Metastatic Breast CancerPhase 1/2NCT03411161
S 81694 Plus Paclitaxel in Metastatic Breast Cancer
A Phase 1/2 study testing Combination therapy (S81694 + paclitaxel) phase I, Paclitaxel and Combination therapy (S81694 + paclitaxel) phase II in people with Metastatic Breast Cancer and Metastatic Triple Negative Breast Cancer, run by Institut de Recherches Internationales Servier at 6 sites in 4 countries.
Trial summary
The purpose of this study is to determine the safety profile, the maximum tolerated dose (MTD) and the associated dose-limiting toxicities (DLTs) of S 81694 in combination with paclitaxel in metastatic breast cancer (mBC) patients, and to investigate the antitumour activity of the combination in metastatic triple… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer, Metastatic Triple Negative Breast Cancer
- What is being tested?
- Combination therapy (S81694 + paclitaxel) phase I, Paclitaxel and Combination therapy (S81694 + paclitaxel) phase II
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 4 Jan 2018to 8 Jun 2020
- Phase
- Phase 1/2
- 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
- For Phase I :
- Histologically or cytologically confirmed metastatic breast cancer, refractory to any standard therapy or for which the standard therapy is considered unsuitable;
- Patient must have at least one evaluable or measurable metastatic lesion (lesions as defined by revised Response Evaluation Criteria in Solid Tumors).
- For Phase II :
- Histologically or cytologically confirmed advanced inoperable triple negative breast cancer with no prior anticancer therapy regimen in metastatic setting;
- Patient with a minimum washout period of 12 months following previous taxane based adjuvant therapy;
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- Patient must have at least one measurable metastatic lesion. Ascites, pleural effusion, and bone metastases are not considered measurable;
- Acceptance of pre-treatment metastatic biopsies for all patients and on-treatment metastatic biopsies in selected centres.
- For the whole study:
- Male or female subjects aged ≥ 18 years old, or legal age of the majority in the country;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Estimated life expectancy of at least 3 months;
- Adequate haematological function based on the last assessment performed within 7 days prior to the first IMP (investigational medicinal product) administration;
- Adequate renal function based on the last assessment performed within 7 days prior to the first IMP administration;
- Adequate hepatic function based on the last assessment performed within 7 days prior to the first IMP administration;
- Female participant of childbearing potential must have a negative pregnancy test (serum) within 7 days prior to the first day of test drug administration. Effective contraception both for female patients of childbearing potential and male patients with parteners of childbearing potential.
Who cannot join
- Other active malignancy within the last 3 years (except for basal cell carcinoma or a non-invasive/in situ cervical cancer or intra-mucosal gastro-intestinal cancers that were treated curatively);
- Presence of grade ≥ 2 toxic effects (excluding alopecia) due to prior cancer therapy;
- Known hypersensitivity to the IMP (S 81694 and paclitaxel) or their excipients;
- Evidence of peripheral neuropathy of grade 2 or higher;
- Participant previously received paclitaxel and discontinued due to toxicity related to paclitaxel;
- Participant known as refractory to taxanes;
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- Any prior cancer therapy within 4 weeks or 5 half-life (whichever is the shorter) before the first IMP administration;
- Participant with current, serious, uncontrolled infections;
- Participant with brain metastasis or leptomeningeal metastasis (except patients with brain metastasis that have been stable post-radiation therapy and who are off steroids for > 2 months);
- History of cardiac disease;
- Uncontrolled arterial hypertension;
- Presence of risk factors for torsades de pointes (e.g. heart failure, hypokalaemia, family history of long QT syndrome);
- Any clinically significant medical condition (e.g. organ dysfunction) or laboratory abnormality likely to jeopardize the patient's safety or to interfere with the conduct of the study, in the investigator's opinion.
