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Acute Myeloid LeukemiaPhase 3NCT02920008

Phase 3 Randomized, Open-Label Study of Guadecitabine vs Treatment Choice in Previously Treated Acute Myeloid Leukemia

A Phase 3 study testing guadecitabine and Treatment Choice (TC) in people with Acute Myeloid Leukemia, run by Astex Pharmaceuticals, Inc. at 95 sites in 15 countries.

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

Multicenter, randomized, open-label, parallel-group study of guadecitabine vs treatment choice (TC). Participants will be randomly assigned in a 1:1 ratio to either guadecitabine or TC. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
guadecitabine and Treatment Choice (TC)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
302 participants
Where
95 sitesin 15 countries
Study dates
16 Mar 2017to 1 Jun 2020
Phase
Phase 3
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

  • Adult participants ≥18 years of age who are able to understand study procedures, comply with them, and provide written informed consent before any study-specific procedure.
  • History of cytologically or histologically confirmed diagnosis of AML (except acute promyelocytic leukemia) according to the 2008 World Health Organization (WHO) classification (bone marrow [BM] or peripheral blood [PB] blast counts ≥20%).
  • Performance status (Eastern Cooperative Oncology Group; ECOG) of 0-2.
  • Participants with AML previously treated with initial induction therapy using a standard intensive chemotherapy regimen, including cytarabine and an anthracycline, and who are refractory to initial induction (primary refractory) or in relapse after such initial induction with or without prior HCT.
  • Participants must have either PB or BM blasts ≥5% at time of randomization.
  • Creatinine clearance or glomerular filtration rate ≥30 mL/min as estimated by the Cockroft-Gault (C-G) or other medically acceptable formulas, such as MDRD (Modification of Diet in Renal Disease) or CKD-EPI (the Chronic Kidney Disease Epidemiology Collaboration).
  • Women of child-bearing potential must not be pregnant or breastfeeding and must have a negative pregnancy test at screening. Women of child-bearing potential and men with female partners of child-bearing potential must agree to practice 2 highly effective contraceptive measures of birth control and must agree not to become pregnant or father a child (a) while receiving treatment of guadecitabine, decitabine, or azacitidine and for at least 3 months after completing treatment and (b) while receiving treatment with high-intensity TC or LDAC and for at least 6 months after completing treatment.

Who cannot join

  • Known clinically active central nervous system (CNS) or extramedullary AML, except leukemia cutis.
  • Participants who are in first relapse after initial induction, if they had a response duration of >12 months from date when first response first documented or if they are good candidates for HCT.
  • BCR-ABL-positive leukemia (chronic myelogenous leukemia in blast crisis).
  • Second malignancy currently requiring active therapy, except breast or prostate cancer stable on or responding to endocrine therapy.
  • Grade 3 or higher Graft Versus Host Disease (GVHD), or GVHD on either a calcineurin inhibitor or prednisone more than 5 mg/day.
  • Prior treatment with guadecitabine for any indication, or more than 2 cycles of prior decitabine or azacitidine.
Show all 13Show fewer
  • Hypersensitivity to decitabine, guadecitabine, or any of their excipients.
  • Treated with any investigational therapy within 2 weeks of the first dose of study treatment.
  • Total serum bilirubin >2.5 × upper limit of normal (ULN; except for participants with Gilbert's Syndrome for whom direct bilirubin is <2.5 × ULN), or liver cirrhosis, or chronic liver disease Child-Pugh Class B or C.
  • Known active human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection. Inactive hepatitis carrier status or low viral hepatitis titer on antivirals is allowed.
  • Known significant mental illness or other condition such as active alcohol or other substance abuse or addiction that, in the opinion of the investigator, predisposes the participant to high risk of noncompliance with the protocol.
  • Refractory congestive heart failure unresponsive to medical treatment; active infection resistant to all antibiotics; or non-AML-associated pulmonary disease requiring >2 liters per minute (LPM) oxygen, or any other condition that puts the participant at an imminent risk of death.
  • Participants with high PB blasts >50% AND poor ECOG PS of 2.

Trial locations and contacts

95 sites in 15 countries.

