Acute Myeloid LeukemiaPhase 2NCT02520011

Alvocidib Biomarker-driven Phase 2 AML Study

A Phase 2 study testing Alvocidib, Cytarabine and Mitoxantrone in people with Acute Myeloid Leukemia, run by Sumitomo Pharma America, Inc. at 38 sites in 4 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

The purpose of this two-stage Phase 2 study is to assess the clinical response (Complete Remission) of ACM (Alvocidib/Cytarabine/Mitoxantrone) compared to CM (Cytarabine/Mitoxantrone) treatment in refractory or relapsed AML patients with demonstrated MCL-1 dependence of ≥ 30% by mitochondrial profiling in bone marrow. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Acute Myeloid Leukemia
What is being tested?: Alvocidib, Cytarabine and Mitoxantrone
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 104 participants
Where: 38 sitesin 4 countries
Study dates: 14 Mar 2016to 12 Feb 2020
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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Be between the ages of ≥18 and ≤65 years
Have an established, pathologically confirmed diagnoses of AML by World Health Organization (WHO) criteria excluding acute promyelocytic leukemia (APL-M3) with a bone marrow of >5% blasts based on histology or flow cytometry
Be in first relapse (within 24 months of CR) or have failed induction therapy* (no CR or CRi after treatment with an intensive regimen (eg, anthracycline/cytarabine ± etoposide, gemtuzumab ozogamicin, or cladribine).
Induction therapy may involve 1 or 2 cycles of the same regimen. Efficacy assessment of induction therapy must be >21 days from the start of the previous induction cycle.
Demonstrate MCL-1 dependence of ≥30% by mitochondrial profiling in bone marrow.
Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤2

Show all 13Show fewer

Have a serum creatinine level ≤1.8 mg/dL
Have an alanine aminotransferase (ALT)/aspartate aminotransferase (AST) level ≤5 times upper limit of normal (ULN)
Have a total bilirubin level ≤2.0 mg/dL (unless secondary to Gilbert syndrome, hemolysis, or leukemia)
Have a left ventricular ejection fraction (LVEF) >45% by echocardiogram (ECHO) or multigated acquisition (MUGA) scan
Be nonfertile or agree to use an adequate method of contraception. Sexually active patients and their partners must use an effective method of contraception associated with a low failure rate during and for at least 6 months after completion of study therapy.
Be able to comply with the requirements of the entire study.
Provide written informed consent prior to any study related procedure.

Who cannot join

Received more than 2 cycles of induction therapy for AML. Investigational agents as part of front-line therapy for AML may by acceptable following discussion with the Medical Monitor. Hydroxyurea is permitted (see #5 below).
Received any previous treatment with alvocidib or any other CDK inhibitor
Received a hematopoietic stem cell transplant within the previous 2 months
Have clinically significant graft versus host disease (GVHD), or GVHD requiring initiation or escalation of treatment within the last 21 days
Require concomitant chemotherapy, radiation therapy, or immunotherapy. Hydroxyurea is allowed up to the evening before starting (but not within 12 hours) of starting treatment on either arm.
Received >360 mg/m2 equivalents of daunorubicin

Show all 17Show fewer

Have a peripheral blast count of >30,000/mm3 (may use hydroxyurea as in #5 above)
Received antileukemic therapy within the last 3 weeks (with the exception of hydroxyurea or if the patient has definite refractory disease). Refractory patients who received therapy within the last 3 weeks may be eligible with prior approval of the Medical Monitor.
Diagnosed with acute promyelocytic leukemia (APL, M3)
Have active central nervous system (CNS) leukemia
Have evidence of uncontrolled disseminated intravascular coagulation
Have an active, uncontrolled infection
Have other life-threatening illness
Have other active malignancies or diagnosed with other malignancies within the last 6 months, except nonmelanoma skin cancer or cervical intraepithelial neoplasia
Have mental deficits and/or psychiatric history that may compromise the ability to give written informed consent or to comply with the study protocol.
Are pregnant and/or nursing
Have received any live vaccine within 14 days prior to first study drug administration.

Trial locations and contacts

38 sites in 4 countries.

