Advanced Soft-tissue SarcomaPhase 1/2EnhancerNCT05809830
Phase I/II of LB-100 Plus Doxorubicin vs. Doxorubicin Alone in First Line of Advanced Soft Tissue Sarcomas
A Phase 1/2 study testing LB-100 plus Doxorrubicin and Doxorubicin in people with Advanced Soft-tissue Sarcoma, run by Grupo Espanol de Investigacion en Sarcomas at 6 sites in Spain.
Trial summary
A Phase I dose-finding stage for the LB-100 plus doxorubicin combination is planned for an initial set of 9-18 patients (21-day cycles). After that, in the Phase II part, patients will be randomized (ratio 1:1) to either the experimental arm (LB-100 plus doxorubicin combination) or the control arm (doxorubicin alone)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Soft-tissue Sarcoma
- What is being tested?
- LB-100 plus Doxorrubicin and Doxorubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 6 sitesSpain
- Study dates
- 29 May 2023to 8 May 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- The patient must provide written informed consent prior to performance of study-specific procedures and must be willing to comply with treatment and follow-up. Informed consent must be obtained prior to start of the screening process. Procedures conducted as part of the patient's routine clinical management (e.g. blood count, imaging tests, etc.) and obtained prior to signature of informed consent may be used for screening or baseline purposes as long as these procedures are conducted as specified in the protocol.
- Age ≥ 18 years.
- Diagnosis of advanced/metastatic soft tissue sarcoma (undifferentiated pleomorphic sarcoma, leiomyosarcoma, myxoid and hypercellular myxoid liposarcoma, myxofibrosarcoma, NOS sarcoma, synovial sarcoma, fibrosarcoma, or malignant nerve sheath tumor) confirmed by central pathology review.
- Mandatory pre-treatment formalin-fixed paraffin embedded (FFPE) tumor tissue must be provided for all subjects without exception for central pathology review and the translational study. If archive biopsy is not available or is older than 3 months, the patient must be willing to have a pre-treatment re-biopsy of primary or metastatic tumor (baseline biopsy) within 28 days prior to enrollment.
- The patient must be willing to undergo a second mandatory biopsy just before the initiation of the 3rd cycle and agree that this sample is used for the translational study.
- Measurable disease according to RECIST v1.1 criteria.
Show all 40Show fewer
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
- The patient must be naïve of any previous treatment with anthracyclines (not even in adjuvant chemotherapy).
- Adequate organ, hepatic, renal, cardiac, and hematologic function.
- Laboratory tests as follows:
- Absolute neutrophil count ≥ 1,200/mm³
- Platelet count ≥ 100,000/mm³
- Hg > 9 g/dL
- Bilirubin ≤ 1.5 mg/dL
- PT and INR ≤ 1.5
- AST and ALT ≤ 2.5 times ULN
- Creatinine ≤ 1.5 mg/dL or estimated creatinine clearance ≥ 60 mL/min
- Blood glucose < 150 mg/dL
- Left ventricular ejection fraction ≥ 50% by echocardiogram or MUGA scan assessed within 28 days before enrollment.
- Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to enrollment. Patients must not be pregnant or nursing at study entry.
- Women and men of reproductive potential must have agreed to use an effective contraceptive method during study treatment and for 3 months after the last dose of study drug.
- The patient must provide written informed consent prior to performance of study-specific procedures and must be willing to comply with treatment and follow-up. Informed consent must be obtained prior to start of the screening process. Procedures conducted as part of the patient's routine clinical management (e.g. blood count, imaging tests, etc.) and obtainedprior to signature of informed consent may be used for screening or baseline purposes as long as these procedures are conducted as specified in the protocol.
- Age ≥ 18 years.
- Diagnosis of advanced/metastatic soft tissue sarcoma (undifferentiated pleomorphic sarcoma or leiomyosarcoma) confirmed by central pathology review.
- Mandatory pre-treatment formalin-fixed paraffin embedded (FFPE) tumor tissue must be provided for all subjects without exception for central pathology review and the translational study. If archive biopsy is not available or is older than 3 months, the patient must be willing to have a pre-treatment re-biopsy of primary or metastatic tumor (baseline biopsy) within 28 days prior to enrollment.