95 sites in 15 countries

Japan17 sites

  • Akita University Hospital

    Akita, 010-8543

  • Chugoku Central Hospital

    Fukuyama-Shi, 720-0001

  • Tokai University Hospital

    Isehara-shi, 259-1193

  • Saitama Medical Center

    Kawagoe-Shi, 350-8550

  • Kobe City Medical Center General Hospital

    Kobe, 650-0047

  • Japanese Red Cross Kyoto Daini Hospital

    Kyoto, 602-8026

  • University Hospital, Kyoto Prefectural University of Medicine

    Kyoto, 602-8566

  • Gunmaken Saiseikai Maebashi Hospital

    Maebashi, 371-0821

  • Nagasaki University Hospital

    Nagasaki, 852-8501

  • The Japanese Red Cross Nagasaki Genbaku Hospital

    Nagasaki, 852-8511

  • Kindai University Hospital

    Osakasayama-Shi, 589-8511

  • Saga University Hospital

    Saga, 849-8501

  • NTT Medical Center Tokyo

    Shinagawa-Ku, 141-8625

  • Shizuoka Cancer Center

    Shizuoka, 411-8777

  • National Hospital Organization Disaster Medical Center

    Tachikawa-Shi, 190-0014

  • Yamagata University Hospital

    Yamagata, 990-9585

  • University of Fukui Hospital

    Yoshida-Gun, 910-1193

Other trials in Japan

United States15 sites

  • University of New Mexico School of Medicine

    Albuquerque, New Mexico, 87106

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • The University of Chicago Medical Center

    Chicago, Illinois, 60637

  • Baylor Research Institute

    Dallas, Texas, 75246

  • Duke Cancer Institute

    Durham, North Carolina, 27710

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey, 07601-1915

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Franciscan Research Center

    Indianapolis, Indiana, 46237

  • University of Southern California

    Los Angeles, California, 90033

  • West Virginia University Hospitals, Inc.

    Morgantown, West Virginia, 26506

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Weill Cornell Medical College

    New York, New York, 10021

  • University of Oklahoma Medical Center

    Oklahoma City, Oklahoma, 73104-5418

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19111-2433

Other trials in United States

Spain11 sites

  • Hospital Clínic de Barcelona

    Barcelona, 8036

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 8041

  • Hospital Duran i Reynals

    Barcelona, 8907

  • Vall d'Hebron Institut d'Oncologia

    Barcelona

  • Hospital San Pedro de Alcántara

    Cáceres, 10003

  • Hospital Universitario Reina Sofía

    Córdoba, 14004

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007

  • Hospital Universitario Central de Asturias

    Oviedo, 33011

  • Hospital Universitario Virgen del Rocío

    Seville, 41013

  • Hospital Universitario Dr. Peset

    Valencia, 46017

  • Hospital Universitari i Politècnic La Fe

    Valencia, 46026

Other trials in Spain

France9 sites

  • Centre Hospitalier de la Côte Basque

    Bayonne, 64100

  • Hôpital de la Conception

    Marseille, 13385

  • CHRU Montpellier - Saint Eloi

    Montpellier, 34295

  • Groupe Hospitalier de la Région de Mulhouse et Sud Alsace

    Mulhouse, 68100

  • Hôpital Saint-Louis

    Paris, 75475

  • CHU Hopitaux de Bordeaux - Hôpital Haut-Lévêque

    Pessac, 33604

  • Centre Hospitalier Lyon-Sud

    Pierre-Bénite, 69310

  • Centre Henri Becquerel

    Rouen, 76038

  • Institut Universitaire du Cancer de Toulouse - Oncopole

    Toulouse, 31059

Other trials in France

Germany8 sites

  • Städtisches Klinikum Braunschweig gGmbH

    Braunschweig, 38114

  • Marien Hospital Düsseldorf GmbH

    Düsseldorf, 40479

  • Universitätsklinikum Halle (Saale)

    Halle, 6120

  • Universitätsklinikum Schleswig-Holstein

    Kiel, 24105

  • Universitätsklinikum Leipzig

    Leipzig, Saxony, 4103

  • Medizinischen Fakultät Mannheim der Universität Heidelberg

    Mannheim

  • Klinikum der Universität München

    München, 81377

  • Universitätsklinikum Ulm

    Ulm, 89081

Other trials in Germany

South Korea7 sites

  • Pusan National University Hospital

    Busan, 49241

  • Seoul National University Hospital

    Seoul, 3080

  • Severance Hospital

    Seoul, 3722

  • Asan Medical Center

    Seoul, 5505

  • Samsung Medical Center

    Seoul, 6351

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul, 6591

  • Ulsan University Hospital (UUH)

