SarcomaPhase 1NCT05578820
Safety, Tolerability and Pharmacokinetics Investigation of Stimotimagene Copolymerplasmid
A Phase 1 study testing Stimotimagene copolymerplasmid and Ganciclovir in people with Sarcoma and Melanoma, run by Gene Surgery LLC at 4 sites in Russia.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of different doses and administration regimens of Stimotimagene copolymerplasmid in patients with histologically confirmed diagnosis of solid tumor and/or its metastases. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sarcoma, Melanoma, Squamous Cell Carcinoma of Head and Neck
- What is being tested?
- Stimotimagene copolymerplasmid and Ganciclovir
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 4 sitesRussia
- Study dates
- 1 Jan 2022to 11 Apr 2024
- Phase
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged 18-75;
- Histologically confirmed diagnosis of a solid tumor and/or its metastases: Sarcoma, Melanoma, Squamous Cell Carcinoma of Head and Neck, Breast Neoplasms, Uterine Cervical Neoplasms, Vulvar Neoplasms, Penile Neoplasms, Anus Neoplasms
- Patients for whom surgery is not indicated;
- Patients with exhausted methods of drug and radiation therapy;
- Presence of clearly detectable and measurable by instrumental methods (ultrasound) tumor mass with a maximum size of at least 10 mm, palpable and accessible for intratumoral injection;
- The injected with the test drug tumor mass must not be located near large blood vessels or nerves;
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- General health according to the ECOG scale 0-2;
- Life expectancy of at least 3 months;
- Hemoglobin ≥ 90 g/l;
- Absolute neutrophil count ≥ 1500/mm3;
- Platelet count ≥ 100,000/mm3;
- Creatinine clearance ≥ 70 ml/min;
- Quick Prothrombin Time more than 55%;
- At least 4 weeks or at least 5 elimination half-lives must elapse between previous chemotherapy, targeted therapy, radiotherapy, immunotherapy, or experimental antitumor therapy and administration of the study drug;
- Patients must recover from any previous surgery, radiotherapy, localized therapy, or systemic therapy to grade 1 or lower adverse reactions (except alopecia or anemia, for which grade 2 is acceptable);
- Women of childbearing age (not menopausal or surgically sterilized) and men who are sexually active should use a reliable method of contraception (acceptable methods of contraception in this study are: IUDs, oral contraceptives, contraceptive patch, long-acting injectable contraceptives, dual barrier method (condom and spermicide, diaphragm and spermicide) during the study and at least 30 days after the last dose of Cymeven® for female patients and at least 90 days after the last dose of Cymeven® for male patients;
- Ability to follow protocol procedures throughout the study;
- Presence of Patient Informed Consent to Participate in a Clinical Trial.
Who cannot join
- The investigator's concern that injecting the drug into the tumor mass may lead to life-threatening side effects, if tumor swelling or inflammation occurs after treatment;
- History of hypersensitivity to ganciclovir, valganciclovir, or any other component of Cymeven®;
- History of hypersensitivity to acyclovir or pencyclovir (or their prodrugs valacyclovir or famciclovir, respectively);
- History of allergic reactions to antibiotics;
- History of allergic reaction to polyethylene glycol or polyethyleneimine;
- The following medications are scheduled to be taken during the potential therapy period:
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- imipenem/cylastatin
- drugs that have myelosuppressive effects or impair renal function: nucleoside analogues (e.g., zidovudine, didanosine, stavudine), immunosuppressants (e.g., cyclosporine, tacrolimus, mycophenolate mofetil), anticancer drugs (e.g, doxorubicin, vincristine, vinblastine, hydroxyurea) and anti-infective drugs (e.g., trimethoprim/sulfamides, dapsone, amphotericin B, flucytosine, pentamidine);
- probenecid;
- Pregnancy or lactation;
- Presence of primary multiple malignant diseases;
- Presence of connection of the tumor mass with the main vessels according to ultrasound/CT/MRI data;
- Radiation damage (ulceration, necrosis);
- High risk/continued bleeding;
- Systemic connective tissue disease (scleroderma, etc.);
- Exacerbation of allergic diseases at the time of inclusion in the study;
- Liver function disorder;
- Presence of acute and acute chronic infections within the last 4 weeks before inclusion in the study (including tuberculosis, abscess, phlegmon);
- Exacerbations of chronic diseases of the cardiovascular, bronchopulmonary, urogenital, gastrointestinal, musculoskeletal, nervous and immune systems at the time of inclusion in the study;
- Presence of mental illness;
- A history of active primary immunodeficiency;
- Presence of HIV, active hepatitis B or C;
- Brain metastases, carcinomatous meningitis at the moment of inclusion in the study;
- Patient's participation in another clinical trial less than 30 days before inclusion in this study;
- Any condition that, in the opinion of the investigator, might interfere with adequate treatment delivery, including difficult contact with the patient (inadequate perception of information provided about the patient's condition and planned/conducted treatment, refusal to comply with recommendations).
