Diffuse Intrinsic Pontine GliomaPhase 1NCT02420613
Vorinostat and Temsirolimus With or Without Radiation Therapy in Treating Younger Patients With Newly Diagnosed or Progressive Diffuse Intrinsic Pontine Glioma
A Phase 1 study testing Radiation Therapy, Temsirolimus and Vorinostat in people with Diffuse Intrinsic Pontine Glioma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This phase I trial studies the side effects and best dose of temsirolimus when given together with vorinostat and with or without radiation therapy in treating younger patients with newly diagnosed or progressive diffuse intrinsic pontine glioma, a tumor that arises from the middle portion of the brain stem. Read more about this study
- Who is it for?
- Ages 7 months to 21 years
- Conditions the study is for
- Diffuse Intrinsic Pontine Glioma
- What is being tested?
- Radiation Therapy, Temsirolimus and Vorinostat
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2015to 28 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 7 months to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients must be > than 6 months and =< 21 years of age at the time of study consent
- Patients with newly diagnosed or progressive DIPG as confirmed by gadolinium enhanced magnetic resonance imaging (MRI) are eligible; MRI must demonstrate that at least 2/3 of the tumor is situated in the pons and that the origin of the tumor is clearly in the pons; biopsy is not required; tumors with features not typical of diffuse intrinsic brainstem glioma are not eligible; these include dorsally exophytic brainstem gliomas, cervicomedullary junction tumors, and focal low grade gliomas of the midbrain or brainstem which should undergo resection and pathologic evaluation; patients, who have received re-irradiation for progression of the tumor, will be eligible if they show evidence of measurable progressive disease after the re-irradiation; patients at diagnosis with involvement of the spine will not be eligible, however if at progression features of spine involvement are present they will be eligible for stratum II
- Patients must have a Karnofsky >= 50% for patients > 16 years of age and Lansky >= 50 for patients=< 16 years of age; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
- Patients must have fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy or radiation to grade 2 or less
- Patients must not have received myelosuppressive therapy within 3 weeks of enrollment onto this study (6 weeks if prior nitrosourea)
- At least 14 days must have passed after the last dose of a long-acting growth factor (e.g. Neulasta) or 7 days for short-acting growth factor
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- At least 7 days must have elapsed after the last of a biologic agent that is not a monoclonal antibody, to be enrolled on this study
- At least 6 weeks since the completion of any type of immunotherapy, e.g. tumor vaccines
- At least 3 half-lives must have elapsed after treatment with a monoclonal antibody and enrollment on this study
- >= 2 weeks must have elapsed for local palliative radiotherapy (re-irradiation for progressive disease or upfront radiation therapy [RT] at initial diagnosis) and enrollment on study for stratum II; at least 24 weeks must have elapsed if patient received craniospinal radiotherapy due to any other prior malignancies
- The patient must have no evidence of active graft vs. host disease, and >= 12 weeks must have elapsed since transplant or stem cell infusion and enrollment on this study for any other pathology
- Prior treatment with vorinostat is allowed but at least 3 weeks must have elapsed from the last dose and effects of prior therapy have resolved
- Patients with central nervous system (CNS) tumors who are receiving steroids are eligible
- Peripheral absolute neutrophil count (ANC) >= 1000/uL
- Platelet count >= 100,000/uL (transfusion independent)
- Hemoglobin >= 10.0 gm/dL (transfusion independent)
- Serum creatinine =< 1.5 x institutional upper limit of normal for age
- Bilirubin (sum of conjugated + unconjugated) less than 1.5 x upper limit of normal (ULN) for age
- Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 110 U/L; for the purpose of this study, the ULN for SGPT is 45 U/L
- Serum albumin must be >=2 g/dL
- Prothrombin time (PT) and international normalized ratio (INR) < 1.2 x ULN
- Patients with seizure disorder may be enrolled if on non-enzyme inducing anticonvulsants and well controlled
- Serum cholesterol and serum triglyceride levels must be less than 300 mg/dl
- Females > 13 years of age or who have achieved menarche must have a negative pregnancy test within 2 weeks of starting treatment (urine or serum) to be eligible and if sexually active must also agree to use contraception; male sexually active patients must agree to use an effective method of contraception
- Patient's current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life