    Ulsan, 44033

Other trials in South Korea

Canada5 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2V2

  • McGill University Health Centre

    Montreal, Quebec, H4A 3J1

  • Hopital Maisonneuve Rosemont

    Montreal, H1T 2M4

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2C1

Other trials in Canada

Hungary5 sites

  • SE ÁOK I. sz. Belgyógyászati Klinika

    Budapest, 1083

  • Debreceni Egyetem Klinikai Központ

    Debrecen, 4032

  • Somogy Megyei Kaposi Mór Oktató Kórház

    Kaposvár, 7400

  • Pecsi Tudomanyegyetem Klinikai Központ

    Pécs

  • Szegedi Tudományegyetem

    Szeged, 6725

Other trials in Hungary

Italy5 sites

  • IRCCS AOU San Martino - IST

    Genova, 16132

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

    Milan, 20122

  • Ospedale San Raffaele - Milano

    Milan, 20132

  • A.O.R.N. "A. Cardarelli"

    Naples, 80131

  • A.S.U Integrata di Udine - Presidio Ospedaliero Santa Maria della Misericordia

    Udine, 33100

Other trials in Italy

United Kingdom4 sites

  • Heart of England NHS Foundation Trust - Heartlands Hospital

    Birmingham, B9 5SS

  • University Hospitals Bristol NHS Foundation Trust - Bristol Haematology and Oncology Centre

    Bristol, BS2 8ED

  • East Kent Hospitals University NHS Foundation Trust - Kent and Canterbury Hospital

    Canterbury, CT1 3NG

  • St. James's University Hospital

    Leeds, LS9 7TF

Other trials in United Kingdom

Belgium3 sites

  • AZ Sint-Jan Brugge-Oostende AV

    Bruges, 8000

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • Universitair Ziekenhuis Gent

    Ghent, 9000

Other trials in Belgium

Denmark2 sites

  • Aarhus University Hospital

    Aarhus C, 8000

  • Rigshospitalet

    Copenhagen, 2100

Other trials in Denmark

Ukraine2 sites

  • Khmelnytskyi Regional Hospital

    Khmelnytskyi, 29000

  • Poltava Regional Clinical Hospital named after M. V. Sklifosovskoho

    Poltava, 36011

Other trials in Ukraine

Poland1 site

  • Instytut Hematologii i Transfuzjologi

    Warsaw, 02-776

Other trials in Poland

Sweden1 site

  • Sahlgrenska University Hospital

    Gothenburg, 413 45

Other trials in Sweden

About this study

Official title: A Phase 3, Multicenter, Randomized, Open-Label Study of Guadecitabine (SGI-110) Versus Treatment Choice in Adults With Previously Treated Acute Myeloid Leukemia

Multicenter, randomized, open-label, parallel-group study of guadecitabine vs treatment choice (TC). Participants will be randomly assigned in a 1:1 ratio to either guadecitabine or TC. TC options include the 8 high or low intensity, locally available regimens below; or Best supportive Care (BSC) alone:

  • High intensity (intermediate or high dose cytarabine [HiDAC]; mitoxantrone, etoposide, and cytarabine [MEC]; or fludarabine, cytarabine, granulocyte colony stimulating factor [G-CSF], +/- idarubicin [FLAG/FLAG-Ida]).
  • Low intensity (low dose cytarabine [LDAC], decitabine, or azacitidine).
  • BSC.
Read the detailed description

This Phase 3, randomized, open-label, parallel-group multicenter study of the efficacy and safety of guadecitabine in adults with previously treated acute myeloid leukemia (AML) will be conducted in approximately 20 countries. There will be a 14-day screening period, a treatment period, a safety follow-up visit, and a long-term follow-up period. The study is expected to last approximately 2 years. Duration of individual participant participation will vary, and participants may continue to receive treatment for as long as they continue to benefit.

Approximately 404 participants from approximately 100 study centers will be randomly assigned to either guadecitabine or treatment choice (TC) in a 1:1 ratio (approximately 202 participants per group). TC is as follows:

  • High intensity: intermediate or high dose cytarabine (HiDAC); mitoxantrone, etoposide, and cytarabine (MEC); or fludarabine, cytarabine, G-CSF, +/- idarubicin (FLAG/FLAG-Ida).
  • Low intensity: low dose cytarabine (LDAC), decitabine, or azacitidine.
  • Best Supportive Care (BSC).

