Metastatic HER2-positive Breast Cancer With Brain MetastasisPhase 2KIARANCT03203616
Kadcyla In pAtients With bRAin Metastasis
A Phase 2 study testing KADCYLA 160 MG Injection in people with Metastatic HER2-positive Breast Cancer With Brain Metastasis, run by Jules Bordet Institute.
Trial summary
Women with breast cancer often develop metastases in the brain. Currently, treatment of these metastases is difficult and relies on radiotherapy or surgery which often fail. Therefore, development of new methods of treatment for breast cancer with brain metastasis is very important. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic HER2-positive Breast Cancer With Brain Metastasis
- What is being tested?
- KADCYLA 160 MG Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 23 Feb 2018to 27 Aug 2018
- Phase
- Phase 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must meet all these criteria in order to be eligible for the study:
- General Criteria:
- Female patients (≥ 18 years);
- Histologically confirmed HER2-positive breast cancer patients (IHC 3+ and/or ISH positive);
- Patients should have previously received trastuzumab and a taxane, separately or in combination. Patients should have either received prior therapy for locally advanced or metastatic disease, or developed disease recurrence during or within six months of completing adjuvant therapy;
- At least one measurable brain metastasis as defined by RECIST 1.1 (≥ 10 mm);
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- Any hormone receptor status;
- Predicted life expectancy > 3 months;
- Any previous anti-HER2 therapies are allowed, other than T-DM1;
- ECOG performance score 0-2;
- No significant cardiac history and a current LVEF ≥ 50%. LVEF should be determined within 21 days before enrolment;
- Adequate organ function, evidenced by the following laboratory results. Exams are to be performed at a maximum of 7 days before enrolment.
- Absolute neutrophil count > 1,500 cells/mm3 without growth factor support (14 days after last peg-filgrastrim, 7 days for regular filgrastrim).
- Platelet count > 100,000 cells/mm3 without transfusion 2 weeks prior assessment
- Hemoglobin > 9 g/dL without transfusion 2 weeks prior assessment.
- Aspartate aminotransferase and alanine aminotransferase < 2.5 x upper limit of normal (ULN).
- Total bilirubin ≤ 1.5 x ULN unless the patient has documented Gilbert's syndrome, in which case direct (conjugated) bilirubin level needs to be within normal limits.
- Serum alkaline phosphatase ≤ 2.5 x ULN. Patients with bone metastases: alkaline phosphatase ≤ 5 x ULN.
- Serum creatinine < 2.0 mg/dL or < 177 μmol/L.
- International normalized ratio (INR) and activated partial thromboplastin time or partial thromboplastin time < 1.5 ULN unless patient receiving anticoagulant therapy
- For women of childbearing potential a serum pregnancy test will be done up to 7 days before enrolment (and it must be negative) and an agreement to use one highly-effective form of non-hormonal contraception (true abstinence, vasectomy, oophorectomy/hysterectomy, IUD) or two effective forms of non-hormonal contraception (e.g., condoms plus spermicidal agent) at study entry (to be put in place within 2 weeks prior to enrolment), during the administration of T-DM1 and for 7 months after the last administration of T-DM1 will be obtained
- Signed informed consent obtained before any study-specific procedure;
- Able and willing to comply with the protocol; including the willingness to provide samples (primary if available and blood) for translational research.
- Cohort 1 additional specific criteria:
- No corticosteroids at enrolment
- Oligosymptomatic or asymptomatic brain metastases not requiring immediate local therapy.
- Cohort 2 additional specific criteria:
- Radiologically confirmed brain progression after previous local therapy (neurosurgery, radiosurgery to the brain, stereotactic radiotherapy to the brain, or whole brain radiotherapy) with at least 3 months between end of local therapy and brain progression.
- Decreasing corticosteroid dose or stable dose for at least one week prior to enrolment
Who cannot join
- Patients who exhibit any of the following conditions at screening will be ineligible for admission into the study:
- General Criteria:
- Single brain metastasis with indication of surgical resection
- Pregnant or breast-feeding women
- Documented leptomeningeal disease
- Having received any investigational therapy within ≤ 28 days or 5 half-lives at ICF signature, whichever is longer
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- Having received hormonal therapy within 14 days of enrolment
- Having received trastuzumab within 21 days of enrolment
- Prior enrolment in a T-DM1-containing study, regardless of whether the patient received T-DM1 or not
- History of intolerance (including Grade 3 or 4 infusion reaction) or hypersensitivity to trastuzumab or murine proteins or any component of the product.
