Squamous Cell Carcinoma of Head and NeckPhase 1NCT04091867
sEphB4-HSA With RT+Chemo or Cetux in Patients With Intermediate to High Risk LAHNSCC
A Phase 1 study testing sEphB4-HSA with chemotherapy, Cetuximab and Radiation Therapy in people with Squamous Cell Carcinoma of Head and Neck, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This is a Phase I dose-escalation study of sEphB4-HSA in combination with chemotherapy, cetuximab and radiotherapy (RT). The purpose is to estimate the maximum tolerated dose (MTD) that can be administered concurrently with Cetuximab and radiation in patients with locally advanced, Stage III or IV A-B squamous cell… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Squamous Cell Carcinoma of Head and Neck
- What is being tested?
- sEphB4-HSA with chemotherapy, Cetuximab and Radiation Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2020to 25 Oct 2022
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision to sign and date the consent form.
- Stated willingness to comply with all study procedures and be available for the duration of the study.
- Patients must be willing to consent for two mandatory biopsies to be collected at baseline and again one week after the loading dose of sEphB4-HSA. A third optional biopsy will be collected if feasible 5-10 days after initiation of radiation treatment.
- Be a male or female aged 18-100.
- Pathologically confirmed (from the primary lesion and/or regional lymph nodes) squamous cell carcinoma of the oropharynx, hypopharynx, oral cavity, unknown primary, or larynx.
- High risk, locally advanced HNSCC which may include any of the following by AJCC 8th Edition:
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- Stage III Hypopharyngeal Carcinoma AJCC v8
- Stage III Laryngeal Cancer AJCC v8
- Stage III Lip and Oral Cavity Cancer AJCC v8
- Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8 or Stage III Oropharyngeal (p16-positive) Carcinoma ≥ 10 pack-years history of smoking
- Stage IVA Hypopharyngeal Carcinoma AJCC v8
- Stage IVA Laryngeal Cancer AJCC v8
- Stage IVA Lip and Oral Cavity Cancer AJCC v8
- Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8 or Stage IVA Oropharyngeal (p16-positive) Carcinoma ≥ 10 pack-years history of smoking
- Stage IVB Hypopharyngeal Carcinoma AJCC v8
- Stage IVB Laryngeal Cancer AJCC v8
- Stage IVB Lip and Oral Cavity Cancer AJCC v8
- Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8 or Stage IVB Oropharyngeal (p16-positive) Carcinoma ≥ 10 pack-years history of smoking
- Patient is not a candidate for definitive surgical resection
- Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below:
- Hemoglobin ≥ 9.0 g/dL
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
- White blood cells (WBC) > 3 x 109/L
- Platelet count ≥ 100 x 109/L
- Total bilirubin < 1.5 x institutional upper limit of normal
- AST and ALT < 2.5 x institutional upper limit of normal
- For women of childbearing potential, a negative serum pregnancy test within 28 day screening to confirm eligibility. (Note: Pregnancy test will be repeated within 48 hours prior to the first dose of sEphB4-HAS) .
- ECOG performance status ≤ 2.
- Be deemed ineligible by a medical oncologist to receive concurrent platinum-based chemotherapy with radiotherapy or patient refusal of platinum-based chemotherapy.
- Be deemed eligible by a medical oncologist to receive cetuximab.
- Agreement to exercise appropriate use of contraception, as indicated.
- For females of reproductive potential: use of highly effective contraception from time of screening through 12 weeks following the final dose of study treatment (see section 8.5).
- For males of reproductive potential: use of condoms from time of screening through 12 weeks following the final dose of study treatment.
- Pretreatment imaging to include the following within 28 days of treatment initiation:
- CT Neck (with contrast unless contraindicated) with CT chest OR PET-CT. MRI of the neck with contrast (unless contraindicated) can replace CT neck.
- N.B.: a CT Neck performed for radiation planning and read by a radiologist may serve as appropriate staging and planning tools.
