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AMLPhase 1/2VOYAGENCT02152956

Flotetuzumab in Primary Induction Failure (PIF) or Early Relapse (ER) Acute Myeloid Leukemia (AML)

A Phase 1/2 study testing Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off, Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off and Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off in people with AML, run by MacroGenics at 43 sites in 8 countries.

Terminated

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

Official record
Search all trials

Trial summary

Open-label, multi-dose, single-arm, multi-center, Phase 1/2 study conducted in three segments: the Single Patient Dose Escalation Segment (complete), followed by the Multi-Patient Dose Escalation Segment (complete) and the Maximum Tolerated Dose and Schedule (MTDS) Expansion Cohort Segment (closed). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
AML
What is being tested?
Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off, Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off and Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off
Could I receive a placebo?
No, everyone receives an active treatment
How many people
244 participants
Where
43 sitesin 8 countries
Study dates
9 Jun 2014to 5 Jul 2022
Phase
Phase 1/2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Confirmed diagnosis of primary or secondary AML [any subtype except acute promyelocytic leukemia (APL)] according to World Health Organization (WHO) classification
  • Patients with AML must meet one of the following criteria, a or b:
  • Primary Induction Failure (PIF) AML, defined as disease refractory to either, i or ii:
  • i. An intensive induction attempt, per institution. Induction attempts include high-dose and/or standard-dose cytarabine ± an anthracyclines/anthracenedione ± an anti-metabolite, with or without growth factor or targeted therapy containing regimens. Examples include but are not limited to: 1 cycle of high dose cytarabine (HiDAC) containing regimen, 1 cycle of liposomal cytarabine and daunorubicin, 2 cycles of standard dose cytarabine containing regimen
  • ii. For adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy; PIF is defined as AML refractory to one of the following less intensive regimens: i ≥ 2 but ≤ 4 cycles of Bcl-2 inhibitors in combination with azacitidine, decitabine, or low dose cytarabine, or ii ≥ 2 but ≤ 4 cycles of gemtuzumab ozogamicin monotherapy
  • Early relapse (ER) AML, defined as AML in first relapse with initial CR1 duration < 6 months
Show all 11Show fewer
  • Limit of 3 prior lines of therapy (excluding focal radiation therapy for palliative purposes): up to 2 induction (induction, re-induction) or 1 induction plus/minus 1 consolidation attempt, followed by a maximum of 1 salvage/re-induction attempt.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2
  • Life expectancy of at least 4 weeks
  • Peripheral blast count </= 20,000/mm3 at the time of first dose
  • Acceptable laboratory parameters and adequate organ reserve

Who cannot join

  • History of allogeneic stem cell transplantation
  • Prior treatment with an anti-CD123-directed agent
  • Need for concurrent other cytoreductive chemotherapy
  • Any active untreated autoimmune disorders (with the exception of vitiligo, resolved childhood atopic dermatitis, prior Grave's disease now euthyroid clinically and with stable supplementation)
  • Second primary malignancy that requires active therapy. Adjuvant hormonal therapy is allowed.
  • Antitumor therapy or investigational agent within 14 days or 5 half-lives of Cycle 1 Day 1.
Show all 15Show fewer
  • Requirement, at the time of study entry, for concurrent steroids > 10 mg/day of oral prednisone or the equivalent, except steroid inhaler, otic preparations, nasal spray or ophthalmic solution
  • Use of immunosuppressant medications in the 2 weeks prior to Cycle 1 Day 1
  • Use of granulocyte colony stimulating or granulocyte-macrophage colony stimulating factor in the 2 weeks prior to Cycle 1 Day 1
  • Known central nervous system (CNS) leukemia
  • Active uncontrolled infection (including, but not limited to viral, bacterial, fungal, or mycobacterial infection),
  • Known human immunodeficiency virus infection, unless all of the following criteria are met: CD4+ count ≥ 350 cells/μL, undetectable viral load, and receiving highly active antiretroviral therapy.
  • Known, active, history of or current acute or chronic hepatitis B or C virus (HBV) infection (as evidenced by detectable HBV surface antigen and HBV DNA ≥ 500 IU/mL),
  • History of hepatitis C virus (HCV) infection, unless the infection has been treated and cured,
  • Active SARS-CoV-2 infection. While SARS-CoV-2 testing is not mandatory for study entry, testing for ongoing infection should follow local clinical practice guidelines/standards. Participants with a positive test result for ongoing SARS-CoV-2 infection, known asymptomatic infection, or suspected infection are excluded unless or until asymptomatic and with subsequent negative SARS-CoV-2 laboratory test.

