Gastrointestinal Stromal Tumor, MalignantEarly Phase 1NCT04006769
Entacapone Combination With Imatinib for Treatment of GIST
A Early Phase 1 study testing Entacapone and Imatinib Mesylate in people with Gastrointestinal Stromal Tumor, Malignant, run by Xiangya Hospital of Central South University at 1 site in China.
Trial summary
This study evaluates the combination of entacapone and imatinib in the treatment of gastrointestinal stromal Tumors who have progressed on the setting of at least Imatinib and Sunitinib. 5 participants will be included in this open-label observatory study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Stromal Tumor, Malignant
- What is being tested?
- Entacapone and Imatinib Mesylate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2020to 31 Aug 2022
- Phase
- Early Phase 1
- 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
- Able to provide written informed consent and can understand and comply with the requirements of the study and the schedule of assessments.
- Age ≥ 18 years on the day of signing the informed consent form (or the legal age of consent in the jurisdiction in which the study is taking place).
- Expected life span > 12 weeks.
- Histologically confirmed disease which is currently metastatic/unresectable gastrointestinal stroma tumor(GIST) of c-KIT E11 mutation genotype.
- Patients received imatinib as the first-line treatment and no progression within the first 6 months(no primary resistance to imatinib ). With disease progression following treatment with at least imatinib and sunitinib.
- Patients must be able to provide archival tumor tissues (approximately 4 [at least 2] unstained Formalin Fixed and Paraffin Embedded Tissues （FFPET）slides) for biomarker analysis to assess the expression of FTO and c-KIT protein.
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- At least 1 measurable lesion (the longest diameter≥ 10mm). Note: Computed Tomography（CT） abdomen and pelvis with contrast including peritoneum, or positron emission tomography/computed tomography(PET/CT) performed skull base to knees or whole body before the first day of entacapone.
- Eastern Cooperative Oncology Group-performance status(ECOG PS) ≤ 2,or 3(the symptoms were definitely caused by GIST itself).
- Adequate hematologic and end-organ function, as defined by the following laboratory results (obtained ≤ 28 days prior to the first day of entacapone):
- Absolute neutrophil count (ANC) ≥ 1.5 × 10 9 /L, hemoglobin ≥ 80 g/L and platelets ≥80 × 10 9 /L.
- Total serum bilirubin ≤ 2.5 × upper limit of normal (ULN); Aspartate and alanine aminotransferase (AST and ALT) ≤ 2.5× ULN.
- Estimated creatinine clearance rate≥ 60 mL/min（According to the formula of Cockcroft-Gault）.
- Females of childbearing potential must be willing to practice highly effective method of birth control for the duration of the study, and at least 120 days after the last dose of entacapone or imatinib. Non-sterile males must be willing to use a highly effective method of birth control for the duration of the study and at least 120 days after the last dose of entacapone or imatinib.
Who cannot join
- Age < 18 years on the day of signing the informed consent form (or the legal age of consent in the jurisdiction in which the study is taking place).
- Progression within the first 6 months of first-line imatinib treatment (primary imatinib resistance).
- Patients with active/symptomatic carrier or chronic hepatitis B virus (HBV) whose HBV DNA ≥ 1×104 copies/mL should be excluded. Note: Patients with detectable hepatitis B surface antigen(HBsAg) or HBV DNA should be managed per treatment guidelines. Patients receiving antivirals at screening should have been treated for ≥2 weeks prior to written informed consent and should continue treatment for 6 months after study drug treatment discontinues.
- Note: Patients with active hepatitis C may enroll and those with detectable hepatitis C virus(HCV) RNA who are receiving antiviral therapy at time of screening should remain on continuous, effective antiviral therapy during the study.
- A known history of human immunodeficiency virus(HIV) infection.
- Malignancy other than GIST and still under the active treatment.
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- Was administered a live vaccine ≤ 4 weeks before written informed consent.