- Current peripheral neuropathy of Grade ≥ 3 according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v.4.0.3
- History of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other cancers with a similar outcome as those mentioned above.
- Current unstable ventricular arrhythmia requiring treatment.
- History of symptomatic congestive heart failure (CHF) (New York Heart Association [NYHA] Classes II-IV).
- History of myocardial infarction or unstable angina within 6 months prior to first study drug administration.
- Current dyspnoea at rest due to complications of advanced malignancy or currently requiring continuous oxygen therapy.
- Current severe, uncontrolled systemic disease other than cancer (e.g., clinically significant pulmonary, hypertension or metabolic disease)
- Concurrent, serious, uncontrolled infections or current known infection with HIV, active hepatitis B and/or hepatitis C.
- Major surgical procedure or significant traumatic injury within 28 days before enrolment or anticipation of the need for major surgery during the course of study treatment.
- Known contraindications for undergoing MRI or CT, including to receive contrast media,
- Cohort 1 : additional specific criteria:
- Previous neurosurgery or radiotherapy (radiosurgery, stereotactic radiotherapy, whole brain radiotherapy) to the brain Cohort 2 : no additional specific criteria
About this study
Official title: Multicenter, Non-randomised, Open-label, Single Agent Phase II Study to Determine the Clinical Benefit of Trastuzumab Emtansine (T-DM1) in HER2-positive Metastatic Breast Cancer Patients With Brain Metastasis
Women with breast cancer often develop metastases in the brain. Currently, treatment of these metastases is difficult and relies on radiotherapy or surgery which often fail. Therefore, development of new methods of treatment for breast cancer with brain metastasis is very important. T-DM1 is a drug that is already in everyday use for a specific type of breast cancer called HER2-positive breast cancer. The objective of this study is to investigate whether T-DM1 is also effective in brain metastasis and can help patients to live longer and better
Read the detailed description
This is a multicentre, non-randomised, open label, single arm, phase II study of T-DM1 in patients with metastatic breast cancer and with brain metastasis who have already failed at least one line of anti-HER2 therapy for systemic disease. The study sample is composed of 2 distinct cohorts of patients.
Cohort number 1 is composed of patients with asymptomatic or oligosymptomatic brain metastasis (single or multiple), measurable according to RECIST 1.1, who have not received any local therapy (neither surgery, radiosurgery nor whole brain radiotherapy) for brain metastasis.
Cohort number 2 is composed of patients with brain metastasis (single or multiple), measurable according to RECIST 1.1, previously treated with local therapy (surgery, radiosurgery or whole brain radiotherapy) and with radiologically confirmed brain progression, with a minimum period of 3 months between the end of local therapy and brain progression.
A total number of 110 are planned for screening, in order to enrol 97 patients. A minimum of 87 evaluable patients is necessary. Inclusion of patients in both cohorts will follow a two-stage Simon optimal design. During the study, both brain assessments via magnetic-resonance imaging (MRI) and systemic assessments with computerised tomography (CT) will be performed every 3 cycles (9 weeks) of therapy.
Study treatment consists of T-DM1, 3.6 mg/kg every 3 weeks. Patients will receive study medication until unacceptable toxicity, voluntary withdrawal from study treatment, disease progression, death or pregnancy, whichever occurs first. Patients who experience only progression in the brain and who receive local therapy may remain in the study until systemic progression (or any of the other reasons stated previously), at the investigator's discretion.
After the end of study treatment, all patients will have a safety visit within 30 days (+/- 7 days) from the last T-DM1 administration date. After the safety visit, according the reason of end of study treatment, the follow-up period will begin, as described below:
- If study treatment stopped due to progression of disease Patients will enter directly in survival follow-up. No visits are mandatory per protocol after the safety visit. Chart review and/or phone call to check if the patient is still alive are to be performed, every 6 months, in order to acquire data for the overall survival endpoint. Patients in survival follow-up who are of childbearing potential must be tested for pregnancy at 3 months and at 7 months after end of study treatment. These tests can be ordered by the investigator during regular out of study follow-up visits.
