Treatment-naïvePhase 1NCT04548700
Liposomal Mitoxantrone Hydrochloride Injection,Cyclophosphamide, Vincristine and Prednisone in the Treatment of PTCL
A Phase 1 study testing Dose-finding stage: Liposomal mitoxantrone hydrochloride, Cyclophosphamide, Vincristine and Prednisone and Dose-expansion stage: Liposomal mitoxantrone hydrochloride, Cyclophosphamide, Vincristine and Prednisone in people with Treatment-naïve and Peripheral T Cell Lymphoma, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
This is a multicentre, open-label, single-arm, phase Ib clinical study to evaluate the safety, tolerability, efficacy and pharmacokinetics of liposomal mitoxantrone hydrochloride in combination with Cyclophosphamide, Vincristine and Prednisone in the frontline treatment of patients with peripheral T cell lymphoma… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Treatment-naïve, Peripheral T Cell Lymphoma
- What is being tested?
- Dose-finding stage: Liposomal mitoxantrone hydrochloride, Cyclophosphamide, Vincristine and Prednisone and Dose-expansion stage: Liposomal mitoxantrone hydrochloride, Cyclophosphamide, Vincristine and Prednisone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteChina
- Study dates
- 24 Dec 2020to 30 Nov 2023
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects fully understand and voluntarily participate in this study and sign informed consent
- Age ≥18, ≤70years, no gender limitation
- Histologically confirmed diagnosis of treatment-naïve PTCL. Eligible histologies are limited to the following: Peripheral T-cell lymphoma - not otherwise specified (PTCL-NOS),Angioimmunoblastic T-cell lymphoma (AITL), ALK -positive Anaplastic Large cell Lymphoma（ALCL）, ALK-negative ALCL; Other PTCL that investigators consider to be appropriate to be enrolled
- PTCL with fluorodeoxyglucose (FDG) avidity that can be evaluated by PET/CT
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1
- The following required baseline laboratory data: Absolute neutrophil count (ANC) ≥1.5×109/L, Platelet count (PLT) ≥75×109/L, Hemoglobin(HB)≥ 80g/L, Total bilirubin (TBIL) ≤1.5X upper limit of normal (ULN) , Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5X ULN , Serum creatinine (Scr) ≤1.5X ULN
- Females of childbearing potential must have a negative serum beta human chorionic gonadotrophin (β-hCG) pregnancy test result prior to enrollment and must agree to use an effective contraception method for the duration of the study treatment and 12 months after the last dose of study therapy
- Males of reproductive potential must agree to use an effective contraceptive method for the duration of the study treatment and 12 months after the last dose of study therapy
Who cannot join
- Current diagnosis of any of the following: extranodal natural killer/T-cell lymphoma, nasal type(NKTCL), Mycosis fungoides (MF)/ Sézary syndrome (SS), Primary cutaneous ALCL，and Adult T-cell leukemia/lymphoma
- Leukemic phase of lymphoma (≥20% lymphoma cell in the bone marrow), or central nervous system (CNS) involvement, or hemophagocytic syndrome
- Life expectancy < 6 months
- History of allergy to anthracyclines or liposomes
- History of contraindications to cyclophosphamide, vincristine or prednisone
- Prior anti-lymphoma therapy except short-term or low-dose corticosteroid treatment
Show all 19Show fewer
- Impaired cardiac function or significant cardiac disease
- Positive test results for HBsAg antigen and HBV-DNA, or hepatitis C virus (HCV) antibody or human immunodeficiency virus (HIV) antibody
- Major surgery within 4～6weeks prior to screening. Or have a surgical schedule during the study
- A serious infection within 4 weeks prior to screening and not suitable for the study according to the judgment of the investigator
- Uncontrolled hypertension at screening
- Uncontrolled diabetes at screening
- History of active visceral hemorrhage in the recent 3 months prior to screening
- History of other tumors in the past five years prior to screening. Patients with curable tumors (such as skin basal cell carcinoma, carcinoma in situ of the cervix or of the breast, intramucosal carcinoma in situ of the gastrointestinal tract or localized prostate cancer) could be enrolled after completely cured
- History of solid organ transplantation
- Known psychiatric disorders or cognitive disorder
- Known alcohol or drug abuse
- Pregnant or breastfeeding women
- Not suitable for this study as determined by the investigator due to other reasons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of Liposomal Mitoxantrone Hydrochloride Injection Combined With Cyclophosphamide, Vincristine and Prednisone in the Treatment of Untreated PTCL
This is a multicentre, open-label, single-arm, phase Ib clinical study to evaluate the safety, tolerability, efficacy and pharmacokinetics of liposomal mitoxantrone hydrochloride in combination with Cyclophosphamide, Vincristine and Prednisone in the frontline treatment of patients with peripheral T cell lymphoma (PTCL).
