Polycythemia VeraPhase 2PVNCT00928707
Phase II Study of GIVINOSTAT (ITF2357) in Combination With Hydroxyurea in Polycythemia Vera
A Phase 2 study testing GIVINOSTAT (ITF2357) 50 mg o.d. + MTD Hydroxyurea and GIVINOSTAT (ITF2357) 50 mg b.i.d. + MTD Hydroxyurea in people with Polycythemia Vera, run by Italfarmaco at 22 sites in Italy.
Trial summary
The primary objective of the study was to evaluate the efficacy of Givinostat in combination with hydroxyurea in patients with JAK2V617F-positive Polycythemia Vera (PV) non-responders to the maximum tolerated dose of hydroxyurea monotherapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Polycythemia Vera
- What is being tested?
- GIVINOSTAT (ITF2357) 50 mg o.d. + MTD Hydroxyurea and GIVINOSTAT (ITF2357) 50 mg b.i.d. + MTD Hydroxyurea
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 22 sitesItaly
- Study dates
- Jun 2009to Oct 2011
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written Informed Consent.
- Age ≥18 years.
- Confirmed diagnosis of Polycythemia Vera according to the revised World Health Organization (WHO) criteria.
- JAK2V617F positivity.
- Non-response to the maximum tolerated dose of hydroxyurea monotherapy for at least 3 months.
- ECOG (Eastern Cooperative Oncology Group) performance status <3.
- Use of an effective means of contraception for women of childbearing potential and men with partners of childbearing potential.
- Willingness and capability to comply with the requirements of the study.
Who cannot join
- Active bacterial or mycotic infection requiring antimicrobial treatment.
- Pregnancy or lactation.
- A marked baseline prolongation of QT/QTc (corrected) interval (e.g. repeated demonstration of a QTc interval > 450 ms, according to Bazett's correction formula).
- Use of concomitant medications that prolong the QT/QTc interval.
- Clinically significant cardiovascular disease including:
- Uncontrolled hypertension, myocardial infarction, unstable angin, within 6 months from study start;
Show all 20Show fewer
- New York Heart Association (NYHA) Grade II or greater congestive heart failure;
- History of any cardiac arrhythmia requiring medication (irrespective of its severity);
- A history of additional risk factors for torsade de pointes (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
- Positive blood test for HIV (Human Immunodeficiency Virus)
- Active HBV (Hepatitis B Virus) and/or HCV (Hepatitis C Virus) infection.
- Platelets count <100x109/L within 14 days before enrolment.
- Absolute neutrophil count <1.2x109/L within 14 days before enrolment.
- Serum creatinine >2xULN (upper limit of normal).
- Total serum bilirubin >1.5xULN.
- Serum aspartate aminotransferase (AST) / alanine aminotransferase (ALT) > 3xULN.
- History of other diseases, metabolic dysfunctions, physical examination findings, or clinical laboratory findings giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk from treatment complications.
- Interferon alpha within 14 days before enrolment.
- Anagrelide within 7 days before enrolment.