- Measurable disease according to RECIST v1.1 criteria.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
- The patient must be naïve of any previous treatment with anthracyclines (not even in adjuvant chemotherapy).
- Adequate organ, hepatic, renal, cardiac, and hematologic function.
- Laboratory tests as follows:
- Absolute neutrophil count ≥ 1,200/mm³
- Platelet count ≥ 100,000/mm³
- Hg > 9 g/dL
- Bilirubin ≤ 1.5 mg/dL
- PT and INR ≤ 1.5
- AST and ALT ≤ 2.5 times ULN
- Creatinine ≤ 1.5 mg/dL or estimated creatinine clearance ≥ 60 mL/min
- Blood glucose < 150 mg/dL 10. Left ventricular ejection fraction ≥ 50% by echocardiogram or MUGA scan assessed within 28 days before enrollment.
- 11. Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to enrollment. Patients must not be pregnant or nursing at study entry.
- 12. Women and men of reproductive potential must have agreed to use an effective contraceptive method during study treatment and for 3 months after the last dose of study drug.
Who cannot join
- Diagnosis different from the elegible histological subtypes.
- Previous treatment with doxorubicin, epirubicin, idarubicin, and/or other anthracyclines or any other systemic therapy. The exception is previous systemic therapy for a previous neoplasm (see exclusion criteria 10), if this is controlled, as long as it did not include anthracyclines.
- Uncontrolled intercurrent illness including (not limited to): symptomatic congestive heart failure (CHF) (New York Heart Association [NYHA] III/IV), unstable angina pectoris or coronary angioplasty, or stenting within 24 weeks prior to registration, unstable cardiac arrhythmia (ongoing cardiac dysrhythmias of NCI CTCAE version 5.0 Grade >= 2), known psychiatric illness that would limit study compliance, intra-cardiac defibrillators, known cardiac metastases, or abnormal cardiac valve morphology (>= Grade 3).
- HBV and HCV serologies must be performed prior to inclusion. If HbsAg is positive it is recommended to reject the existence of replicative phase (HbaAg+, DNA VHB+). If these were positives the inclusion is not recommended, remaining at investigators' discretion the preventive treatment with lamivudine. If a potential patient is positive for anti-HCV antibodies, presence of the virus should be ruled out with a qualitative PCR, or the patient should NOT be included in the study (if a qualitative PCR cannot be performed then patient will not be able to enter the study).
- Any of the following diseases/illnesses within the previous 6 months:
- Myocardial infarction
Show all 34Show fewer
- Severe or unstable angina
- Coronary or peripheral artery bypass graft
- Cerebrovascular accident or transient ischemic attack (TIA)
- Pulmonary embolism
- Evidence of a bleeding diathesis.
- Ongoing cardiac dysrhythmias > Grade 2.
- Prolonged QTc interval (i.e., QTc > 450 msec for males or QTc > 470 msec for females) on baseline ECG.
- History of allergy to study drug components.
- History of another cancer with the exception of adequately treated basal cell carcinoma or in situ cervical cancer, or with a relapse-free interval longer than 3 years after treatment of the primary cancer with no substantial risk of recurrence.
- Presence of brain or central nervous system metastases at the time of enrollment.
- Patient is unwilling to provide mandatory translational tumor samples or biopsies (if required) cannot be easily taken.
- Diagnosis of any sarcoma different from undifferentiated pleomorphic sarcoma and leiomyosarcoma.
- Previous treatment with doxorubicin, epirubicin, idarubicin, and/or other anthracyclines or any other systemic therapy. The exception is previous systemic therapy for a previous neoplasm (see exclusion criteria 10), if this is controlled, as long as it did not include anthracyclines.
- Uncontrolled intercurrent illness including (not limited to): symptomatic congestive heart failure (CHF) (New York Heart Association [NYHA] III/IV), unstable angina pectoris or coronary angioplasty, or stenting within 24 weeks prior to registration, unstable cardiac arrhythmia (ongoing cardiac dysrhythmias of NCI CTCAE version 5.0 Grade >= 2), known psychiatric illness that would limit study compliance, intra-cardiac defibrillators, known cardiac metastases, or abnormal cardiac valve morphology (>= Grade 3).