Trial locations and contacts
4 sites in 1 country.
Russia4 sites
GBUZ Moscow Clinical Scientific Center named after Loginov MHD
Moscow, 111123
FSBI N.N. Blokhin National Medical Research Center of Oncology of the Ministry of Health of Russia
Moscow, 115478
FSBI National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I.Kulakov of the Ministry of Health of Russia
Moscow, 117997
National Medical Research Radiological Centre of the Ministry of Health of the Russian Federation
Moscow, 125284
About this study
Official title: An Open Multicenter Study of the Safety, Tolerability, and Pharmacokinetics of Different Doses of Stimotimagene Copolymerplasmid at Patients With Advanced-stage Solid Tumors With Cymeven® (Ganciclovir) Infusions
The purpose of this study is to evaluate the safety and tolerability of different doses and administration regimens of Stimotimagene copolymerplasmid in patients with histologically confirmed diagnosis of solid tumor and/or its metastases.
Read the detailed description
Stimotimagene copolymerplasmid is an anti-tumor gene therapy drug, contains super-coiled plasmid DNA encapsulated in polycationic envelope (PPT: polyethyleneimine (PEI) - polyethylene glycol (PEG) - TAT peptide). The plasmid encodes two therapeutic genes: herpes simplex virus thymidine kinase (HSVtk) and human granulocyte-macrophage colony-stimulating factor (hGM-CSF). HSVtk converts the prodrug ganciclovir to a toxin in cells that have been transfected by Stimotimagene copolymerplasmid, GM-CSF stimulates proliferation and differentiation of antigen-presenting cells.
Stimotimagene copolymerplasmid therapy is two-staged: (1) intratumoral injection of Stimotimagene copolymerplasmid, (2) intravenous administration of ganciclovir (Cimeven®) This is the first-in-human study of Stimotimagene copolymerplasmid which will be conducted in three arms. In this study dose escalation (Arm1) and number of drug administrations (Arms 2 and 3) will be explored. All study parts will investigate the safety, tolerability and pharmacokinetic profile of Stimotimagene copolymerplasmid.
- Conditions
- Sarcoma, Melanoma, Squamous Cell Carcinoma of Head and Neck, Breast Neoplasms, Uterine Cervical Neoplasms, Vulvar Neoplasms
- Being tested
- Stimotimagene copolymerplasmid, Ganciclovir
- Medical subject headings
- Sarcoma, Melanoma, Squamous Cell Carcinoma of Head and Neck, Breast Neoplasms, Uterine Cervical Neoplasms, Vulvar Neoplasms, Penile Neoplasms, Anus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stimotimagene copolymerplasmidBiological
Also called AntioncoRAN-M
Gene therapy drug, Intratumoral administration
GanciclovirDrug
Also called Cymeven®
Antiviral drug, Intravenous administration
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation phase | Experimental | Stimotimagene copolymerplasmid will be administered intratumoral once in a dose of 20 mkg of DNA per 1 cm3 of tumor (for cohort 1) and 40 mkg of DNA per 1 cm3 of tumor (for cohort 2).
Ganciclovir (Cimeven®) will be administrated intravenous twice a day at 12-hour intervals for 15 days. Receives: Biological: Stimotimagene copolymerplasmid; Drug: Ganciclovir |
| Two times administration of Stimotimagene copolymerplasmid | Experimental | Stimotimagene copolymerplasmid will be administered intratumorally twice with 5-day interval in the optimal dose selected at previous stage of the trial.