- If study treatment stopped for any other reason than progression (either toxicity or voluntary withdrawal from study treatment) Patients will enter first in efficacy follow-up after the safety visit and then in survival follow-up when progression disease is observed.
During efficacy follow-up, 9 weekly efficacy assessments continue according to the same timetable they would have followed had treatment interruption not occurred. This consists of imaging assessments (MRI and CT) and medical visits, as well as QoL evaluations. During this period, treatment is at the discretion of the local physician/investigator.
This follow-up is to continue until disease progression or until voluntary withdrawal of the patient from the study. In case this follow-up is impossible (due to patient refusing to perform assessments or other reasons), survival data can be collected every 6 months via chart review or telephone. Patients in follow-up who are of childbearing potential must be tested for pregnancy at 3 months and at 7 months after end of study treatment. Once a patient has progressed while on efficacy follow-up, they will enter into survival follow-up as per description above.
- Being tested
- KADCYLA 160 MG Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KADCYLA 160 MG InjectionDrug
Also called T-DM1, trastuzumab emtansine
Kadcyla 160Mg Powder for Injection: 3.6 mg/kg iv every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Kadcyla (T-DM1) | Experimental | trastuzumab emtansine given every 3 weeks at the standard dose (3.6 mg/kg) via intravenous infusion, until disease progression, intolerable toxicity or consent withdrawal. A median of 9 cycles per patient is expected Receives: Drug: KADCYLA 160 MG Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Benefit (CB)
defined as complete response plus partial response plus stable disease in the brain, measured by RECIST 1.1, as determined by the local investigators.
Measured: 9 weeks
Secondary outcomes (22)
CB in the brain RECIST 1.1
measured by RECIST 1.1 criteria, as determined by central evaluation
Measured: 9 weeks
CB in the brain RANO
measured by RANO brain metastases criteria, as determined by the local investigators
Measured: 9 weeks
General and cardiac-specific safety
AEs and SAEs according NCI-CTCAE v4.03
Measured: up to 30 days after last treatment administration
CB: Systemic
defined as complete response plus partial response plus stable disease in non brain areas
Measured: 9 weeks
CB: bi-compartmental
defined as complete response plus partial response plus stable disease in the whole body
Measured: 9 weeks
Overall Response (OR) in the brain
defined as complete response plus partial response in brain
Measured: 9 weeks
Overall Response (OR) systemic
defined as complete response plus partial response in non brain
Measured: 9 weeks
Overall Response (OR) bi-compartmental
defined as complete response plus partial response in the whole body
Measured: 9 weeks
Best Response (BR) in the brain
defined as the best obtained response in the brain
Measured: 1 year
Best Response (BR) systemic
defined as the best obtained response in the non brain
Measured: 1 year
Best Response (BR) bi-compartmental
defined as the best obtained response in the whole body
Measured: 1 year
Brain Progression free survival (PFS)
defined as time between enrolment in the study and progression in the brain
Measured: 1 year
Systemic PFS
defined as time between enrolment in the study and progression in areas other than the brain
Measured: 1 year
Bi-compartmental PFS
defined as time between enrolment in the study and progression of disease
Measured: 1 year
Duration of response in the brain
defined as time from documentation of tumour response in the brain (PR or CR) to disease progression in the brain
Measured: 1 year
Duration of response systemic
systemic defined as time from documentation of non-brain tumour response (PR or CR) to non-brain progression
Measured: 1 year
Duration of response bi-compartmental
Bi-compartmental defined as time between response and progression
Measured: 1 year
Duration of Clinical Benefit (DCB) in the brain
defined as the time elapsed between determination of SD, PR or CR and determination of disease progression in the brain
Measured: 1 year
Duration of Clinical Benefit (DCB) systemic
defined as the time elapsed between determination of SD, PR or CR and determination of systemic disease progression
Measured: 1 year
Duration of Clinical Benefit (DCB) bi-compartmental
defined as the time elapsed between determination of SD, PR or CR and determination of bi-compartmental disease progression
Measured: 1 year
Overall survival
defined as time between enrolment in the study and death
Measured: 1 year
Quality of life
Quality of life will be assessed using the EORTC validated questionnaires