Country

City, postcode or hospital

38 sites in 4 countries

United States26 sites

University of Michigan
Ann Arbor, Michigan, 48109
Northside Hospital
Atlanta, Georgia, 30342
Sidney Kimmel Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287
Roswell Park Cancer Center Institute
Buffalo, New York, 14263
University of North Carolina
Chapel Hill, North Carolina, 27599
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Ohio State University
Columbus, Ohio, 43210
Baylor Sammons Cancer Center
Dallas, Texas, 75246
Duke
Durham, North Carolina, 27710
East Carolina University
Greenville, North Carolina, 27858
Hudson Valley Cancer Center
Hawthorne, New York, 10532
MD Anderson Cancer Center
Houston, Texas, 77030
University of Iowa
Iowa City, Iowa, 52242
Mayo Clinic Florida
Jacksonville, Florida, 32224
University of California Los Angeles (UCLA)
Los Angeles, California, 90095
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Morristown Cancer Center
Morristown, New Jersey, 07960
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Columbia University Medical Center
New York, New York, 10032
University of Nebraska Medical Center
Omaha, Nebraska, 68198
West Penn Allegheny Hospital
Pittsburgh, Pennsylvania, 15224
Mayo Clinic Rochester
Rochester, Minnesota, 55905
University of California San Diego UCSD
San Diego, California, 92093-2024
Honor Health Research Institute
Scottsdale, Arizona, 85258
University of Kansas Medical Center
Westwood, Kansas, 66205

Other trials in United States

Spain8 sites

Complejo Hospitalario Universitario de Albacete
Albacete, 02006
Institut Catala d'Oncologia
Badalona
Hospital Clinic de Barcelona
Barcelona, 08036
Hospital San Pedro de Alcantara
Cáceres
Hospital Regional Universitario de Malaga
Málaga, Malaga, 29010
Hospital Universitario Central de Asturias - HUCA
Oviedo, 33011
Hospital Clinico Universitario de Salamanca
Salamanca, 37007
Hospital Universitari i Politècnic La Fe
Valencia

Other trials in Spain

United Kingdom3 sites

Univ Hospital of Bristol
Bristol
University Hospitals of Wales
Cardiff, Wales, CF10 3NS
Guys Hospital St. Thomas
London

Other trials in United Kingdom

Canada1 site

Princess Margaret Cancer Center
Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: Phase 2, Randomized, Biomarker-driven Clinical Study in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With MCL-1 Dependence ≥30%

Read the detailed description

In Stage 1 of the study, all eligible AML patients with demonstrated MCL-1 dependence of ≥ 30% by mitochondrial profiling in bone marrow will receive treatment with ACM.

In Stage 2, all eligible AML patients with demonstrated MCL-1 dependence of ≥ 30% by mitochondrial profiling in bone marrow will be randomized 1:1 to receive either treatment with ACM or CM.

Conditions: Acute Myeloid Leukemia
Being tested: Alvocidib, Cytarabine, Mitoxantrone
Keywords: Refractory AML, Relapsed AML, AML
Medical subject headings: Leukemia, Myeloid, Acute

What participants receive

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

AlvocidibDrug
CytarabineDrug
Also called ara-c
MitoxantroneDrug
Also called mitoxantrone hydrochloride

Study groups in NCT02520011
Study group	Role	What they receive
ACM (Stage 1 / Stage 2)	Experimental	A: alvocidib, 30 mg/m2 as a 30 minute intravenous (IV) bolus followed by 60 mg/m2 over 4 hours as an IV infusion administered daily on Days 1-3; C: cytarabine (ara-c), 2 gm/m2 by continuous IV infusion over 72 hours on Days 6-8; M: mitoxantrone (mitoxantrone hydrochloride), 40 mg/m2 by IV infusion over 1-2 hours starting 12 hours after completing cytarabine Receives: Drug: Alvocidib; Drug: Cytarabine; Drug: Mitoxantrone
CM (Stage 2)	Active comparator	C: cytarabine (ara-c), 2 gm/m2 by continuous IV infusion over 72 hours on Days 1-3; M: mitoxantrone (mitoxantrone hydrochloride), 40 mg/m2 by IV infusion over 1-2 hours starting 12 hours after completing cytarabine Receives: Drug: Cytarabine; Drug: Mitoxantrone

What is being measured

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

Complete Response (CR) Rate in Patients With Relapsed or Refractory AML
Complete Remission (CR) rate = Percentage of patients achieving CR after Cycle 1 as defined in Stage 1 by the International Working Group (IWG) Criteria and 2010 European LeukemiaNet (EN) criteria in patients with relapsed or refractory AML with MCL-1 dependence >30% and in Stage 2 by the 2017 ELN criteria.
The study was terminated in January 2020 due to a steady and marked reduction in enrollment. Thus, the efficacy endpoints could not be analyzed. As sufficient efficacy results were not available to analyze patients based on the percentage of MCL-1 dependency the treatment efficacy was summarized by distributing the safety population into 6 groups based on whether the patients received the ACM vs CM regimen and their disease stages at study entry.
Measured: Best response after at least 1 cycle through study completion approximately 4 years

Timeline

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

14 Mar 201612 Feb 2020

First posted11 Aug 2015 (estimated)
Study start14 Mar 2016
Primary completion12 Feb 2020
Study completion12 Feb 2020

Why it stopped: Due to slow enrollment, the extensive time projected to conclude the study hypothesis rendered the study no longer reasonably feasible to complete.