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
Belgium2 sites
Institut Jules Bordet Clinique Oncologie Médicale
Brussels, 1000
UZ Leuven Campus Gasthuisberg Dept. of General Medical
Leuven, 3000
Japan2 sites
Chiba cancer center Breast surgery
Chiba, 2608717
Osaka International Cancer Institute
Osaka, 5418567
France1 site
Institut de Cancérologie de l'Ouest site Saint Herblain
Saint-Herblain, 44805
Netherlands1 site
Erasmus MC Section Clinical Pharmacology
Rotterdam, 30145
About this study
Official title: Phase I/II Trial of S 81694 Administered Intravenously in Combination With Paclitaxel to Evaluate the Safety, Pharmacokinetic and Efficacy in Metastatic Breast Cancer
The purpose of this study is to determine the safety profile, the maximum tolerated dose (MTD) and the associated dose-limiting toxicities (DLTs) of S 81694 in combination with paclitaxel in metastatic breast cancer (mBC) patients, and to investigate the antitumour activity of the combination in metastatic triple negative breast cancer (mTNBC) patients.
- Being tested
- Combination therapy (S81694 + paclitaxel) phase I, Paclitaxel, Combination therapy (S81694 + paclitaxel) phase II
- Keywords
- Mps1, Mps1i, S81694, breast cancer, triple negative breast cancer, phase I, phase II
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms, Mucopolysaccharidosis I
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination therapy (S81694 + paclitaxel) phase IDrug
Dose escalation S 81694 (IV); paclitaxel started at 80 mg/m²,(IV)
PaclitaxelDrug
Paclitaxel (IV) at 80 mg/m²/week
Combination therapy (S81694 + paclitaxel) phase IIDrug
S 81694 (IV) at RP2D; paclitaxel (IV) at 80 mg/m²/week
| Study group | Role | What they receive |
|---|---|---|
| Combination therapy (S81694 + paclitaxel) phase I | Experimental | Phase I: Single arm, non-randomized study in metastatic breast cancer patients. S81694 given intravenously every two weeks at different doses on D1 and D15 last for 28 days. The participants will also receive paclitaxel intravenously on D1, D8 and D15 last for 28 days. Receives: Drug: Combination therapy (S81694 + paclitaxel) phase I |
| paclitaxel phase II | Active comparator | Phase II: Randomised phase II part , two-arm, in untreated metastatic triple negative breast cancer patients.
Paclitaxel given intravenously on D1, D8, and D15 at 80 mg/m² during a 28-day cycle. Receives: Drug: Paclitaxel |
| Combination therapy (S81694 + paclitaxel) phase II | Experimental | Phase II: Randomised phase II part , two-arm, in untreated metastatic triple negative breast cancer patients.
S 81694 given intravenously on D1 and D15 at recommended phase 2 dose (RP2D). Paclitaxel given intravenously on D1, D8, and D15 during a 28-day cycle. Receives: Drug: Combination therapy (S81694 + paclitaxel) phase II |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of DLTs (dose-limiting toxicities)
Safety criterion - A DLT is defined as any toxicity attributable to S81694 or the combination that occurs before the end of Cycle 1
Measured: Through study completion, an average of 4 years
Safety and tolerability assessed by incidence of Adverse Events
Safety and tolerability criteria - Incidence of treatment-emergent adverse events (AEs) graded according to NCI CTCAE v4.03
Measured: Through study completion, an average of 4 years
Abnormalities in laboratory tests (haematology, blood biochemistry and urinalysis)
Safety and tolerability criteria disease progression according to RECIST v1.1 or death due to any cause
Measured: Through study completion, an average of 4 years
Abnormalities in physical examination and performance status (ECG) (mm/s)
Safety and tolerability criteria
Measured: Through study completion, an average of 4 years
Abnormalities in blood pressure (mmHg)
Safety and tolerability criteria - Treatment-emergent changes in physical examinations, ECOG performance status, at periodic intervals during the study and at End of Treatment
Measured: Through study completion, an average of 4 years
Abnormalities in heart rate (BPM (beat per minute))
Safety and tolerability criteria - Treatment-emergent changes in physical examinations, ECOG performance status, at periodic intervals during the study and at End of Treatment
Measured: Through study completion, an average of 4 years
Abnormalities in body temperature (C°degree celsius)
Safety and tolerability criteria - Treatment-emergent changes in physical examinations, ECOG performance status, at periodic intervals during the study and at End of Treatment
Measured: Through study completion, an average of 4 years
Abnormalities in respiration rate (cycles per minute)
Safety and tolerability criteria - Treatment-emergent changes in physical examinations, ECOG performance status, at periodic intervals during the study and at End of Treatment
Measured: Through study completion, an average of 4 years
Abnormalities in body weight (Kg)
Safety and tolerability criteria - Treatment-emergent changes in physical examinations, ECOG performance status, at periodic intervals during the study and at End of Treatment
Measured: Through study completion, an average of 4 years
Progression free survival (PFS) [based on Investigator review of the images according to RECIST 1.1]
Efficacy criterion - time from the date of first study drug intake until the date of the investigator-assessed disease progression or death due to any cause whichever occurs first.