- Patients must have a life expectancy of >= 2 months; neurologic deficits in patients with CNS tumors must have been relatively stable for a minimum of 1 week prior to starting protocol therapy
Who cannot join
- Patients with other malignancies will not be eligible for stratum I or II; patients with disseminated disease including to the spine will not be eligible for stratum 1 but will be eligible for stratum II
- Patients must not have a history of myocardial infarction, severe or unstable angina, clinically significant peripheral vascular disease, grade 2 or greater heart failure, or serious and inadequately controlled cardiac arrhythmia
- Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal/human studies
- Patients who are currently receiving enzyme inducing anticonvulsants are not eligible
- Patients who are currently receiving therapeutic anticoagulants (including aspirin, low molecular weight heparin, and others) are not eligible
- Patients who are currently receiving angiotensin-converting enzyme (ACE) inhibitors are not eligible due to the development of angioneurotic edema-type reactions in some subjects who received concurrent treatment with temsirolimus + ACE inhibitors
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- Patients who are receiving cyclosporine, tacrolimus or other agents to prevent either graft-versus-host disease post bone marrow transplant or organ rejection post-transplant are not eligible for this trial
- Patients with history of allergic reactions attributed to compounds of similar chemical; or biologic composition to vorinostat or temsirolimus are not eligible
- Patients who have an uncontrolled infection are not eligible
- Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible
- Patients with newly diagnosed DIPG who have received vorinostat previously will not be eligible for stratum I; patients with progressive DIPG will be eligible if they have received either one of the two drugs vorinostat or temsirolimus but will not be eligible for stratum II if have received both the drugs before
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study of Suberoylanilide Hydroxamic Acid (SAHA, Vorinostat) With Temsirolimus in Children With Newly Diagnosed or Progressive Diffuse Intrinsic Pontine Glioma (DIPG)
This phase I trial studies the side effects and best dose of temsirolimus when given together with vorinostat and with or without radiation therapy in treating younger patients with newly diagnosed or progressive diffuse intrinsic pontine glioma, a tumor that arises from the middle portion of the brain stem. Vorinostat and temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving temsirolimus and vorinostat with or without radiation therapy may be a better treatment for younger patients with diffuse intrinsic pontine glioma.
Read the detailed description
PRIMARY OBJECTIVES:
- To estimate the maximum tolerated dose (MTD) or recommended phase 2 dose of temsirolimus in combination with vorinostat given every four weeks in patients with diffuse intrinsic pontine glioma (DIPG).
II. To define and describe the toxicities of the combination vorinostat and temsirolimus administered on this schedule.
SECONDARY OBJECTIVES:
- To define the antitumor activity of the combination of vorinostat and temsirolimus within the confines of a phase 1 study.
II. To assess the biologic effects of vorinostat and temsirolimus on the signaling pathways of interest in these tumors.
III. To evaluate response with advanced neuroimaging (including magnetic resonance spectroscopy) and correlate with fiber tract changes using tractography and fractional anisotropy.
OUTLINE: This is a dose-escalation study of temsirolimus. Patients are assigned to 1 of 2 arms.
ARM I:
CHEMORADIOTHERAPY PHASE: Patients receive vorinostat once daily (QD) and undergo radiation therapy QD for 30 fractions over 6-7 weeks.
MAINTENANCE PHASE: Four to six weeks after the completion of radiation therapy, patients receive vorinostat PO QD and temsirolimus intravenously (IV) over 30-90 minutes on days 1-8 of each cycle. Treatment repeats every 28 days for 10 cycles in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive vorinostat PO QD and temsirolimus IV over 30-90 minutes on days 1-8 of each cycle. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 3, 6, 9, and 12 months.
- Conditions
- Diffuse Intrinsic Pontine Glioma
- Being tested
- Radiation Therapy, Temsirolimus, Vorinostat
- Medical subject headings
- Diffuse Intrinsic Pontine Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation TherapyRadiation
Also called Cancer Radiotherapy, ENERGY_TYPE, Irradiate, Irradiated
Undergo radiation therapy
TemsirolimusDrug
Also called CCI-779, CCI-779 Rapamycin Analog, Cell Cycle Inhibitor 779, Rapamycin Analog
Given IV
VorinostatDrug
Also called L-001079038, MSK-390, SAHA, Suberanilohydroxamic Acid
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Arm I (vorinostat, radiation therapy, temsirolimus) | Experimental | CHEMORADIOTHERAPY PHASE: Patients receive vorinostat QD and undergo radiation therapy QD for 30 fractions over 6-7 weeks.
