Advanced Solid TumorPhase 1NCT05344742
A Study of Mitoxantrone Hydrochloride Liposome Injection Combination Therapy in Chinese Patients With Advanced Solid Tumors
A Phase 1 study testing Mitoxantrone Hydrochloride Liposome injection, Capecitabine and Albumin-paclitaxel in people with Advanced Solid Tumor, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..
Trial summary
The purpose of this study is to evaluate the tolerability, safety, pharmacokinetics (PK) and efficacy of mitoxantrone hydrochloride liposome injection combination therapy in Chinese patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- Mitoxantrone Hydrochloride Liposome injection, Capecitabine and Albumin-paclitaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- No sites listed yet
- Study dates
- Apr 2022to Mar 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients fully understand and voluntarily participate in this study and sign informed consent;
- Aged 18-65 years, male or female;
- Patients with advanced solid tumors confirmed by histopathology or cytologically and who have failed standard therapy;
- At least one measurable lesion according to RECIST v1.1 at baseline;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1;
- Adverse events（AEs） from the previous treatment have resolved to ≤ Grade 1 based on CTCAE (except for alopecia, hyperpigmentation and the toxicity without safety risk judged by the investigator);
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- Adequate organ function defined as:
- Absolute neutrophil count (ANC) ≥1.5*10^9/L (No Granulocyte Colony Stimulating Factor treatment within 2 weeks prior to the laboratory test);
- Hemoglobin ≥ 90 g/L (No red blood cell transfusion within 2 weeks prior to the laboratory test);
- Platelet count ≥ 100*10^9/L (No platelet transfusion within 2 weeks prior to the laboratory test);
- Creatinine ≤1.5 upper limit of normal (ULN);
- Total bilirubin ≤1.5 ULN;
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3ULN, ≤ 5ULN for patients with liver metastases;
- Coagulation: prothrombin time (PT) and International Normalization Ratio (INR) ≤1.5ULN；
- Female patients must have a urine or blood human chorionic gonadotropin（HCG） negative test before enrolment (except for menopause and hysterectomy); Patients and their partners must agree to use effective contraceptives measures during the study until 6 months after the end of the last dose.
Who cannot join
- History of severe allergy to mitoxantrone hydrochloride or liposomal drugs; allergy to capecitabine or any excipients of its components; previous serious and unexpected reaction to fluoropyrimidine or known allergy to fluorouracil; known complete deficiency of dihydropyrimidine dehydrogenase (DPD) activity; allergy to paclitaxel or human albumin;
- Cerebral or meningeal metastases;
- Life expectancy < 3 months;
- Patients with chronic hepatitis B (HBsAg or HBcAb positive with HBV DNA ≥ 2000 IU/mL), chronic hepatitis C (HCV antibody positive with HCV RNA above the lower limit of detection of the study center), or human immunodeficiency virus (HIV) antibody positive;
- Active bacterial, fungal or viral infections that require intravenous infusion treatment within 1 week prior to the first dose;
- Any anticancer treatment within 4 weeks prior to the first dose (e.g., radiotherapy, targeted therapy, immunotherapy, endocrine therapy, etc.); Traditional Chinese medicine or proprietary Chinese medicine with an approved oncology indication within 2 weeks prior to the first dose;
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- Enrolled in any other clinical trials within 4 weeks prior to the first dose;
- Patients have undergone major surgery within 3 months prior to the first dose, or have a surgical schedule during the study period;
- Serious thrombosis or thromboembolism as judged by the investigator within 6 months prior to screening;
- History of additional malignant tumor within 3 years, except for locally curable cancer that has been cured, such as basal or squamous cell skin cancer or in situ prostate, cervical or breast cancer;
- Patients with the following cardiac function defects:
- Long QTc syndrome or QTc interval > 480 ms;
- Complete left bundle branch block, II-III degree atrioventricular block (except after pacemaker implantation);
- Severe, uncontrolled arrhythmias requiring pharmacological treatment;
- History of chronic congestive heart failure, NYHA grade III~IV;