- Any other investigational drug within 28 days before enrolment.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
Italy22 sites
Azienda Ospedaliero-Universitaria Policlinico Consorziale di Bari
Bari, BA, 70124
Azienda Ospedaliera Ospedali Riuniti di Bergamo
Bergamo, 24100
Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione Garibaldi di Catania
Catania, CT, 95126
Azienda Ospedaliera Santa Croce e Carle di Cuneo
Cuneo, CN, 12100
Azienda Ospedaliero-Universitaria Careggi di Firenze
Florence, FI, 50134
Azienda Ospedaliera Universitaria Policlinico "Gaetano Martino" di Messina
Messina, ME, 98125
Azienda Ospedaliera San Gerardo di Monza
Monza, MB, 20052
Azienda Ospedaliera Universitaria Università degli Studi di Napoli Federico II
Naples, 80131
Azienda Ospedaliera Universitaria S. Luigi Gonzaga di Orbassano
Orbassano, TO, 10043
Azienda Ospedaliera Ospedali Riuniti "Villa Sofia - Cervello" di Palermo
Palermo, PA, 90146
Fondazione I.R.C.C.S.-Policlinico San Matteo, Pavia
Pavia, PV, 27100
Azienda Ospedaliera Santa Maria della Misericordia di Perugia
Perugia, PG, 06156
Azienda Unità Sanitaria Locale di Pescara, Presidio Ospedaliero "Spirito Santo"
Pescara, PE, 65124
Azienda Ospedaliera Universitaria Pisana
Pisa, PI, 56126
Azienda Ospedaliera Ospedale San Carlo di Potenza
Potenza, Point, 85100
Azienda Ospedaliera "Bianchi-Melacrino-Morelli"
Reggio Calabria, RC, 891225
Università "Campus Bio-Medico", Rome
Rome, 00128
Policlinico Universitario Agostino Gemelli di Roma
Rome, 00168
Fondazione I. R. C. C. S. - Casa sollievo della sofferenza di San Giovanni Rotondo
San Giovanni Rotondo, FG, 71013
Azienda Ospedaliero-Universitaria San Giovanni Battista("Le Molinette") di Torino
Torino, TO, 10126
Ospedale Mauriziano Umberto I
Torino, TO, 10128
Ospedale San Bortolo di Vicenza
Vicenza, VI, 36100
About this study
Official title: Phase II Study of the Histone-deacetylase Inhibitor GIVINOSTAT (ITF2357) in Combination With Hydroxyurea in Patients With JAK2V617F Positive Polycythemia Vera Non-responder to Hydroxyurea Monotherapy.
The primary objective of the study was to evaluate the efficacy of Givinostat in combination with hydroxyurea in patients with JAK2V617F-positive Polycythemia Vera (PV) non-responders to the maximum tolerated dose of hydroxyurea monotherapy.
The secondary objectives of this study were:
- To evaluate the safety and tolerability of Givinostat in combination with hydroxyurea in patients with JAK2V617Fpositive PV non-responders to the maximum tolerated dose of hydroxyurea monotherapy;
- To explore the impact in terms of efficacy and tolerability of Givinostat 50 mg dose escalation in patients not achieving at least a partial response at the time when the primary endpoint was assessed (week 12);
- To evaluate the molecular response (JAK2 mutated allele burden) by quantitative Real Time-Polymerase Chain Reaction (RT-PCR);
- To evaluate the reduction of the fraction of JAK2V617F positive clonogenic progenitors.
Read the detailed description
This is a multicentre, randomized, open-label, phase II study testing GIVINOSTAT (ITF2357) in combination with hydroxyurea in a population of patients with JAK2V617F positive Polycythemia Vera non-responders to the maximum tolerated dose of hydroxyurea monotherapy for at least 3 months.
Recruited patients will be randomly assigned to one of the following treatment groups:
- group A: 50 mg o.d. of oral GIVINOSTAT (ITF2357) in combination with the maximum tolerated dose of hydroxyurea monotherapy already in use before admission to the study;
- group B: 50 mg b.i.d. of oral GIVINOSTAT (ITF2357) in combination with the maximum tolerated dose of hydroxyurea monotherapy already in use before admission to the study.
The two groups will be balanced for number and for Centre in order to provide valuable information on both treatment regimens.
In both groups assigned doses shall remain stable until week 12, which is when the primary endpoint is assessed, unless specific tolerability issues arise which impose dose reduction.
After the primary endpoint assessment at week 12, one of the following treatment schedules will be chosen case by case on the basis of the achieved clinical response and continued for up to 12 further weeks:
- Partial or Complete Response at week 12:
- group A: continue 50 mg o.d.;
- group B: continue 50 mg b.i.d.;
- No Response at week 12:
- group A: increase to 50 mg b.i.d.;
- group B: increase to 50 mg t.i.d.. At any time during study course, if toxicity is observed, GIVINOSTAT (ITF2357) treatment will be discontinued until recovery and then restarted at a reduced dose level. The drug will be definitively withdrawn in case of reappearance of toxicity even at a reduced daily dose. Overall, the treatment will last up to a maximum of 24 cumulative weeks of drug administration.