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 Acute Myeloid 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 104 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02520011
Sponsor's protocol ID: TPI-ALV-201
Status last verified: Nov 2023
First submitted: 6 Aug 2015
Last updated: 15 Nov 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
Venetoclax and HMA Treatment of Older and Unfit Adults With FLT3 Mutated Acute Myeloid Leukemia (AML) (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia
RecruitingPhase 2
Comparing Different Treatment Lengths for Venetoclax in Older People With Newly Diagnosed Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia
Recruiting
Involvement of CDA and/or dCK Metabolizing Enzymes in the Response to Azacytidine Treatment of Patients With Hematologic Malignancies
Myelodysplastic Syndromes (MDS), Leukemia Acute Myeloid - AML
RecruitingPhase 2
Comparing Cytarabine + Daunorubicin Therapy Versus Cytarabine + Daunorubicin + Venetoclax Versus Venetoclax + Azacitidine in Younger Patients With Intermediate Risk AML (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia
RecruitingPhase 1/2
CLN-049 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
Relapsed/Refractory Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS)

All Acute Myeloid Leukemia trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 2, Randomized, Biomarker-driven Clinical Study in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With MCL-1 Dependence ≥30%
ClinicalTrials.gov ID: NCT02520011
Acronym / sponsor ID: TPI-ALV-201
Conditions: Acute Myeloid Leukemia
Keywords: Refractory AML, Relapsed AML, AML
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Due to slow enrollment, the extensive time projected to conclude the study hypothesis rendered the study no longer reasonably feasible to complete.
Enrolment: 104 participants (actual)
Lead sponsor: Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
Study start: 14 Mar 2016 (actual)
Primary completion: 12 Feb 2020 (actual)
Study completion: 12 Feb 2020 (actual)
First posted: 11 Aug 2015 (estimated)
Results: Posted 15 Jul 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

In Stage 1 of the study, all eligible AML patients with demonstrated MCL-1 dependence of ≥ 30% by mitochondrial profiling in bone marrow will receive treatment with ACM.

In Stage 2, all eligible AML patients with demonstrated MCL-1 dependence of ≥ 30% by mitochondrial profiling in bone marrow will be randomized 1:1 to receive either treatment with ACM or CM.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
ACM (Stage 1 / Stage 2)	Experimental	Drug: Alvocidib, Drug: Cytarabine, Drug: MitoxantroneA: alvocidib, 30 mg/m2 as a 30 minute intravenous (IV) bolus followed by 60 mg/m2 over 4 hours as an IV infusion administered daily on Days 1-3; C: cytarabine (ara-c), 2 gm/m2 by continuous IV infusion over 72 hours on Days 6-8; M: mitoxantrone (mitoxantrone hydrochloride), 40 mg/m2 by IV infusion over 1-2 hours starting 12 hours after completing cytarabine
CM (Stage 2)	Active comparator	Drug: Cytarabine, Drug: MitoxantroneC: cytarabine (ara-c), 2 gm/m2 by continuous IV infusion over 72 hours on Days 1-3; M: mitoxantrone (mitoxantrone hydrochloride), 40 mg/m2 by IV infusion over 1-2 hours starting 12 hours after completing cytarabine

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Be between the ages of ≥18 and ≤65 years
Have an established, pathologically confirmed diagnoses of AML by World Health Organization (WHO) criteria excluding acute promyelocytic leukemia (APL-M3) with a bone marrow of >5% blasts based on histology or flow cytometry
Be in first relapse (within 24 months of CR) or have failed induction therapy* (no CR or CRi after treatment with an intensive regimen (eg, anthracycline/cytarabine ± etoposide, gemtuzumab ozogamicin, or cladribine).
Induction therapy may involve 1 or 2 cycles of the same regimen. Efficacy assessment of induction therapy must be >21 days from the start of the previous induction cycle.
Demonstrate MCL-1 dependence of ≥30% by mitochondrial profiling in bone marrow.

Key exclusion criteria (17 listed)

Received more than 2 cycles of induction therapy for AML. Investigational agents as part of front-line therapy for AML may by acceptable following discussion with the Medical Monitor. Hydroxyurea is permitted (see #5 below).
Received any previous treatment with alvocidib or any other CDK inhibitor
Received a hematopoietic stem cell transplant within the previous 2 months
Have clinically significant graft versus host disease (GVHD), or GVHD requiring initiation or escalation of treatment within the last 21 days
Require concomitant chemotherapy, radiation therapy, or immunotherapy. Hydroxyurea is allowed up to the evening before starting (but not within 12 hours) of starting treatment on either arm.

