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B-cell Follicular LymphomaPhase 1NCT00697346

Study of MLN8237 in Participants With Advanced Hematological Malignancies

A Phase 1 study testing Alisertib in people with B-cell Follicular Lymphoma and B-cell Marginal Zone Lymphoma, run by Millennium Pharmaceuticals, Inc. at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is an open-label, multicenter, phase 1 study of MLN8237 in participants with advanced hematological malignancies for whom there are limited standard treatment options. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Alisertib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
10 sitesUnited States
Study dates
11 Jul 2008to 19 Oct 2016
Phase
Phase 1
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Relapsed or refractory disease and a histologically or cytologically confirmed hematological malignancy of the following type for which standard curative treatment does not exist or is no longer effective:
  • B-cell Follicular lymphoma
  • B-cell Marginal zone lymphoma
  • Diffuse large B-cell lymphoma
  • B-cell Mantle cell lymphoma
  • B-cell Small lymphocytic lymphoma (SLL)
Show all 17Show fewer
  • B-Cell Chronic lymphocytic leukemia (B-CLL)
  • Multiple myeloma
  • Waldenstrom's macroglobulinemia
  • Noncutaneous peripheral T-cell lymphoma not otherwise specified (PTCL-NOS)
  • Angioimmunoblastic T-cell lymphoma (AITL), anaplastic large cell lymphoma, enteropathy associated T-cell lymphoma (EATCL), NK lymphoma (NKL)
  • Participants with diffuse large B-cell lymphoma must have failed, be ineligible for, or have refused an autologous stem cell transplant. There is no restriction regarding the maximum number of prior regimens.
  • Aged 18 years or older
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
  • Radiographically or clinically evaluable disease for Part 1 of this study and measurable disease for Part 2 of this study
  • Suitable venous access for the conduct of blood sampling for MLN8237 pharmacokinetics (PK)
  • Recovered from the reversible effects of prior antineoplastic treatment (with the exception of alopecia and Grade 1 neuropathy)

Who cannot join

  • Pregnant or lactating
  • Treatment with clinically significant enzyme inducers within 14 days prior to the first dose of MLN8237 as specified in the protocol
  • Prior allogeneic bone marrow (or other organ) transplantation
  • Newly diagnosed or uncontrolled cancer-related central nervous system (CNS) disease
  • Systemic antineoplastic treatment within 21 days preceding the first dose of study treatment. Exceptions requiring a 42-day recovery period from last treatment include: Nitrosoureas, mitomycin C or Rituximab, alemtuzumab (Campath®), or other unconjugated therapeutic antibody (21 days if clear evidence of progressive disease)
  • Treatment with radioimmunoconjugates or toxin immunoconjugates such as ibritumomab tiuxetan (Zevalin™), or tositumomab (Bexxar®) within 56 days preceding the first dose of study treatment
Show all 13Show fewer
  • Antineoplastic treatment with glucocorticoids within 21 days preceding the first dose of study treatment
  • Radiotherapy involving <25% of the hematopoietically active bone marrow within 21 days preceding first dose of study treatment
  • Radiotherapy involving ≥25% of the hematopoietically active bone marrow within 42 days preceding first dose of study treatment
  • Inability to swallow capsules or known gastrointestinal (GI) disease or GI procedures that could interfere with the oral absorption or tolerance of MLN8237. Examples include, but are not limited to, partial gastrectomy, history of small intestine surgery, and celiac disease.
  • History of uncontrolled sleep apnea syndrome and other conditions that could result in excessive daytime sleepiness such as severe chronic obstructive pulmonary disease
  • Known or suspected human immunodeficiency virus (HIV) positive or hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection. Testing is not required in the absence of clinical findings or suspicion.
  • Participants who fail to meet laboratory values as specified in the protocol during the screening period

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • Study site

    Baltimore, Maryland

  • Study site

    Buffalo, New York

  • Study site

    Chapel Hill, North Carolina

  • Study site

    Hackensack, New Jersey

  • Study site

    Houston, Texas

  • Study site

    Lexington, Kentucky

  • Study site

    Nashville, Tennessee

  • Study site

    Omaha, Nebraska

  • Study site

    San Antonio, Texas

  • Study site

    Scottsdale, Arizona

Other trials in United States

About this study

Official title: An Open-label, Phase 1 Study of MLN8237, a Novel Aurora A Kinase Inhibitor, in Patients With Advanced Hematological Malignancies

This is an open-label, multicenter, phase 1 study of MLN8237 in participants with advanced hematological malignancies for whom there are limited standard treatment options.