MAINTENANCE PHASE: Four to six weeks after the completion of radiation therapy, patients receive vorinostat PO QD and temsirolimus IV over 30-90 minutes on days 1-8 of each cycle. Treatment repeats every 28 days for 10 cycles in the absence of disease progression or unacceptable toxicity. Receives: Radiation: Radiation Therapy; Drug: Temsirolimus; Drug: Vorinostat |
| Arm II (vorinostat, temsirolimus) | Experimental | Patients receive vorinostat PO QD and temsirolimus IV over 30-90 minutes on days 1-8 of each cycle. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. Receives: Drug: Temsirolimus; Drug: Vorinostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) of temsirolimus
MTD will be defined as the highest dose studied in which six patients have been treated and at most two patients with dose limiting toxicities (DLTs) are observed. DLTs will be monitored for the first course of the combination of vorinostat and temsirolimus.
Measured: 28 days (course 1)
Incidence of toxic death
Measured: Up to 12 months
Incidence of adverse events
Adverse events will be tabulated by dose, grade, and attribution.
Measured: Up to 12 months
Secondary outcomes (1)
Radiographic response
Will be evaluated using the Response Evaluation Criteria in Solid Tumors from the National Cancer Institute. Best response will be tabulated by dose and category (complete response, partial response, stable disease and progressive disease).
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2015 (estimated)
- Study start5 Oct 2015
- Primary completion28 Mar 2025
- Study completion28 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diffuse Intrinsic Pontine GliomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Wafik T Zaky, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02420613
- Sponsor's protocol ID
- 2014-0135
- Other IDs
- NCI-2015-00817, 2014-0135, P30CA016672
- Status last verified
- Mar 2025
- First submitted
- 15 Apr 2015
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Stitzlein LM, Baig MU, Chandra J, McGovern S, Paulino A, Ketonen LM, Khatua S, Zaky W. Phase I Study of Vorinostat and Temsirolimus in Newly Diagnosed or Progressive Diffuse Intrinsic Pontine Glioma. Pediatr Blood Cancer. 2025 May;72(5):e31619. doi: 10.1002/pbc.31619. Epub 2025 Feb 25.
PubMed 40000388
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Suberoylanilide Hydroxamic Acid (SAHA, Vorinostat) With Temsirolimus in Children With Newly Diagnosed or Progressive Diffuse Intrinsic Pontine Glioma (DIPG)
- ClinicalTrials.gov ID
- NCT02420613
- Acronym / sponsor ID
- 2014-0135
- Conditions
- Diffuse Intrinsic Pontine Glioma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 5 Oct 2015 (actual)
- Primary completion
- 28 Mar 2025 (actual)
- Study completion
- 28 Mar 2025 (actual)
- First posted
- 20 Apr 2015 (estimated)
- 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 phase I trial studies the side effects and best dose of temsirolimus when given together with vorinostat and with or without radiation therapy in treating younger patients with newly diagnosed or progressive diffuse intrinsic pontine glioma, a tumor that arises from the middle portion of the brain stem. Vorinostat and temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving temsirolimus and vorinostat with or without radiation therapy may be a better treatment for younger patients with diffuse intrinsic pontine glioma.
Detailed description
PRIMARY OBJECTIVES:
- To estimate the maximum tolerated dose (MTD) or recommended phase 2 dose of temsirolimus in combination with vorinostat given every four weeks in patients with diffuse intrinsic pontine glioma (DIPG).
II. To define and describe the toxicities of the combination vorinostat and temsirolimus administered on this schedule.
SECONDARY OBJECTIVES:
- To define the antitumor activity of the combination of vorinostat and temsirolimus within the confines of a phase 1 study.
II. To assess the biologic effects of vorinostat and temsirolimus on the signaling pathways of interest in these tumors.
III. To evaluate response with advanced neuroimaging (including magnetic resonance spectroscopy) and correlate with fiber tract changes using tractography and fractional anisotropy.
OUTLINE: This is a dose-escalation study of temsirolimus. Patients are assigned to 1 of 2 arms.
ARM I:
CHEMORADIOTHERAPY PHASE: Patients receive vorinostat once daily (QD) and undergo radiation therapy QD for 30 fractions over 6-7 weeks.