Read the detailed description
The study is to investigate the safety, tolerability, efficacy and pharmacokinetics of liposomal mitoxantrone hydrochloride in combination with Cyclophosphamide, Vincristine and Prednisone in the frontline treatment of patients with PTCL by conducting in two stages, Dose-finding stage and Dose-expansion stage.In Dose-finding stage, patients with treatment-naïve PTCL will be assigned to receive sequentially higher doses of liposomal mitoxantrone hydrochloride ranging from 12 to 18 mg/m2 plus Cyclophosphamide, Vincristine and Prednisone (28 days per cycle). The dose escalation will follow the classic 3+3 design. The recommended Phase 2 dose (RP2D) of liposomal mitoxantrone hydrochloride will be determined according to the Dose-finding results. In Dose-expansion stage, additional patients will be recruited into two groups, the Q4W group（28 days per cycle）and the Q3W group（21 days per cycle）, to receive liposomal mitoxantrone hydrochloride at the RP2D combined with Cyclophosphamide, Vincristine and Prednisone. All patients will receive the treatment for the planned 6 cycles or until disease progression or unacceptable drug-related adverse events.
- Conditions
- Treatment-naïve, Peripheral T Cell Lymphoma
- Being tested
- Dose-finding stage: Liposomal mitoxantrone hydrochloride, Cyclophosphamide, Vincristine and Prednisone, Dose-expansion stage: Liposomal mitoxantrone hydrochloride, Cyclophosphamide, Vincristine and Prednisone
- Medical subject headings
- Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dose-finding stage: Liposomal mitoxantrone hydrochloride, Cyclophosphamide, Vincristine and PrednisoneDrug
Also called Part1
Drug: Liposomal mitoxantrone hydrochloride (12 mg/m2, 15 mg/m2, 18 mg/m2) will be administered by an intravenous infusion on day 1 of each 28-day cycle.
Drug: Cyclophosphamide (750 mg/m2) will be administered by an intravenous infusion on day 1 of each 28-day cycle.
Drug: Vincristine (1.4 mg/m2 with 2 mg as the maximum dose) will be administered by an intravenous injection on day 1 of each 28-day cycle.
Drug: Prednisone (100 mg/d) will be taken orally from day 1 to day 5 of each 28-day cycle.
Dose-expansion stage: Liposomal mitoxantrone hydrochloride, Cyclophosphamide, Vincristine and PrednisoneDrug
Also called Part2
Drug: Liposomal mitoxantrone hydrochloride (at RP2D) will be administered by an intravenous infusion on day 1 of each 28- or 21-day cycle.
Drug: Cyclophosphamide (750 mg/m2) will be administered by an intravenous infusion on day 1 of each 28- or 21-day cycle.
Drug: Vincristine (1.4 mg/m2 with 2 mg as the maximum dose) will be administered by an intravenous injection on day 1 of each 28- or 21-day cycle.
Drug: Prednisone (100 mg/d) will be taken orally from day 1 to day 5 of each 28- or 21-day.
| Study group | Role | What they receive |
|---|---|---|
| Dose-finding and dose-expansion | Experimental | Dose-finding stage: Patients with treatment-naïve PTCL will receive sequentially higher doses of liposomal mitoxantrone hydrochloride in combination with Cyclophosphamide, Vincristine and Prednisone for 6 cycles (planned) (28 days per cycle). The initial dose of liposomal mitoxantrone hydrochloride is 12 mg/m2.