- Any of the following medical conditions may threaten the safety of patients or affect the trial obedience including symptomatic heart failure requiring systematic treatment, unstable angina , acute myocardial infarction and severe chronic or active infections (including tuberculosis infection) requiring systemic antibacterial, antifungal, or antiviral therapy.
- History of severe hypersensitivity reactions to any ingredient of entacapone and imatinib.
- Pheochromocytoma or history of neuroleptic malignant syndrome(NMS) and/or non-traumatic rhabdomyolysis (NRML).
- Female in pregnancy or lactation(Urine or serum pregnancy test and documented as negative within 7 days prior to the first dose of entacapone for the female with fertility expectation or sexual intercourse.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Entacapone in Combination With Imatinib Mesylate for Treatment of Patients With Gastrointestinal Stromal Tumors(GIST) Following Failure of at Least Imatinib and Sunitinib
This study evaluates the combination of entacapone and imatinib in the treatment of gastrointestinal stromal Tumors who have progressed on the setting of at least Imatinib and Sunitinib. 5 participants will be included in this open-label observatory study.
Read the detailed description
The eligibility criteria are patients whose histologically confirmed disease which is currently metastatic/unresectable gastrointestinal stroma tumor (GIST) of c-KIT E11 mutation genotype. He received imatinib as the first-line treatment and no progression within the first 6 months (no primary resistance to imatinib), with disease progression following treatment with at least imatinib and sunitinib, and at least 1 measurable lesion (the longest diameter≥ 10mm). Age should be more or equal 18 years with adequate hematologic and end-organ function and good performance ((ECOG PS) ≤ 2, or 3 (the symptoms were definitely caused by GIST itself).
This study is single group assignment and open label. The intervention/treatment is Entacapone combined with Imatinib. Entacapone began with 200mg tablet (Orion pharma, Switzerland) by mouth, three times a day and then escalated to final dose of 1.0 grams three times per day within one week, until disease progression, intolerable toxicity, or withdrawal of informed consent, whichever occurs first. Imatinib mesylate 400mg tablet by mouth, once a day until disease progression, intolerable toxicity, or withdrawal of informed consent, whichever occurs first. Periodically routine blood test including liver and kidney function, troponin and electrocardiogram were conducted throughout the entire clinical course.
Clinic visits are performed at 16 points: visit 1, baseline, and then follow up after first dose as planned: 1st month, and every 2 months in the first year, followed by every 3 months until 3 years or 31 days after withdraw. The study design is visualized in Figure 1 below.
- Being tested
- Entacapone, Imatinib Mesylate
- Keywords
- entacapone, Imatinib mesylate, GIST, treatment
- Medical subject headings
- Gastrointestinal Stromal Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EntacaponeDrug
Also called Comtan, Comtess
Entacapone tablet
Imatinib MesylateDrug
Also called Gleevec
Imatinib Mesylate tablet
| Study group | Role | What they receive |
|---|---|---|
| Entacapone & Imatinib mesylate | Experimental | Entacapone 200mg tablet (Orion pharma,Switzerland) by mouth, three times a day and then escalated to final dose of 1.0 grams three times per day within one week, until disease progression, intolerable toxicity, or withdrawal of informed consent, whichever occurs first.
And Imatinib mesylate 400mg tablet by mouth, once a day until disease progression, intolerable toxicity, or withdrawal of informed consent, whichever occurs first. Receives: Drug: Entacapone; Drug: Imatinib Mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AE) And Serious Adverse Events(SAE)
According to Criteria CTCAE5.0, the ratio of AE and SAE which were defined by the Common Terminology Criteria for Adverse Events, CTCAE.
Measured: 36 months or 31 days after last dose, which come first.
Secondary outcomes (2)
Objective Response Rate(ORR)
The ORR is the proportion of the patients who achieved complete response (CR) or partial responses(PR) according to CHOI criteria.