- HBV and HCV serologies must be performed prior to inclusion. If HbsAg is positive it is recommended to reject the existence of replicative phase (HbaAg+, DNA VHB+). If these were positives the inclusion is not recommended, remaining at investigators' discretion the preventive treatment with lamivudine. If a potential patient is positive for anti-HCV antibodies, presence of the virus should be ruled out with a qualitative PCR, or the patient should NOT be included in the study (if a qualitative PCR cannot be performed then patient will not be able to enter the study).
- Any of the following diseases/illnesses within the previous 6 months:
- Myocardial infarction
- Severe or unstable angina
- Coronary or peripheral artery bypass graft
- Cerebrovascular accident or transient ischemic attack (TIA)
- Pulmonary embolism
- Evidence of a bleeding diathesis.
- Ongoing cardiac dysrhythmias > Grade 2.
- Prolonged QTc interval (i.e., QTc > 450 msec for males or QTc > 470 msec for females) on baseline ECG.
- History of allergy to study drug components.
- History of another cancer with the exception of adequately treated basal cell carcinoma or in situ cervical cancer, or with a relapse-free interval longer than 3 years after treatment of the primary cancer with no substantial risk of recurrence.
- Presence of brain or central nervous system metastases at the time of enrollment.
- Patient is unwilling to provide mandatory translational tumor samples or biopsies (if required) cannot be easily taken.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Spain6 sites
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, 08026
Hospital Clínico San Carlos
Madrid, Madrid, 28040
Hospital Fundación Jiménez Díaz
Madrid, Madrid, 28040
Hospital Universitario La Paz
Madrid, Madrid, 28046
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, Murcia, 30120
Hospital Clínico Universitario de Valencia
Valencia, Valencia, 46010
About this study
Official title: Phase I/II Randomized Trial of LB-100 Plus Doxorubicin vs. Doxorubicin Alone in First Line of Advanced Soft Tissue Sarcomas
A Phase I dose-finding stage for the LB-100 plus doxorubicin combination is planned for an initial set of 9-18 patients (21-day cycles). After that, in the Phase II part, patients will be randomized (ratio 1:1) to either the experimental arm (LB-100 plus doxorubicin combination) or the control arm (doxorubicin alone) to, comparatively, evaluate the efficacy of the LB-100 plus doxorubicin combination vs. doxorubicin alone
- Conditions
- Advanced Soft-tissue Sarcoma
- Being tested
- LB-100 plus Doxorrubicin, Doxorubicin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LB-100 plus DoxorrubicinDrug
In Phase one the intervention will be LB-100 plus Doxorrubicin. The experimental arm in Phase II will also be LB-100 plus Doxorrubicin
DoxorubicinDrug
The control arm in Phase II will be Doxorrubicin alone
| Study group | Role | What they receive |
|---|---|---|
| LB-100 plus doxorubicin | Experimental | * LB-100 will be administered during the first 3 days of each cycle (days 1, 2, and 3) at RP2D as a 2-hour intravenous infusion (with 500 mL of physiological saline solution), every 3 weeks (21-day cycles until progression or intolerance).
* Doxorubicin will be administered only once (day 1) of each cycle at RP2D as a 20-minute infusion after completion of LB-100, every 3 weeks (up to a maximum of 6 x 21-day cycles). Receives: Drug: LB-100 plus Doxorrubicin |
| Doxorubicin alone | Active comparator | Control: Doxorubicin will be administered only once (day 1) of each cycle at RP2D as a 20-minute infusion every 3 weeks (up to a maximum of 6 x 21-day cycles). Receives: Drug: Doxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximun Tolerated Dose (MTD) (Phase I)
The MTD of LB-100 in combination with doxorubicin will be determined by assessing adverse events according to CTCAE v5.0.