Dose-expansion stage: Patients with treatment-naïve PTCL will receive liposomal mitoxantrone hydrochloride at RP2D in combination with Cyclophosphamide, Vincristine and Prednisone for 6 cycles (planned) (28 or 21 days per cycle). Receives: Drug: Dose-finding stage: Liposomal mitoxantrone hydrochloride, Cyclophosphamide, Vincristine and Prednisone; Drug: Dose-expansion stage: Liposomal mitoxantrone hydrochloride, Cyclophosphamide, Vincristine and Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-finding stage: The incidence of dose limited toxicities (DLTs)
To identify the DLTs
Measured: Cycle 1 (28 days)
Dose-finding stage:The incidence of AE and SAE
To identify the incidence of AE and SAE, abnormalities in clinical laboratory assessments, ECGs, echocardiography, vital sign assessments, and physical exams
Measured: up to 24 weeks
Dose-expansion stage: The incidence of AE and SAE
To identify the incidence of AE and SAE, abnormalities in clinical laboratory assessments, ECGs, echocardiography, vital sign assessments, and physical exams
Measured: up to 18-24 weeks
Secondary outcomes (12)
Dose-finding stage: complete response(CR) rate
To investigate the preliminary antitumor efficacy
Measured: up to 24 weeks
Dose-finding stage: duration of complete response（DoCR）
To investigate the preliminary antitumor efficacy
Measured: Throughout study completion,an average of 18 months
Dose-finding stage: overall response rate (ORR)
To investigate the preliminary antitumor efficacy
Measured: up to 24 weeks
Dose-finding stage: progression-free survival（PFS）
To investigate the preliminary antitumor efficacy
Measured: Throughout study completion,an average of 18 months
Dose-finding stage：the pharmacokinetic parameters Cmax
To investigate the PK characteristics
Measured: Cycle 1 to Cycle 6(each cycle is 28 days)
Dose-finding stage：the pharmacokinetic parameters AUC0-t
To investigate the PK characteristics
Measured: Cycle 1 to Cycle 6(each cycle is 28 days)
Dose-expansion stage: CR rate
To investigate the preliminary antitumor efficacy
Measured: up to 24 weeks
Dose-expansion stage: DoCR
To investigate the preliminary antitumor efficacy
Measured: Throughout study completion,an average of 18 months
Dose-expansion stage: ORR
To investigate the preliminary antitumor efficacy
Measured: up to 18-24 weeks
Dose-expansion stage: PFS
To investigate the preliminary antitumor efficacy
Measured: Throughout study completion,an average of 18 months
Dose-expansion stage: the pharmacokinetic parameters Cmax
To investigate the PK characteristics
Measured: Cycle 1(each cycle is 21or28 days)
Dose-expansion stage: the pharmacokinetic parameters AUC0-t
To investigate the PK characteristics
Measured: Cycle 1(each cycle is 21or28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start24 Dec 2020
- Primary completion30 Jun 2023
- Study completion30 Nov 2023
Why it stopped: The sponsor has adjusted its R\&D strategy.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment-naïveStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Huiqiang Huang, Doctor, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04548700
- Sponsor's protocol ID
- HE071-CSP-011
- Status last verified
- Aug 2020
- First submitted
- 28 Aug 2020
- Last updated
- 7 Mar 2024
- 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 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of Liposomal Mitoxantrone Hydrochloride Injection Combined With Cyclophosphamide, Vincristine and Prednisone in the Treatment of Untreated PTCL
- ClinicalTrials.gov ID
- NCT04548700
- Acronym / sponsor ID
- HE071-CSP-011
- Conditions
- Treatment-naïve, Peripheral T Cell Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The sponsor has adjusted its R\&D strategy.
