Clear Cell Renal CarcinomaPhase 1NCT03556046
89Zr-girentuximab ) Dosimetry in CCRC Study - ZIR-DOSE
A Phase 1 study testing 89Zr-Girentuximab in people with Clear Cell Renal Carcinoma, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
The study is designed to explore the safety and tolerability as well as diagnostic 89Zr-girentuximab for imaging CCRC by PET/CT. This study does not offer any treatment for patients with CCRC; therefore, patients will be offered state of the art therapeutic options after imaging with the study drug 89Zr-girentuximab. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Clear Cell Renal Carcinoma
- What is being tested?
- 89Zr-Girentuximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- 5 Apr 2018to 17 Dec 2018
- Phase
- Phase 1
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Male or female >50 years of age
- Clinical suspicion of CCRC, based on imaging evidence of a renal mass, requiring further diagnostic work-up or patients with established diagnosis of CCRC requiring imaging for recurrent disease
- Life expectancy of at least 6 months
- Consent to practise double-barrier contraception until end of study (7 days after 89Zr-girentuximab injection)
Who cannot join
- Known hypersensitivity to girentuximab
- Known uncontrolled hyperthyreoidism
- Exposure to any experimental diagnostic or therapeutic drug within 30 days from the date of planned administration of 89Zr-girentuximab
- Exposure to any radiopharmaceutical within 30 days (corresponding to 8 half-lives of 89Zr) prior to the administration of 89Zr-girentuximab.
- Ongoing toxicity grade 2 from previous standard or investigational therapies (Common Terminology Criteria for Adverse Events [CTCAE] version 4.03)
- Planned (for the period between injection of 89Zr-girentuximab and imaging) antineoplastic therapies
Show all 11Show fewer
- Established renal cell carcinomas of other histological entities than CCRC
- Known brain metastases
- Serious non-malignant disease (e.g. psychiatric, infectious, autoimmune or metabolic), that may interfere with the objectives of the study or with the safety or compliance of the patient, as judged by the investigator
- Pregnant or breast-feeding women. Female patients of childbearing potential or male patients with female partners of childbearing potential, unless willing to practice full and true sexual abstinence or being surgically/permanently sterile or with a history of hysterectomy for women, not willing to practice effective double-barrier contraception by using: a non-oral, injected or implanted non-oestrogen progesterone based hormonal method, male condom, vaginal diaphragm, cervical cap, intrauterine device, during the study period and within a period of 30 days (corresponding to 8 half-lives of 89Zr) after receiving study drug.
- Patients not able to declare meaningful informed consent on their own (e.g. with legal guardian for mental disorders)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Phase I Study to Assess Safety, Tolerability, Radiation Dosimetry, and Imaging Properties of 89Zr-labelled Girentuximab (89Zr-girentuximab) for in Vivo Detection of Clear Cell Renal Carcinoma (CCRC) by Positron Emission Tomography (PET) Using Different PET Imaging Methodologies
The study is designed to explore the safety and tolerability as well as diagnostic 89Zr-girentuximab for imaging CCRC by PET/CT. This study does not offer any treatment for patients with CCRC; therefore, patients will be offered state of the art therapeutic options after imaging with the study drug 89Zr-girentuximab. Cancer treatment will not be delayed by study participation.
Read the detailed description
The identification of RCC is crucial for planning possible surgery and treatment. The aim of this study is to investigate the safety, tolerability, radiation dosimetry, as well as the diagnostic performance of 89Zr-girentuximab PET/CT in patients with suspected CCRC. The results of this study will be used to pave the way for further studies with 89Zr-girentuximab as a PET/CT imaging agent which was shown to have higher diagnostic resolution 124I-girentuximab in animal studies due to prolonged trapping of the radiolabel in the tumour and simultaneous washout from normal tissues. It is anticipated to develop 89Zr-girentuximab as an improved imaging agent for CCRC.
This will be an exploratory, open-label, Phase 1 study to evaluate safety, tolerability, whole body dosimetry, and imaging properties of 89Zr-girentuximab, when image acquisition is made using different PET reconstruction methods, namely time-of-flight (TOF-PET) and conventional (PET) reconstruction, in order to estimate a possible impact of variable scanner technology on image quality variability in a planned multi-centre study.