Measured: 36 Months
Quality of Life(QOL)
The data was collected using EORTC QLQ-C30 V3.0 questionnaire
Measured: Difference between baseline and the timepoint of the best efficacy within 181 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start30 Oct 2020
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal Stromal Tumor, MalignantStudies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lun-Quan Sun, Xiangya Hospital of Central South University
- Investigators
- Bin Li, MD, Principal investigator, Xiangya Hospital, Central South University, Changsha, Hunan,China,410008
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04006769
- Sponsor's protocol ID
- gist-ent
- Status last verified
- Oct 2023
- First submitted
- 27 Jun 2019
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Publications
Demetri GD, von Mehren M, Blanke CD, Van den Abbeele AD, Eisenberg B, Roberts PJ, Heinrich MC, Tuveson DA, Singer S, Janicek M, Fletcher JA, Silverman SG, Silberman SL, Capdeville R, Kiese B, Peng B, Dimitrijevic S, Druker BJ, Corless C, Fletcher CD, Joensuu H. Efficacy and safety of imatinib mesylate in advanced gastrointestinal stromal tumors. N Engl J Med. 2002 Aug 15;347(7):472-80. doi: 10.1056/NEJMoa020461.
PubMed 12181401Demetri GD, van Oosterom AT, Garrett CR, Blackstein ME, Shah MH, Verweij J, McArthur G, Judson IR, Heinrich MC, Morgan JA, Desai J, Fletcher CD, George S, Bello CL, Huang X, Baum CM, Casali PG. Efficacy and safety of sunitinib in patients with advanced gastrointestinal stromal tumour after failure of imatinib: a randomised controlled trial. Lancet. 2006 Oct 14;368(9544):1329-38. doi: 10.1016/S0140-6736(06)69446-4.
PubMed 17046465Tabone S, Theou N, Wozniak A, Saffroy R, Deville L, Julie C, Callard P, Lavergne-Slove A, Debiec-Rychter M, Lemoine A, Emile JF. KIT overexpression and amplification in gastrointestinal stromal tumors (GISTs). Biochim Biophys Acta. 2005 Jun 30;1741(1-2):165-72. doi: 10.1016/j.bbadis.2005.03.011. Epub 2005 Apr 13.
PubMed 15869870Peng S, Xiao W, Ju D, Sun B, Hou N, Liu Q, Wang Y, Zhao H, Gao C, Zhang S, Cao R, Li P, Huang H, Ma Y, Wang Y, Lai W, Ma Z, Zhang W, Huang S, Wang H, Zhang Z, Zhao L, Cai T, Zhao YL, Wang F, Nie Y, Zhi G, Yang YG, Zhang EE, Huang N. Identification of entacapone as a chemical inhibitor of FTO mediating metabolic regulation through FOXO1. Sci Transl Med. 2019 Apr 17;11(488):eaau7116. doi: 10.1126/scitranslmed.aau7116.
PubMed 30996080Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.
PubMed 19097774Li Z, He J, Cao Z, Zhou S, Zhu Y, Duan Y, Jiang A, Guan Y, Gao J, Tian J, Liu L, Rong Z, Liu H, Liu X, Xiao H, Deng Y, Li B, Sun L. Targeting the SETD2-FTO-KIT pathway as a pharmacological strategy for TKI-refractory GIST. Acta Pharm Sin B. 2026 Sep;16(9):6045-6065. doi: 10.1016/j.apsb.2026.07.016. Epub 2026 Jul 15.
PubMed 42764990
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Entacapone in Combination With Imatinib Mesylate for Treatment of Patients With Gastrointestinal Stromal Tumors(GIST) Following Failure of at Least Imatinib and Sunitinib
- ClinicalTrials.gov ID
- NCT04006769
- Acronym / sponsor ID
- gist-ent
- Keywords
- entacapone, Imatinib mesylate, GIST, treatment
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the combination of entacapone and imatinib in the treatment of gastrointestinal stromal Tumors who have progressed on the setting of at least Imatinib and Sunitinib. 5 participants will be included in this open-label observatory study.
