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Pancreatic Cancer Non-resectablePhase 3NCT03984214

Efficacy and Safety of Dronabinol in the Improvement of Chemotherapy-induced and Tumor-related Symptoms in Advanced Pancreatic Cancer

A Phase 3 study testing Dronabinol in Oral Dosage Form in people with Pancreatic Cancer Non-resectable and Chemotherapy-induced Nausea and Vomiting, run by Arbeitsgemeinschaft medikamentoese Tumortherapie at 11 sites in 2 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

Aim of this phase III trial is to investigate the efficacy and safety of dronabinol (orally administered tetrahydrocannabinol (THC)) as adjuvant therapy to first-line standard chemotherapy in patients with metastatic pancreatic cancer for improvement of chemotherapy- and tumor-related symptoms applicated by individual… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Dronabinol in Oral Dosage Form
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
109 participants
Where
11 sitesin 2 countries
Study dates
16 Dec 2019to 25 Sep 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female subjects aged ≥18
  • Patients with diagnosis of locally advanced, inoperable or metastatic pancreatic cancer, eligible for first-line chemotherapy with FOLFIRINOX or gemcitabine+Abraxane®
  • According to investigator life expectancy of > 4 months at screening
  • Female patients must either be post-menopausal or surgically sterilized or use a highly effective method of birth control (hormonal contraceptives, intra-uterine devices, or diaphragms with spermicide) for the duration of the study and/or must have a negative pregnancy test (female patients with childbearing potential only)
  • Willing and able to provide written informed consent.
  • Written informed consent given prior to any trial-related procedure not part of the normal medical practice.

Who cannot join

  • Patients who are members of the staff of the trial center, staff of the sponsor or CRO, the investigator him/herself or close relatives of the investigator.
  • Simultaneous participation in another interventional clinical trial, participation in another trial with less than 30 days or five half-lives of the IMP (whatever is longer) to screening, or previous participation in this trial.
  • Ineligible for chemotherapy treatment with FOLFIRINOX or gemcitabine+Abraxane®
  • Use of dronabinol or cannabis-based medicine with THC as constituent within 6 months before screening. A urine drug test will be performed during screening phase.
  • Use of marihuana within the last 4 weeks and unwillingness to abstain for the duration of the study. A urine drug test will be performed during screening phase.
  • Currently receiving chemotherapy or anticipated use of chemotherapy due to any condition not related to locally advanced or metastatic pancreatic cancer
Show all 17Show fewer
  • History of or existing cardiac diseases or pathological findings (e.g. chronic insufficiency NYHA III/IV, severe arrhythmia, unstable angina pectoris, myocardial infarction within the past 6 months, significant QT-prolongation etc.), which in the opinion of the investigator might interfere with the safety or tolerability of the study treatment. An ECG has to be done to exclude pathological findings and must not be older than 3 months before screening or if none is available, has to be performed during the screening phase and assessed prior to randomization
  • Clinically relevant, severe pulmonary diseases, uncontrolled hypertension, or poorly controlled diabetes
  • History of or existing relevant CNS and/or psychiatric disorders (e.g. schizophrenia, psychosis, manic and/or depressive disorders, suicidal ideations, etc) which might interfere with the safety or tolerability of the study treatment. Patients with reactive depression are not excluded from participation.
  • Known current or past (within the last year prior to screening) alcohol, narcotics or drug abuse
  • Pregnancy or breast feeding
  • Known allergy to cannabinoids and other constituents of the investigational medicinal product
  • Intake of prohibited concomitant medication
  • Any other substantial medical condition that in the opinion of the investigator could create undue risk to the subject or could affect adherence with the trial protocol
  • Legal incapacity, limited legal capacity or any other condition which makes the subject unable to understand the subject information and informed consent form (ICF)
  • Patients unable or unwilling to waive driving motor vehicles or using machines especially during titration period
  • Unable or unwilling to comply with the protocol regulations

Trial locations and contacts

11 sites in 2 countries.