Ganciclovir (Cimeven®) will be administrated intravenous twice a day at 12-hour intervals for 15 days. Receives: Biological: Stimotimagene copolymerplasmid; Drug: Ganciclovir |
| Tree times administration of Stimotimagene copolymerplasmid | Experimental | Stimotimagene copolymerplasmid will be administered intratumorally three times with 5-day interval in the optimal dose selected at first stage of the trial.
Ganciclovir (Cimeven®) will be administrated intravenous twice a day at 12-hour intervals for 15 days. Receives: Biological: Stimotimagene copolymerplasmid; Drug: Ganciclovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety (Presence/absence of dose-limiting toxicities (DLTs))
Assessment of presence/absence of dose-limiting toxicities (DLTs)
Measured: Through study completion, an average of 1 year
Safety (Frequency and severity of adverse events (CTCAE classification))
Assessment of frequency and severity of adverse events (CTCAE classification)
Measured: Through study completion, an average of 1 year
Safety (Number of cases of early termination of participation in the study due to the development of Serious Adverse Events and Other Adverse Events associated with the study therapy)
Assessment of number of cases of early termination of participation in the study due to the development of Serious Adverse Events and Other Adverse Events associated with the study therapy)
Measured: Through study completion, an average of 1 year
Pharmacokinetics (Quantitative content of plasmid DNA (pTKhGM) in patients' peripheral blood)
Assessment of quantitative content of plasmid DNA (pTKhGM) in patients' peripheral blood at:
Day -1 (baseline), Day 1 (4 h and 8 h after drug administration), Day 2 (24 h after drug administration), Day 3 (48 h after drug administration), Days 5, 7, 12, 17, 25, 30±3, 60±5, 90±7, 130±3 for patients from 1st step of the study; Day -1 (baseline), Day 1 (4 h and 8 h after drug administration), Day 2 (24 h after drug administration), Day 3 (48 h after drug administration), Day 6 (before drug administration and 8 h after drug administration), Days 7, 12, 17, 25, 30±3, 60±5, 90±7, 130±3 for patients from 2nd step of the study; Day -1 (baseline), Day 1 (4 h and 8 h after drug administration), Day 2 (24 h after drug administration), Day 3 (48 h after drug administration), Day 6 (before drug administration and 8 h after drug administration), Day 7, Day 11 (before drug administration and 8 h after drug administration), Days 12, 17, 25, 30±3, 60±5, 90±7, 130±3 for patients from 3rd step of the
Measured: Through study completion, an average of 1 year
Pharmacokinetics (Quantitative content of plasmid DNA (pTKhGM) in patients' urine)
Assessment of quantitative content of plasmid DNA (pTKhGM) in patients' urine at:
Day -1 (baseline), Day 1 (4 h and 8 h after drug administration), Day 2 (24 h after drug administration), Day 3 (48 h after drug administration), Days 5, 7, 12, 17, 25, 30±3, 60±5, 90±7, 130±3 for patients from 1st step of the study; Day -1 (baseline), Day 1 (4 h and 8 h after drug administration), Day 2 (24 h after drug administration), Day 3 (48 h after drug administration), Day 6 (before drug administration and 8 h after drug administration), Days 7, 12, 17, 25, 30±3, 60±5, 90±7, 130±3 for patients from 2nd step of the study; Day -1 (baseline), Day 1 (4 h and 8 h after drug administration), Day 2 (24 h after drug administration), Day 3 (48 h after drug administration), Day 6 (before drug administration and 8 h after drug administration), Day 7, Day 11 (before drug administration and 8 h after drug administration), Days 12, 17, 25, 30±3, 60±5, 90±7, 130±3 for patients from 3rd step of the study.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start1 Jan 2022
- Primary completion11 Apr 2024
- Study completion11 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gene Surgery LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Irina Alekseenko, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05578820
- Sponsor's protocol ID
- NTI1GSA
- Status last verified
- Jun 2024
- First submitted
- 3 Oct 2022
- Last updated
- 1 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Multicenter Study of the Safety, Tolerability, and Pharmacokinetics of Different Doses of Stimotimagene Copolymerplasmid at Patients With Advanced-stage Solid Tumors With Cymeven® (Ganciclovir) Infusions
- ClinicalTrials.gov ID
- NCT05578820
- Acronym / sponsor ID
- NTI1GSA
- Conditions
- Sarcoma, Melanoma, Squamous Cell Carcinoma of Head and Neck, Breast Neoplasms, Uterine Cervical Neoplasms, Vulvar Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Gene Surgery LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 11 Apr 2024 (actual)
- Study completion
- 11 Apr 2024 (actual)
- First posted
- 13 Oct 2022 (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.