- General history and physical examination by a radiation or medical oncologist within 28 days prior to enrollment.
- Examination by an ENT or head and neck surgeon, including laryngopharyngoscopy (mirror and/or fiberoptic and/or direct procedure) within 56 days prior to enrollment.
- Dental evaluation and, if applicable, prophylaxis per NCCN guidelines performed within 84 days of treatment initiation.
- Eligible for definitive therapy.
Who cannot join
- Pregnant, attempting to conceive, lactating, or declining to use appropriate contraception for duration of study.
- Hypertension that is uncontrolled (requiring 3+ antihypertensive medications to control).
- Hypertension at screening (SBP ≥140mmHg or DBP ≥90mmHg, corresponding to Stage 2 according to JNC 7).
- Prior history of allergic or infusion reaction to cetuximab or sEphB4.
- Febrile illness within 7 days prior to enrollment.
- Concomitant use of EGFR-directed therapies (besides cetuximab given as part of this trial), including erlotinib, gefitinib.
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- Major surgery (excluding tumor biopsy) within 4 weeks prior to start of study treatment.
- Prior unrelated malignancy requiring current active treatment within 3 years prior to enrollment with exceptions of cervical carcinoma in situ, basal cell carcinoma of skin, resected T1-T2N0M0 differentiated thyroid cancers, Ta bladder cancer, prostatic adenocarcinoma of low or intermediate risk (per NCCN criteria).
- Treatment with another investigational drug or other intervention within 30 days of treatment start.
- Resectable oral cavity primary site
- p16-positive carcinoma of the oropharynx or unknown primary that are T0-3, N0-1 (AJCC 8th Edition) AND ≤ 10 pack-year smoking history
- Stage IVC (M1) disease per AJCC 8th edition.
- Prior receipt of systemic chemotherapy for the study cancer (including "induction" or "neoadjuvant" chemotherapy) within 60 days of diagnosis; prior chemotherapy for a different cancer diagnosis is allowed.
- Any severe, active comorbidity, defined as follows:
- Cardiovascular disease or cerebrovascular disease, for example cerebrovascular accidents or myocardial infarction ≤ 6 months prior to study enrollment, unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure (CHF), or serious cardiac arrhythmia uncontrolled by medication or with the potential to interfere with protocol treatment;
- Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months prior to enrollment;
- History or evidence upon physical/neurological examination of central nervous system disease (e.g., seizures) unrelated to cancer unless adequately controlled by medication;
- Acute bacterial or fungal infection requiring intravenous antibiotics within 7 days of enrollment;
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration;
- Patients known to be HIV positive or have active viral hepatitis, defined as positive HCV quantitative titers and/or +Hep B sAg and +IgM anti-HepB. Confirmatory testing is not required for the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Hospital
Aurora, Colorado, 80045
About this study
Official title: A Phase I/Ib Study of sEphB4-HSA in Combination With Chemotherapy or Cetuximab and Radiation Therapy in Patients With Intermediate to High Risk, Locally-Advanced Squamous Cell Carcinomas of the Head and Neck
This is a Phase I dose-escalation study of sEphB4-HSA in combination with chemotherapy, cetuximab and radiotherapy (RT). The purpose is to estimate the maximum tolerated dose (MTD) that can be administered concurrently with Cetuximab and radiation in patients with locally advanced, Stage III or IV A-B squamous cell carcinomas of the head or neck with a history of at least ten pack-years of smoking.