In addition, different acquisition durations (5 -20 min) will be explored using an activity dose of 37 mBq (1 mCi), in order to establish, whether acquisition time has an impact on diagnostic performance.
It is anticipated to recruit 8-10 patients with suspected or established CCRC to
- Receive a slow intravenous injection with 89Zr-girentuximab (1-2 minutes slow bolus injection), followed by
- Dosimetric and tumour PET/CT imaging. The study duration will be approximately 12 months. Primary endpoint is safety, a part of which is determining the effective dose (mSv/MBq) to the whole body, and absorbed dose (mGy/MBq) to individually discernible organs.
Secondary endpoints include physicians assessment of PET image quality and tumour detectability comparing the following reconstruction settings:
TOF-PET PET 37 MBq 5, 10, 15 and 20 min 5, 10, 15 and 20 min Additionally, images partitioned to acquisition times of 5, 10, 15 and 20 min will be comparatively analysed in a blinded read.
In order to comprehensively characterise safety and tolerability, standard safety parameters (labs, 12-lead ECG, adverse events, and concomitant medications) will be systematically assessed at baseline and at appropriate intervals post dosing. Patients with clinical suspicion of CCRC, based on imaging evidence of a renal mass, requiring further diagnostic work-up, or patients with established diagnosis of CCRC requiring imaging for recurrent disease will be recruited by the urological service of the study centre, and undergo a formal screening visit, during which the study schedule will be planned, and consent obtained.
All successfully screened patients will be injected with 89Zr-girentuximab on Day 0 by the nuclear medicine service, followed by:
Sequential static whole body PET/CT imaging:
For dosimetry analysis, biodistribution whole body PET/CT imaging will be performed at 0.5, 4, 24, 72 and 168±24 h (Day 7±1) post injection, using low dose CT. Patients will be imaged on a TOF-PET scanner, offering the possibility of TOF (time-of-flight) and non-TOF reconstruction.
Comparative tumour PET/CT imaging:
On Days 3 and 7±1 (after the biodistribution whole body scans on Days 3 and 7), tumour imaging will be performed using gated or list mode acquisition, for generation of sub-partitioned data. Such data allow the mathematical generation of statistically independent images for various dose levels, based on the actual dose administered in the trial. Acquisition will be for 20 min.
An end of study visit will be conducted on Day 8±1. 89Zr-girentuximab dosimetry will be centrally analysed for absorbed organ and whole body doses in a standardised fashion. In addition, tumour absorbed doses will be determined for scientific purposes (estimation of achievable tumour doses of therapeutic nuclides labelled to girentuximab).
All image data analyses will be performed / confirmed centrally.
- Conditions
- Clear Cell Renal Carcinoma
- Being tested
- 89Zr-Girentuximab
- Keywords
- Clear Cell Renal Carcinoma
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
89Zr-GirentuximabDiagnostic test
Single diagnostic injection on Day 0, followed by diagnostic scans on Days 3 and 7±1, as well as the whole body dosimetric imaging on Days 0, 1, 3 and 7±1
| Study group | Role | What they receive |
|---|---|---|
| 89Zr-girentuximab | Experimental | A single administration of 37 MBq (+/-10%) 89Zr-girentuximab, containing a mass dose of 5 mg of girentuximab Receives: Diagnostic Test: 89Zr-Girentuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety parameter Physical Examination
Frequency of occurrence and severity of abnormal findings in safety investigations regarding the physical examination.
Measured: 8 days
Safety parameter Vital Signs
Frequency of occurrence and severity of abnormal findings in safety investigations regarding the Vital signs including the 12-lead ECG.
Measured: 8 days
Safety parameter Adverse Events
Frequency of occurrence and severity of abnormal findings in safety investigations regarding Adverse Events.
Measured: 8 days
Safety parameter Laboratory examinations
Frequency of occurrence and severity of abnormal findings in safety investigations regarding Laboratory examinations.
