Lymphoma, Non-HodgkinPhase 1/2NCT02431403
ESHAP-Imatinib for Refractory/Relapsed Non-Hodgkin's Lymphoma
A Phase 1/2 study testing ESHAP-Imatinib in people with Lymphoma, Non-Hodgkin, run by Pusan National University Hospital at 5 sites in South Korea.
Trial summary
Open-labeled, multicenter, phase I/II study of imatinib combined with ESHAP as salvage therapy in relapsed/refractory non-Hodgkin's lymphoma Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Lymphoma, Non-Hodgkin
- What is being tested?
- ESHAP-Imatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 5 sitesSouth Korea
- Study dates
- Feb 2015to Feb 2020
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically diagnosed non-Hodgkin's lymphoma, refractory or relapsed after 1st line treatment.
- Paraffin block of the lesions available for immunohistochemical analysis
- Candidate for ESHAP salvage therapy
- Evidence of at least one lesion with a diameter of 1.5 cm
- Age of over 20 years
- Eastern cooperative oncology group performance status (ECOG) less than or equal to 2.
Show all 10Show fewer
- Adequate kidney function with serum creatinine< 2.5 mg/dL, creatinine clearance ≥ 50 mL/min
- Adequate liver function with aspartate transaminase (AST)/alanine aminotransferase (ALT) lower than or equal to 3 times the normal upper limit; Total bilirubin lower than or equal to 1.5 times the upper limit ;alkaline phosphatase lower than or equal to 5 times the normal upper limit.
- Adequate bone marrow function with absolute neutrophil count ≥ 1,000/uL; platelets ≥ 75,000/uL; hemoglobin ≥ 9.0 g/dL
- Patients who gave voluntarily informed consent before performing any test test that is not part of routine care of patients
Who cannot join
- Patients with history of exposure to imatinib or other Bcr-Abl tyrosine-kinase inhibitors
- Known or suspected hypersensitivity to imatinib
- Potential use or usage alteration of CYP3A4 inducers or inhibitors from prior to 21 days of to the test regimen until the initiation of round 2 ESHAP. Exceptions are itraconazole and fluconazole for treatment or prevention of fungal infection, hydrocortisone and dexamethasone for treatment of nausea/vomiting/fluid retention, and methylprednisolone as a part of the ESHAP regimen.
- Known involvement of the central nervous system (CNS) by lymphoma.
- Pregnant or breast-feeding. Females of childbearing potential who do not agree to undergo pregnancy tests or repeated use effective birth control while included in the clinical trial.
- Serious or uncontrolled medical condition, such as presence of abnormal or clinically significant cardiac disease, such as acute myocardial infarction or unstable angina within 6 months prior to initiation of treatment with ESHAP-imatinib, serious neurological or psychological conditions such as dementia or epilepsy, or uncontrolled active infection.
- Prior history of malignancy other than to non-Hodgkin's lymphoma (except basal or squamous cell skin and in situ carcinoma of the cervix) unless the patient free of disease beyond 5 years are.
- HIV positive and in treatment.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites, 5 recruiting
- Recruiting
Dong-A University Hospital
Busan
Ji Sook Park, dongahicrc5@naver.com
- Recruiting
Inje University Busan Paik Hospital
Busan
Jin Hwa Kong, +82-51-890-6987, velika-jh@nate.com
- Recruiting
Kosin University Gospel Hospital
Busan
Saet Byeol Park, siou7777@naver.com
- Recruiting
Pusan National University Hospital
Busan
Younghee Kim, +82-51-240-7899, shinyspring@naver.com
- Recruiting
Ulsan University Hospital
Ulsan
Mi Sun Jeon, uuh3103@naver.com
About this study
Official title: Open-labeled, Multicenter, Phase I/II Study of Imatinib Combined With ESHAP as Salvage Therapy in Relapsed/Refractory Non-Hodgkin's Lymphoma
Open-labeled, multicenter, phase I/II study of imatinib combined with ESHAP as salvage therapy in relapsed/refractory non-Hodgkin's lymphoma
- Conditions
- Lymphoma, Non-Hodgkin
- Being tested
- ESHAP-Imatinib
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESHAP-ImatinibDrug
After selection of the maximum-tolerated dose of the combination ESHAP with imatinib a phase 2 of the study will be performed in order to evaluate the ORR of ESHAP-imatinib.