Read the detailed description
RT combined with the EGFR-targeted agent cetuximab represents a valuable alternative to platinum-based CRT and is FDA-approved for initial treatment of LAHNSCC, but outcomes remain unfavorable. Recently, EphB4 has emerged as another rational target. While minimally expressed in normal tissue, it is highly expressed in LAHNSCC and has been implicated in resistance to both EGFR-targeted therapy and to RT. Suppression of EphB4 in the preclinical setting has enhanced tumor death and enhanced radiosensitivity. The novel agent sEphB4-HSA is a fusion protein that binds the ligand for EphB4 and leads to inhibition of tumor proliferation and angiogenesis. It was well-tolerated as monotherapy in a phase I trial but has yet to be explored in combination with radiotherapy or EGFR-directed treatments. A combined modality approach adding sEphB4-HSA to standard-of-care RT plus cetuximab represents a rational, targeted approach for investigation in patients with high risk LAHNSS p16-negative or any patient with heavy smoking histories. Moreover, a short window period of sEphB4-HSA monotherapy between baseline biopsy and repeat biopsy prior to initiation of cetuximab with RT will both minimize potential treatment delay and allow for the identification of potential biomarkers of response to sEphB4-HSA. Finally, a third optional biopsy, to be done if feasible after initiation of cetuximab-radiation, will allow us to identify radiosensitization markers and potential markers for treatment de-escalation. MTD.
- Conditions
- Squamous Cell Carcinoma of Head and Neck
- Being tested
- sEphB4-HSA with chemotherapy, Cetuximab, Radiation Therapy
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sEphB4-HSA with chemotherapyDrug
sEphB4-HSA is a fusion protein combining the soluble extracellular EphB4 domain with albumin that targets the ephrin B2 receptor, which is thought to mediate resistance to EGFR-targeted therapy, and acts as a radiosensitizer by enhancing DNA damage and promoting apoptosis. Concurrent chemotherapy drug (either cisplatin or carboplatin): Per treating physician discretion, and treatment plan is based per NCCN guidelines. These can be administered in tri-weekly or weekly doses during the radiation period. The participant will receive the first infusion on Day 15 (+/- 3 days).
CetuximabDrug
Loading dose 400 mg/m2 on D9 Concurrent dose 250mg/m2 weekly D15± 3 day window
Radiation TherapyRadiation
6930 cGy IMRT starting D15-D18
| Study group | Role | What they receive |
|---|---|---|
| sEphB4-HSA with CRT | Experimental | sEphB4-HSA: Loading dose at fixed dose of 10mg/Kg per below schema on D1 Concurrent dose per below schema D15-43 and given on an every other week basis Concurrent chemotherapy drug (either cisplatin or carboplatin): Per treating physician discretion, and treatment plan is based per NCCN guidelines. These can be administered in tri-weekly or weekly doses during the radiation period. The participant will receive the first infusion on Day 15 (+/- 3 days).
Cetuximab:
Loading dose 400 mg/m2 on D9 Concurrent dose 250mg/m2 weekly D15± 3 day window
RT:
6930 cGy IMRT starting D15-D18 Receives: Drug: sEphB4-HSA with chemotherapy; Drug: Cetuximab; Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is whether a dose-limiting toxicity (DLT) occurs
Severe cetuximab-associated rash is defined as per Lacouture 2010 criteria69, namely > 20 papules or pustules OR > 5 areas of erythema or edema < 1 cm (this is grade 3A) or > 20 papules/pustules OR > 5 areas of erythema or edema < 1 cm AND pain, pruritus, or effect on emotions or functioning (this is a commonly used criteria for grading of rash specifically related to EGFR inhibitors, such as cetuximab).
Measured: 13 weeks
Secondary outcomes (4)
To assess the effect of adding sEphB4-HSA to radiation and cetuximab in newly-diagnosed EGFR-expressing LAHNSCC and heavy smoking histories on Locoregional disease
Tumor response will be assessed in participants with measurable disease at start of therapy by measuring change in size (and/or FDG avidity) on CT (and/or PET/CT). LRC will be calculated as the time from completion of locoregional therapy until disease recurrence at the primary site or in the neck.
Measured: 13 weeks
To assess the effect of adding sEphB4-HSA to radiation and cetuximab in newly-diagnosed EGFR-expressing LAHNSCC and heavy smoking histories on Distant Control
DC will be calculated as the time from completion of locoregional therapy until disease recurrence at a site other than the primary site or neck.