Guadecitabine will be given subcutaneous (SC) at a dose of 60 microgram per meter square (mg/m^2) in 28-day cycles. In Cycle 1, guadecitabine will be given for 10 days on Days 1-5 and Days 8-12. Cycle 2 will be either the 5-day regimen (Days 1-5) or 10-day regimen (Days 1-5 and 8-12) based on assessment of disease response and hematologic recovery at the end of Cycle 1. In subsequent cycles, guadecitabine treatment will be for 5 days only (Days 1-5).

Being tested
guadecitabine, Treatment Choice (TC)
Keywords
AML, acute myeloid leukemia, guadecitabine, SGI-110, Phase 3
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.

  • guadecitabineDrug

    Also called SGI-110

    In Cycle 1, guadecitabine will be given for 10 days on Days 1-5 and Days 8-12. In Cycle 2, the guadecitabine dose will be 60 mg/m^2 for either 10 days (Days 1-5 and 8-12) or 5 days (Days 1-5 only) based on assessment of disease response, and hematological recovery by Day ≥28.

  • Treatment Choice (TC)Drug

    • High intensity: intermediate or high dose cytarabine (HiDAC); mitoxantrone, etoposide, and cytarabine (MEC); or fludarabine, cytarabine, G-CSF, +/- idarubicin (FLAG/FLAG-Ida).
    • Low intensity: low dose cytarabine (LDAC), decitabine, or azacitidine.
    • Best Supportive Care (BSC).
Study groups in NCT02920008
Study groupRoleWhat they receive
guadecitabineExperimentalGuadecitabine will be given SC at a dose of 60 mg/m^2 in 28-day cycles (delayed as necessary to allow blood count recovery).
Receives: Drug: guadecitabine
Treatment Choice (TC)Active comparator1. High intensity 2. Low intensity 3. Best supportive care (BSC).
Receives: Drug: Treatment Choice (TC)

What is being measured

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

  1. Overall Survival

    Overall survival is defined as number of days from day of randomization to date of death, regardless of cause.

    Measured: From the date of randomization until the date of death, or approximately 34 months

Secondary outcomes (13)

  1. Event-Free Survival

    Event-free survival is defined as number of days from randomization to earliest date of treatment discontinuation (for reasons other than initiation of hematopoietic cell transplant [HCT]), start of alternative anti-leukemia therapy (except HCT), or death.

    Measured: From the date of randomization until the date of death, or approximately 38 months

  2. Long-Term Survival

    Survival rate at 1 year after randomization; participants were also followed to estimate 2-year survival rate.

    Measured: Up to approximately 38 months

  3. Number of Days Alive and Out of the Hospital (NDAOH)

    Number of days participants alive and out of hospital during first 6 months of the study.

    Measured: 6 months

  4. Transfusion Independence Rate

    Number of participants without red blood cells (RBC) or platelet transfusion for any 8-week period after treatment divided by total number of participants in efficacy analysis.

    Measured: Baseline up to approximately 38 months

  5. Complete Response Rate

    The Complete response (CR) rate based on modified International Working Group (IWG) 2003 AML Response Criteria was calculated as the number of participants with a best response of CR divided by the total number of participants included in the efficacy analysis. CR as per modified 2003 IWG AML Response Criteria is absolute neutrophil count (ANC) ≥1000/μL, platelets ≥100,000/μL, independence from red blood cells (RBC) and platelet transfusions over the past week, no leukemic blasts in peripheral blood and bone marrow should contain less than 5% blast cells.

    Measured: Baseline to end of treatment, or approximately 38 months

  6. Combined Complete Response and Complete Response With Partial Hematologic Recovery Rate

    The combined CR and CR with partial hematologic recovery rate based on modified International Working Group (IWG) 2003 AML Response Criteria was calculated as number of participants with CR and CR with partial hematologic recovery divided by the total number of participants included in the efficacy analysis. CR as per modified 2003 IWG AML Response Criteria is absolute neutrophil count (ANC) ≥1000/μL, platelets ≥100,000/μL, independence from red blood cells (RBC) and platelet transfusions over the past week, no leukemic blasts in peripheral blood and bone marrow should contain less than 5% blast cells.