| Study group | Role | What they receive |
|---|---|---|
| ESHAP-Imatinib 100mg | Experimental | Imatinib 100 mg combined with ESHAP
* ESAHP D1-4 Etoposide 40mg/m2 D1-4 Cisplatin 25mg/m2 D5 Cytarabine 2000mg/m2 D1-5 Methylprednisolone 250mg/m2 D6 Pegfilgrastim 6mg Receives: Drug: ESHAP-Imatinib |
| ESHAP-Imatinib 200mg | Experimental | Imatinib 200 mg combined with ESHAP
* ESAHP D1-4 Etoposide 40mg/m2 D1-4 Cisplatin 25mg/m2 D5 Cytarabine 2000mg/m2 D1-5 Methylprednisolone 250mg/m2 D6 Pegfilgrastim 6mg Receives: Drug: ESHAP-Imatinib |
| ESHAP-Imatinib 400mg | Experimental | Imatinib 400 mg combined with ESHAP
* ESAHP D1-4 Etoposide 40mg/m2 D1-4 Cisplatin 25mg/m2 D5 Cytarabine 2000mg/m2 D1-5 Methylprednisolone 250mg/m2 D6 Pegfilgrastim 6mg Receives: Drug: ESHAP-Imatinib |
| ESHAP-Imatinib 300mg | Experimental | Imatinib 300 mg combined with ESHAP
* ESAHP D1-4 Etoposide 40mg/m2 D1-4 Cisplatin 25mg/m2 D5 Cytarabine 2000mg/m2 D1-5 Methylprednisolone 250mg/m2 D6 Pegfilgrastim 6mg Receives: Drug: ESHAP-Imatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events
Adverse events are recorded and analyzed from the time of enrollment to last day of ESHAP-imatinib treatment
Measured: Up to 33 weeks
Secondary outcomes (3)
Phase I/II Overall Response Rate (ORR)
Measured: Week 4, Week 10, Week 16
Phase II Event-Free Survival
Measured: Up to 3 years
Phase II Overall Survival
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2015 (estimated)
- Study startFeb 2015
- Primary completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Lymphoma, Non-HodgkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pusan National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jooseop Chung, Pusan National University Hospital
- Investigators
- Jooseop Chung, Principal investigator, Pusan National Universty Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02431403
- Sponsor's protocol ID
- IMACEL
- Status last verified
- May 2015
- First submitted
- 21 Apr 2015
- Last updated
- 5 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Edling CE, Hallberg B. c-Kit--a hematopoietic cell essential receptor tyrosine kinase. Int J Biochem Cell Biol. 2007;39(11):1995-8. doi: 10.1016/j.biocel.2006.12.005. Epub 2007 Jan 20.
PubMed 17350321Escribano L, Ocqueteau M, Almeida J, Orfao A, San Miguel JF. Expression of the c-kit (CD117) molecule in normal and malignant hematopoiesis. Leuk Lymphoma. 1998 Aug;30(5-6):459-66. doi: 10.3109/10428199809057558.
PubMed 9711908Ikeda H, Kanakura Y, Tamaki T, Kuriu A, Kitayama H, Ishikawa J, Kanayama Y, Yonezawa T, Tarui S, Griffin JD. Expression and functional role of the proto-oncogene c-kit in acute myeloblastic leukemia cells. Blood. 1991 Dec 1;78(11):2962-8.
PubMed 1720040Pinto A, Gloghini A, Gattei V, Aldinucci D, Zagonel V, Carbone A. Expression of the c-kit receptor in human lymphomas is restricted to Hodgkin's disease and CD30+ anaplastic large cell lymphomas. Blood. 1994 Feb 1;83(3):785-92.
PubMed 7507733Hongyo T, Li T, Syaifudin M, Baskar R, Ikeda H, Kanakura Y, Aozasa K, Nomura T. Specific c-kit mutations in sinonasal natural killer/T-cell lymphoma in China and Japan. Cancer Res. 2000 May 1;60(9):2345-7.