11 sites in 2 countries

Austria8 sites

  • KABEG-Klinikum Klagenfurt am Woerthersee, Abteilung f. Anaesthesie u. Intensivmedizin

    Klagenfurt, 9020

  • LKH Hochsteiermark - Standort Leoben Abteilung für Innere Medizin und Hämatologie und internistische Onkologie

    Leoben, 8700

  • IIIrd Medical Department, Private Medical University Hospital Salzburg

    Salzburg, State of Salzburg, 5020

  • Krankenhaus d. Barmherzigen Brüder, Abt. f. Innere Medizin

    Sankt Veit an der Glan, 9300

  • Pyhrn-Eisenwurzen Klinikum Steyr, Interne Medizin II

    Steyr, A-4400

  • Hanusch Krankenhaus der Wiener Gebietskrankenkasse

    Vienna, State of Vienna, 1140

  • Klinikum Wels-Grieskirchen GmbH, Abteilung für Innere Medizin IV

    Wels, Upper Austria, 4600

  • KH Zams, Innere Medizin, Internistische Onkologie u. Haematologie

    Zams, 6511

Other trials in Austria

Germany3 sites

  • Universitätsmedizin Göttingen Abt. f. Gastroenterologie, gastrointestinale Onkologie u. Endokrinologie

    Göttingen, 37075

  • München Klinik Neuperlach

    München, 81737

  • Marienhospital Onkologie, Hämatologie, Palliativmedizin

    Stuttgart, 07199

Other trials in Germany

About this study

Official title: Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Clinical Trial to Investigate the Efficacy and Safety of Dronabinol in the Improvement of ChemOthErapy-induced and Tumor-Related Symptoms in Patients With Locally Advanced or Metastatic Pancreatic Cancer During First-line Chemotherapy (DIsCOvER)

Aim of this phase III trial is to investigate the efficacy and safety of dronabinol (orally administered tetrahydrocannabinol (THC)) as adjuvant therapy to first-line standard chemotherapy in patients with metastatic pancreatic cancer for improvement of chemotherapy- and tumor-related symptoms applicated by individual titration up to the maximum tolerated dose.

Read the detailed description

Patients with pancreatic cancer suffer from multiple symptoms related to the tumor itself or induced by the chemotherapy. The available supportive therapy is still not able to relief all symptoms that are caused by the malignancy itself as well as by the antineoplastic therapy.

Additionally, anorexia and weight loss, that often result in increased morbidity and mortality in this patient population as well as in psycho-social burden and suffering in patients and their relatives, are unmet needs in pancreatic cancer patients.

Therapeutic approaches focus on treating the malignancy itself, additional nutritional support and physical examination might prevent patients from further side effects such as sarcopenia.

During the last decades a number of appetite-modulating drugs have been under clinical investigation. A number of studies focused on the endocannabinoid system, which is involved amongst others in appetite-modulating, antiemetic, analgesic and anti-inflammatory processes.

As dronabinol is already used as magistral formulation, its beneficial effect has often been observed in these patients in the clinical routine, especially in patients with therapy-refractory nausea and emesis. Due to its broad efficacy it might be of benefit for patients suffering from malignancy. Thus, investigators want to evaluate the efficacy of dronabinol in the improvement of chemotherapy-induced and tumor-related symptoms in advanced pancreatic patients during systemic first-line chemotherapy. However, data on optimal dosage are conflicting yet.

In detail, investigators want to study whether dronabinol has a positive influence on quality of life and whether symptoms caused by the tumor or by the chemotherapy itself might be palliated by dronabinol. Beneficial and potential harmful side effects and the personal perception of advanced pancreatic cancer patients will be documented.

Being tested
Dronabinol in Oral Dosage Form, Placebo in Oral Dosage Form
Keywords
Dronabinol, THC, Placebo, Pancreatic Cancer, Chemotherapy-induced Nausea and Vomiting, Tumor related symptoms, Quality of life, EORTC QLQ-C30, FOLFIRINOX, Abraxane, Gemcitabine
Medical subject headings
Vomiting, Pancreatic Neoplasms

What participants receive

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

  • Dronabinol in Oral Dosage FormDrug

    Also called BX-1

    Titration period for 4 weeks: titration according to tolerability from 2.5 mg (3 x 1 droplet) up to 30 mg (3 x 12 droplets) per day; dose increased by 2.5 mg (3 x 1 droplet) every other day Maintenance period for 12 weeks: individually tolerated maximum dose (up to 30 mg ≙ 3 x 12 droplets) at end of titration period will be continued for maintenance treatment Tapering period for 2 weeks: dose is decreased every other day by 5 mg (3 x 2 droplets) Safety follow-up: 4 weeks after end of treatment

