Children With Relapsed Solid Tumor, Lymphoma or LeukemiaPhase 1/2NCT01422499
Vorinostat in Children
A Phase 1/2 study testing zolinza/vorinostat in people with Children With Relapsed Solid Tumor, Lymphoma or Leukemia, run by National Center for Tumor Diseases, Heidelberg at 10 sites in Germany.
Trial summary
The aim of this study is to define a dose recommendation of vorinostat in pediatric oncology, to determine pharmacokinetics of vorinostat in children, determine response rates, safety and feasibility. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Children With Relapsed Solid Tumor, Lymphoma or Leukemia
- What is being tested?
- zolinza/vorinostat
- Type of treatment
- Pill or oral medicine
- How many people
- 50 participants
- Where
- 10 sitesGermany
- Study dates
- Mar 2012to 24 Mar 2017
- 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children and adolescents (3-18 years) with relapsed or therapy-refractory solid tumor, lymphoma or leukemia following standard first-line or relapse protocols in pediatric oncology
- Diagnosis confirmed by one of the Pathological, Radiological or Study Reference Centers recognized by the GPOH
- No other simultaneous anti-neoplastic treatment or radiation during the study and 1 months before enrolment
- Sufficient general condition (Lansky Score >50%)
- Life expectancy > 3 months
- Liver enzymes (ALT or AST) < 5x upper limit of normal reference value, bilirubin and creatinine < 3x upper limit of normal reference value
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- Solid tumors: leukocytes > 2000/µl, thrombocytes > 50.000/µl and adequate bone marrow function to permit evaluations of hematopoietic toxicity
- No CTC grade 3 or 4 toxicity from previous treatments
- Normal ECG
- Written informed consent of the legal representatives and the patient if the patient is able to understand the study situation and to give consent (must be available before enrolment in the trial)
- Women with childbearing potential agree to use adequate contraception or to abstain from heterosexual activity throughout the study, starting with Visit 1.
- Sexually active male patient agrees to use an adequate method of contraception for the duration of the study
- Solid tumors: measurable disease activity according to RECIST criteria
Who cannot join
- History of deep vein thrombosis or pulmonary embolism
- Pregnancy and lactation
- Patient with concomitant treatments and/or anti-neoplastic treatment such as chemotherapy, immune therapy, and differentiation therapy, other targeted therapy, radiation. The use of valproic acid as prior antiepileptic therapy is allowed with a 30-day washout period.
- Prior exposure to Histone Deacetylase Inhibitors
- Known active HBV, HCV or HIV infection
- Patient with concomitant treatments such as amber [Hypericum perforatum], plant extracts, vitamins, and other anti-oxidative compounds
Show all 10Show fewer
- Participation in other clinical trials or observation period of competing trials, respectively
- Patient is unable to swallow vorinostat suspension or capsules
- Patient on coumarin-derivative anticoagulants
- Any other medication which could accentuate known dose-dependent adverse effects of the study drug, for instance bone marrow depression or QT-prolongation
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Germany10 sites
Childrens's Hospital, Pediatric Oncology and Hematology
Augsburg, 86156
Prof. Hess Childrens's Hospital, Pediatric Oncology and Hematology
Bremen, 28205
University Children's Hospital, Pediatric Oncology and Hematology
Cologne, 50937
University Childrens's Hospital, Pediatric Oncology and Hematology
Essen, 45122
University Children's Hospital, Clinic IV
Freiburg im Breisgau, 79106
Department of Pediatric Oncology and Hematology University Hospital Eppendorf (UKE)
Hamburg, 20246
University Children's Hospital, Pediatric Oncology and Hematology, MHH
Hanover, 30625
Clinic for Pediatric Oncology, Hematology, Immunology and Clinical Cooperation Unit Pediatric Oncology
Heidelberg, Baden-Wurttemberg, 69198
University Childrens's Hospital, Pediatric Oncology and Hematology
Jena, 07743
Department of Pediatric Oncology and Hematology University Children's Hospital
Münster, 48149
About this study
Official title: Phase I/II Intra-patient Dose Escalation Study of Vorinostat in Children With Relapsed Solid Tumor, Lymphoma or Leukemia
The aim of this study is to define a dose recommendation of vorinostat in pediatric oncology, to determine pharmacokinetics of vorinostat in children, determine response rates, safety and feasibility.