The purpose of this study is to evaluate the safety and tolerability of different doses and administration regimens of Stimotimagene copolymerplasmid in patients with histologically confirmed diagnosis of solid tumor and/or its metastases.
Detailed description
Stimotimagene copolymerplasmid is an anti-tumor gene therapy drug, contains super-coiled plasmid DNA encapsulated in polycationic envelope (PPT: polyethyleneimine (PEI) - polyethylene glycol (PEG) - TAT peptide). The plasmid encodes two therapeutic genes: herpes simplex virus thymidine kinase (HSVtk) and human granulocyte-macrophage colony-stimulating factor (hGM-CSF). HSVtk converts the prodrug ganciclovir to a toxin in cells that have been transfected by Stimotimagene copolymerplasmid, GM-CSF stimulates proliferation and differentiation of antigen-presenting cells.
Stimotimagene copolymerplasmid therapy is two-staged: (1) intratumoral injection of Stimotimagene copolymerplasmid, (2) intravenous administration of ganciclovir (Cimeven®) This is the first-in-human study of Stimotimagene copolymerplasmid which will be conducted in three arms. In this study dose escalation (Arm1) and number of drug administrations (Arms 2 and 3) will be explored. All study parts will investigate the safety, tolerability and pharmacokinetic profile of Stimotimagene copolymerplasmid.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose escalation phase | Experimental | Biological: Stimotimagene copolymerplasmid, Drug: GanciclovirStimotimagene copolymerplasmid will be administered intratumoral once in a dose of 20 mkg of DNA per 1 cm3 of tumor (for cohort 1) and 40 mkg of DNA per 1 cm3 of tumor (for cohort 2). Ganciclovir (Cimeven®) will be administrated intravenous twice a day at 12-hour intervals for 15 days. |
| Two times administration of Stimotimagene copolymerplasmid | Experimental | Biological: Stimotimagene copolymerplasmid, Drug: GanciclovirStimotimagene copolymerplasmid will be administered intratumorally twice with 5-day interval in the optimal dose selected at previous stage of the trial. Ganciclovir (Cimeven®) will be administrated intravenous twice a day at 12-hour intervals for 15 days. |
| Tree times administration of Stimotimagene copolymerplasmid | Experimental | Biological: Stimotimagene copolymerplasmid, Drug: GanciclovirStimotimagene copolymerplasmid will be administered intratumorally three times with 5-day interval in the optimal dose selected at first stage of the trial. Ganciclovir (Cimeven®) will be administrated intravenous twice a day at 12-hour intervals for 15 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Men and women aged 18-75;
- Histologically confirmed diagnosis of a solid tumor and/or its metastases: Sarcoma, Melanoma, Squamous Cell Carcinoma of Head and Neck, Breast Neoplasms, Uterine Cervical Neoplasms, Vulvar Neoplasms, Penile Neoplasms, Anus Neoplasms
- Patients for whom surgery is not indicated;
- Patients with exhausted methods of drug and radiation therapy;
- Presence of clearly detectable and measurable by instrumental methods (ultrasound) tumor mass with a maximum size of at least 10 mm, palpable and accessible for intratumoral injection;
Key exclusion criteria (25 listed)
- The investigator's concern that injecting the drug into the tumor mass may lead to life-threatening side effects, if tumor swelling or inflammation occurs after treatment;
- History of hypersensitivity to ganciclovir, valganciclovir, or any other component of Cymeven®;
- History of hypersensitivity to acyclovir or pencyclovir (or their prodrugs valacyclovir or famciclovir, respectively);
- History of allergic reactions to antibiotics;
- History of allergic reaction to polyethylene glycol or polyethyleneimine;
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 |
|---|---|---|
| Stimotimagene copolymerplasmidAlso: AntioncoRAN-MGene therapy drug, Intratumoral administration | Biological | Dose escalation phase, Tree times administration of Stimotimagene copolymerplasmid, Two times administration of Stimotimagene copolymerplasmid |