    Measured: Baseline to end of treatment, or approximately 38 months

  7. Composite Complete Response Rate

    Composite complete response rate based on modified IWG 2003 AML Response Criteria defined as number of participants with best response of CR, CR with incomplete platelet recovery (CRp), or CR with incomplete blood count recovery (CRi) divided by total number of participants in efficacy analysis. CR as per modified 2003 IWG AML Response Criteria is ANC ≥1000/μL, platelets ≥100,000/μL, independence from RBC and platelet transfusions over the past week, no leukemic blasts in peripheral blood and bone marrow should contain less than 5% blast cells. CRp is defined as ANC ≥1000/μL, Platelets <100,000/μL, independence from RBC transfusions over the past week, no leukemic blasts and bone marrow should contain less than 5% blast cells. CRi is defined as ANC <1000/μL, no leukemic blasts and bone marrow should contain less than 5% blast cells.

    Measured: Baseline to end of treatment, or approximately 38 months

  8. Hematopoietic Cell Transplant (HCT) Rate

    Number of participants who received HCT after randomization divided by total number of participants in efficacy analysis.

    Measured: Baseline to long term follow-up or approximately 38 months

  9. Duration of Complete Response (CR) + CR With Partial Hematologic Recovery (CRh)

    The time from first CR or CRh to time of relapse (the date of the earliest of the following 3 events):

    1. relapse (defined as the earliest time point whereby BM assessment or PB assessment by the investigator indicate relapse/disease progression due to confirmed reappearance of leukemic blasts in PB or ≥5% leukemic blasts in BM, or clinical progression determined by the investigator),
    2. start of alternative therapy (except HCT) or
    3. death.

    Measured: Baseline to end of treatment, or approximately 38 months

  10. Change From Baseline in EuroQoL-5 Dimension 5 Level (EQ-5D-5L) Index Scores

    Index score is calculated based on 5-level version of the EQ-5D descriptive system using the value set for England.

    The range of index score is from -0.281 (for the worst health state, score of 5 for all categories) to 1 (for the best health state, score of 1 for all categories).

    Measured: Baseline to 6 months

  11. Change in EQ-5D-5L Visual Analogue Scale (VAS) Score

    VAS score is obtained using vertical 20-cm visual analogue scale with the top value of 100 labelled as 'the best health you can imagine' and the bottom value of 0 labelled as 'the worst health you can imagine'.

    Measured: Baseline to 6 months

  12. Percentage of Participants With Adverse Events (AEs)

    An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including a clinically significant abnormal finding in laboratory tests or other diagnostic procedures), symptom, or disease temporally associated with the use of a drug, without any judgment about causality.

    Measured: From first dose until 30 days after the last dose of study drug, or approximately 38 months

  13. All-Cause Mortality

    All-cause mortality in the first 30 days and first 60 days after the start of treatment divided by the total number of participants receiving at least one dose of study treatment.

    Measured: From the first dose until 60 days after the first dose of study drug

Timeline

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

  1. First posted30 Sep 2016 (estimated)
  2. Study start16 Mar 2017
  3. Primary completion20 Jan 2020
  4. Study completion1 Jun 2020

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
302 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02920008
Sponsor's protocol ID
SGI-110-06
Status last verified
Jul 2024
First submitted
28 Sep 2016
Last updated
28 Aug 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Roboz GJ, Sanz G, Griffiths EA, Yee K, Kantarjian H, Recher C, Byrne MT, Patkowska E, Kim HJ, Thomas X, Moors I, Stock W, Illes A, Fenaux P, Miyazaki Y, Yamauchi T, O'Connell CL, Hao Y, Keer HN, Azab M, Dohner H. Guadecitabine vs TC in relapsed/refractory AML after intensive chemotherapy: a randomized phase 3 ASTRAL-2 trial. Blood Adv. 2024 Apr 23;8(8):2020-2029. doi: 10.1182/bloodadvances.2023012062.

    PubMed 38231126

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing guadecitabine and Treatment Choice (TC) in people with Acute Myeloid Leukemia, run by Astex Pharmaceuticals, Inc. at 95 sites in 15 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 7 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 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 95 sites in Japan, United States, Spain, France, Germany and 10 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 25 May 2023). 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?

Overall Survival (time frame: From the date of randomization until the date of death, or approximately 34 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 NCT02920008, 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 28 Aug 2024.

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