Read the detailed description
Relapsed or progressive solid tumors and leukemias have a very poor prognosis in children despite intense multimodal treatment protocols involving polychemotherapy, surgery, and radiation. Therefore, innovative treatment strategies targeting specific molecular mechanisms are urgently required. A novel class of compounds with promising anti-tumoral activities is histone deacetylase (HDAC)-inhibitors. HDACs are key enzymes involved in regulation of chromatin-structure and function of several proteins, and aberrant activities of HDACs are found in many cancer cells. Pharmacological inhibition of HDACs causes cell cycle arrest, apoptosis, differentiation, inhibition of clonogenic growth, and anti-angiogenic effects in numerous cancer cells. In addition, promising anti-tumoral activity has been shown in several pre-clinical pediatric tumor models such as neuroblastoma, medulloblastoma, glioblastoma, retinoblastoma, rhabdomyosarcoma, osteosarcoma, Ewing's sarcoma, ATRT, and acute lymphoblastic leukemia. Several HDAC inhibitors are now in Phase I-III clinical trials in adult patients demonstrating a good safety profile and promising anti-neoplastic activity. The first of these compounds, suberoylanilide hydroxamic acid (SAHA, vorinostat, Zolinza), was recently approved by the FDA for the treatment of refractory cutaneous T-cell lymphoma. Vorinostat showed linear pharmacokinetics, good oral bioavailability and a broad range of anti-tumor activity in a Phase I clinical trial including 73 adult relapsed tumor patients. The determined peak plasma levels were in the range of 658±439 ng/ml (corresponding to 2.5±1.7 µM). At these concentrations, anti-tumoral effects on pediatric cancer cells and leukemias have been documented in vitro. Furthermore, vorinostat passes the blood brain barrier in mice, thus making it a suitable compound for the treatment of brain tumors.
The aim of this study is to define a dose recommendation of vorinostat in pediatric oncology, to determine pharmacokinetics of vorinostat in children, determine response rates, safety and feasibility. The design is an open, multicenter Phase I/II trial. Children and adolescents (3-18 years) with relapsed or therapy-refractory solid tumor, lymphoma or leukemia following standard treatment protocols in pediatric oncology will be included. 50 patients will be recruited over 2 years. Vorinostat will be taken orally once per day on an outpatient basis and the dose will be escalated until the individual maximum tolerated dose is established. This dose will then be applied for 3 months, when tumor response will be evaluated. Patients without progression at first response evaluation will continue treatment for a maximum of 9 months. After end of treatment (EOT) follow-up evaluations will be performed for 3 months. Pharmacokinetic studies will be performed in plasma, and in optional cerebrospinal fluid samples. Biomarkers (BMP4, IL-6, IL10 induction following Vorinostat treatment, basal histone acetylation, HDACs and H23B in archived tumor samples) will be determined and correlated with treatment response.
- Being tested
- zolinza/vorinostat
- Keywords
- pediatric oncology, relapsed solid tumor, lymphoma, leukemia, vorinostat
- Medical subject headings
- Lymphoma, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zolinza/vorinostatDrug
orally once per day (suspension of 50mg/ml or capsules of 100 mg vorinostat); starting dose will be 180 mg/m²/d; escalated with increments of 50 mg/m²/d every two weeks until dose limiting toxicity (grade 3 or 4 toxicity according to CTC) occurs or up to a maximum dose of 580 mg/m²/d; This dose will then be applied for 3 months. Patients without progression at first response evaluation will continue treatment for a maximum of 9 months.
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine a safe dose recommended (SDR) for the routine application of oral vorinostat (involving dose escalation) in children and adolescents (3-18 years) with relapsed/refractory solid tumor, lymphoma or leukemia.
A SDR is defined as the highest dose with no ≥ grade 3 toxicity according to CTC criteria (Dose Limiting Toxicity) in no more than 1/50 patient in this study.
Dose Limiting Toxicity (DLT) is defined as any grade 3 or 4 toxicity according the CTCAE version 4.0 and judged by the investigator as definitely, probably or possibly related to the study drug.
However, all DLTs will be subject to a second assessment by the Coordinating Investigator or a designated person.