Detailed description
The eligibility criteria are patients whose histologically confirmed disease which is currently metastatic/unresectable gastrointestinal stroma tumor (GIST) of c-KIT E11 mutation genotype. He received imatinib as the first-line treatment and no progression within the first 6 months (no primary resistance to imatinib), with disease progression following treatment with at least imatinib and sunitinib, and at least 1 measurable lesion (the longest diameter≥ 10mm). Age should be more or equal 18 years with adequate hematologic and end-organ function and good performance ((ECOG PS) ≤ 2, or 3 (the symptoms were definitely caused by GIST itself).
This study is single group assignment and open label. The intervention/treatment is Entacapone combined with Imatinib. Entacapone began with 200mg tablet (Orion pharma, Switzerland) by mouth, three times a day and then escalated to final dose of 1.0 grams three times per day within one week, until disease progression, intolerable toxicity, or withdrawal of informed consent, whichever occurs first. Imatinib mesylate 400mg tablet by mouth, once a day until disease progression, intolerable toxicity, or withdrawal of informed consent, whichever occurs first. Periodically routine blood test including liver and kidney function, troponin and electrocardiogram were conducted throughout the entire clinical course.
Clinic visits are performed at 16 points: visit 1, baseline, and then follow up after first dose as planned: 1st month, and every 2 months in the first year, followed by every 3 months until 3 years or 31 days after withdraw. The study design is visualized in Figure 1 below.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Entacapone & Imatinib mesylate | Experimental | Drug: Entacapone, Drug: Imatinib MesylateEntacapone 200mg tablet (Orion pharma,Switzerland) by mouth, three times a day and then escalated to final dose of 1.0 grams three times per day within one week, until disease progression, intolerable toxicity, or withdrawal of informed consent, whichever occurs first. And Imatinib mesylate 400mg tablet by mouth, once a day until disease progression, intolerable toxicity, or withdrawal of informed consent, whichever occurs first. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Able to provide written informed consent and can understand and comply with the requirements of the study and the schedule of assessments.
- Age ≥ 18 years on the day of signing the informed consent form (or the legal age of consent in the jurisdiction in which the study is taking place).
- Expected life span > 12 weeks.
- Histologically confirmed disease which is currently metastatic/unresectable gastrointestinal stroma tumor(GIST) of c-KIT E11 mutation genotype.
- Patients received imatinib as the first-line treatment and no progression within the first 6 months(no primary resistance to imatinib ). With disease progression following treatment with at least imatinib and sunitinib.
Key exclusion criteria (11 listed)
- Age < 18 years on the day of signing the informed consent form (or the legal age of consent in the jurisdiction in which the study is taking place).
- Progression within the first 6 months of first-line imatinib treatment (primary imatinib resistance).
- Patients with active/symptomatic carrier or chronic hepatitis B virus (HBV) whose HBV DNA ≥ 1×104 copies/mL should be excluded. Note: Patients with detectable hepatitis B surface antigen(HBsAg) or HBV DNA should be managed per treatment guidelines. Patients receiving antivirals at screening should have been treated for ≥2 weeks prior to written informed consent and should continue treatment for 6 months after study drug treatment discontinues.
- Note: Patients with active hepatitis C may enroll and those with detectable hepatitis C virus(HCV) RNA who are receiving antiviral therapy at time of screening should remain on continuous, effective antiviral therapy during the study.
- A known history of human immunodeficiency virus(HIV) infection.
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 |
|---|---|---|
| EntacaponeAlso: Comtan, ComtessEntacapone tablet | Drug | Entacapone & Imatinib mesylate |
| Imatinib MesylateAlso: GleevecImatinib Mesylate tablet | Drug | Entacapone & Imatinib mesylate |
Primary outcome
Adverse Events (AE) And Serious Adverse Events(SAE)
Time frame: 36 months or 31 days after last dose, which come first.