The study will recruit subjects of both genders with an established diagnosis of JAK2V617F positive Polycythemia Vera according to the revised WHO criteria, in need of cytoreductive therapy, non-responders to the maximum tolerated dose of hydroxyurea monotherapy for at least 3 months.
- Conditions
- Polycythemia Vera
- Being tested
- GIVINOSTAT (ITF2357) 50 mg o.d. + MTD Hydroxyurea, GIVINOSTAT (ITF2357) 50 mg b.i.d. + MTD Hydroxyurea
- Keywords
- Polycythemia Vera, GIVINOSTAT, ITF2357
- Medical subject headings
- Polycythemia Vera
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GIVINOSTAT (ITF2357) 50 mg o.d. + MTD HydroxyureaDrug
Also called GIVINOSTAT (ITF2357), ONCOCARBIDE (HYDROXYUREA)
50 mg o.d. of GIVINOSTAT + MTD of HU monotherapy
GIVINOSTAT (ITF2357) 50 mg b.i.d. + MTD HydroxyureaDrug
Also called GIVINOSTAT (ITF2357), ONCOCARBIDE (HYDROXYUREA)
50 mg b.i.d. of GIVINOSTAT + MTD HU monotherapy
| Study group | Role | What they receive |
|---|---|---|
| GIVINOSTAT + MTD Hydroxyurea (HU)_1 | Experimental | 50 mg o.d. of GIVINOSTAT + maximum tolerated dose (MTD) of Hydroxyurea (HU) monotherapy Receives: Drug: GIVINOSTAT (ITF2357) 50 mg o.d. + MTD Hydroxyurea |
| GIVINOSTAT + MTD Hydroxyurea (HU)_2 | Experimental | 50 mg b.i.d. of GIVINOSTAT + maximum tolerated dose (MTD) of Hydroxyurea (HU) monotherapy Receives: Drug: GIVINOSTAT (ITF2357) 50 mg b.i.d. + MTD Hydroxyurea |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients With Overall Haematological Response at Week 12.
The percentage of patients with overall (complete or partial) response at week 12 were assessed. · Complete response: 1. HCT (Hematocrit) < 45% without phlebotomy, and 2. platelets ≤ 400 x109/L, and 3. WBC (white blood cell) ≤ 10 x 109/L, and 4. no splenomegaly, and 5. no disease related systemic symptoms (microvascular disturbances, pruritus, headache); · Partial response: 1. HCT < 45% without phlebotomy, or 2. fulfilment of at least 3 of the other above mentioned criteria; · No response: any response that did not satisfy the criteria set for partial response.
Measured: At week 12 of treatment
Secondary outcomes (3)
Percentage of Patients With Overall Haematological Response at Week 24 by Dose Escalation After Week 12.
Haematological response after a 50 mg increase of the initial Givinostat dose in non-responder patients at the time when the primary endpoint was assessed (week 12).
- Complete response:
- HCT< 45% without phlebotomy, and
- platelets ≤ 400 x109/L, and
- WBC ≤ 10 x 109/L, and
- no splenomegaly, and
- no disease related systemic symptoms (microvascular disturbances, pruritus, headache);
- Partial response:
- HCT < 45% without phlebotomy, or
- fulfilment of at least 3 of the other above mentioned criteria;
- No response: any response that did not satisfy the criteria set for partial response.
Measured: At week 24 of treatment
Change From Baseline of the JAK2V617F Allele Burden by Quantitative RT-PCR
To determine JAK2V617F mutational status, a quantitative RT-PCR (Real Time-Polymerase Chain Reaction) is executed on peripheral blood granulocyte and haematopoietic colonies (with and without hepatocyte growth factors - HGFs).
Measured: At weeks 12, 24, at "drop out visit" and at "End of Study" (EOS). EOS stays for 7 days after last drug intake if patient is withdrawn from the study before week 24.
Percentage of Patients With a Reduction of the Fraction of JAK2V617F Positive Clonogenic Progenitor by Timepoints
JAK2V617F genotyping and quantification were performed on gradient-separated mononuclear cells during the pre-treatment evaluations (baseline), halfway through the study (12th weeks) and at the end of the study period (24th weeks).
