as PR nor sufficient increase to qualify for PD.
Measured: Baseline through Disease Progression or Death from Any Cause to 28 months
Progression-Free Survival (PFS)
PFS defined as the from randomization date to the first evidence of disease progression as defined by RECIST v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of first dose, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.
Measured: Baseline to Disease Progression or Death (up to 9 months)
Duration of Response (DoR)
DoR the time from the date of an objective response until Progressive Disease (PD): was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
Measured: Date of CR or PR to Date of Disease Progression or Death Due to Any Cause up to 9 months
Overall Survival (OS)
OS defined as from randomization date to the date of death due to any cause. For each participant who is not known to have died as of the data-inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive.
Measured: Baseline up to 28 months
Change From Baseline in Lung Cancer Symptom Scale Score (LCSS)
LCSS is a 9-item questionnaire, six measuring major symptoms for lung malignancies (appetite, fatigue, cough, dyspnea, hemoptysis and pain), and 3 summation items related to total symptomatic distress, activity status and overall quality of life. Participant responses were measured using visual analogue scales (VAS) with 100-mm lines. The LCSS total score was defined as the mean of the 9 items of the scale, each scored between 0 (for best outcome) to 100 (for worst outcome).
Measured: Baseline up to 9 months
Change From Baseline on the Average Symptom Burden Index (ASBI)
ABSI was the mean score for the six major lung cancer symptoms (appetite, fatigue, cough, dyspnea, hemoptysis and pain), each scored between 0 (for best outcome) to 100 (for worst outcome).
Measured: Baseline up to 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 May 201612 Feb 2019

First posted13 Apr 2016 (estimated)
Study start11 May 2016
Primary completion31 Jul 2017
Study completion12 Feb 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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Small Cell Lung CancerStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe 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 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 133 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02735980
Sponsor's protocol ID: 16015
Other IDs: I4D-MC-JTJH, 2015-005069-21, 2015
Status last verified: 1 May 2019
First submitted: 31 Mar 2016
Last updated: 17 Mar 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Publications

Jin T, Xu L, Wang P, Hu X, Zhang R, Wu Z, Du W, Kan W, Li K, Wang C, Zhou Y, Li J, Liu T. Discovery and Development of a Potent, Selective, and Orally Bioavailable CHK1 Inhibitor Candidate: 5-((4-((3-Amino-3-methylbutyl)amino)-5-(trifluoromethyl)pyrimidin-2-yl)amino)picolinonitrile. J Med Chem. 2021 Oct 28;64(20):15069-15090. doi: 10.1021/acs.jmedchem.1c00994. Epub 2021 Oct 19.
PubMed 34665631

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2 Study of LY2606368 in Patients With Extensive Stage Disease Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT02735980
Acronym / sponsor ID: 16015
Conditions: Small Cell Lung Cancer
Keywords: SCLC, LY2606368, CHK1
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 133 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 11 May 2016 (actual)
Primary completion: 31 Jul 2017 (actual)
Study completion: 12 Feb 2019 (actual)
First posted: 13 Apr 2016 (estimated)
Results: Posted 17 Mar 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Prexasertib (Platinum Sensitive Disease)	Experimental	Drug: Prexasertib105 mg/m^2 Intravenous (IV) prexasertib administered of every 14 days with extensive stage disease small cell lung cancer (ED-SCLC) who had platinum-sensitive disease (has prior platinum based therapy with subsequent progression greater or less than 90 days after last dose of platinum based therapy).
Prexasertib (Platinum Resistant Disease)	Experimental	Drug: Prexasertib105 mg/m^2 IV prexasertib administered of every 14 days with extensive stage disease small cell lung cancer (ED-SCLC) who had resistant/refractory disease (did not have an objective response to platinum-based therapy or had progression greater than 90 days after the last dose of platinum).
Prexasertib Exploratory Addendum (Platinum Sensitive Disease)	Experimental	Drug: Prexasertib40 mg/m^2 IV prexasertib Day 1, 2, and Day 3 of a 14 day cycle in participants with ED-SCLC platinum sensitive disease.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Have ED-SCLC and have received a prior platinum-based regimen
Participants in Cohort 1 and in the addendum must have had an objective response to prior platinum-based therapy with subsequent progression ≥90 days after the last dose of platinum
Participants in Cohort 2 must have either not had an objective response to prior platinum based therapy or had progression <90 days after the last dose of platinum
Have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group scale

Key exclusion criteria (4 listed)