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2017
- Study start23 Feb 2018
- Primary completion27 Aug 2018
- Study completion27 Aug 2018
Why it stopped: As most HER2+ patient develop brain mets while on/after having received TDM1, it has proven to be an insurmountable challenge to recruit patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic HER2-positive Breast Cancer With Brain MetastasisStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jules Bordet Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Evandro de Azambuja, MD, Study chair, Jules Bordet Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03203616
- Sponsor's protocol ID
- IJB-BC-TDM1BM-2016
- Acronym
- KIARA
- Status last verified
- Nov 2018
- First submitted
- 24 Apr 2017
- Last updated
- 29 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Non-randomised, Open-label, Single Agent Phase II Study to Determine the Clinical Benefit of Trastuzumab Emtansine (T-DM1) in HER2-positive Metastatic Breast Cancer Patients With Brain Metastasis
- ClinicalTrials.gov ID
- NCT03203616
- Acronym / sponsor ID
- KIARA / IJB-BC-TDM1BM-2016
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: As most HER2+ patient develop brain mets while on/after having received TDM1, it has proven to be an insurmountable challenge to recruit patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Jules Bordet InstituteUniversity, hospital or other
- Study start
- 23 Feb 2018 (actual)
- Primary completion
- 27 Aug 2018 (actual)
- Study completion
- 27 Aug 2018 (actual)
- First posted
- 29 Jun 2017 (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.
Women with breast cancer often develop metastases in the brain. Currently, treatment of these metastases is difficult and relies on radiotherapy or surgery which often fail. Therefore, development of new methods of treatment for breast cancer with brain metastasis is very important. T-DM1 is a drug that is already in everyday use for a specific type of breast cancer called HER2-positive breast cancer. The objective of this study is to investigate whether T-DM1 is also effective in brain metastasis and can help patients to live longer and better
Detailed description
This is a multicentre, non-randomised, open label, single arm, phase II study of T-DM1 in patients with metastatic breast cancer and with brain metastasis who have already failed at least one line of anti-HER2 therapy for systemic disease. The study sample is composed of 2 distinct cohorts of patients.
Cohort number 1 is composed of patients with asymptomatic or oligosymptomatic brain metastasis (single or multiple), measurable according to RECIST 1.1, who have not received any local therapy (neither surgery, radiosurgery nor whole brain radiotherapy) for brain metastasis.
Cohort number 2 is composed of patients with brain metastasis (single or multiple), measurable according to RECIST 1.1, previously treated with local therapy (surgery, radiosurgery or whole brain radiotherapy) and with radiologically confirmed brain progression, with a minimum period of 3 months between the end of local therapy and brain progression.
A total number of 110 are planned for screening, in order to enrol 97 patients. A minimum of 87 evaluable patients is necessary. Inclusion of patients in both cohorts will follow a two-stage Simon optimal design. During the study, both brain assessments via magnetic-resonance imaging (MRI) and systemic assessments with computerised tomography (CT) will be performed every 3 cycles (9 weeks) of therapy.
Study treatment consists of T-DM1, 3.6 mg/kg every 3 weeks. Patients will receive study medication until unacceptable toxicity, voluntary withdrawal from study treatment, disease progression, death or pregnancy, whichever occurs first. Patients who experience only progression in the brain and who receive local therapy may remain in the study until systemic progression (or any of the other reasons stated previously), at the investigator's discretion.
After the end of study treatment, all patients will have a safety visit within 30 days (+/- 7 days) from the last T-DM1 administration date. After the safety visit, according the reason of end of study treatment, the follow-up period will begin, as described below:
- If study treatment stopped due to progression of disease Patients will enter directly in survival follow-up. No visits are mandatory per protocol after the safety visit. Chart review and/or phone call to check if the patient is still alive are to be performed, every 6 months, in order to acquire data for the overall survival endpoint. Patients in survival follow-up who are of childbearing potential must be tested for pregnancy at 3 months and at 7 months after end of study treatment. These tests can be ordered by the investigator during regular out of study follow-up visits.