Read the detailed description

The drug being tested in this study is called alisertib. Alisertib is being tested to treat people who have advanced hematological malignancies. This study determined the dose-limiting toxicity, maximum tolerated dose, safety and pharmacokinetics (how the drug moves through the body) for alisertib when given once or twice a day for 7 to 21 days.

This open label study enrolled 58 patients. Participants were enrolled in one of 3 treatment groups:

  • Part 1: Powder-in-Capsule (PIC) Dose Escalation (alisertib 25 mg PIC, orally twice daily [BID] on Day 1 [loading dose] and then alisertib 25 or 35 mg PIC once daily [QD] for 21 days (D), or alisertib 35, 45, 65 or 90 mg PIC, orally, QD for 14D) in 28-day cycles
  • Part 1: Enteric-coated Tablet (ECT) Dose Escalation (alisertib 40 mg, ECT, orally, QD for 14D or alisertib 30, 40 or 50 mg, orally, BID for 7D) in 28-day cycles
  • Part 2: Participants with Peripheral T-cell Lymphoma (PTCL) (alisertib 50 mg ECT, orally, BID for 7D) in 21-day cycles

All participants received treatment for 12 months or until their disease progressed or they experienced unacceptable alisertib-related toxicity. This multi-center trial was conducted in the United States. The overall time to participate in this study was 422 days. Participants made multiple visits to the clinic, including a final visit 30 days after receiving their last dose of alisertib for a follow-up assessment.

Being tested
Alisertib
Keywords
Drug therapy
Medical subject headings
Lymphoma, B-Cell, Marginal Zone, Lymphoma, Large B-Cell, Diffuse, Leukemia, B-Cell, Leukemia, Lymphocytic, Chronic, B-Cell, Multiple Myeloma, Waldenstrom Macroglobulinemia, Immunoblastic Lymphadenopathy, Lymphoma, Large-Cell, Anaplastic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AlisertibDrug

    Also called MLN8237

    Alisertib (MLN8237) PIC or ECT

Study groups in NCT00697346
Study groupRoleWhat they receive
Part 1: PIC Dose EscalationExperimentalAlisertib 25 or 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days followed by a 7-day recovery period in 28-day cycles or alisertib 35, 45, 65 or 90 mg PIC, orally, (QD for 14 days followed by a 14-day recovery period in 28-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 14 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose), followed by their respective dosage assignment.
Receives: Drug: Alisertib
Part 1: ECT Dose EscalationExperimentalAlisertib 40 mg, Enteric-coated Tablet (ECT) formulation, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles, or alisertib 30, 40 or 50 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 15 cycles).
Receives: Drug: Alisertib
Part 2: PTCLExperimentalParticipants with peripheral T-cell lymphoma (PTCL) received alisertib 50 mg ECT, orally, BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles).
Receives: Drug: Alisertib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Dose-Limiting Toxicity (DLT)

    DLT was evaluated according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 and was defined as any of the following events related to therapy with alisertib:1. Grade 4 neutropenia lasting ≥7 consecutive days, 2. Grade 4 neutropenia with fever and/or infection 3. Platelet count <25,000/mm^3 4. Grade 3 or greater nausea and/or emesis despite use of optimal antiemetic prophylaxis 5. Grade 3 or greater diarrhea despite maximal supportive therapy with loperamide 6. Any other Grade 3 or greater nonhematologic toxicity, with the following exceptions: Grade 3 arthralgia/myalgias, Any grade of alopecia, Brief (<1 week) Grade 3 fatigue 7. Treatment delay of >21 days due to failure of adequate hematologic or non-hematologic recovery from previous cycle of treatment 8. Other alisertib related non-hematologic toxicities ≥Grade 2 that, in the opinion of the investigator required a dose reduction or discontinuation of therapy with alisertib.