Measured: After six months
Progression-free survival (PFS) (Phase II)
Efficacy measured by median PFS according to RECIST v1.1
Measured: After two years
Secondary outcomes (5)
Adverse Events (Phase I and II)
Safety profile/Toxicity assessed by adverse events related to study drugs
Measured: Between six months and two years
Overall Response Rate (ORR) (Phase I and II)
Efficacy measured by the ORR, which is defined as the number of subjects with a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) divided by the number of response evaluable subjects.
Measured: Between six months and two years
Progression-free survival (PFS) (Phase I)
Efficacy measured by median PFS according to RECIST v1.1
Measured: After six months
Overall survival (OS) (Phase I and II)
Censored on the last date a subject was known to be alive
Measured: Between six months and two years
EORTC QLQ-C30 questionnaire (Phase I and II)
Quality of life assessed by using the EORTC QLQ-C30 questionnaire.
Measured: Between six months and two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start29 May 2023
- Primary completion20 Jun 2025 (estimated)
- Study completion8 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Soft-tissue 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- A Phase I dose-finding stage for the LB-100 plus doxorubicin combination is planned for an initial set of 9-18 patients (21-day cycles) In the Phase II part, patients will be enrolled in the trial via randomization. A randomization module (integrated in the eCRF system) will be used to assign patients to either the experimental arm (LB-100 plus doxorubicin) or to the control arm (doxorubicin alone) (1:1 ratio)
- Masking
- None (open label)
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grupo Espanol de Investigacion en Sarcomas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Javier Martín Broto, Principal investigator, Hospital Universitario Fundación Jiménez Díaz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05809830
- Sponsor's protocol ID
- GEIS-74
- Acronym
- Enhancer
- Status last verified
- Feb 2025
- First submitted
- 27 Mar 2023
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Randomized Trial of LB-100 Plus Doxorubicin vs. Doxorubicin Alone in First Line of Advanced Soft Tissue Sarcomas
- ClinicalTrials.gov ID
- NCT05809830
- Acronym / sponsor ID
- Enhancer / GEIS-74
- Conditions
- Advanced Soft-tissue Sarcoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Grupo Espanol de Investigacion en SarcomasUniversity, hospital or other
- Study start
- 29 May 2023 (actual)
- Primary completion
- 20 Jun 2025 (estimated)
- Study completion
- 8 May 2026 (estimated)
- First posted
- 12 Apr 2023 (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.
A Phase I dose-finding stage for the LB-100 plus doxorubicin combination is planned for an initial set of 9-18 patients (21-day cycles). After that, in the Phase II part, patients will be randomized (ratio 1:1) to either the experimental arm (LB-100 plus doxorubicin combination) or the control arm (doxorubicin alone) to, comparatively, evaluate the efficacy of the LB-100 plus doxorubicin combination vs. doxorubicin alone
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A Phase I dose-finding stage for the LB-100 plus doxorubicin combination is planned for an initial set of 9-18 patients (21-day cycles) In the Phase II part, patients will be enrolled in the trial via randomization. A randomization module (integrated in the eCRF system) will be used to assign patients to either the experimental arm (LB-100 plus doxorubicin) or to the control arm (doxorubicin alone) (1:1 ratio)
| Arm | Type | Receives |
|---|---|---|
| LB-100 plus doxorubicin | Experimental | Drug: LB-100 plus Doxorrubicin* LB-100 will be administered during the first 3 days of each cycle (days 1, 2, and 3) at RP2D as a 2-hour intravenous infusion (with 500 mL of physiological saline solution), every 3 weeks (21-day cycles until progression or intolerance). * Doxorubicin will be administered only once (day 1) of each cycle at RP2D as a 20-minute infusion after completion of LB-100, every 3 weeks (up to a maximum of 6 x 21-day cycles). |
| Doxorubicin alone | Active comparator | Drug: DoxorubicinControl: Doxorubicin will be administered only once (day 1) of each cycle at RP2D as a 20-minute infusion every 3 weeks (up to a maximum of 6 x 21-day cycles). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (40 listed)
- The patient must provide written informed consent prior to performance of study-specific procedures and must be willing to comply with treatment and follow-up. Informed consent must be obtained prior to start of the screening process. Procedures conducted as part of the patient's routine clinical management (e.g. blood count, imaging tests, etc.) and obtained prior to signature of informed consent may be used for screening or baseline purposes as long as these procedures are conducted as specified in the protocol.