Trial locations and contacts

43 sites in 8 countries.

43 sites in 8 countries

United States20 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Emory University

    Atlanta, Georgia, 30322

  • University of Maryland

    Baltimore, Maryland, 21201

  • University of North Carolina Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • City of Hope National Medical Center

    Duarte, California, 91010

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • UCSD Moores Cancer Center

    La Jolla, California, 92093

  • Loyola University Chicago - Cardinal Bernadin Cancer Center

    Maywood, Illinois, 60153

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • UCSF - Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94115

  • University of California, San Francisco

    San Francisco, California, 94143

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Stony Brook Medicine

    Stony Brook, New York, 11794

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • Georgetown University - Lombardi Cancer Center

    Washington D.C., District of Columbia, 20057

Other trials in United States

Germany7 sites

  • Charité - Universitätsmedizin Berlin

    Berlin, 13353

  • Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden

    Dresden, 01307

  • Universitätsklinik Hamburg-Eppendorf

    Hamburg, 20246

  • Universitätsklinikum Leipzig

    Leipzig, 04103

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, 55131

  • III. Med. Klinik-Klinikum rechts der Isar-Technische Universität München

    Munich, 81675

  • Medizinische Klinik und II, Universitätsklinikum Würzburg

    Würzbur, 97080

Other trials in Germany

France4 sites

  • Institut Paoli-Calmettes

    Marseille, 13002

  • Centre Hospitalier Universitaire de Nantes

    Nantes, 44093

  • Institut Universitaire du Cancer de Toulouse-Oncopole

    Toulouse, 31059

  • CHRU de Tours - Hôpital Bretonneau

    Tours, 37044

Other trials in France

Italy4 sites

  • Policlinico Sant'Orsola Malpighi

    Bologna, 40138

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)

    Meldola, 74014

  • University Vita-Salute San Raffaele

    Milan, 20132

  • Unità Operativa di Ematologia Ospedale Santa Maria delle Croci

    Ravenna, 48123

Other trials in Italy

Israel2 sites

  • Rambam Health Care Campus

    Haifa

  • Shaare Zedek Medical Center

    Jerusalem

Other trials in Israel

Netherlands2 sites

  • University Medical Center Groningen

    Groningen, 9713

  • Erasmus University Medical Center

    Rotterdam, 3075

Other trials in Netherlands

Spain2 sites

  • Universitat Autonomaa de Barcelona (UAB) - Hospital de la Santa Creu i de Sant Pau

    Barcelona

  • Hospital Universitario 12 de Octubre

    Madrid

Other trials in Spain

United Kingdom2 sites

  • King's Health Partners

    London

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

Other trials in United Kingdom

About this study

Official title: A Phase 1/2, First in Human, Dose Escalation Study of MGD006, a CD123 x CD3 DART® Bi-Specific Antibody Based Molecule, in Patients With Relapsed or Refractory AML or Intermediate-2/High Risk Myelodysplastic Syndrome (MDS)

Open-label, multi-dose, single-arm, multi-center, Phase 1/2 study conducted in three segments: the Single Patient Dose Escalation Segment (complete), followed by the Multi-Patient Dose Escalation Segment (complete) and the Maximum Tolerated Dose and Schedule (MTDS) Expansion Cohort Segment (closed). Having characterized safety and determined the maximum tolerated dose and schedule, the primary objective of this study now is to assess the anti-neoplastic activity of flotetuzumab in patients with PIF/ER AML, as determined by the proportion of patients who achieve CR or CRh. Starting with Cycle 2, patients who are benefiting from flotetuzumab may receive up to a maximum of 8 cycles of treatment.