| GanciclovirAlso: Cymeven®Antiviral drug, Intravenous administration | Drug | Dose escalation phase, Tree times administration of Stimotimagene copolymerplasmid, Two times administration of Stimotimagene copolymerplasmid |
Primary outcome
Safety (Presence/absence of dose-limiting toxicities (DLTs))
Time frame: Through study completion, an average of 1 year
Assessment of presence/absence of dose-limiting toxicities (DLTs)
Safety (Frequency and severity of adverse events (CTCAE classification))
Time frame: Through study completion, an average of 1 year
Assessment of frequency and severity of adverse events (CTCAE classification)
Safety (Number of cases of early termination of participation in the study due to the development of Serious Adverse Events and Other Adverse Events associated with the study therapy)
Time frame: Through study completion, an average of 1 year
Assessment of number of cases of early termination of participation in the study due to the development of Serious Adverse Events and Other Adverse Events associated with the study therapy)
Pharmacokinetics (Quantitative content of plasmid DNA (pTKhGM) in patients' peripheral blood)
Time frame: Through study completion, an average of 1 year
Assessment of quantitative content of plasmid DNA (pTKhGM) in patients' peripheral blood at: Day -1 (baseline), Day 1 (4 h and 8 h after drug administration), Day 2 (24 h after drug administration), Day 3 (48 h after drug administration), Days 5, 7, 12, 17, 25, 30±3, 60±5, 90±7, 130±3 for patients from 1st step of the study; Day -1 (baseline), Day 1 (4 h and 8 h after drug administration), Day 2 (24 h after drug administration), Day 3 (48 h after drug administration), Day 6 (before drug administration and 8 h after drug administration), Days 7, 12, 17, 25, 30±3, 60±5, 90±7, 130±3 for patients from 2nd step of the study; Day -1 (baseline), Day 1 (4 h and 8 h after drug administration), Day 2 (24 h after drug administration), Day 3 (48 h after drug administration), Day 6 (before drug administration and 8 h after drug administration), Day 7, Day 11 (before drug administration and 8 h after drug administration), Days 12, 17, 25, 30±3, 60±5, 90±7, 130±3 for patients from 3rd step of the
Pharmacokinetics (Quantitative content of plasmid DNA (pTKhGM) in patients' urine)
Time frame: Through study completion, an average of 1 year
Assessment of quantitative content of plasmid DNA (pTKhGM) in patients' urine at: Day -1 (baseline), Day 1 (4 h and 8 h after drug administration), Day 2 (24 h after drug administration), Day 3 (48 h after drug administration), Days 5, 7, 12, 17, 25, 30±3, 60±5, 90±7, 130±3 for patients from 1st step of the study; Day -1 (baseline), Day 1 (4 h and 8 h after drug administration), Day 2 (24 h after drug administration), Day 3 (48 h after drug administration), Day 6 (before drug administration and 8 h after drug administration), Days 7, 12, 17, 25, 30±3, 60±5, 90±7, 130±3 for patients from 2nd step of the study; Day -1 (baseline), Day 1 (4 h and 8 h after drug administration), Day 2 (24 h after drug administration), Day 3 (48 h after drug administration), Day 6 (before drug administration and 8 h after drug administration), Day 7, Day 11 (before drug administration and 8 h after drug administration), Days 12, 17, 25, 30±3, 60±5, 90±7, 130±3 for patients from 3rd step of the study.
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 1 Jul 2024.
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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.
Irina Alekseenko study director
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Stimotimagene copolymerplasmid and Ganciclovir in people with Sarcoma and Melanoma, run by Gene Surgery LLC at 4 sites in Russia.
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 18 inclusion and 25 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 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Russia. 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 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.
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?
Safety (Presence/absence of dose-limiting toxicities (DLTs)) (time frame: Through study completion, an average of 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jul 2024.