MAINTENANCE PHASE: Four to six weeks after the completion of radiation therapy, patients receive vorinostat PO QD and temsirolimus intravenously (IV) over 30-90 minutes on days 1-8 of each cycle. Treatment repeats every 28 days for 10 cycles in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive vorinostat PO QD and temsirolimus IV over 30-90 minutes on days 1-8 of each cycle. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 3, 6, 9, and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (vorinostat, radiation therapy, temsirolimus) | Experimental | Radiation: Radiation Therapy, Drug: Temsirolimus, Drug: VorinostatCHEMORADIOTHERAPY PHASE: Patients receive vorinostat QD and undergo radiation therapy QD for 30 fractions over 6-7 weeks. MAINTENANCE PHASE: Four to six weeks after the completion of radiation therapy, patients receive vorinostat PO QD and temsirolimus IV over 30-90 minutes on days 1-8 of each cycle. Treatment repeats every 28 days for 10 cycles in the absence of disease progression or unacceptable toxicity. |
| Arm II (vorinostat, temsirolimus) | Experimental | Drug: Temsirolimus, Drug: VorinostatPatients receive vorinostat PO QD and temsirolimus IV over 30-90 minutes on days 1-8 of each cycle. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 7 months to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (26 listed)
- Patients must be > than 6 months and =< 21 years of age at the time of study consent
- Patients with newly diagnosed or progressive DIPG as confirmed by gadolinium enhanced magnetic resonance imaging (MRI) are eligible; MRI must demonstrate that at least 2/3 of the tumor is situated in the pons and that the origin of the tumor is clearly in the pons; biopsy is not required; tumors with features not typical of diffuse intrinsic brainstem glioma are not eligible; these include dorsally exophytic brainstem gliomas, cervicomedullary junction tumors, and focal low grade gliomas of the midbrain or brainstem which should undergo resection and pathologic evaluation; patients, who have received re-irradiation for progression of the tumor, will be eligible if they show evidence of measurable progressive disease after the re-irradiation; patients at diagnosis with involvement of the spine will not be eligible, however if at progression features of spine involvement are present they will be eligible for stratum II
- Patients must have a Karnofsky >= 50% for patients > 16 years of age and Lansky >= 50 for patients=< 16 years of age; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
- Patients must have fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy or radiation to grade 2 or less
- Patients must not have received myelosuppressive therapy within 3 weeks of enrollment onto this study (6 weeks if prior nitrosourea)
Key exclusion criteria (11 listed)
- Patients with other malignancies will not be eligible for stratum I or II; patients with disseminated disease including to the spine will not be eligible for stratum 1 but will be eligible for stratum II
- Patients must not have a history of myocardial infarction, severe or unstable angina, clinically significant peripheral vascular disease, grade 2 or greater heart failure, or serious and inadequately controlled cardiac arrhythmia
- Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal/human studies
- Patients who are currently receiving enzyme inducing anticonvulsants are not eligible
- Patients who are currently receiving therapeutic anticoagulants (including aspirin, low molecular weight heparin, and others) are not eligible
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 |
|---|---|---|
| Radiation TherapyAlso: Cancer Radiotherapy, ENERGY_TYPE, Irradiate, IrradiatedUndergo radiation therapy | Radiation | Arm I (vorinostat, radiation therapy, temsirolimus) |
| TemsirolimusAlso: CCI-779, CCI-779 Rapamycin Analog, Cell Cycle Inhibitor 779, Rapamycin AnalogGiven IV | Drug | Arm I (vorinostat, radiation therapy, temsirolimus), Arm II (vorinostat, temsirolimus) |
| VorinostatAlso: L-001079038, MSK-390, SAHA, Suberanilohydroxamic AcidGiven PO | Drug | Arm I (vorinostat, radiation therapy, temsirolimus), Arm II (vorinostat, temsirolimus) |
Primary outcome
Maximum tolerated dose (MTD) of temsirolimus
Time frame: 28 days (course 1)
MTD will be defined as the highest dose studied in which six patients have been treated and at most two patients with dose limiting toxicities (DLTs) are observed. DLTs will be monitored for the first course of the combination of vorinostat and temsirolimus.
Incidence of toxic death
Time frame: Up to 12 months
Incidence of adverse events
Time frame: Up to 12 months
Adverse events will be tabulated by dose, grade, and attribution.
1 secondary outcome
Radiographic response
Time frame: Up to 12 months
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 2 Apr 2025.
- Derived from this study: PubMed 40000388Stitzlein LM, Baig MU, Chandra J, McGovern S, Paulino A, Ketonen LM, Khatua S, Zaky W. Phase I Study of Vorinostat and Temsirolimus in Newly Diagnosed or Progressive Diffuse Intrinsic Pontine Glioma. Pediatr Blood Cancer. 2025 May;72(5):e31619. doi: 10.1002/pbc.31619. Epub 2025 Feb 25.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Wafik T Zaky principal investigator
M.D. Anderson Cancer Center
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 Radiation Therapy, Temsirolimus and Vorinostat in people with Diffuse Intrinsic Pontine Glioma, run by M.D. Anderson Cancer Center at 1 site in United States.
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 26 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2025. 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 United States. 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?
Maximum tolerated dose (MTD) of temsirolimus (time frame: 28 days (course 1)). 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?
On the ClinicalTrials.gov record for NCT02420613, which also lists 1 linked publication.
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 2 Apr 2025.