  • Placebo in Oral Dosage FormDrug

    Titration period for 4 weeks: titration according to tolerability from 3 x 1 droplet up to 3 x 12 droplets per day; dose increased by 3 x 1 droplet every other day Maintenance period for 12 weeks: individually tolerated maximum dose (up to 3 x 12 droplets) at end of titration period will be continued for maintenance treatment Tapering period for 2 weeks: dose is decreased every other day by 3 x 2 droplets Safety follow-up: 4 weeks after end of treatment

Study groups in NCT03984214
Study groupRoleWhat they receive
DronabinolActive comparatorBX-1 contains 25 mg dronabinol/ml (2.5% delta-9-trans-tetrahydrocannabinol = THC), oral solution; three applications per day from 2.5 mg (3 x 1 droplet) up to 30 mg (3 x 12 droplets)
Receives: Drug: Dronabinol in Oral Dosage Form
PlaceboPlacebo comparatorPlacebo: oral solution with cannabis flavor without active substance and otherwise identical to active comparator, three applications per day from 3 x 1 droplet up to 3 x 12 droplets
Receives: Drug: Placebo in Oral Dosage Form

What is being measured

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

  1. Standardized area under the curve of the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30 symptom summary score over the on-treatment period.

    The EORTC-QLQ-C30 is an integrated system for assessing the health-related quality of life (QoL) of cancer patients participating in international clinical trials.

    The validated QLQ-C30 summary score is calculated as mean score of the 13 of the 15 EORTC QLQ-C30 scales (v3.0), based on 27 of 30 items (the Financial Impact scale and Quality of Life score are not included). A high score for a symptom scale / item (fatigue, nausea and vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea) represents a high level of symptomatology / problems. A high score for a functional scale (physical functioning, role functioning, cognitive functioning, emotional functioning, social functioning) represents a high / healthy level of functioning. Scores for individual items: "Not at All" = 1 point, "A Little" = 2 points, "Quite a Bit" = 3 points, "Very Much" = 4 points.

    A linear transformation is used to standardize the raw score, so that overall scores range from 0 to 100.

    Measured: Prior to treatment start until end of 16 weeks maintenance treatment

Secondary outcomes (23)

  1. Standardized area under the curve of the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30 symptom summary score over the maintenance period

    The European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) is an integrated system for assessing the health-related quality of life (QoL) of cancer patients participating in international clinical trials.

    The validated QLQ-C30 summary score is calculated as mean score of items. A high score for a symptom scale / item (fatigue, nausea and vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea) represents a high level of symptomatology / problems.

    Scores for individual items: "Not at All" = 1 point, "A Little" = 2 points, "Quite a Bit" = 3 points, "Very Much" = 4 points. A linear transformation is used to standardize the raw score, so that overall scores range from 0 to 100.

    Measured: After 4 weeks of treatment until week 16

  2. Change of European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30 symptom summary score from baseline to summary score over the maintenance period

    The European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) is an integrated system for assessing the health-related quality of life (QoL) of cancer patients participating in international clinical trials.

    The validated QLQ-C30 summary score is calculated as mean score of items. A high score for a symptom scale / item (fatigue, nausea and vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea) represents a high level of symptomatology / problems.

    Scores for individual items: "Not at All" = 1 point, "A Little" = 2 points, "Quite a Bit" = 3 points, "Very Much" = 4 points. A linear transformation is used to standardize the raw score, so that overall scores range from 0 to 100.

    Measured: From treatment start until week 16

  3. Symptom scales of European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30

    A high score for a symptom scale / item (fatigue, nausea and vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea) represents a high level of symptomatology / problems.

    Scores for individual items: "Not at All" = 1 point, "A Little" = 2 points, "Quite a Bit" = 3 points, "Very Much" = 4 points. A linear transformation is used to standardize the raw score, so that overall scores range from 0 to 100.

    Measured: At baseline and 2-weekly until end of treatment at week 18

  4. Global quality of life of the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30

    The European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) is an integrated system for assessing the health-related quality of life (QoL) of cancer patients participating in international clinical trials.

    The validated QLQ-C30 summary score is calculated as mean score of items. A high score for the global health status (overall health during the past week) and global QoL (overall quality of life during the past week) represents a high QoL.