Measured: After finding the individual MTD this dose will be applied for 3 months. Patients without progression at first response evaluation will continue treatment for a maximum of 9 months.
Secondary outcomes (5)
pharmacokinetics
Quantification of vorinostat concentration by mass spectrometry and enzymatically (AUC, Cmax, Cmin, tmax, Clearance, and t1/2).
The pharmacokinetic study will investigate the correlation between dose administered, plasma concentration, CSF concentrations, intracellular inhibition of HDAC activity and glucuronosyltransferase polymorphisms as well as observed treatment responses and toxicities.
Additionally:Intracellular HDAC activity in leukocytes using a fluorescence based enzymatic assay
Measured: d 8, when maximum tolerated dose (MTD) ist reached and after 3 months treatment at MTD
antitumor effectiveness
antitumor effectiveness of vorinostat as measured by treatment response rate
Measured: three months after start of treatment with the individual MTD
association of the histone deacetylase (HDAC)-inhibiting activity with the dose administered, toxicity, and treatment response
Intracellular vorinostat concentrations and pharmacologic target (HDAC) inhibition in peripheral leukocytes will be determined as a pharmacodynamic surrogate parameter. The latter assay is based on conversion of a fluorigenic acetyl-substrate by the enzymatic activity of HDACs which is specifically inhibited by vorinostat in a concentration dependent manner. The performance of the assay in patient plasma samples has been validated according to the FDA recommendations "Guidance for Industry Bioanalytical Method Validation".
Measured: d8, after reaching the MTD and after 3 months treatment at MTD
safety
The analysis of safety assessments will include summaries of the following categories of safety and tolerability data collected for each subject:
- Drug Exposure(s)
- Adverse Events (AEs and SAEs, AEs leading to withdrawal)
- Clinical Laboratory Investigations
- Hemodynamics (vital signs)
- ECG Investigations
Frequencies of patients experiencing at least one AE will be displayed. Severity of the AEs will be graded according to the CTCAEv4.0. Summary tables will present the number of patients observed with AEs, the corresponding percentages and 95% CI.
Measured: during dose escalation and during 3 months treatment at MTD every week; during prolongation of treatment and follow-up every second week
duration of response in responding patients
MRI and MIBG (in case of neuroblastoma)
Measured: every 3 months until progression of tumor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2011 (estimated)
- Study startMar 2012
- Primary completion24 Mar 2017
- Study completion24 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Children With Relapsed Solid Tumor, Lymphoma or LeukemiaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Center for Tumor Diseases, Heidelberg
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Heidelberg, Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Olaf Witt, Prof. Dr., Principal investigator, University Hospital Heidelberg and German Cancer Research Center (DKFZ)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01422499
- Sponsor's protocol ID
- NCT-2007-11-02-1004
- Status last verified
- Apr 2018
- First submitted
- 3 Aug 2011
- Last updated
- 11 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
van Tilburg CM, Milde T, Witt R, Ecker J, Hielscher T, Seitz A, Schenk JP, Buhl JL, Riehl D, Fruhwald MC, Pekrun A, Rossig C, Wieland R, Flotho C, Kordes U, Gruhn B, Simon T, Linderkamp C, Sahm F, Taylor L, Freitag A, Burhenne J, Foerster KI, Meid AD, Pfister SM, Karapanagiotou-Schenkel I, Witt O. Phase I/II intra-patient dose escalation study of vorinostat in children with relapsed solid tumor, lymphoma, or leukemia. Clin Epigenetics. 2019 Dec 10;11(1):188. doi: 10.1186/s13148-019-0775-1.
PubMed 31823832Witt O, Milde T, Deubzer HE, Oehme I, Witt R, Kulozik A, Eisenmenger A, Abel U, Karapanagiotou-Schenkel I. Phase I/II intra-patient dose escalation study of vorinostat in children with relapsed solid tumor, lymphoma or leukemia. Klin Padiatr. 2012 Oct;224(6):398-403. doi: 10.1055/s-0032-1323692. Epub 2012 Aug 22.