- Cardiac ejection fraction < 50% within 6 months prior to screening;
- Severe heart valve disease (regurgitation or stenosis) requiring medical treatment
- Uncontrollable hypertension (defined as a measured systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg under pharmacological control);
- ECG evidence of myocardial infarction, unstable angina, history of severe pericardial disease, and acute ischemic or severe conduction system abnormalities within 6 months prior to screening;
- Lactating female;
- Significant gastrointestinal disease during screening, which may affect the intake, transportation or absorption of drugs (such as inability to swallow, chronic diarrhoea, intestinal obstruction, etc.);
- Patients who diagnosed with peripheral nerve dysfunction affect their daily life；
- Serious and/or uncontrolled medical condition that, in the judgment of the investigator, may affect the patient's participation in this study (including, but not limited to: diabetes not effectively controlled, kidney disease requiring dialysis, severe liver disease, life-threatening autoimmune and bleeding disorders, substance abuse, neurological disorders, etc.);
- Not suitable for this study as decided by the investigator due to other reasons.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multicenter, Open-label, Phase I Dose-escalation and Dose-expansion Study of Mitoxantrone Hydrochloride Liposome Injection Combination Therapy in Chinese Patients With Advanced Solid Tumors
The purpose of this study is to evaluate the tolerability, safety, pharmacokinetics (PK) and efficacy of mitoxantrone hydrochloride liposome injection combination therapy in Chinese patients with advanced solid tumors.
Read the detailed description
This is a multicenter, open-label, phase I dose-escalation and dose-expansion study aimed to evaluate the tolerability, safety, pharmacokinetics and efficacy of mitoxantrone hydrochloride liposome injection combination therapy. This study consists of two phases: dose-escalation phase and dose expansion phase.
The dose-escalation phase will be conducted to determine the maximum tolerated dose (MTD) of mitoxantrone hydrochloride liposome injection combination therapy in patients with advanced solid tumors based on a Rolling-6 design. Patients enrolled in this phase will be allocated to two arms A and B. The patients of A arm will receive mitoxantrone hydrochloride liposome injection and capecitabine followed by a 3-week DLT observation period. The patients of B arm will receive mitoxantrone hydrochloride liposome injection and albumin-paclitaxel followed by a 3-week DLT observation period.
After DLT observation, one dose cohort will be selected for dose-expansion to further explore the safety and efficacy of study drug according to the dose-escalation results. In the dose-expansion phase, patients will receive mitoxantrone hydrochloride liposome injection combination therapy every 3 weeks (q3w, a cycle) until disease progression, intolerable toxicity, death, or withdrawal by investigator or patient decision (a maximum of 6 cycles).
- Conditions
- Advanced Solid Tumor
- Being tested
- Mitoxantrone Hydrochloride Liposome injection, Capecitabine, Albumin-paclitaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitoxantrone Hydrochloride Liposome injectionDrug
Mitoxantrone hydrochloride liposome injection will be administered intravenously once every 3 weeks (a cycle)
CapecitabineDrug
The fixed dose of oral capecitabine will be administered 1000mg/m^2, twice daily, from day 1 to day 14.
Albumin-paclitaxelDrug
The fixed dose of albumin-paclitaxel will be set as 260 mg/m^2, once every three weeks.
| Study group | Role | What they receive |
|---|---|---|
| Mitoxantrone Hydrochloride Liposome Injection and Capecitabine | Experimental | Dose-escalation phase: Patients will receive mitoxantrone hydrochloride liposome injection and capecitabine followed by a 3-week DLT observation period. The initial dose of mitoxantrone hydrochloride liposome injection will be set as 18 mg/m^2, and then the dose will be sequentially escalated to 24 mg/m^2 and 30 mg/m^2. The frequency of administration will be once every three weeks. The fixed dose of capecitabine will be set as 1000 mg/m^2, twice daily, from day 1 to day 14. Every 3 weeks will be set as a treatment cycle, and the administration of drugs is planned for 6 cycles.