Measured: Through study completion, an average of 4 years
Secondary outcomes (6)
The PK (pharmacokinetic) profile of S 81694 and paclitaxel plasma concentration : Area under the plasma concentration-time curve (AUC)
Safety and tolerability criteria
Measured: Through study completion, an average of 3 years
The PK profile of S 81694 and paclitaxel plasma concentration : Elimination half-life (T½)
Safety and tolerability criteria
Measured: Through study completion, an average of 3 years
The PK profile of S 81694 and paclitaxel plasma concentration : Maximum plasma concentration (Cmax)
Safety and tolerability criteria
Measured: Through study completion, an average of 3 years
The PK profile of S 81694 and paclitaxel plasma concentration : Minimum plasma concentration (Cmin)
Safety and tolerability criteria
Measured: Through study completion, an average of 3 years
Overall Response Rate (ORR) [ based on Investigator review of the images according to RECIST 1.1]
Efficacy criterion
Measured: Through study completion, an average of 4 years
Incidence of treatment-emergent adverse events (AEs) graded according to NCI CTCAE v4.03
Safety criterion
Measured: Through study completion, an average of 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2018
- Study start4 Jan 2018
- Primary completion8 Jun 2020
- Study completion8 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study will be conducted in two successive parts: * a dose escalation phase I part, which is a single arm, non-randomised and non-comparative study in patient with mBC * a randomised phase II part, which is a two-arm, randomised study at RP2D (recommended phase II dose), to evaluate the efficacy and the safety of S 81694 in combination with paclitaxel (experimental arm) versus paclitaxel alone (comparator arm) in untreated mTNBC
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recherches Internationales Servier
- Sponsor type
- University, hospital or other
- Collaborators
- ADIR, a Servier Group company
- Responsible party
- Sponsor
- Investigators
- Mario CAMPONE, Pr, Principal investigator, Institut de Cancérologie de l'Ouest site Saint Herblain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03411161
- Sponsor's protocol ID
- CL1-81694-003
- Other IDs
- 2017-002459-27, 2017
- Status last verified
- May 2021
- First submitted
- 13 Dec 2017
- Last updated
- 25 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data. Access can be requested for all interventional clinical studies: * used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). * where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope. In addition, access can be requested for all interventional clinical studies in patients: * sponsored by Servier * with a first patient enrolled as of 1 January 2004 onwards * for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Trial of S 81694 Administered Intravenously in Combination With Paclitaxel to Evaluate the Safety, Pharmacokinetic and Efficacy in Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT03411161
- Acronym / sponsor ID
- CL1-81694-003
- Keywords
- Mps1, Mps1i, S81694, breast cancer, triple negative breast cancer, phase I, phase II
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Institut de Recherches Internationales ServierUniversity, hospital or other
- Collaborators
- ADIR, a Servier Group company
- Study start
- 4 Jan 2018 (actual)
- Primary completion
- 8 Jun 2020 (actual)
- Study completion
- 8 Jun 2020 (actual)
- First posted
- 26 Jan 2018 (actual)
- 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.