Measured: 13 weeks
To assess the effect of adding sEphB4-HSA to radiation and cetuximab in newly-diagnosed EGFR-expressing LAHNSCC and heavy smoking histories on Disease Free Survival
DFS will be calculated as the time from completion of locoregional therapy until either disease recurrence at any site or until death.
Measured: 13 weeks
Overall Survival
OS will be calculated as the time from diagnosis of LAHNSCC to death
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2019
- Study start6 Jan 2020
- Primary completion14 May 2021
- Study completion25 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of Head and NeckStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Model description
- This study will be enrolled using a 3+3 model. All patients will receive a fixed loading dose of 10 mg/kg to be followed by the assigned dose level during the concurrent phase. The 3+3 design model applies only to the concurrent phase. An expansion cohort of 6 patients will be added for testing biological endpoints.
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Vasgene Therapeutics, Inc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04091867
- Sponsor's protocol ID
- 16-2575.cc
- Other IDs
- NCI-2019-06321
- Status last verified
- Feb 2025
- First submitted
- 9 Aug 2019
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/Ib Study of sEphB4-HSA in Combination With Chemotherapy or Cetuximab and Radiation Therapy in Patients With Intermediate to High Risk, Locally-Advanced Squamous Cell Carcinomas of the Head and Neck
- ClinicalTrials.gov ID
- NCT04091867
- Acronym / sponsor ID
- 16-2575.cc
- Conditions
- Squamous Cell Carcinoma of Head and Neck
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Vasgene Therapeutics, Inc
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 14 May 2021 (actual)
- Study completion
- 25 Oct 2022 (actual)
- First posted
- 17 Sep 2019 (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 Phase I dose-escalation study of sEphB4-HSA in combination with chemotherapy, cetuximab and radiotherapy (RT). The purpose is to estimate the maximum tolerated dose (MTD) that can be administered concurrently with Cetuximab and radiation in patients with locally advanced, Stage III or IV A-B squamous cell carcinomas of the head or neck with a history of at least ten pack-years of smoking.
Detailed description
RT combined with the EGFR-targeted agent cetuximab represents a valuable alternative to platinum-based CRT and is FDA-approved for initial treatment of LAHNSCC, but outcomes remain unfavorable. Recently, EphB4 has emerged as another rational target. While minimally expressed in normal tissue, it is highly expressed in LAHNSCC and has been implicated in resistance to both EGFR-targeted therapy and to RT. Suppression of EphB4 in the preclinical setting has enhanced tumor death and enhanced radiosensitivity. The novel agent sEphB4-HSA is a fusion protein that binds the ligand for EphB4 and leads to inhibition of tumor proliferation and angiogenesis. It was well-tolerated as monotherapy in a phase I trial but has yet to be explored in combination with radiotherapy or EGFR-directed treatments. A combined modality approach adding sEphB4-HSA to standard-of-care RT plus cetuximab represents a rational, targeted approach for investigation in patients with high risk LAHNSS p16-negative or any patient with heavy smoking histories. Moreover, a short window period of sEphB4-HSA monotherapy between baseline biopsy and repeat biopsy prior to initiation of cetuximab with RT will both minimize potential treatment delay and allow for the identification of potential biomarkers of response to sEphB4-HSA. Finally, a third optional biopsy, to be done if feasible after initiation of cetuximab-radiation, will allow us to identify radiosensitization markers and potential markers for treatment de-escalation. MTD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study will be enrolled using a 3+3 model. All patients will receive a fixed loading dose of 10 mg/kg to be followed by the assigned dose level during the concurrent phase. The 3+3 design model applies only to the concurrent phase. An expansion cohort of 6 patients will be added for testing biological endpoints.
| Arm | Type | Receives |
|---|---|---|
| sEphB4-HSA with CRT | Experimental | Drug: sEphB4-HSA with chemotherapy, Drug: Cetuximab, Radiation: Radiation TherapysEphB4-HSA: Loading dose at fixed dose of 10mg/Kg per below schema on D1 Concurrent dose per below schema D15-43 and given on an every other week basis Concurrent chemotherapy drug (either cisplatin or carboplatin): Per treating physician discretion, and treatment plan is based per NCCN guidelines. These can be administered in tri-weekly or weekly doses during the radiation period. The participant will receive the first infusion on Day 15 (+/- 3 days). Cetuximab: Loading dose 400 mg/m2 on D9 Concurrent dose 250mg/m2 weekly D15± 3 day window RT: 6930 cGy IMRT starting D15-D18 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (40 listed)
- Provision to sign and date the consent form.