Dose-expansion phase: one dose cohort will be selected for dose-expansion to further evaluate the safety and efficacy of mitoxantrone hydrochloride liposome injection and capecitabine, and the administration of drugs is planned for 6 cycles. Receives: Drug: Mitoxantrone Hydrochloride Liposome injection; Drug: Capecitabine |
| Mitoxantrone Hydrochloride Liposome Injection and albumin-paclitaxel | Experimental | Dose-escalation phase: Patients will receive mitoxantrone hydrochloride liposome injection and albumin-paclitaxel followed by a 3-week DLT observation period. The initial dose of mitoxantrone hydrochloride liposome injection will be set as 18 mg/m^2, and then the dose is sequentially escalated to 24 mg/m^2 and 30 mg/m^2. The frequency of administration will be once every three weeks. The fixed dose of albumin-paclitaxel will be set as 260 mg/m^2, once every three weeks. Every 3 weeks will be set as a treatment cycle, and the administration of drugs is planned for 6 cycles.
Dose-expansion phase: one dose cohort will be selected for dose-expansion to further evaluate the safety and efficacy of mitoxantrone hydrochloride liposome injection and albumin-paclitaxel, and the administration of drugs is planned for 6 cycles. Receives: Drug: Mitoxantrone Hydrochloride Liposome injection; Drug: Albumin-paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limit toxicity (DLT)
Dose limiting toxicity
Measured: Up to 21 days after the first dose
Treatment-emergent adverse events (TEAEs):
TEAE is defined as an event that occurs during treatment and does not exist before treatment or worsens compared to before treatment as assessed by CTCAE v5.0.
Measured: From the initiation of the first dose to 28 days after the last dose
Secondary outcomes (12)
Pharmacokinetic profile: Cmax
Peak Plasma Concentration (Cmax)
Measured: Pre-dose and multiple timepoints up to Cycle 4th (each cycle is 21 days)
Objective response rate (ORR)
ORR is defined as the proportion of patients who have a best overall response of complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
Measured: Throughout the study completion, up to 3 years
Disease control rate (DCR)
DCR is defined as the proportion of patients who have a response of CR/PR or stable disease (SD) as per RECIST 1.1.
Measured: Throughout the study completion, up to 3 years
Duration of response (DoR)
DoR is defined as the time from the first assessment of CR or PR until the date of first occurrence of progressive disease (PD) as per RECIST 1.1 or death from any cause, whichever occurs first
Measured: Throughout the study completion, up to 3 years
Progression-free survival (PFS)
PFS is defined as the time from the date of first dose until the date of first documented PD as per RECIST 1.1 or death from any cause, whichever occurs first.
Measured: Throughout the study completion, up to 3 years
Overall survival (OS)
OS is defined as the time from the date of first dose until the date of death from any cause.
Measured: Throughout the study completion, up to 3 years
Pharmacokinetic profile: Tmax
Time to reach maximum concentration (Tmax)
Measured: Pre-dose and multiple timepoints up to Cycle 4th (each cycle is 21 days)
Pharmacokinetic profile: AUC0-t
Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of Last Quantifiable Concentration (AUC0-t)
Measured: Pre-dose and multiple timepoints up to Cycle 4th (each cycle is 21 days)
Pharmacokinetic profile: AUC0-∞
Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-∞)
Measured: Pre-dose and multiple timepoints up to Cycle 4th (each cycle is 21 days)
Pharmacokinetic profile: t1/2
Half-time (t1/2)
Measured: Pre-dose and multiple timepoints up to Cycle 4th (each cycle is 21 days)
Pharmacokinetic profile: CL
Clearance (CL)
Measured: Pre-dose and multiple timepoints up to Cycle 4th (each cycle is 21 days)
Pharmacokinetic profile: Vz
Volume of Distribution (Vz)
Measured: Pre-dose and multiple timepoints up to Cycle 4th (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study startApr 2022 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- More trials run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.The 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05344742
- Sponsor's protocol ID
- HE071-CSP-027
- Status last verified
- Apr 2022
- First submitted
- 12 Apr 2022
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Phase I Dose-escalation and Dose-expansion Study of Mitoxantrone Hydrochloride Liposome Injection Combination Therapy in Chinese Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05344742
- Acronym / sponsor ID
- HE071-CSP-027
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2022 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 25 Apr 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 tolerability, safety, pharmacokinetics (PK) and efficacy of mitoxantrone hydrochloride liposome injection combination therapy in Chinese patients with advanced solid tumors.