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
Alvocidib	Drug	ACM (Stage 1 / Stage 2)
CytarabineAlso: ara-c	Drug	ACM (Stage 1 / Stage 2), CM (Stage 2)
MitoxantroneAlso: mitoxantrone hydrochloride	Drug	ACM (Stage 1 / Stage 2), CM (Stage 2)

Primary outcome

Complete Response (CR) Rate in Patients With Relapsed or Refractory AML
Time frame: Best response after at least 1 cycle through study completion approximately 4 years
Complete Remission (CR) rate = Percentage of patients achieving CR after Cycle 1 as defined in Stage 1 by the International Working Group (IWG) Criteria and 2010 European LeukemiaNet (EN) criteria in patients with relapsed or refractory AML with MCL-1 dependence >30% and in Stage 2 by the 2017 ELN criteria. The study was terminated in January 2020 due to a steady and marked reduction in enrollment. Thus, the efficacy endpoints could not be analyzed. As sufficient efficacy results were not available to analyze patients based on the percentage of MCL-1 dependency the treatment efficacy was summarized by distributing the safety population into 6 groups based on whether the patients received the ACM vs CM regimen and their disease stages at study entry.

Results and safety

Results posted to the registry on 15 Jul 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CM Relapsed/Refractory	11	6
ACM Relapsed/Refractory	79	33
ACM Newly Diagnosed	14	5

Primary outcome: Complete Response (CR) Rate in Patients With Relapsed or Refractory AML

Time frame: Best response after at least 1 cycle through study completion approximately 4 years. Number. Unit: participants

Measure	Stage 2 CM Relapsed/Refractory n = 11	Stage 2 ACM Relapsed/Refractory n = 11	Stage 1 ACM Relapsed/Refractory n = 25	Stages 1 and 2 ACM Relapsed/Refractory n = 79	Stage 1 Newly Diagnosed ACM n = 14	All Stages and Cohorts (Including Randomized Stage): ACM Total n = 93
Complete Remission (CR)	6	2	8	21	6	27
CR with Incomplete Neutrophil Recovery (Cri)	0	3	5	15	2	17
Partial Remission (PR)	0	0	1	1	1	2
Resistant/Relapsed Disease	5	5	5	30	4	34
Not Evaluated	0	1	6	12	1	13

Adverse events

Time frame: Beginning at 1st dose of study drug through 30 days of the last administration of study drug, up to 4 years.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CM Relapsed/Refractory	3 of 11 (27.3%)	11 of 11 (100%)	1 of 11
ACM Relapsed/Refractory	31 of 79 (39.2%)	79 of 79 (100%)	11 of 79
ACM Newly Diagnosed	4 of 14 (28.6%)	14 of 14 (100%)	1 of 14
ACM Total	35 of 93 (37.6%)	93 of 93 (100%)	12 of 93

Limitations and caveats (from the sponsor): The protocol underwent a few major amendments to shorten time to complete and allow for an expeditious analysis and reporting of outcomes. The study was terminated early Jan 2020 due to marked decrease in enrollment and thus could not reach all of its efficacy endpoints. Only select analyses could be performed. Treatment efficacy was summarized by distributing the safety population into 6 groups based on whether the patients received ACM or CM regimen and their disease stages at study entry.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Acute Myeloid Leukemia

RecruitingPhase 2
Venetoclax and HMA Treatment of Older and Unfit Adults With FLT3 Mutated Acute Myeloid Leukemia (AML) (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia
RecruitingPhase 2
Comparing Different Treatment Lengths for Venetoclax in Older People With Newly Diagnosed Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia
Recruiting
Involvement of CDA and/or dCK Metabolizing Enzymes in the Response to Azacytidine Treatment of Patients With Hematologic Malignancies
Myelodysplastic Syndromes (MDS), Leukemia Acute Myeloid - AML
RecruitingPhase 2
Comparing Cytarabine + Daunorubicin Therapy Versus Cytarabine + Daunorubicin + Venetoclax Versus Venetoclax + Azacitidine in Younger Patients With Intermediate Risk AML (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia
RecruitingPhase 1/2
CLN-049 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
Relapsed/Refractory Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS)

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.

Stephen Anthony, DO study director

Sumitomo Pharma America, Inc.

38 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Alvocidib, Cytarabine and Mitoxantrone in people with Acute Myeloid Leukemia, run by Sumitomo Pharma America, Inc. at 38 sites in 4 countries.

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 17 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: stopped early, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in United States, Spain, United Kingdom, Canada. 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 15 Jul 2021). 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?

Complete Response (CR) Rate in Patients With Relapsed or Refractory AML (time frame: Best response after at least 1 cycle through study completion approximately 4 years). 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 NCT02520011.

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 15 Nov 2023.