    Scores: 1 - 7, 1 = very poor and 7 = excellent. A linear transformation is used to standardize the raw score, so that overall scores range from 0 to 100.

    Measured: At baseline and 2-weekly until end of treatment at week 18

  5. Functional scales of the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30

    The European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) is an integrated system for assessing the health-related quality of life (QoL) of cancer patients participating in international clinical trials. A high score for a functional scale (physical functioning, role functioning, cognitive functioning, emotional functioning, social functioning) represents a high / healthy level of functioning.

    Scores for individual items: "Not at All" = 1 point, "A Little" = 2 points, "Quite a Bit" = 3 points, "Very Much" = 4 points.

    A linear transformation is used to standardize the raw score, so that overall scores range from 0 to 100.

    Measured: At baseline and 2-weekly until end of treatment at week 18

  6. Mean change from baseline of the Glasgow Prognostic Score

    Change of serum levels of the score-defining biomarkers C-reactive protein (CRP) and albumin. Prognostic scores; 0 (CRP ≥ 10 mg/l), 1 (CRP > 10 mg/l and albumin ≥ 35 g/l), 2 CRP > 10 mg/l and albumin < 35g/l). Score 0 indicates good prognosis, score 1 intermediate prognosis and score 2 poor prognosis.

    Measured: At baseline and at end of treatment at week 16

  7. Amount of concomitant medication taken

    Special focus on antiemetic, psychotropic and pain medication

    Measured: From baseline until end of treatment at week 18

  8. Mean time to critical weight-loss (5%)

    Assessed with a standard scale

    Measured: From baseline until end of treatment at week 16

  9. Mean changes from baseline for Bioelectrical Impedance Analysis (BIA) parameter Lean body mass (LBM)

    Mean change of Lean body mass (LBM = Fat free mass FFM) kg

    Measured: At baseline and at end of treatment at week 16

  10. Mean changes from baseline for Bioelectrical Impedance Analysis (BIA) parameter Total body water (TBW)

    Mean change of Total body water (TBW) kg

    Measured: At baseline and at end of treatment at week 16

  11. Mean changes from baseline for Bioelectrical Impedance Analysis (BIA) parameter Fat mass (FM)

    Mean change of Fat mass (FM) kg

    Measured: At baseline and at end of treatment at week 16

  12. Mean changes from baseline for Bioelectrical Impedance Analysis (BIA) parameter Body cell mass (BCM)

    Mean change of Body cell mass (BCM) kg

    Measured: At baseline and at end of treatment at week 16

  13. Mean changes from baseline for Bioelectrical Impedance Analysis (BIA) parameter Extracellular mass (EM)

    Mean change of Extracellular mass (ECM) kg

    Measured: At baseline and at end of treatment at week 16

  14. Mean changes from baseline for Bioelectrical Impedance Analysis (BIA) parameter Phase angle (PA)

    Mean change of Phase angle (PA); Phase Angle has long been linked to nutritional status. This marker is fast becoming recognised as a global health marker in total body health assessment. A higher Phase Angle could mean an increase in muscle mass (body cell mass) or a decrease in fluid, either from recovery from infection or injury (a good thing!) or a decrease in fluid from dehydration (a bad thing!). A loss of fat could also increase Phase Angle.

    A lower Phase Angle could mean a loss of muscle mass (a bad thing), or an increase of fluid (rehydrating which is a good thing, or sign of inflammation or infection - a bad thing), or gaining fat (which could be a good or bad thing depending on your state of health).

    Phase Angle is a direct measurement, (not a calculation using equations) of the cell membrane.

    Measured: At baseline and at end of treatment at week 16

  15. Mean changes from baseline for Bioelectrical Impedance Analysis (BIA) parameter Resistance (Rz)

    Mean change of Resistance (Rz), unit ohm; the resistance reflects the water or fluid in the body

    Measured: At baseline and at end of treatment at week 16

  16. Mean changes from baseline for Bioelectrical Impedance Analysis (BIA) parameter Reactance(Xc)

    Mean change of Reactance (Xc), unit ohm; reactance reflects the body cell mass.