PubMed 10811105Melnyk A, Rodriguez A, Pugh WC, Cabannillas F. Evaluation of the Revised European-American Lymphoma classification confirms the clinical relevance of immunophenotype in 560 cases of aggressive non-Hodgkin's lymphoma. Blood. 1997 Jun 15;89(12):4514-20.
PubMed 9192775Aozasa K, Zaki MA. Epidemiology and pathogenesis of nasal NK/T-cell lymphoma: a mini-review. ScientificWorldJournal. 2011 Feb 14;11:422-8. doi: 10.1100/tsw.2011.41.
PubMed 21336457Brauns TC, Schultewolter T, Dissemond J, Maschke J, Goos M. C-KIT expression in primary cutaneous T-cell lymphomas. J Cutan Pathol. 2004 Oct;31(9):577-82. doi: 10.1111/j.0303-6987.2004.00182.x.
PubMed 15330987Choe YS, Kim JG, Sohn SK, Kim DH, Baek JH, Lee KB, Do YR, Kwon KY, Song HS, Lee MH, Park TI. c-kit Expression and mutations in peripheral T cell lymphomas, except for extra-nodal NK/T cell lymphomas. Leuk Lymphoma. 2006 Feb;47(2):267-70. doi: 10.1080/10428190500281680.
PubMed 16321856Giantin M, Aresu L, Arico A, Gelain ME, Riondato F, Comazzi S, Dacasto M. Evaluation of tyrosine-kinase receptor c-kit mutations, mRNA and protein expression in canine lymphoma: might c-kit represent a therapeutic target? Vet Immunol Immunopathol. 2013 Aug 15;154(3-4):153-9. doi: 10.1016/j.vetimm.2013.05.014. Epub 2013 May 30.
PubMed 23791075Andrae J, Gallini R, Betsholtz C. Role of platelet-derived growth factors in physiology and medicine. Genes Dev. 2008 May 15;22(10):1276-312. doi: 10.1101/gad.1653708.
PubMed 18483217Piccaluga PP, Agostinelli C, Califano A, Rossi M, Basso K, Zupo S, Went P, Klein U, Zinzani PL, Baccarani M, Dalla Favera R, Pileri SA. Gene expression analysis of peripheral T cell lymphoma, unspecified, reveals distinct profiles and new potential therapeutic targets. J Clin Invest. 2007 Mar;117(3):823-34. doi: 10.1172/JCI26833. Epub 2007 Feb 15.
PubMed 17304354Huang Y, de Reynies A, de Leval L, Ghazi B, Martin-Garcia N, Travert M, Bosq J, Briere J, Petit B, Thomas E, Coppo P, Marafioti T, Emile JF, Delfau-Larue MH, Schmitt C, Gaulard P. Gene expression profiling identifies emerging oncogenic pathways operating in extranodal NK/T-cell lymphoma, nasal type. Blood. 2010 Feb 11;115(6):1226-37. doi: 10.1182/blood-2009-05-221275. Epub 2009 Nov 30.
PubMed 19965620Chen YP, Chang KC, Su WC, Chen TY. The expression and prognostic significance of platelet-derived growth factor receptor alpha in mature T- and natural killer-cell lymphomas. Ann Hematol. 2008 Dec;87(12):985-90. doi: 10.1007/s00277-008-0539-z. Epub 2008 Jul 17.
PubMed 18633616Passam FH, Alexandrakis MG, Kafousi M, Fotinou M, Darivianaki K, Tsirakis G, Roussou PA, Stathopoulos EN, Siafakas NM. Histological expression of angiogenic factors: VEGF, PDGFRalpha, and HIF-1alpha in Hodgkin lymphoma. Pathol Res Pract. 2009;205(1):11-20. doi: 10.1016/j.prp.2008.07.007. Epub 2008 Oct 23.
PubMed 18950958
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-labeled, Multicenter, Phase I/II Study of Imatinib Combined With ESHAP as Salvage Therapy in Relapsed/Refractory Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT02431403
- Acronym / sponsor ID
- IMACEL
- Conditions
- Lymphoma, Non-Hodgkin
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Pusan National University HospitalUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Feb 2020 (estimated)
- First posted
- 1 May 2015 (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.