The purpose of this study is to determine the safety profile, the maximum tolerated dose (MTD) and the associated dose-limiting toxicities (DLTs) of S 81694 in combination with paclitaxel in metastatic breast cancer (mBC) patients, and to investigate the antitumour activity of the combination in metastatic triple negative breast cancer (mTNBC) patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This study will be conducted in two successive parts: * a dose escalation phase I part, which is a single arm, non-randomised and non-comparative study in patient with mBC * a randomised phase II part, which is a two-arm, randomised study at RP2D (recommended phase II dose), to evaluate the efficacy and the safety of S 81694 in combination with paclitaxel (experimental arm) versus paclitaxel alone (comparator arm) in untreated mTNBC
| Arm | Type | Receives |
|---|---|---|
| Combination therapy (S81694 + paclitaxel) phase I | Experimental | Drug: Combination therapy (S81694 + paclitaxel) phase IPhase I: Single arm, non-randomized study in metastatic breast cancer patients. S81694 given intravenously every two weeks at different doses on D1 and D15 last for 28 days. The participants will also receive paclitaxel intravenously on D1, D8 and D15 last for 28 days. |
| paclitaxel phase II | Active comparator | Drug: PaclitaxelPhase II: Randomised phase II part , two-arm, in untreated metastatic triple negative breast cancer patients. Paclitaxel given intravenously on D1, D8, and D15 at 80 mg/m² during a 28-day cycle. |
| Combination therapy (S81694 + paclitaxel) phase II | Experimental | Drug: Combination therapy (S81694 + paclitaxel) phase IIPhase II: Randomised phase II part , two-arm, in untreated metastatic triple negative breast cancer patients. S 81694 given intravenously on D1 and D15 at recommended phase 2 dose (RP2D). Paclitaxel given intravenously on D1, D8, and D15 during a 28-day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Histologically or cytologically confirmed metastatic breast cancer, refractory to any standard therapy or for which the standard therapy is considered unsuitable;
- Patient must have at least one evaluable or measurable metastatic lesion (lesions as defined by revised Response Evaluation Criteria in Solid Tumors).
- Histologically or cytologically confirmed advanced inoperable triple negative breast cancer with no prior anticancer therapy regimen in metastatic setting;
- Patient with a minimum washout period of 12 months following previous taxane based adjuvant therapy;
- Patient must have at least one measurable metastatic lesion. Ascites, pleural effusion, and bone metastases are not considered measurable;
Key exclusion criteria (13 listed)
- Other active malignancy within the last 3 years (except for basal cell carcinoma or a non-invasive/in situ cervical cancer or intra-mucosal gastro-intestinal cancers that were treated curatively);
- Presence of grade ≥ 2 toxic effects (excluding alopecia) due to prior cancer therapy;
- Known hypersensitivity to the IMP (S 81694 and paclitaxel) or their excipients;
- Evidence of peripheral neuropathy of grade 2 or higher;
- Participant previously received paclitaxel and discontinued due to toxicity related to paclitaxel;
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 |
|---|---|---|
| Combination therapy (S81694 + paclitaxel) phase IDose escalation S 81694 (IV); paclitaxel started at 80 mg/m²,(IV) | Drug | Combination therapy (S81694 + paclitaxel) phase I |
| PaclitaxelPaclitaxel (IV) at 80 mg/m²/week | Drug | paclitaxel phase II |
| Combination therapy (S81694 + paclitaxel) phase IIS 81694 (IV) at RP2D; paclitaxel (IV) at 80 mg/m²/week | Drug | Combination therapy (S81694 + paclitaxel) phase II |
Primary outcome
Incidence of DLTs (dose-limiting toxicities)
Time frame: Through study completion, an average of 4 years
Safety criterion - A DLT is defined as any toxicity attributable to S81694 or the combination that occurs before the end of Cycle 1
Safety and tolerability assessed by incidence of Adverse Events
Time frame: Through study completion, an average of 4 years
Safety and tolerability criteria - Incidence of treatment-emergent adverse events (AEs) graded according to NCI CTCAE v4.03
Abnormalities in laboratory tests (haematology, blood biochemistry and urinalysis)
Time frame: Through study completion, an average of 4 years
Safety and tolerability criteria disease progression according to RECIST v1.1 or death due to any cause