Detailed description
This is a multicenter, open-label, phase I dose-escalation and dose-expansion study aimed to evaluate the tolerability, safety, pharmacokinetics and efficacy of mitoxantrone hydrochloride liposome injection combination therapy. This study consists of two phases: dose-escalation phase and dose expansion phase.
The dose-escalation phase will be conducted to determine the maximum tolerated dose (MTD) of mitoxantrone hydrochloride liposome injection combination therapy in patients with advanced solid tumors based on a Rolling-6 design. Patients enrolled in this phase will be allocated to two arms A and B. The patients of A arm will receive mitoxantrone hydrochloride liposome injection and capecitabine followed by a 3-week DLT observation period. The patients of B arm will receive mitoxantrone hydrochloride liposome injection and albumin-paclitaxel followed by a 3-week DLT observation period.
After DLT observation, one dose cohort will be selected for dose-expansion to further explore the safety and efficacy of study drug according to the dose-escalation results. In the dose-expansion phase, patients will receive mitoxantrone hydrochloride liposome injection combination therapy every 3 weeks (q3w, a cycle) until disease progression, intolerable toxicity, death, or withdrawal by investigator or patient decision (a maximum of 6 cycles).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mitoxantrone Hydrochloride Liposome Injection and Capecitabine | Experimental | Drug: Mitoxantrone Hydrochloride Liposome injection, Drug: CapecitabineDose-escalation phase: Patients will receive mitoxantrone hydrochloride liposome injection and capecitabine followed by a 3-week DLT observation period. The initial dose of mitoxantrone hydrochloride liposome injection will be set as 18 mg/m^2, and then the dose will be sequentially escalated to 24 mg/m^2 and 30 mg/m^2. The frequency of administration will be once every three weeks. The fixed dose of capecitabine will be set as 1000 mg/m^2, twice daily, from day 1 to day 14. Every 3 weeks will be set as a treatment cycle, and the administration of drugs is planned for 6 cycles. Dose-expansion phase: one dose cohort will be selected for dose-expansion to further evaluate the safety and efficacy of mitoxantrone hydrochloride liposome injection and capecitabine, and the administration of drugs is planned for 6 cycles. |
| Mitoxantrone Hydrochloride Liposome Injection and albumin-paclitaxel | Experimental | Drug: Mitoxantrone Hydrochloride Liposome injection, Drug: Albumin-paclitaxelDose-escalation phase: Patients will receive mitoxantrone hydrochloride liposome injection and albumin-paclitaxel followed by a 3-week DLT observation period. The initial dose of mitoxantrone hydrochloride liposome injection will be set as 18 mg/m^2, and then the dose is sequentially escalated to 24 mg/m^2 and 30 mg/m^2. The frequency of administration will be once every three weeks. The fixed dose of albumin-paclitaxel will be set as 260 mg/m^2, once every three weeks. Every 3 weeks will be set as a treatment cycle, and the administration of drugs is planned for 6 cycles. Dose-expansion phase: one dose cohort will be selected for dose-expansion to further evaluate the safety and efficacy of mitoxantrone hydrochloride liposome injection and albumin-paclitaxel, and the administration of drugs is planned for 6 cycles. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients fully understand and voluntarily participate in this study and sign informed consent;
- Aged 18-65 years, male or female;
- Patients with advanced solid tumors confirmed by histopathology or cytologically and who have failed standard therapy;
- At least one measurable lesion according to RECIST v1.1 at baseline;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1;