Open-labeled, multicenter, phase I/II study of imatinib combined with ESHAP as salvage therapy in relapsed/refractory non-Hodgkin's lymphoma
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ESHAP-Imatinib 100mg | Experimental | Drug: ESHAP-ImatinibImatinib 100 mg combined with ESHAP * ESAHP D1-4 Etoposide 40mg/m2 D1-4 Cisplatin 25mg/m2 D5 Cytarabine 2000mg/m2 D1-5 Methylprednisolone 250mg/m2 D6 Pegfilgrastim 6mg |
| ESHAP-Imatinib 200mg | Experimental | Drug: ESHAP-ImatinibImatinib 200 mg combined with ESHAP * ESAHP D1-4 Etoposide 40mg/m2 D1-4 Cisplatin 25mg/m2 D5 Cytarabine 2000mg/m2 D1-5 Methylprednisolone 250mg/m2 D6 Pegfilgrastim 6mg |
| ESHAP-Imatinib 400mg | Experimental | Drug: ESHAP-ImatinibImatinib 400 mg combined with ESHAP * ESAHP D1-4 Etoposide 40mg/m2 D1-4 Cisplatin 25mg/m2 D5 Cytarabine 2000mg/m2 D1-5 Methylprednisolone 250mg/m2 D6 Pegfilgrastim 6mg |
| ESHAP-Imatinib 300mg | Experimental | Drug: ESHAP-ImatinibImatinib 300 mg combined with ESHAP * ESAHP D1-4 Etoposide 40mg/m2 D1-4 Cisplatin 25mg/m2 D5 Cytarabine 2000mg/m2 D1-5 Methylprednisolone 250mg/m2 D6 Pegfilgrastim 6mg |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically diagnosed non-Hodgkin's lymphoma, refractory or relapsed after 1st line treatment.
- Paraffin block of the lesions available for immunohistochemical analysis
- Candidate for ESHAP salvage therapy
- Evidence of at least one lesion with a diameter of 1.5 cm
- Age of over 20 years
Key exclusion criteria (8 listed)
- Patients with history of exposure to imatinib or other Bcr-Abl tyrosine-kinase inhibitors
- Known or suspected hypersensitivity to imatinib
- Potential use or usage alteration of CYP3A4 inducers or inhibitors from prior to 21 days of to the test regimen until the initiation of round 2 ESHAP. Exceptions are itraconazole and fluconazole for treatment or prevention of fungal infection, hydrocortisone and dexamethasone for treatment of nausea/vomiting/fluid retention, and methylprednisolone as a part of the ESHAP regimen.
- Known involvement of the central nervous system (CNS) by lymphoma.
- Pregnant or breast-feeding. Females of childbearing potential who do not agree to undergo pregnancy tests or repeated use effective birth control while included in the clinical trial.
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 |
|---|---|---|
| ESHAP-ImatinibAfter selection of the maximum-tolerated dose of the combination ESHAP with imatinib a phase 2 of the study will be performed in order to evaluate the ORR of ESHAP-imatinib. | Drug | ESHAP-Imatinib 100mg, ESHAP-Imatinib 200mg, ESHAP-Imatinib 300mg, ESHAP-Imatinib 400mg |
Primary outcome
Number of Adverse Events
Time frame: Up to 33 weeks
Adverse events are recorded and analyzed from the time of enrollment to last day of ESHAP-imatinib treatment
3 secondary outcomes
Phase I/II Overall Response Rate (ORR)
Time frame: Week 4, Week 10, Week 16
Phase II Event-Free Survival
Time frame: Up to 3 years
Phase II Overall Survival
Time frame: Up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2015.
- Background: PubMed 17350321Edling CE, Hallberg B. c-Kit--a hematopoietic cell essential receptor tyrosine kinase. Int J Biochem Cell Biol. 2007;39(11):1995-8. doi: 10.1016/j.biocel.2006.12.005. Epub 2007 Jan 20.