Baseline: n=22 (50 mg od); 22 (50 mg bid) Week 12: n=20 (50 mg od); 19 (50 mg bid) Week 24: n=18 (50 mg od); 18 (50 mg bid)
Measured: Baseline, at weeks 12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionJul 2011
- Study completionOct 2011
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.
- Other trials for Polycythemia VeraStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Italfarmaco
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alessandro Rambaldi, MD, Principal investigator, Azienda Ospedaliera Ospedali Riuniti di Bergamo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00928707
- Sponsor's protocol ID
- DSC/08/2357/38
- Acronym
- PV
- Status last verified
- Oct 2019
- First submitted
- 25 Jun 2009
- Last updated
- 31 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of the Histone-deacetylase Inhibitor GIVINOSTAT (ITF2357) in Combination With Hydroxyurea in Patients With JAK2V617F Positive Polycythemia Vera Non-responder to Hydroxyurea Monotherapy.
- ClinicalTrials.gov ID
- NCT00928707
- Acronym / sponsor ID
- PV / DSC/08/2357/38
- Conditions
- Polycythemia Vera
- Keywords
- Polycythemia Vera, GIVINOSTAT, ITF2357
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- ItalfarmacoIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 26 Jun 2009 (estimated)
- Results
- Posted 31 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study was to evaluate the efficacy of Givinostat in combination with hydroxyurea in patients with JAK2V617F-positive Polycythemia Vera (PV) non-responders to the maximum tolerated dose of hydroxyurea monotherapy.
The secondary objectives of this study were:
- To evaluate the safety and tolerability of Givinostat in combination with hydroxyurea in patients with JAK2V617Fpositive PV non-responders to the maximum tolerated dose of hydroxyurea monotherapy;
- To explore the impact in terms of efficacy and tolerability of Givinostat 50 mg dose escalation in patients not achieving at least a partial response at the time when the primary endpoint was assessed (week 12);
- To evaluate the molecular response (JAK2 mutated allele burden) by quantitative Real Time-Polymerase Chain Reaction (RT-PCR);
- To evaluate the reduction of the fraction of JAK2V617F positive clonogenic progenitors.
Detailed description
This is a multicentre, randomized, open-label, phase II study testing GIVINOSTAT (ITF2357) in combination with hydroxyurea in a population of patients with JAK2V617F positive Polycythemia Vera non-responders to the maximum tolerated dose of hydroxyurea monotherapy for at least 3 months.
Recruited patients will be randomly assigned to one of the following treatment groups:
- group A: 50 mg o.d. of oral GIVINOSTAT (ITF2357) in combination with the maximum tolerated dose of hydroxyurea monotherapy already in use before admission to the study;
- group B: 50 mg b.i.d. of oral GIVINOSTAT (ITF2357) in combination with the maximum tolerated dose of hydroxyurea monotherapy already in use before admission to the study.
The two groups will be balanced for number and for Centre in order to provide valuable information on both treatment regimens.
In both groups assigned doses shall remain stable until week 12, which is when the primary endpoint is assessed, unless specific tolerability issues arise which impose dose reduction.
After the primary endpoint assessment at week 12, one of the following treatment schedules will be chosen case by case on the basis of the achieved clinical response and continued for up to 12 further weeks:
- Partial or Complete Response at week 12:
- group A: continue 50 mg o.d.;
- group B: continue 50 mg b.i.d.;
- No Response at week 12:
- group A: increase to 50 mg b.i.d.;
- group B: increase to 50 mg t.i.d.. At any time during study course, if toxicity is observed, GIVINOSTAT (ITF2357) treatment will be discontinued until recovery and then restarted at a reduced dose level. The drug will be definitively withdrawn in case of reappearance of toxicity even at a reduced daily dose. Overall, the treatment will last up to a maximum of 24 cumulative weeks of drug administration.