    Measured: At baseline and at end of treatment at week 16

  17. Mean change from baseline of muscle strength

    To assess physical strength of patient's handgrip strength will be measured prior and after study treatment using a hydraulic hand dynamometer; mean value of three consecutive measurements will be documented

    Measured: At baseline and at end of treatment at week 16

  18. Proportion of patients not adhering to individual baseline chemotherapy regimen

    Percentage of patients who do not receive full dose of planned chemotherapy regimen and/or within scheduled time frame (interruption or delay)

    Measured: From baseline until end of treatment at week 18

  19. Chemotherapeutic dose intensity over the treatment period of 18 weeks

    The total amount of applied chemotherapy over the study treatment phase is documented

    Measured: From baseline until end of treatment at week 18

  20. Frequency and severity of (serious) adverse events (S)AE

    Assessed with Common Terminology Criteria for Adverse Events (NCI-CTCAE V5.0)

    Measured: From baseline until safety visit at week 22

  21. Incidence of adverse drug reactions (ARs)

    Frequency and severity of ARs

    Measured: From baseline until safety visit at week 22

  22. Progression-free survival (PFS)

    PFS in months; ; patients will be asked to agree on collection of data regarding PFS also after end of trial

    Measured: From treatment start until the date of first documented progression or death from any cause assessed up to week 22

  23. Overall survival (OS)

    OS in months; ; patients will be asked to agree on collection of data regarding PFS also after end of trial

    Measured: From treatment start until death from any cause assessed up to week 22

Timeline

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

  1. First posted12 Jun 2019
  2. Study start16 Dec 2019
  3. Primary completion25 Sep 2024
  4. Study completion25 Sep 2024

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
Double blind
Who is masked
Participant, Investigator
Enrolment
109 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03984214
Sponsor's protocol ID
AGMT_DISCOVER
Status last verified
Sep 2024
First submitted
28 May 2019
Last updated
10 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • van Amerongen G, Kanhai K, Baakman AC, Heuberger J, Klaassen E, Beumer TL, Strijers RLM, Killestein J, van Gerven J, Cohen A, Groeneveld GJ. Effects on Spasticity and Neuropathic Pain of an Oral Formulation of Delta9-tetrahydrocannabinol in Patients WithProgressive Multiple Sclerosis. Clin Ther. 2018 Sep;40(9):1467-1482. doi: 10.1016/j.clinthera.2017.01.016. Epub 2017 Feb 9.

    PubMed 28189366

  • Davis MP. Cannabinoids for Symptom Management and Cancer Therapy: The Evidence. J Natl Compr Canc Netw. 2016 Jul;14(7):915-22. doi: 10.6004/jnccn.2016.0094.

    PubMed 27407130

  • Cannabis-In-Cachexia-Study-Group; Strasser F, Luftner D, Possinger K, Ernst G, Ruhstaller T, Meissner W, Ko YD, Schnelle M, Reif M, Cerny T. Comparison of orally administered cannabis extract and delta-9-tetrahydrocannabinol in treating patients with cancer-related anorexia-cachexia syndrome: a multicenter, phase III, randomized, double-blind, placebo-controlled clinical trial from the Cannabis-In-Cachexia-Study-Group. J Clin Oncol. 2006 Jul 20;24(21):3394-400. doi: 10.1200/JCO.2005.05.1847.

    PubMed 16849753

  • Turgeman I, Bar-Sela G. Cannabis Use in Palliative Oncology: A Review of the Evidence for Popular Indications. Isr Med Assoc J. 2017 Feb;19(2):85-88.

    PubMed 28457056

  • Jatoi A, Windschitl HE, Loprinzi CL, Sloan JA, Dakhil SR, Mailliard JA, Pundaleeka S, Kardinal CG, Fitch TR, Krook JE, Novotny PJ, Christensen B. Dronabinol versus megestrol acetate versus combination therapy for cancer-associated anorexia: a North Central Cancer Treatment Group study. J Clin Oncol. 2002 Jan 15;20(2):567-73. doi: 10.1200/JCO.2002.20.2.567.

    PubMed 11786587

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dronabinol in Oral Dosage Form in people with Pancreatic Cancer Non-resectable and Chemotherapy-induced Nausea and Vomiting, run by Arbeitsgemeinschaft medikamentoese Tumortherapie at 11 sites in 2 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 6 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: finished, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Austria, Germany. 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Standardized area under the curve of the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30 symptom summary score over the on-treatment period. (time frame: Prior to treatment start until end of 16 weeks maintenance treatment). 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 NCT03984214, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.

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