PubMed 22915450
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Intra-patient Dose Escalation Study of Vorinostat in Children With Relapsed Solid Tumor, Lymphoma or Leukemia
- ClinicalTrials.gov ID
- NCT01422499
- Acronym / sponsor ID
- NCT-2007-11-02-1004
- Keywords
- pediatric oncology, relapsed solid tumor, lymphoma, leukemia, vorinostat
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- National Center for Tumor Diseases, HeidelbergUniversity, hospital or other
- Collaborators
- University Hospital Heidelberg, Merck Sharp & Dohme LLC
- Study start
- Mar 2012 (actual)
- Primary completion
- 24 Mar 2017 (actual)
- Study completion
- 24 Mar 2017 (actual)
- First posted
- 24 Aug 2011 (estimated)
- 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 aim of this study is to define a dose recommendation of vorinostat in pediatric oncology, to determine pharmacokinetics of vorinostat in children, determine response rates, safety and feasibility.
Detailed description
Relapsed or progressive solid tumors and leukemias have a very poor prognosis in children despite intense multimodal treatment protocols involving polychemotherapy, surgery, and radiation. Therefore, innovative treatment strategies targeting specific molecular mechanisms are urgently required. A novel class of compounds with promising anti-tumoral activities is histone deacetylase (HDAC)-inhibitors. HDACs are key enzymes involved in regulation of chromatin-structure and function of several proteins, and aberrant activities of HDACs are found in many cancer cells. Pharmacological inhibition of HDACs causes cell cycle arrest, apoptosis, differentiation, inhibition of clonogenic growth, and anti-angiogenic effects in numerous cancer cells. In addition, promising anti-tumoral activity has been shown in several pre-clinical pediatric tumor models such as neuroblastoma, medulloblastoma, glioblastoma, retinoblastoma, rhabdomyosarcoma, osteosarcoma, Ewing's sarcoma, ATRT, and acute lymphoblastic leukemia. Several HDAC inhibitors are now in Phase I-III clinical trials in adult patients demonstrating a good safety profile and promising anti-neoplastic activity. The first of these compounds, suberoylanilide hydroxamic acid (SAHA, vorinostat, Zolinza), was recently approved by the FDA for the treatment of refractory cutaneous T-cell lymphoma. Vorinostat showed linear pharmacokinetics, good oral bioavailability and a broad range of anti-tumor activity in a Phase I clinical trial including 73 adult relapsed tumor patients. The determined peak plasma levels were in the range of 658±439 ng/ml (corresponding to 2.5±1.7 µM). At these concentrations, anti-tumoral effects on pediatric cancer cells and leukemias have been documented in vitro. Furthermore, vorinostat passes the blood brain barrier in mice, thus making it a suitable compound for the treatment of brain tumors.
The aim of this study is to define a dose recommendation of vorinostat in pediatric oncology, to determine pharmacokinetics of vorinostat in children, determine response rates, safety and feasibility. The design is an open, multicenter Phase I/II trial. Children and adolescents (3-18 years) with relapsed or therapy-refractory solid tumor, lymphoma or leukemia following standard treatment protocols in pediatric oncology will be included. 50 patients will be recruited over 2 years. Vorinostat will be taken orally once per day on an outpatient basis and the dose will be escalated until the individual maximum tolerated dose is established. This dose will then be applied for 3 months, when tumor response will be evaluated. Patients without progression at first response evaluation will continue treatment for a maximum of 9 months. After end of treatment (EOT) follow-up evaluations will be performed for 3 months. Pharmacokinetic studies will be performed in plasma, and in optional cerebrospinal fluid samples. Biomarkers (BMP4, IL-6, IL10 induction following Vorinostat treatment, basal histone acetylation, HDACs and H23B in archived tumor samples) will be determined and correlated with treatment response.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (13 listed)
- Children and adolescents (3-18 years) with relapsed or therapy-refractory solid tumor, lymphoma or leukemia following standard first-line or relapse protocols in pediatric oncology
- Diagnosis confirmed by one of the Pathological, Radiological or Study Reference Centers recognized by the GPOH
- No other simultaneous anti-neoplastic treatment or radiation during the study and 1 months before enrolment
- Sufficient general condition (Lansky Score >50%)
- Life expectancy > 3 months
Key exclusion criteria (10 listed)
- History of deep vein thrombosis or pulmonary embolism
- Pregnancy and lactation
- Patient with concomitant treatments and/or anti-neoplastic treatment such as chemotherapy, immune therapy, and differentiation therapy, other targeted therapy, radiation. The use of valproic acid as prior antiepileptic therapy is allowed with a 30-day washout period.