Patients will receive daily increasing doses of flotetuzumab for the first week of Cycle 1 (Lead-In Dosing) followed by 3 weeks of continuous intravenous infusion at a the assigned dose. Subsequent cycles are each 4 weeks of continuous infusion at the assigned dose. Dosing may continue for up to 8 cycles. Follow up visits may continue for 6 months after treatment is discontinued.

Conditions
AML
Being tested
Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off, Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off, Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off, Flotetuzumab 100 ng/kg/day, 4 days on and 3 days off, Flotetuzumab 300 ng/kg/day, 4 days on 3 days off, after one-step lead-in dose
Keywords
AML, leukemia, myelogenous, myeloid, refractory
Medical subject headings
Leukemia

What participants receive

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

  • Flotetuzumab 3 ng/kg/day, 4 days on and 3 days offBiological

    Also called MGD006

    Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART® molecule.

  • Flotetuzumab 10 ng/kg/day, 4 days on and 3 days offBiological

    Also called MGD006

    Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART molecule.

  • Flotetuzumab 30 ng/kg/day, 4 days on and 3 days offBiological

    Also called MGD006

    Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART molecule.

  • Flotetuzumab 100 ng/kg/day, 4 days on and 3 days offBiological

    Also called MGD006

    Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART molecule.

  • Flotetuzumab 300 ng/kg/day, 4 days on 3 days off, after one-step lead-in doseBiological

    Also called MGD006

    Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART molecule.

  • Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after one-step lead-in doseBiological

    Also called MGD006

    Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART® molecule.

  • Flotetuzumab 500 ng/kg/day, continuous infusion, after multi-step lead-in doseBiological

    Also called MGD006

    Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART molecule.

  • Flotetuzumab 700 ng/kg/day, 4 days on 3 days off, after multi-step lead-in doseBiological

    Also called MGD006

    Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART molecule.

  • Flotetuzumab 700 ng/kg/day, continuous infusion, after multi-step lead-in doseBiological

    Also called MGD006

    Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART molecule.

  • RuxolitinibDrug

    Also called Jakafi

    Oral inhibitor of JAK kinase

  • Flotetuzumab 300 ng/kg/day, continuous infusion, after multi-step lead-in doseBiological

    Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART molecule.

Study groups in NCT02152956
Study groupRoleWhat they receive
Cohort 0-aExperimentalNot described
Receives: Biological: Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off
Cohort 0-bExperimentalNot described
Receives: Biological: Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off
Cohort 0-cExperimentalNot described
Receives: Biological: Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off
Cohort 0-dExperimentalNot described
Receives: Biological: Flotetuzumab 100 ng/kg/day, 4 days on and 3 days off
Cohort 1ExperimentalNot described
Receives: Biological: Flotetuzumab 300 ng/kg/day, 4 days on 3 days off, after one-step lead-in dose
Cohort 2ExperimentalNot described
Receives: Biological: Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after one-step lead-in dose
Cohort 2aExperimentalNot described
Receives: Biological: Flotetuzumab 500 ng/kg/day, continuous infusion, after multi-step lead-in dose
Cohort 3ExperimentalNot described
Receives: Biological: Flotetuzumab 700 ng/kg/day, 4 days on 3 days off, after multi-step lead-in dose
Cohort 6ExperimentalNot described
Receives: Biological: Flotetuzumab 300 ng/kg/day, continuous infusion, after multi-step lead-in dose
Cohort 7ExperimentalNot described
Receives: Biological: Flotetuzumab 500 ng/kg/day, continuous infusion, after multi-step lead-in dose
Cohort 8ExperimentalNot described
Receives: Biological: Flotetuzumab 700 ng/kg/day, continuous infusion, after multi-step lead-in dose
MTD ExpansionExperimentalNot described
Receives: Biological: Flotetuzumab 500 ng/kg/day, continuous infusion, after multi-step lead-in dose
MTD expansion with RuxolitinibExperimentalNot described
Receives: Biological: Flotetuzumab 500 ng/kg/day, continuous infusion, after multi-step lead-in dose; Drug: Ruxolitinib