    Measured: From first dose of study drug to 30 days after the last dose (up to 422 days)

  2. Maximum Tolerated Dose (MTD) of Alisertib

    MTD was defined as the highest dose at which DLT occurred in 0/3 or 1/6 participants.

    Measured: From first dose of study drug to 30 days after the last dose (up to 422 days)

  3. Cmax: Maximum Observed Concentration for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 1

    Measured: Cycle 1 Day 1 predose and at multiple timepoints (up to 24 hours) postdose

  4. Cmax: Maximum Observed Concentration for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 21

    Measured: Cycle 1 Day 21 predose and at multiple timepoints (up to 6 hours) postdose

  5. Tmax: Time of First Occurrence of Cmax for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 1

    Measured: Cycle 1 Day 1 predose and at multiple timepoints (up to 24 hours) postdose

  6. Tmax: Time of First Occurrence of Cmax for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 21

    Measured: Cycle 1 Day 21 predose and at multiple timepoints (up to 6 hours) postdose

  7. AUCt: Area Under the Concentration Time Curve From Time 0 to Time t for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 21

    Measured: Cycle 1 Day 21 predose and at multiple time points (up to 6 hours) postdose

  8. Terminal Half-Life (t1/2) for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 21

    Measured: Cycle 1 Day 21 predose and at multiple time points (up to 6 hours) postdose

  9. Accumulation Ratio (Rac) for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 21

    Measured: Cycle 1 Day 21 predose and at multiple time points (up to 6 hours) postdose

  10. Peak/Trough Ratio for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 21

    Measured: Cycle 1 Day 21 predose and at multiple timepoints (up to 6 hours) postdose

  11. CLss/F: Apparent Oral Clearance at Steady State for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 21

    Measured: Cycle 1 Day 21 predose and at multiple timepoints (up to 6 hours) postdose

  12. Cmax: Maximum Observed Concentration for Alisertib as Pill in Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing at Day 1

    Measured: Cycle 1 Day 1 predose and at multiple timepoints (up to 24 hours) postdose

  13. Cmax: Maximum Observed Concentration for Alisertib as Pill in Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing at Day 14

    Measured: Cycle 1 Day 14 predose and at multiple timepoints (up to 8 hours) postdose

  14. Tmax: Time of First Occurrence of Cmax for Alisertib as Pill in Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing at Day 1

    Measured: Cycle 1 Day 1 predose and at multiple timepoints (up to 24 hours) postdose

  15. Tmax: Time of First Occurrence of Cmax for Alisertib as Pill in Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing at Day 14

    Measured: Cycle 1 Day 14 predose and at multiple timepoints (up to 8 hours) postdose

  16. AUCt: Area Under the Concentration Time Curve From Time 0 to Time t for Alisertib as Pill in Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing at Day 14

    Measured: Cycle 1 Day 14 predose and at multiple timepoints (up to 8 hours) postdose

  17. Accumulation Ratio (Rac) for Alisertib as Pill in Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing at Day 14

    Measured: Cycle 1 Day 14 predose and at multiple timepoints (up to 8 hours) postdose

  18. Peak/Trough Ratio for Alisertib as Pill in Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing at Day 14

    Measured: Cycle 1 Day 14 predose and at multiple timepoints (up to 8 hours) postdose

  19. CLss/F: Apparent Oral Clearance at Steady State for Alisertib as Pill in Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing at Day 14

    Measured: Cycle 1 Day 14 predose and at multiple timepoints (up to 8 hours) postdose

  20. Cmax: Maximum Observed Concentration for Alisertib as Enteric Coated Tablet (ECT) With Once Daily for 14 Days (QD14D) Dosing at Day 1

    Measured: Cycle 1 Day 1 predose and at multiple timepoints (up to 24 hours) postdose