- Prior exposure to Histone Deacetylase Inhibitors
- Known active HBV, HCV or HIV infection
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 |
|---|---|---|
| zolinza/vorinostatorally once per day (suspension of 50mg/ml or capsules of 100 mg vorinostat); starting dose will be 180 mg/m²/d; escalated with increments of 50 mg/m²/d every two weeks until dose limiting toxicity (grade 3 or 4 toxicity according to CTC) occurs or up to a maximum dose of 580 mg/m²/d; This dose will then be applied for 3 months. Patients without progression at first response evaluation will continue treatment for a maximum of 9 months. | Drug | – |
Primary outcome
To determine a safe dose recommended (SDR) for the routine application of oral vorinostat (involving dose escalation) in children and adolescents (3-18 years) with relapsed/refractory solid tumor, lymphoma or leukemia.
Time frame: After finding the individual MTD this dose will be applied for 3 months. Patients without progression at first response evaluation will continue treatment for a maximum of 9 months.
A SDR is defined as the highest dose with no ≥ grade 3 toxicity according to CTC criteria (Dose Limiting Toxicity) in no more than 1/50 patient in this study. Dose Limiting Toxicity (DLT) is defined as any grade 3 or 4 toxicity according the CTCAE version 4.0 and judged by the investigator as definitely, probably or possibly related to the study drug. However, all DLTs will be subject to a second assessment by the Coordinating Investigator or a designated person.
5 secondary outcomes
pharmacokinetics
Time frame: d 8, when maximum tolerated dose (MTD) ist reached and after 3 months treatment at MTD
antitumor effectiveness
Time frame: three months after start of treatment with the individual MTD
association of the histone deacetylase (HDAC)-inhibiting activity with the dose administered, toxicity, and treatment response
Time frame: d8, after reaching the MTD and after 3 months treatment at MTD
safety
Time frame: during dose escalation and during 3 months treatment at MTD every week; during prolongation of treatment and follow-up every second week
duration of response in responding patients
Time frame: every 3 months until progression of tumor
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 11 Apr 2018.
- Derived from this study: PubMed 31823832van Tilburg CM, Milde T, Witt R, Ecker J, Hielscher T, Seitz A, Schenk JP, Buhl JL, Riehl D, Fruhwald MC, Pekrun A, Rossig C, Wieland R, Flotho C, Kordes U, Gruhn B, Simon T, Linderkamp C, Sahm F, Taylor L, Freitag A, Burhenne J, Foerster KI, Meid AD, Pfister SM, Karapanagiotou-Schenkel I, Witt O. Phase I/II intra-patient dose escalation study of vorinostat in children with relapsed solid tumor, lymphoma, or leukemia. Clin Epigenetics. 2019 Dec 10;11(1):188. doi: 10.1186/s13148-019-0775-1.
- Derived from this study: PubMed 22915450Witt O, Milde T, Deubzer HE, Oehme I, Witt R, Kulozik A, Eisenmenger A, Abel U, Karapanagiotou-Schenkel I. Phase I/II intra-patient dose escalation study of vorinostat in children with relapsed solid tumor, lymphoma or leukemia. Klin Padiatr. 2012 Oct;224(6):398-403. doi: 10.1055/s-0032-1323692. Epub 2012 Aug 22.
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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.
Olaf Witt, Prof. Dr. principal investigator
University Hospital Heidelberg and German Cancer Research Center (DKFZ)
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing zolinza/vorinostat in people with Children With Relapsed Solid Tumor, Lymphoma or Leukemia, run by National Center for Tumor Diseases, Heidelberg at 10 sites in Germany.
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 13 inclusion and 10 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 11 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany. 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?
To determine a safe dose recommended (SDR) for the routine application of oral vorinostat (involving dose escalation) in children and adolescents (3-18 years) with relapsed/refractory solid tumor, lymphoma or leukemia. (time frame: After finding the individual MTD this dose will be applied for 3 months. Patients without progression at first response evaluation will continue treatment for a maximum of 9 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01422499, which also lists 2 linked publications.
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 11 Apr 2018.