- Enrolment
- 38 participants (actual)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Dec 2020 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 14 Sep 2020 (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 is a multicentre, open-label, single-arm, phase Ib clinical study to evaluate the safety, tolerability, efficacy and pharmacokinetics of liposomal mitoxantrone hydrochloride in combination with Cyclophosphamide, Vincristine and Prednisone in the frontline treatment of patients with peripheral T cell lymphoma (PTCL).
Detailed description
The study is to investigate the safety, tolerability, efficacy and pharmacokinetics of liposomal mitoxantrone hydrochloride in combination with Cyclophosphamide, Vincristine and Prednisone in the frontline treatment of patients with PTCL by conducting in two stages, Dose-finding stage and Dose-expansion stage.In Dose-finding stage, patients with treatment-naïve PTCL will be assigned to receive sequentially higher doses of liposomal mitoxantrone hydrochloride ranging from 12 to 18 mg/m2 plus Cyclophosphamide, Vincristine and Prednisone (28 days per cycle). The dose escalation will follow the classic 3+3 design. The recommended Phase 2 dose (RP2D) of liposomal mitoxantrone hydrochloride will be determined according to the Dose-finding results. In Dose-expansion stage, additional patients will be recruited into two groups, the Q4W group（28 days per cycle）and the Q3W group（21 days per cycle）, to receive liposomal mitoxantrone hydrochloride at the RP2D combined with Cyclophosphamide, Vincristine and Prednisone. All patients will receive the treatment for the planned 6 cycles or until disease progression or unacceptable drug-related adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose-finding and dose-expansion | Experimental | Drug: Dose-finding stage: Liposomal mitoxantrone hydrochloride, Cyclophosphamide, Vincristine and Prednisone, Drug: Dose-expansion stage: Liposomal mitoxantrone hydrochloride, Cyclophosphamide, Vincristine and PrednisoneDose-finding stage: Patients with treatment-naïve PTCL will receive sequentially higher doses of liposomal mitoxantrone hydrochloride in combination with Cyclophosphamide, Vincristine and Prednisone for 6 cycles (planned) (28 days per cycle). The initial dose of liposomal mitoxantrone hydrochloride is 12 mg/m2. Dose-expansion stage: Patients with treatment-naïve PTCL will receive liposomal mitoxantrone hydrochloride at RP2D in combination with Cyclophosphamide, Vincristine and Prednisone for 6 cycles (planned) (28 or 21 days per cycle). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects fully understand and voluntarily participate in this study and sign informed consent
- Age ≥18, ≤70years, no gender limitation
- Histologically confirmed diagnosis of treatment-naïve PTCL. Eligible histologies are limited to the following: Peripheral T-cell lymphoma - not otherwise specified (PTCL-NOS),Angioimmunoblastic T-cell lymphoma (AITL), ALK -positive Anaplastic Large cell Lymphoma（ALCL）, ALK-negative ALCL; Other PTCL that investigators consider to be appropriate to be enrolled
- PTCL with fluorodeoxyglucose (FDG) avidity that can be evaluated by PET/CT
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1
Key exclusion criteria (19 listed)
- Current diagnosis of any of the following: extranodal natural killer/T-cell lymphoma, nasal type(NKTCL), Mycosis fungoides (MF)/ Sézary syndrome (SS), Primary cutaneous ALCL，and Adult T-cell leukemia/lymphoma
- Leukemic phase of lymphoma (≥20% lymphoma cell in the bone marrow), or central nervous system (CNS) involvement, or hemophagocytic syndrome
- Life expectancy < 6 months
- History of allergy to anthracyclines or liposomes
- History of contraindications to cyclophosphamide, vincristine or prednisone
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 |
|---|---|---|