- Background: PubMed 9711908Escribano L, Ocqueteau M, Almeida J, Orfao A, San Miguel JF. Expression of the c-kit (CD117) molecule in normal and malignant hematopoiesis. Leuk Lymphoma. 1998 Aug;30(5-6):459-66. doi: 10.3109/10428199809057558.
- Background: PubMed 1720040Ikeda H, Kanakura Y, Tamaki T, Kuriu A, Kitayama H, Ishikawa J, Kanayama Y, Yonezawa T, Tarui S, Griffin JD. Expression and functional role of the proto-oncogene c-kit in acute myeloblastic leukemia cells. Blood. 1991 Dec 1;78(11):2962-8.
- Background: PubMed 7507733Pinto A, Gloghini A, Gattei V, Aldinucci D, Zagonel V, Carbone A. Expression of the c-kit receptor in human lymphomas is restricted to Hodgkin's disease and CD30+ anaplastic large cell lymphomas. Blood. 1994 Feb 1;83(3):785-92.
- Background: PubMed 10811105Hongyo T, Li T, Syaifudin M, Baskar R, Ikeda H, Kanakura Y, Aozasa K, Nomura T. Specific c-kit mutations in sinonasal natural killer/T-cell lymphoma in China and Japan. Cancer Res. 2000 May 1;60(9):2345-7.
- Background: PubMed 9192775Melnyk A, Rodriguez A, Pugh WC, Cabannillas F. Evaluation of the Revised European-American Lymphoma classification confirms the clinical relevance of immunophenotype in 560 cases of aggressive non-Hodgkin's lymphoma. Blood. 1997 Jun 15;89(12):4514-20.
- Background: PubMed 21336457Aozasa K, Zaki MA. Epidemiology and pathogenesis of nasal NK/T-cell lymphoma: a mini-review. ScientificWorldJournal. 2011 Feb 14;11:422-8. doi: 10.1100/tsw.2011.41.
- Background: PubMed 15330987Brauns TC, Schultewolter T, Dissemond J, Maschke J, Goos M. C-KIT expression in primary cutaneous T-cell lymphomas. J Cutan Pathol. 2004 Oct;31(9):577-82. doi: 10.1111/j.0303-6987.2004.00182.x.
- Background: PubMed 16321856Choe YS, Kim JG, Sohn SK, Kim DH, Baek JH, Lee KB, Do YR, Kwon KY, Song HS, Lee MH, Park TI. c-kit Expression and mutations in peripheral T cell lymphomas, except for extra-nodal NK/T cell lymphomas. Leuk Lymphoma. 2006 Feb;47(2):267-70. doi: 10.1080/10428190500281680.
- Background: PubMed 23791075Giantin M, Aresu L, Arico A, Gelain ME, Riondato F, Comazzi S, Dacasto M. Evaluation of tyrosine-kinase receptor c-kit mutations, mRNA and protein expression in canine lymphoma: might c-kit represent a therapeutic target? Vet Immunol Immunopathol. 2013 Aug 15;154(3-4):153-9. doi: 10.1016/j.vetimm.2013.05.014. Epub 2013 May 30.
- Background: PubMed 18483217Andrae J, Gallini R, Betsholtz C. Role of platelet-derived growth factors in physiology and medicine. Genes Dev. 2008 May 15;22(10):1276-312. doi: 10.1101/gad.1653708.
- Background: PubMed 17304354Piccaluga PP, Agostinelli C, Califano A, Rossi M, Basso K, Zupo S, Went P, Klein U, Zinzani PL, Baccarani M, Dalla Favera R, Pileri SA. Gene expression analysis of peripheral T cell lymphoma, unspecified, reveals distinct profiles and new potential therapeutic targets. J Clin Invest. 2007 Mar;117(3):823-34. doi: 10.1172/JCI26833. Epub 2007 Feb 15.
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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.
Jooseop Chung principal investigator
Pusan National Universty Hospital
5 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 ESHAP-Imatinib in people with Lymphoma, Non-Hodgkin, run by Pusan National University Hospital at 5 sites in South Korea.
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 10 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 5 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyunhee Jung (+82-51-240-7053, jung77@pnuh.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Adverse Events (time frame: Up to 33 weeks). 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 NCT02431403, which also lists 29 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 5 May 2015.