Measured: 8 days
Safety parameter concomitant medications
Frequency of occurrence and severity of abnormal findings in safety investigations regarding concomitant medications.
Measured: 8 days
Secondary outcomes (5)
Radiation dosimetry
Normalised whole body effective radiation dose (mSv/MBq)
Measured: Whole body (neck to mid-thigh) static PET/CT scans will be acquired in supine position at 0.5, 4, 24, 72 and 168±24 h (Day 7±1) post injection, using low dose CT without contrast agent.
Diagnostic efficacy
Visualisation of tumours will be qualitatively assessed across acquisition conditions (AC; i.e. reconstruction (Non-TOF/TOF), acquisition duration; details see above) by 2 readers experienced in oncology who will be blinded with regard to the AC.
- Percentage of images rated good or excellent / AC
- Percentage of images rated unevaluable / AC
- Total number of tumour lesions detectable / AC
- Comparative analysis of 5, 10, 15 and 20 min results at lesion basis.
Measured: PET image acquisitions will be obtained in list mode on a TOF-capable machine for a period of 20 minutes.
Tumour dosimetry Absorbed dose
Absorbed dose (Gy) from 89Zr-girentuximab to discernible tumour lesions, considering tumour volume, determined by pre-study contrast enhanced CT.
Measured: PET/CT, Days 3 (72 h) and 7(168 h)±1 post-infusion, with the contrast enhanced anatomical CT acquired as part of the baseline scan.
Tumour dosimetry Activity
Determination of tumour tissue girentuximab exposure kinetics and AUC values (area under the curve), considering 89Zr-girentuximab specific activity at injection time point, injected activity, decay correction using the physical half-life of 89Zr, and anatomical tumour volume to obtain mg/mL.
Measured: PET/CT, Days 3 (72 h) and 7(168 h)±1 post-infusion, with the contrast enhanced anatomical CT acquired as part of the baseline scan.
Tumour dosimetry absorbed Dose
Estimation of achievable absorbed tumour doses (Gy), assuming identical tumour biodistribution as observed for 89Zr-girentuximab, however therapeutic labelling with alpha and beta emitters.
Measured: PET/CT, Days 3 (72 h) and 7(168 h)±1 post-infusion, with the contrast enhanced anatomical CT acquired as part of the baseline scan.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2018
- Study start5 Apr 2018
- Primary completion17 Dec 2018
- Study completion17 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Clear Cell Renal CarcinomaStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ABX CRO, Telix Pharmaceuticals (Innovations) Pty Limited
- Responsible party
- Sponsor
- Investigators
- Michael Tapner, Study director, ABX CROPeter F. A. Mulders, Prof., Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03556046
- Sponsor's protocol ID
- TLX-89Zr-TX-250-001D
- Status last verified
- May 2018
- First submitted
- 18 May 2018
- Last updated
- 1 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Merkx RIJ, Lobeek D, Konijnenberg M, Jimenez-Franco LD, Kluge A, Oosterwijk E, Mulders PFA, Rijpkema M. Phase I study to assess safety, biodistribution and radiation dosimetry for 89Zr-girentuximab in patients with renal cell carcinoma. Eur J Nucl Med Mol Imaging. 2021 Sep;48(10):3277-3285. doi: 10.1007/s00259-021-05271-w. Epub 2021 Mar 2.
PubMed 33651116
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Phase I Study to Assess Safety, Tolerability, Radiation Dosimetry, and Imaging Properties of 89Zr-labelled Girentuximab (89Zr-girentuximab) for in Vivo Detection of Clear Cell Renal Carcinoma (CCRC) by Positron Emission Tomography (PET) Using Different PET Imaging Methodologies
- ClinicalTrials.gov ID
- NCT03556046
- Acronym / sponsor ID
- TLX-89Zr-TX-250-001D
- Conditions
- Clear Cell Renal Carcinoma
- Keywords
- Clear Cell Renal Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- ABX CRO, Telix Pharmaceuticals (Innovations) Pty Limited
- Study start
- 5 Apr 2018 (actual)
- Primary completion
- 17 Dec 2018 (actual)
- Study completion
- 17 Dec 2018 (actual)
- First posted
- 14 Jun 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 study is designed to explore the safety and tolerability as well as diagnostic 89Zr-girentuximab for imaging CCRC by PET/CT. This study does not offer any treatment for patients with CCRC; therefore, patients will be offered state of the art therapeutic options after imaging with the study drug 89Zr-girentuximab. Cancer treatment will not be delayed by study participation.