According to Criteria CTCAE5.0, the ratio of AE and SAE which were defined by the Common Terminology Criteria for Adverse Events, CTCAE.
2 secondary outcomes
Objective Response Rate(ORR)
Time frame: 36 Months
Quality of Life(QOL)
Time frame: Difference between baseline and the timepoint of the best efficacy within 181 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Background: PubMed 12181401Demetri GD, von Mehren M, Blanke CD, Van den Abbeele AD, Eisenberg B, Roberts PJ, Heinrich MC, Tuveson DA, Singer S, Janicek M, Fletcher JA, Silverman SG, Silberman SL, Capdeville R, Kiese B, Peng B, Dimitrijevic S, Druker BJ, Corless C, Fletcher CD, Joensuu H. Efficacy and safety of imatinib mesylate in advanced gastrointestinal stromal tumors. N Engl J Med. 2002 Aug 15;347(7):472-80. doi: 10.1056/NEJMoa020461.
- Background: PubMed 17046465Demetri GD, van Oosterom AT, Garrett CR, Blackstein ME, Shah MH, Verweij J, McArthur G, Judson IR, Heinrich MC, Morgan JA, Desai J, Fletcher CD, George S, Bello CL, Huang X, Baum CM, Casali PG. Efficacy and safety of sunitinib in patients with advanced gastrointestinal stromal tumour after failure of imatinib: a randomised controlled trial. Lancet. 2006 Oct 14;368(9544):1329-38. doi: 10.1016/S0140-6736(06)69446-4.
- Background: PubMed 15869870Tabone S, Theou N, Wozniak A, Saffroy R, Deville L, Julie C, Callard P, Lavergne-Slove A, Debiec-Rychter M, Lemoine A, Emile JF. KIT overexpression and amplification in gastrointestinal stromal tumors (GISTs). Biochim Biophys Acta. 2005 Jun 30;1741(1-2):165-72. doi: 10.1016/j.bbadis.2005.03.011. Epub 2005 Apr 13.
- Background: PubMed 30996080Peng S, Xiao W, Ju D, Sun B, Hou N, Liu Q, Wang Y, Zhao H, Gao C, Zhang S, Cao R, Li P, Huang H, Ma Y, Wang Y, Lai W, Ma Z, Zhang W, Huang S, Wang H, Zhang Z, Zhao L, Cai T, Zhao YL, Wang F, Nie Y, Zhi G, Yang YG, Zhang EE, Huang N. Identification of entacapone as a chemical inhibitor of FTO mediating metabolic regulation through FOXO1. Sci Transl Med. 2019 Apr 17;11(488):eaau7116. doi: 10.1126/scitranslmed.aau7116.
- Background: PubMed 19097774Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.
- Derived from this study: PubMed 42764990Li Z, He J, Cao Z, Zhou S, Zhu Y, Duan Y, Jiang A, Guan Y, Gao J, Tian J, Liu L, Rong Z, Liu H, Liu X, Xiao H, Deng Y, Li B, Sun L. Targeting the SETD2-FTO-KIT pathway as a pharmacological strategy for TKI-refractory GIST. Acta Pharm Sin B. 2026 Sep;16(9):6045-6065. doi: 10.1016/j.apsb.2026.07.016. Epub 2026 Jul 15.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available.
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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.
Bin Li, MD principal investigator
Xiangya Hospital, Central South University, Changsha, Hunan,China,410008
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Entacapone and Imatinib Mesylate in people with Gastrointestinal Stromal Tumor, Malignant, run by Xiangya Hospital of Central South University at 1 site in China.
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 11 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 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Adverse Events (AE) And Serious Adverse Events(SAE) (time frame: 36 months or 31 days after last dose, which come first.). 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 NCT04006769, which also lists 6 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 18 Oct 2023.