Key exclusion criteria (24 listed)
- History of severe allergy to mitoxantrone hydrochloride or liposomal drugs; allergy to capecitabine or any excipients of its components; previous serious and unexpected reaction to fluoropyrimidine or known allergy to fluorouracil; known complete deficiency of dihydropyrimidine dehydrogenase (DPD) activity; allergy to paclitaxel or human albumin;
- Cerebral or meningeal metastases;
- Life expectancy < 3 months;
- Patients with chronic hepatitis B (HBsAg or HBcAb positive with HBV DNA ≥ 2000 IU/mL), chronic hepatitis C (HCV antibody positive with HCV RNA above the lower limit of detection of the study center), or human immunodeficiency virus (HIV) antibody positive;
- Active bacterial, fungal or viral infections that require intravenous infusion treatment within 1 week prior to the first dose;
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 |
|---|---|---|
| Mitoxantrone Hydrochloride Liposome injectionMitoxantrone hydrochloride liposome injection will be administered intravenously once every 3 weeks (a cycle) | Drug | Mitoxantrone Hydrochloride Liposome Injection and Capecitabine, Mitoxantrone Hydrochloride Liposome Injection and albumin-paclitaxel |
| CapecitabineThe fixed dose of oral capecitabine will be administered 1000mg/m^2, twice daily, from day 1 to day 14. | Drug | Mitoxantrone Hydrochloride Liposome Injection and Capecitabine |
| Albumin-paclitaxelThe fixed dose of albumin-paclitaxel will be set as 260 mg/m^2, once every three weeks. | Drug | Mitoxantrone Hydrochloride Liposome Injection and albumin-paclitaxel |
Primary outcome
Dose Limit toxicity (DLT)
Time frame: Up to 21 days after the first dose
Dose limiting toxicity
Treatment-emergent adverse events (TEAEs):
Time frame: From the initiation of the first dose to 28 days after the last dose
TEAE is defined as an event that occurs during treatment and does not exist before treatment or worsens compared to before treatment as assessed by CTCAE v5.0.
12 secondary outcomes
Pharmacokinetic profile: Cmax
Time frame: Pre-dose and multiple timepoints up to Cycle 4th (each cycle is 21 days)
Objective response rate (ORR)
Time frame: Throughout the study completion, up to 3 years
Disease control rate (DCR)
Time frame: Throughout the study completion, up to 3 years
Duration of response (DoR)
Time frame: Throughout the study completion, up to 3 years
Progression-free survival (PFS)
Time frame: Throughout the study completion, up to 3 years
Overall survival (OS)
Time frame: Throughout the study completion, up to 3 years
Pharmacokinetic profile: Tmax
Time frame: Pre-dose and multiple timepoints up to Cycle 4th (each cycle is 21 days)
Pharmacokinetic profile: AUC0-t
Time frame: Pre-dose and multiple timepoints up to Cycle 4th (each cycle is 21 days)
Pharmacokinetic profile: AUC0-∞
Time frame: Pre-dose and multiple timepoints up to Cycle 4th (each cycle is 21 days)
Pharmacokinetic profile: t1/2
Time frame: Pre-dose and multiple timepoints up to Cycle 4th (each cycle is 21 days)
Pharmacokinetic profile: CL
Time frame: Pre-dose and multiple timepoints up to Cycle 4th (each cycle is 21 days)
Pharmacokinetic profile: Vz
Time frame: Pre-dose and multiple timepoints up to Cycle 4th (each cycle is 21 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mitoxantrone Hydrochloride Liposome injection, Capecitabine and Albumin-paclitaxel in people with Advanced Solid Tumor, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..
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 15 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanping Liu (+86-010-63930582, liuyanping@mail.ecspc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limit toxicity (DLT) (time frame: Up to 21 days after the first dose). 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 25 Apr 2022.