Detailed description
The identification of RCC is crucial for planning possible surgery and treatment. The aim of this study is to investigate the safety, tolerability, radiation dosimetry, as well as the diagnostic performance of 89Zr-girentuximab PET/CT in patients with suspected CCRC. The results of this study will be used to pave the way for further studies with 89Zr-girentuximab as a PET/CT imaging agent which was shown to have higher diagnostic resolution 124I-girentuximab in animal studies due to prolonged trapping of the radiolabel in the tumour and simultaneous washout from normal tissues. It is anticipated to develop 89Zr-girentuximab as an improved imaging agent for CCRC.
This will be an exploratory, open-label, Phase 1 study to evaluate safety, tolerability, whole body dosimetry, and imaging properties of 89Zr-girentuximab, when image acquisition is made using different PET reconstruction methods, namely time-of-flight (TOF-PET) and conventional (PET) reconstruction, in order to estimate a possible impact of variable scanner technology on image quality variability in a planned multi-centre study.
In addition, different acquisition durations (5 -20 min) will be explored using an activity dose of 37 mBq (1 mCi), in order to establish, whether acquisition time has an impact on diagnostic performance.
It is anticipated to recruit 8-10 patients with suspected or established CCRC to
- Receive a slow intravenous injection with 89Zr-girentuximab (1-2 minutes slow bolus injection), followed by
- Dosimetric and tumour PET/CT imaging. The study duration will be approximately 12 months. Primary endpoint is safety, a part of which is determining the effective dose (mSv/MBq) to the whole body, and absorbed dose (mGy/MBq) to individually discernible organs.
Secondary endpoints include physicians assessment of PET image quality and tumour detectability comparing the following reconstruction settings:
TOF-PET PET 37 MBq 5, 10, 15 and 20 min 5, 10, 15 and 20 min Additionally, images partitioned to acquisition times of 5, 10, 15 and 20 min will be comparatively analysed in a blinded read.
In order to comprehensively characterise safety and tolerability, standard safety parameters (labs, 12-lead ECG, adverse events, and concomitant medications) will be systematically assessed at baseline and at appropriate intervals post dosing. Patients with clinical suspicion of CCRC, based on imaging evidence of a renal mass, requiring further diagnostic work-up, or patients with established diagnosis of CCRC requiring imaging for recurrent disease will be recruited by the urological service of the study centre, and undergo a formal screening visit, during which the study schedule will be planned, and consent obtained.
All successfully screened patients will be injected with 89Zr-girentuximab on Day 0 by the nuclear medicine service, followed by:
Sequential static whole body PET/CT imaging:
For dosimetry analysis, biodistribution whole body PET/CT imaging will be performed at 0.5, 4, 24, 72 and 168±24 h (Day 7±1) post injection, using low dose CT. Patients will be imaged on a TOF-PET scanner, offering the possibility of TOF (time-of-flight) and non-TOF reconstruction.
Comparative tumour PET/CT imaging:
On Days 3 and 7±1 (after the biodistribution whole body scans on Days 3 and 7), tumour imaging will be performed using gated or list mode acquisition, for generation of sub-partitioned data. Such data allow the mathematical generation of statistically independent images for various dose levels, based on the actual dose administered in the trial. Acquisition will be for 20 min.
An end of study visit will be conducted on Day 8±1. 89Zr-girentuximab dosimetry will be centrally analysed for absorbed organ and whole body doses in a standardised fashion. In addition, tumour absorbed doses will be determined for scientific purposes (estimation of achievable tumour doses of therapeutic nuclides labelled to girentuximab).