  21. Cmax: Maximum Observed Concentration for Alisertib as Enteric Coated Tablet (ECT) With Once Daily for 14 Days (QD14D) Dosing at Day 14

    Measured: Cycle 1 Day 14 predose and at multiple timepoints (up to 8 hours) postdose

  22. Tmax: Time of First Occurrence of Cmax for Alisertib as Enteric Coated Tablet (ECT) With Once Daily for 14 Days (QD14D) Dosing at Day 1

    Measured: Cycle 1 Day 1 predose and at multiple timepoints (up to 24 hours) postdose

  23. Tmax: Time of First Occurrence of Cmax for Alisertib as Enteric Coated Tablet (ECT) With Once Daily for 14 Days (QD14D) Dosing at Day 14

    Measured: Cycle 1 Day 14 predose and at multiple timepoints (up to 8 hours) postdose

  24. AUCt: Area Under the Concentration Time Curve From Time 0 to Time t for Alisertib as Enteric Coated Tablet (ECT) With Once Daily for 14 Days (QD14D) Dosing at Day 14

    Measured: Cycle 1 Day 14 predose and at multiple timepoints (up to 8 hours) postdose

  25. Terminal Half Life for Alisertib as Enteric Coated Tablet (ECT) With Once Daily for 14 Days (QD14D) Dosing at Day 14

    Measured: Cycle 1 Day 14 predose and at multiple timepoints (up to 8 hours) postdose

  26. Peak/Trough Ratio for Alisertib as Enteric Coated Tablet (ECT) With Once Daily for 14 Days (QD14D) Dosing at Day 14

    Measured: Cycle 1 Day 14 predose and at multiple timepoints (up to 8 hours) postdose

  27. CLss/F: Apparent Oral Clearance at Steady State for Alisertib as Enteric Coated Tablet (ECT) With Once Daily for 14 Days (QD14D) Dosing at Day 14

    Measured: Cycle 1 Day 14 predose and at multiple timepoints (up to 8 hours) postdose

  28. Cmax: Maximum Observed Concentration for Alisertib as Enteric Coated Tablet (ECT) With Twice Daily for 7 Days (BID7D) Dosing at Day 1

    Measured: Cycle 1 Day 1 predose and at multiple timepoints (up to 12 hours) postdose

  29. Cmax: Maximum Observed Concentration for Alisertib as Enteric Coated Tablet (ECT) With Twice Daily for 7 Days (BID7D) Dosing at Day 7

    Measured: Cycle 1 Day 7 predose and at multiple timepoints (up to 12 hours) postdose

  30. Tmax: Time of First Occurrence of Cmax for Alisertib as Enteric Coated Tablet (ECT) With Twice Daily for 7 Days (BID7D) Dosing at Day 1

    Measured: Cycle 1 Day 1 predose and at multiple timepoints (up to 12 hours) postdose

  31. Tmax: Time of First Occurrence of Cmax for Alisertib as Enteric Coated Tablet (ECT) With Twice Daily for 7 Days (BID7D) Dosing at Day 7

    Measured: Cycle 1 Day 7 predose and at multiple timepoints (up to 12 hours) postdose

  32. AUCt: Area Under the Concentration Time Curve From Time 0 to Time t for Alisertib as Enteric Coated Tablet (ECT) With Twice Daily for 7 Days (BID7D) Dosing at Day 1

    Measured: Cycle 1 Days 1 predose and at multiple timepoints (up to 12 hours) postdose

  33. AUCt: Area Under the Concentration Time Curve From Time 0 to Time t for Alisertib as Enteric Coated Tablet (ECT) With Twice Daily for 7 Days (BID7D) Dosing at Day 7

    Measured: Cycle 1 Day 7 predose and at multiple timepoints (up to 12 hours) postdose

  34. Terminal Half-Life (t1/2) for Alisertib as Enteric Coated Tablet (ECT) With Twice Daily for 7 Days (BID7D) Dosing at Day 7

    Measured: Cycle 1 Day 7 predose and at multiple timepoints (up to 12 hours) postdose