| Dose-finding stage: Liposomal mitoxantrone hydrochloride, Cyclophosphamide, Vincristine and PrednisoneAlso: Part1Drug: Liposomal mitoxantrone hydrochloride (12 mg/m2, 15 mg/m2, 18 mg/m2) will be administered by an intravenous infusion on day 1 of each 28-day cycle. Drug: Cyclophosphamide (750 mg/m2) will be administered by an intravenous infusion on day 1 of each 28-day cycle. Drug: Vincristine (1.4 mg/m2 with 2 mg as the maximum dose) will be administered by an intravenous injection on day 1 of each 28-day cycle. Drug: Prednisone (100 mg/d) will be taken orally from day 1 to day 5 of each 28-day cycle. | Drug | Dose-finding and dose-expansion |
| Dose-expansion stage: Liposomal mitoxantrone hydrochloride, Cyclophosphamide, Vincristine and PrednisoneAlso: Part2Drug: Liposomal mitoxantrone hydrochloride (at RP2D) will be administered by an intravenous infusion on day 1 of each 28- or 21-day cycle. Drug: Cyclophosphamide (750 mg/m2) will be administered by an intravenous infusion on day 1 of each 28- or 21-day cycle. Drug: Vincristine (1.4 mg/m2 with 2 mg as the maximum dose) will be administered by an intravenous injection on day 1 of each 28- or 21-day cycle. Drug: Prednisone (100 mg/d) will be taken orally from day 1 to day 5 of each 28- or 21-day. | Drug | Dose-finding and dose-expansion |
Primary outcome
Dose-finding stage: The incidence of dose limited toxicities (DLTs)
Time frame: Cycle 1 (28 days)
To identify the DLTs
Dose-finding stage:The incidence of AE and SAE
Time frame: up to 24 weeks
To identify the incidence of AE and SAE, abnormalities in clinical laboratory assessments, ECGs, echocardiography, vital sign assessments, and physical exams
Dose-expansion stage: The incidence of AE and SAE
Time frame: up to 18-24 weeks
To identify the incidence of AE and SAE, abnormalities in clinical laboratory assessments, ECGs, echocardiography, vital sign assessments, and physical exams
12 secondary outcomes
Dose-finding stage: complete response(CR) rate
Time frame: up to 24 weeks
Dose-finding stage: duration of complete response（DoCR）
Time frame: Throughout study completion,an average of 18 months
Dose-finding stage: overall response rate (ORR)
Time frame: up to 24 weeks
Dose-finding stage: progression-free survival（PFS）
Time frame: Throughout study completion,an average of 18 months
Dose-finding stage：the pharmacokinetic parameters Cmax
Time frame: Cycle 1 to Cycle 6(each cycle is 28 days)
Dose-finding stage：the pharmacokinetic parameters AUC0-t
Time frame: Cycle 1 to Cycle 6(each cycle is 28 days)
Dose-expansion stage: CR rate
Time frame: up to 24 weeks
Dose-expansion stage: DoCR
Time frame: Throughout study completion,an average of 18 months
Dose-expansion stage: ORR
Time frame: up to 18-24 weeks
Dose-expansion stage: PFS
Time frame: Throughout study completion,an average of 18 months
Dose-expansion stage: the pharmacokinetic parameters Cmax
Time frame: Cycle 1(each cycle is 21or28 days)
Dose-expansion stage: the pharmacokinetic parameters AUC0-t
Time frame: Cycle 1(each cycle is 21or28 days)
Results and safety
The study was stopped early (reason given: The sponsor has adjusted its R\&D strategy.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 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.
Huiqiang Huang, Doctor principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dose-finding stage: Liposomal mitoxantrone hydrochloride, Cyclophosphamide, Vincristine and Prednisone and Dose-expansion stage: Liposomal mitoxantrone hydrochloride, Cyclophosphamide, Vincristine and Prednisone in people with Treatment-naïve and Peripheral T Cell Lymphoma, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. 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 8 inclusion and 19 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: stopped early, as of the sponsor's last update on 7 Mar 2024. 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?
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 was stopped early (reason given: The sponsor has adjusted its R\&D strategy.). Results are not available in the source record.
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?
Dose-finding stage: The incidence of dose limited toxicities (DLTs) (time frame: Cycle 1 (28 days)). The study lists 3 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 7 Mar 2024.