All image data analyses will be performed / confirmed centrally.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 89Zr-girentuximab | Experimental | Diagnostic Test: 89Zr-GirentuximabA single administration of 37 MBq (+/-10%) 89Zr-girentuximab, containing a mass dose of 5 mg of girentuximab |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Written informed consent
- Male or female >50 years of age
- Clinical suspicion of CCRC, based on imaging evidence of a renal mass, requiring further diagnostic work-up or patients with established diagnosis of CCRC requiring imaging for recurrent disease
- Life expectancy of at least 6 months
- Consent to practise double-barrier contraception until end of study (7 days after 89Zr-girentuximab injection)
Key exclusion criteria (11 listed)
- Known hypersensitivity to girentuximab
- Known uncontrolled hyperthyreoidism
- Exposure to any experimental diagnostic or therapeutic drug within 30 days from the date of planned administration of 89Zr-girentuximab
- Exposure to any radiopharmaceutical within 30 days (corresponding to 8 half-lives of 89Zr) prior to the administration of 89Zr-girentuximab.
- Ongoing toxicity grade 2 from previous standard or investigational therapies (Common Terminology Criteria for Adverse Events [CTCAE] version 4.03)
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 |
|---|---|---|
| 89Zr-GirentuximabSingle diagnostic injection on Day 0, followed by diagnostic scans on Days 3 and 7±1, as well as the whole body dosimetric imaging on Days 0, 1, 3 and 7±1 | Diagnostic test | 89Zr-girentuximab |
Primary outcome
Safety parameter Physical Examination
Time frame: 8 days
Frequency of occurrence and severity of abnormal findings in safety investigations regarding the physical examination.
Safety parameter Vital Signs
Time frame: 8 days
Frequency of occurrence and severity of abnormal findings in safety investigations regarding the Vital signs including the 12-lead ECG.
Safety parameter Adverse Events
Time frame: 8 days
Frequency of occurrence and severity of abnormal findings in safety investigations regarding Adverse Events.
Safety parameter Laboratory examinations
Time frame: 8 days
Frequency of occurrence and severity of abnormal findings in safety investigations regarding Laboratory examinations.
Safety parameter concomitant medications
Time frame: 8 days
Frequency of occurrence and severity of abnormal findings in safety investigations regarding concomitant medications.
5 secondary outcomes
Radiation dosimetry
Time frame: Whole body (neck to mid-thigh) static PET/CT scans will be acquired in supine position at 0.5, 4, 24, 72 and 168±24 h (Day 7±1) post injection, using low dose CT without contrast agent.
Diagnostic efficacy
Time frame: PET image acquisitions will be obtained in list mode on a TOF-capable machine for a period of 20 minutes.
Tumour dosimetry Absorbed dose
Time frame: PET/CT, Days 3 (72 h) and 7(168 h)±1 post-infusion, with the contrast enhanced anatomical CT acquired as part of the baseline scan.
Tumour dosimetry Activity
Time frame: PET/CT, Days 3 (72 h) and 7(168 h)±1 post-infusion, with the contrast enhanced anatomical CT acquired as part of the baseline scan.
Tumour dosimetry absorbed Dose
Time frame: PET/CT, Days 3 (72 h) and 7(168 h)±1 post-infusion, with the contrast enhanced anatomical CT acquired as part of the baseline scan.
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 1 Apr 2019.
- Derived from this study: PubMed 33651116Merkx RIJ, Lobeek D, Konijnenberg M, Jimenez-Franco LD, Kluge A, Oosterwijk E, Mulders PFA, Rijpkema M. Phase I study to assess safety, biodistribution and radiation dosimetry for 89Zr-girentuximab in patients with renal cell carcinoma. Eur J Nucl Med Mol Imaging. 2021 Sep;48(10):3277-3285. doi: 10.1007/s00259-021-05271-w. Epub 2021 Mar 2.
- 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.
Michael Tapner study director
ABX CRO
Peter F. A. Mulders, Prof. principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 89Zr-Girentuximab in people with Clear Cell Renal Carcinoma, run by Radboud University Medical Center at 1 site in Netherlands.
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 11 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 1 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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 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?
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?
Safety parameter Physical Examination (time frame: 8 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03556046, 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 1 Apr 2019.