Have received more than 2 prior therapies for ED-SCLC (including immunotherapy, targeted therapies, or chemotherapy)
Have symptomatic central nervous system (CNS) malignancy or metastasis. Asymptomatic participants with treated CNS metastases are eligible for this study if they are not currently receiving corticosteroids to treat CNS metastases
Have previously completed or withdrawn from this study or any other study investigating prexasertib or a checkpoint kinase I (CHK1) inhibitor or have shown hypersensitivity to any of the components of the prexasertib formulation
Have a serious cardiac condition

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
PrexasertibAlso: LY2606368Administered IV	Drug	Prexasertib (Platinum Resistant Disease), Prexasertib (Platinum Sensitive Disease), Prexasertib Exploratory Addendum (Platinum Sensitive Disease)

Primary outcome

Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])
Time frame: Baseline to 10 months
ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions

9 secondary outcomes

Pharmacokinetics(PK): Maximum Concentration (Cmax) of Prexasertib Cohort 1 and Cohort 2
Time frame: Cycle 1,3, 5, and 7: Day 1, Day 2 and Day 3- Prior to start of infusion, end of infusion plus 10 minutes, Day 8: anytime
Pharmacokinetics(PK): Maximum Concentration of Prexasertib Cohort 3 (40 mg/m^2, Protocol Addenda)
Time frame: Cycle 1,3, 5, and 7: Day 1, Day 2 and Day 3- Prior to start of infusion, end of infusion plus 10 minutes, Day 8: anytime
Pharmacokinetics: Area Under the Concentration Curve of Prexasertib
Time frame: Cycle 1,3, 5, and 7: Day 1, Day 2 and Day 3- Prior to start of infusion, end of infusion plus 10 minutes, Day 8: anytime
Disease Control Rate: Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD)
Time frame: Baseline through Disease Progression or Death from Any Cause to 28 months
Progression-Free Survival (PFS)
Time frame: Baseline to Disease Progression or Death (up to 9 months)
Duration of Response (DoR)
Time frame: Date of CR or PR to Date of Disease Progression or Death Due to Any Cause up to 9 months
Overall Survival (OS)
Time frame: Baseline up to 28 months
Change From Baseline in Lung Cancer Symptom Scale Score (LCSS)
Time frame: Baseline up to 9 months
Change From Baseline on the Average Symptom Burden Index (ASBI)
Time frame: Baseline up to 9 months

Results and safety

Results posted to the registry on 17 Mar 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
105 mg/m^2 Prexasertib (Platinum Sensitive Disease)	58	48
105 mg/m^2 Prexasertib (Platinum Resistant Disease)	60	49
40 mg/m2 Prexasertib Exploratory Addendum	15	14

Primary outcome: Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])

Time frame: Baseline to 10 months. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Prexasertib (Platinum Sensitive Disease) n = 58	Prexasertib (Platinum Resistant Disease) n = 60	Prexasertib Exploratory Addendum (Platinum Sensitive Disease) n = 15
Value	5.2 (0.7 to 9.6)	0 (0.0 to 3.7)	0 (0.0 to 14.8)

Population analysed: All randomized participants who received at least 1 dose of study drug.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: up to 28 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
105 mg/m^2 Prexasertib (Platinum Sensitive Disease)	21 of 56 (37.5%)	56 of 56 (100%)	10 of 56
105 mg/m^2 Prexasertib (Platinum Resistant Disease)	16 of 60 (26.7%)	59 of 60 (98.3%)	7 of 60
40 mg/m2 Prexasertib Exploratory Addendum	6 of 15 (40%)	15 of 15 (100%)	11 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34665631Jin T, Xu L, Wang P, Hu X, Zhang R, Wu Z, Du W, Kan W, Li K, Wang C, Zhou Y, Li J, Liu T. Discovery and Development of a Potent, Selective, and Orally Bioavailable CHK1 Inhibitor Candidate: 5-((4-((3-Amino-3-methylbutyl)amino)-5-(trifluoromethyl)pyrimidin-2-yl)amino)picolinonitrile. J Med Chem. 2021 Oct 28;64(20):15069-15090. doi: 10.1021/acs.jmedchem.1c00994. Epub 2021 Oct 19.
Click here for more information about this study: A Study of Prexasertib (LY2606368) in Participants With Extensive Stage Disease Small Cell Lung CancerLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

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RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
RecruitingPhase 2
A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity
Carcinoma, Neuroendocrine, Tumor, Neuroendocrine
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer

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.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

41 sites in 10 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Prexasertib in people with Small Cell Lung Cancer, run by Eli Lilly and Company at 41 sites in 10 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 4 inclusion and 4 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 17 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 41 sites in United States, Turkey (Türkiye), France, Greece, Netherlands and 5 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 17 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?

Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR]) (time frame: Baseline to 10 months). 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 NCT02735980, 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 17 Mar 2020.