  35. Accumulation Ratio (Rac) for Alisertib as Enteric Coated Tablet (ECT) With Twice Daily for 7 Days (BID7D) Dosing at Day 7

    Measured: Cycle 1 Day 7 predose and at multiple timepoints (up to 12 hours) postdose

  36. Peak/Trough Ratio for Alisertib as Enteric Coated Tablet (ECT) With Twice Daily for 7 Days (BID7D) Dosing at Day 7

    Measured: Cycle 1 Day 7 predose and at multiple timepoints (up to 12 hours) postdose

  37. CLss/F: Apparent Oral Clearance at Steady State for Alisertib as Enteric Coated Tablet (ECT) With Twice Daily for 7 Days (BID7D) Dosing at Day 7

    Measured: Cycle 1 Day 7 predose and at multiple timepoints (up to 12 hours) postdose

Secondary outcomes (4)

  1. Best Overall Response Rate Based on Investigator's Assessment

    Best overall response rate is defined as the percentage of participants with complete response (CR) or partial response (PR) as assessed by the Investigator using International Working Group (IWG) Criteria. CR is defined as the disappearance of all evidence of disease and the definition for PR includes at least a 50% decrease in sum of the product of the diameters and no new lesions.

    Measured: Baseline and every 2 cycles up to Month 12 until disease progression, 30 days after end of treatment (up to 422 days)

  2. Duration of Response (DOR)

    DOR is defined as the time from the date of first documentation of a response (either CR or PR) to the date of first documentation of progressive disease (PD) according to International Working Group (IWG) criteria. CR is defined as the disappearance of all evidence of disease and the definition for PR includes at least a 50% decrease in sum of the product of the diameters and no new lesions. PD is defined as any new lesion or increase by >50% of previously involved sites from nadir.

    Measured: Baseline and every 2 cycles up to Month 12 until disease progression, 30 days after end of treatment (up to 422 days)

  3. Number of Participants With Polymorphisms in Gene Encoding Enzyme UGT1A1

    One peripheral blood sample (approximately 4 mL) was to be obtained on Day 1 of Cycle 1 prior to the first dose of alisertib to genotype participants for polymorphisms in UGT1A1 because UGT1A1 is one of the enzymes responsible for glucuronidation of alisertib, which is expected to contribute to the clearance of alisertib.

    wt=wild type. *28=polymorphism in the promoter region of a UGT1A1 allele resulting in reduced UGT1A1 expression. Not determined = blood sample was not evaluable.

    Measured: Cycle 1 Day 1 predose

  4. Number of Participants With Polymorphisms in Aurora A Kinase

    Measured: Cycle 1 Day 1 predose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2008 (estimated)
  2. Study start11 Jul 2008
  3. Primary completion1 Oct 2016
  4. Study completion19 Oct 2016

Resources

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
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00697346
Sponsor's protocol ID
C14003
Other IDs
U1111-1187-1184
Status last verified
Feb 2019
First submitted
11 Jun 2008
Last updated
31 May 2019
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Kelly KR, Shea TC, Goy A, Berdeja JG, Reeder CB, McDonagh KT, Zhou X, Danaee H, Liu H, Ecsedy JA, Niu H, Benaim E, Iyer SP. Phase I study of MLN8237--investigational Aurora A kinase inhibitor--in relapsed/refractory multiple myeloma, non-Hodgkin lymphoma and chronic lymphocytic leukemia. Invest New Drugs. 2014 Jun;32(3):489-99. doi: 10.1007/s10637-013-0050-9. Epub 2013 Dec 20.

    PubMed 24352795

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Alisertib in people with B-cell Follicular Lymphoma and B-cell Marginal Zone Lymphoma, run by Millennium Pharmaceuticals, Inc. at 10 sites in United States.

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 17 inclusion and 13 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 May 2019. 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 United States. 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?

Yes. Results are posted in the registry (first posted 31 May 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?

Number of Participants With Dose-Limiting Toxicity (DLT) (time frame: From first dose of study drug to 30 days after the last dose (up to 422 days)). The study lists 37 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 NCT00697346, 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 31 May 2019.

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