The study will recruit subjects of both genders with an established diagnosis of JAK2V617F positive Polycythemia Vera according to the revised WHO criteria, in need of cytoreductive therapy, non-responders to the maximum tolerated dose of hydroxyurea monotherapy for at least 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GIVINOSTAT + MTD Hydroxyurea (HU)_1 | Experimental | Drug: GIVINOSTAT (ITF2357) 50 mg o.d. + MTD Hydroxyurea50 mg o.d. of GIVINOSTAT + maximum tolerated dose (MTD) of Hydroxyurea (HU) monotherapy |
| GIVINOSTAT + MTD Hydroxyurea (HU)_2 | Experimental | Drug: GIVINOSTAT (ITF2357) 50 mg b.i.d. + MTD Hydroxyurea50 mg b.i.d. of GIVINOSTAT + maximum tolerated dose (MTD) of Hydroxyurea (HU) monotherapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Written Informed Consent.
- Age ≥18 years.
- Confirmed diagnosis of Polycythemia Vera according to the revised World Health Organization (WHO) criteria.
- JAK2V617F positivity.
- Non-response to the maximum tolerated dose of hydroxyurea monotherapy for at least 3 months.
Key exclusion criteria (20 listed)
- Active bacterial or mycotic infection requiring antimicrobial treatment.
- Pregnancy or lactation.
- A marked baseline prolongation of QT/QTc (corrected) interval (e.g. repeated demonstration of a QTc interval > 450 ms, according to Bazett's correction formula).
- Use of concomitant medications that prolong the QT/QTc interval.
- Clinically significant cardiovascular disease including:
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 |
|---|---|---|
| GIVINOSTAT (ITF2357) 50 mg o.d. + MTD HydroxyureaAlso: GIVINOSTAT (ITF2357), ONCOCARBIDE (HYDROXYUREA)50 mg o.d. of GIVINOSTAT + MTD of HU monotherapy | Drug | GIVINOSTAT + MTD Hydroxyurea (HU)_1 |
| GIVINOSTAT (ITF2357) 50 mg b.i.d. + MTD HydroxyureaAlso: GIVINOSTAT (ITF2357), ONCOCARBIDE (HYDROXYUREA)50 mg b.i.d. of GIVINOSTAT + MTD HU monotherapy | Drug | GIVINOSTAT + MTD Hydroxyurea (HU)_2 |
Primary outcome
Percentage of Patients With Overall Haematological Response at Week 12.
Time frame: At week 12 of treatment
The percentage of patients with overall (complete or partial) response at week 12 were assessed. · Complete response: 1. HCT (Hematocrit) < 45% without phlebotomy, and 2. platelets ≤ 400 x109/L, and 3. WBC (white blood cell) ≤ 10 x 109/L, and 4. no splenomegaly, and 5. no disease related systemic symptoms (microvascular disturbances, pruritus, headache); · Partial response: 1. HCT < 45% without phlebotomy, or 2. fulfilment of at least 3 of the other above mentioned criteria; · No response: any response that did not satisfy the criteria set for partial response.
3 secondary outcomes
Percentage of Patients With Overall Haematological Response at Week 24 by Dose Escalation After Week 12.
Time frame: At week 24 of treatment
Change From Baseline of the JAK2V617F Allele Burden by Quantitative RT-PCR
Time frame: At weeks 12, 24, at "drop out visit" and at "End of Study" (EOS). EOS stays for 7 days after last drug intake if patient is withdrawn from the study before week 24.
Percentage of Patients With a Reduction of the Fraction of JAK2V617F Positive Clonogenic Progenitor by Timepoints
Time frame: Baseline, at weeks 12 and 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Alessandro Rambaldi, MD principal investigator
Azienda Ospedaliera Ospedali Riuniti di Bergamo
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GIVINOSTAT (ITF2357) 50 mg o.d. + MTD Hydroxyurea and GIVINOSTAT (ITF2357) 50 mg b.i.d. + MTD Hydroxyurea in people with Polycythemia Vera, run by Italfarmaco at 22 sites in Italy.
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 8 inclusion and 20 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 31 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Italy. 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 31 Oct 2019). 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 Patients With Overall Haematological Response at Week 12. (time frame: At week 12 of treatment). 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 31 Oct 2019.