- Age ≥ 18 years.
- Diagnosis of advanced/metastatic soft tissue sarcoma (undifferentiated pleomorphic sarcoma, leiomyosarcoma, myxoid and hypercellular myxoid liposarcoma, myxofibrosarcoma, NOS sarcoma, synovial sarcoma, fibrosarcoma, or malignant nerve sheath tumor) confirmed by central pathology review.
- Mandatory pre-treatment formalin-fixed paraffin embedded (FFPE) tumor tissue must be provided for all subjects without exception for central pathology review and the translational study. If archive biopsy is not available or is older than 3 months, the patient must be willing to have a pre-treatment re-biopsy of primary or metastatic tumor (baseline biopsy) within 28 days prior to enrollment.
- The patient must be willing to undergo a second mandatory biopsy just before the initiation of the 3rd cycle and agree that this sample is used for the translational study.
Key exclusion criteria (34 listed)
- Diagnosis different from the elegible histological subtypes.
- Previous treatment with doxorubicin, epirubicin, idarubicin, and/or other anthracyclines or any other systemic therapy. The exception is previous systemic therapy for a previous neoplasm (see exclusion criteria 10), if this is controlled, as long as it did not include anthracyclines.
- Uncontrolled intercurrent illness including (not limited to): symptomatic congestive heart failure (CHF) (New York Heart Association [NYHA] III/IV), unstable angina pectoris or coronary angioplasty, or stenting within 24 weeks prior to registration, unstable cardiac arrhythmia (ongoing cardiac dysrhythmias of NCI CTCAE version 5.0 Grade >= 2), known psychiatric illness that would limit study compliance, intra-cardiac defibrillators, known cardiac metastases, or abnormal cardiac valve morphology (>= Grade 3).
- HBV and HCV serologies must be performed prior to inclusion. If HbsAg is positive it is recommended to reject the existence of replicative phase (HbaAg+, DNA VHB+). If these were positives the inclusion is not recommended, remaining at investigators' discretion the preventive treatment with lamivudine. If a potential patient is positive for anti-HCV antibodies, presence of the virus should be ruled out with a qualitative PCR, or the patient should NOT be included in the study (if a qualitative PCR cannot be performed then patient will not be able to enter the study).
- Any of the following diseases/illnesses within the previous 6 months:
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 |
|---|---|---|
| LB-100 plus DoxorrubicinIn Phase one the intervention will be LB-100 plus Doxorrubicin. The experimental arm in Phase II will also be LB-100 plus Doxorrubicin | Drug | LB-100 plus doxorubicin |
| DoxorubicinThe control arm in Phase II will be Doxorrubicin alone | Drug | Doxorubicin alone |
Primary outcome
Maximun Tolerated Dose (MTD) (Phase I)
Time frame: After six months
The MTD of LB-100 in combination with doxorubicin will be determined by assessing adverse events according to CTCAE v5.0.
Progression-free survival (PFS) (Phase II)
Time frame: After two years
Efficacy measured by median PFS according to RECIST v1.1
5 secondary outcomes
Adverse Events (Phase I and II)
Time frame: Between six months and two years
Overall Response Rate (ORR) (Phase I and II)
Time frame: Between six months and two years
Progression-free survival (PFS) (Phase I)
Time frame: After six months
Overall survival (OS) (Phase I and II)
Time frame: Between six months and two years
EORTC QLQ-C30 questionnaire (Phase I and II)
Time frame: Between six months and two years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Individual participant dataSharing planned: No
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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.
Javier Martín Broto principal investigator
Hospital Universitario Fundación Jiménez Díaz
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing LB-100 plus Doxorrubicin and Doxorubicin in people with Advanced Soft-tissue Sarcoma, run by Grupo Espanol de Investigacion en Sarcomas at 6 sites in Spain.
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 40 inclusion and 34 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: under way, not looking for participants, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain. 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?
This study is still under way. Results are not available in the source record yet.
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?
Maximun Tolerated Dose (MTD) (Phase I) (time frame: After six months). The study lists 2 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 21 Mar 2025.