- If study treatment stopped for any other reason than progression (either toxicity or voluntary withdrawal from study treatment) Patients will enter first in efficacy follow-up after the safety visit and then in survival follow-up when progression disease is observed.
During efficacy follow-up, 9 weekly efficacy assessments continue according to the same timetable they would have followed had treatment interruption not occurred. This consists of imaging assessments (MRI and CT) and medical visits, as well as QoL evaluations. During this period, treatment is at the discretion of the local physician/investigator.
This follow-up is to continue until disease progression or until voluntary withdrawal of the patient from the study. In case this follow-up is impossible (due to patient refusing to perform assessments or other reasons), survival data can be collected every 6 months via chart review or telephone. Patients in follow-up who are of childbearing potential must be tested for pregnancy at 3 months and at 7 months after end of study treatment. Once a patient has progressed while on efficacy follow-up, they will enter into survival follow-up as per description above.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kadcyla (T-DM1) | Experimental | Drug: KADCYLA 160 MG Injectiontrastuzumab emtansine given every 3 weeks at the standard dose (3.6 mg/kg) via intravenous infusion, until disease progression, intolerable toxicity or consent withdrawal. A median of 9 cycles per patient is expected |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Female patients (≥ 18 years);
- Histologically confirmed HER2-positive breast cancer patients (IHC 3+ and/or ISH positive);
- Patients should have previously received trastuzumab and a taxane, separately or in combination. Patients should have either received prior therapy for locally advanced or metastatic disease, or developed disease recurrence during or within six months of completing adjuvant therapy;
- At least one measurable brain metastasis as defined by RECIST 1.1 (≥ 10 mm);
- Any hormone receptor status;
Key exclusion criteria (22 listed)
- Patients who exhibit any of the following conditions at screening will be ineligible for admission into the study:
- Single brain metastasis with indication of surgical resection
- Pregnant or breast-feeding women
- Documented leptomeningeal disease
- Having received any investigational therapy within ≤ 28 days or 5 half-lives at ICF signature, whichever is longer
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 |
|---|---|---|
| KADCYLA 160 MG InjectionAlso: T-DM1, trastuzumab emtansineKadcyla 160Mg Powder for Injection: 3.6 mg/kg iv every 3 weeks | Drug | Kadcyla (T-DM1) |
Primary outcome
Clinical Benefit (CB)
Time frame: 9 weeks
defined as complete response plus partial response plus stable disease in the brain, measured by RECIST 1.1, as determined by the local investigators.
22 secondary outcomes
CB in the brain RECIST 1.1
Time frame: 9 weeks
CB in the brain RANO
Time frame: 9 weeks
General and cardiac-specific safety
Time frame: up to 30 days after last treatment administration
CB: Systemic
Time frame: 9 weeks
CB: bi-compartmental
Time frame: 9 weeks
Overall Response (OR) in the brain
Time frame: 9 weeks
Overall Response (OR) systemic
Time frame: 9 weeks
Overall Response (OR) bi-compartmental
Time frame: 9 weeks
Best Response (BR) in the brain
Time frame: 1 year
Best Response (BR) systemic
Time frame: 1 year
Best Response (BR) bi-compartmental
Time frame: 1 year
Brain Progression free survival (PFS)
Time frame: 1 year
Systemic PFS
Time frame: 1 year
Bi-compartmental PFS
Time frame: 1 year
Duration of response in the brain
Time frame: 1 year
Duration of response systemic
Time frame: 1 year
Duration of response bi-compartmental
Time frame: 1 year
Duration of Clinical Benefit (DCB) in the brain
Time frame: 1 year
Duration of Clinical Benefit (DCB) systemic
Time frame: 1 year
Duration of Clinical Benefit (DCB) bi-compartmental
Time frame: 1 year
Overall survival
Time frame: 1 year
Quality of life
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2018.
- 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.
Evandro de Azambuja, MD study chair
Jules Bordet Institute
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KADCYLA 160 MG Injection in people with Metastatic HER2-positive Breast Cancer With Brain Metastasis, run by Jules Bordet Institute.
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 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Clinical Benefit (CB) (time frame: 9 weeks). 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 29 Nov 2018.