What is being measured

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

  1. Efficacy Based on CR or CRh Rate

    Proportion of patients achieving a best response of CR (morphologic CR [mCR], cytogenetic CR [CRc], molecular CR [CRm], or CRh per Interworking Group AML response criteria.

    CR is defined as mCR, CRc, CRm or CRh. mCR is defined as: normal. neutrophil and platelet counts, less than 5% blast cells in a bone marrow (BM) smear and. no extramedullary disease.

    CRc is defined as: CR with no evidence of cytogenetic abnormalities in the bone marrow.

    CRm is defined as: CR with no evidence of molecular abnormalities in the bone marrow.

    CRh is defined as: CR with partial hematologic recovery.

    Measured: up to 14 months

Secondary outcomes (22)

  1. Overall Complete Response Rate

    Rate of CR + CRh + CRi (CR with incomplete blood cell recovery [CR with incomplete neutrophil {CRn}or platelet recovery {CRp}]) + MLFS (morphologic leukemia-free state)

    Measured: up to 14 months

  2. CR Rate

    Proportion of patients achieving a best response of CR (morphologic CR [mCR], cytogenetic CR [CRc], or molecular CR [CRm] per Interworking Group AML response criteria.

    CR is defined as mCR, CRc, CRm or CRh. mCR is defined as: normal. neutrophil and platelet counts, less than 5% blast cells in a bone marrow (BM) smear and. no extramedullary disease.

    CRc is defined as: CR with no evidence of cytogenetic abnormalities in the bone marrow.

    CRm is defined as: CR with no evidence of molecular abnormalities in the bone marrow.

    CRh is defined as: CR with partial hematologic recovery.

    Measured: up to 14 months

  3. CRh Rate

    Proportion of patients achieving a best response of CRh per Interworking Group AML response criteria.

    CRh is defined as: CR with partial hematologic recovery.

    Measured: up to 14 months

  4. Overall Response Rate

    Proportion of patients achieving a best response of CR, CRh, CRi, MLFS or partial response per Interworking Group AML response criteria.

    CR is defined as mCR, CRc, CRm or CRh. mCR is defined as: normal. neutrophil and platelet counts, less than 5% blast cells in a bone marrow (BM) smear and. no extramedullary disease.

    CRc is defined as: CR with no evidence of cytogenetic abnormalities in the bone marrow.

    CRm is defined as: CR with no evidence of molecular abnormalities in the bone marrow.

    CRh is defined as: CR with partial hematologic recovery.

    Measured: up to 14 months

  5. HSCT Rate

    Rate of successful hematopoietic stem cell transplantation (HSCT) after the start flotetuzumab treatment and before subsequent therapy.

    Measured: up to 8 months

  6. Occurrence of Dose Limiting Toxicity

    Maximum Tolerated Dose/Schedule: the MTDS is defined as the highest dose/schedule administered during any Cohort in the study at which the incidence of DLT is < 33% during the first cycle of MGD006 treatment.

    Measured: Cycle 1 of a 28 day cycle.

  7. Occurrence of Adverse Events (AEs)

    Cycle 1 through end of treatment

    Measured: up to 9 months

  8. Occurrence of Serious Adverse Events (SAEs)

    Measured: up to 9 months

  9. Participants With Anti-drug Antibodies

    Occurrence of anti-drug antibody

    Measured: Study Day 1, then every 28 days through 28-days after the last dose (up to 8 months)

  10. Number of Patients With Infusion Related Reaction (IRR)

    Determine safety and efficacy of tocilizumab in the treatment of IRR/CRS as measured by incidence of IRR/CRS