Abnormalities in physical examination and performance status (ECG) (mm/s)
Time frame: Through study completion, an average of 4 years
Safety and tolerability criteria
Abnormalities in blood pressure (mmHg)
Time frame: Through study completion, an average of 4 years
Safety and tolerability criteria - Treatment-emergent changes in physical examinations, ECOG performance status, at periodic intervals during the study and at End of Treatment
Abnormalities in heart rate (BPM (beat per minute))
Time frame: Through study completion, an average of 4 years
Safety and tolerability criteria - Treatment-emergent changes in physical examinations, ECOG performance status, at periodic intervals during the study and at End of Treatment
Abnormalities in body temperature (C°degree celsius)
Time frame: Through study completion, an average of 4 years
Safety and tolerability criteria - Treatment-emergent changes in physical examinations, ECOG performance status, at periodic intervals during the study and at End of Treatment
Abnormalities in respiration rate (cycles per minute)
Time frame: Through study completion, an average of 4 years
Safety and tolerability criteria - Treatment-emergent changes in physical examinations, ECOG performance status, at periodic intervals during the study and at End of Treatment
Abnormalities in body weight (Kg)
Time frame: Through study completion, an average of 4 years
Safety and tolerability criteria - Treatment-emergent changes in physical examinations, ECOG performance status, at periodic intervals during the study and at End of Treatment
Progression free survival (PFS) [based on Investigator review of the images according to RECIST 1.1]
Time frame: Through study completion, an average of 4 years
Efficacy criterion - time from the date of first study drug intake until the date of the investigator-assessed disease progression or death due to any cause whichever occurs first.
6 secondary outcomes
The PK (pharmacokinetic) profile of S 81694 and paclitaxel plasma concentration : Area under the plasma concentration-time curve (AUC)
Time frame: Through study completion, an average of 3 years
The PK profile of S 81694 and paclitaxel plasma concentration : Elimination half-life (T½)
Time frame: Through study completion, an average of 3 years
The PK profile of S 81694 and paclitaxel plasma concentration : Maximum plasma concentration (Cmax)
Time frame: Through study completion, an average of 3 years
The PK profile of S 81694 and paclitaxel plasma concentration : Minimum plasma concentration (Cmin)
Time frame: Through study completion, an average of 3 years
Overall Response Rate (ORR) [ based on Investigator review of the images according to RECIST 1.1]
Time frame: Through study completion, an average of 4 years
Incidence of treatment-emergent adverse events (AEs) graded according to NCI CTCAE v4.03
Time frame: Through study completion, an average of 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2021.
- Individual participant dataSharing planned: Yes. Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data. Access can be requested for all interventional clinical studies: * used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). * where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope. In addition, access can be requested for all interventional clinical studies in patients: * sponsored by Servier * with a first patient enrolled as of 1 January 2004 onwards * for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.
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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.
Mario CAMPONE, Pr principal investigator
Institut de Cancérologie de l'Ouest site Saint Herblain
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Combination therapy (S81694 + paclitaxel) phase I, Paclitaxel and Combination therapy (S81694 + paclitaxel) phase II in people with Metastatic Breast Cancer and Metastatic Triple Negative Breast Cancer, run by Institut de Recherches Internationales Servier at 6 sites in 4 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 16 inclusion and 13 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 25 May 2021. 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 Belgium, Japan, France, 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of DLTs (dose-limiting toxicities) (time frame: Through study completion, an average of 4 years). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2021.