    Measured: During study drug administration (up to 8 months)

  11. Number of Patients With Cytokine Release Syndrome (CRS)

    Measured: up to 9 months

  12. Maximum Serum Concentration of Flotetuzumab

    Measure the pharmacokinetics (PK) of flotetuzumab

    Measured: Study day 1, then every 28 days and 28 days after the last dose (up to 8 months)

  13. Post-baseline Transfusion Independence Rate

    The number of patients who were transfusion-dependent at baseline and did not receive transfusions during any consecutive 56-day period will be calculated. The number of patients who are transfusion independent at baseline and remain independent during any 56-day post-baseline period will also be calculated.

    Measured: 56 days

  14. Number of Patients Alive at 6 Months

    Measured: 6 months

  15. Event-free Survival

    Time from the first dose of study drug until date of evidence of primary refractory disease to flotetuzumab, relapse from CR, CRh or CRi, or death from any cause, whichever occurs first.

    Measured: Up to 2 years

  16. Mortality Rate

    number of deaths from any cause within 30, 60, 90, or 180 days of first dose of study drug

    Measured: Throughout the study, up to 3 years.

  17. Number of Patients Alive at 12 Months

    Number of patients alive at 1 year from first dose of study drug

    Measured: 1 year

  18. Median Time to Response

    Time from first dose of study drug to first CR, CRh, CRi, or MLFS

    Measured: up to 14 months

  19. Duration of Response of Patients With CR or CRh

    Time of initial documentation of response to the time of disease relapse or death due to any cause, whichever occurs first.

    Measured: Up to 2 years

  20. Overall Survival

    Time from first dose to death from any cause

    Measured: Up to 2 years

  21. Rate of Hospitalization for Patients in the Expansion Cohort After Initial Discharge

    Initial dosing procedures were performed as a hospital inpatient. Incidence rate of hospitalization after discharge from the hospital will be calculated

    Measured: up to 8 months

  22. Duration of Hospitalization for Patients in the Expansion Cohort

    Duration of hospitalization will be characterized after discharge from initial dosing will be characterized

    Measured: up to 8 months

Timeline

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

  1. First posted2 Jun 2014 (estimated)
  2. Study start9 Jun 2014
  3. Primary completion5 Jul 2022
  4. Study completion5 Jul 2022

Why it stopped: Business decision

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
244 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02152956
Sponsor's protocol ID
CP-MGD006-01
Acronym
VOYAGE
Status last verified
Jan 2024
First submitted
28 May 2014
Last updated
30 Jan 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Expanded access
Available

Publications

  • Uy GL, Aldoss I, Foster MC, Sayre PH, Wieduwilt MJ, Advani AS, Godwin JE, Arellano ML, Sweet KL, Emadi A, Ravandi F, Erba HP, Byrne M, Michaelis L, Topp MS, Vey N, Ciceri F, Carrabba MG, Paolini S, Huls GA, Jongen-Lavrencic M, Wermke M, Chevallier P, Gyan E, Recher C, Stiff PJ, Pettit KM, Lowenberg B, Church SE, Anderson E, Vadakekolathu J, Santaguida M, Rettig MP, Muth J, Curtis T, Fehr E, Guo K, Zhao J, Bakkacha O, Jacobs K, Tran K, Kaminker P, Kostova M, Bonvini E, Walter RB, Davidson-Moncada JK, Rutella S, DiPersio JF. Flotetuzumab as salvage immunotherapy for refractory acute myeloid leukemia. Blood. 2021 Feb 11;137(6):751-762. doi: 10.1182/blood.2020007732.

    PubMed 32929488

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off, Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off and Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off in people with AML, run by MacroGenics at 43 sites in 8 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 11 inclusion and 15 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 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in United States, Germany, France, Italy, Israel and 3 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 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?

Yes. Results are posted in the registry (first posted 30 Jan 2024). 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?

Efficacy Based on CR or CRh Rate (time frame: up to 14 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 NCT02152956, 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 30 Jan 2024.

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