- Stated willingness to comply with all study procedures and be available for the duration of the study.
- Patients must be willing to consent for two mandatory biopsies to be collected at baseline and again one week after the loading dose of sEphB4-HSA. A third optional biopsy will be collected if feasible 5-10 days after initiation of radiation treatment.
- Be a male or female aged 18-100.
- Pathologically confirmed (from the primary lesion and/or regional lymph nodes) squamous cell carcinoma of the oropharynx, hypopharynx, oral cavity, unknown primary, or larynx.
Key exclusion criteria (20 listed)
- Pregnant, attempting to conceive, lactating, or declining to use appropriate contraception for duration of study.
- Hypertension that is uncontrolled (requiring 3+ antihypertensive medications to control).
- Hypertension at screening (SBP ≥140mmHg or DBP ≥90mmHg, corresponding to Stage 2 according to JNC 7).
- Prior history of allergic or infusion reaction to cetuximab or sEphB4.
- Febrile illness within 7 days prior to enrollment.
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 |
|---|---|---|
| sEphB4-HSA with chemotherapysEphB4-HSA is a fusion protein combining the soluble extracellular EphB4 domain with albumin that targets the ephrin B2 receptor, which is thought to mediate resistance to EGFR-targeted therapy, and acts as a radiosensitizer by enhancing DNA damage and promoting apoptosis. Concurrent chemotherapy drug (either cisplatin or carboplatin): Per treating physician discretion, and treatment plan is based per NCCN guidelines. These can be administered in tri-weekly or weekly doses during the radiation period. The participant will receive the first infusion on Day 15 (+/- 3 days). | Drug | sEphB4-HSA with CRT |
| CetuximabLoading dose 400 mg/m2 on D9 Concurrent dose 250mg/m2 weekly D15± 3 day window | Drug | sEphB4-HSA with CRT |
| Radiation Therapy6930 cGy IMRT starting D15-D18 | Radiation | sEphB4-HSA with CRT |
Primary outcome
The primary endpoint is whether a dose-limiting toxicity (DLT) occurs
Time frame: 13 weeks
Severe cetuximab-associated rash is defined as per Lacouture 2010 criteria69, namely > 20 papules or pustules OR > 5 areas of erythema or edema < 1 cm (this is grade 3A) or > 20 papules/pustules OR > 5 areas of erythema or edema < 1 cm AND pain, pruritus, or effect on emotions or functioning (this is a commonly used criteria for grading of rash specifically related to EGFR inhibitors, such as cetuximab).
4 secondary outcomes
To assess the effect of adding sEphB4-HSA to radiation and cetuximab in newly-diagnosed EGFR-expressing LAHNSCC and heavy smoking histories on Locoregional disease
Time frame: 13 weeks
To assess the effect of adding sEphB4-HSA to radiation and cetuximab in newly-diagnosed EGFR-expressing LAHNSCC and heavy smoking histories on Distant Control
Time frame: 13 weeks
To assess the effect of adding sEphB4-HSA to radiation and cetuximab in newly-diagnosed EGFR-expressing LAHNSCC and heavy smoking histories on Disease Free Survival
Time frame: 13 weeks
Overall Survival
Time frame: 13 weeks
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 24 Feb 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.
The record lists no contact. Use the official record to reach the sponsor.
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 sEphB4-HSA with chemotherapy, Cetuximab and Radiation Therapy in people with Squamous Cell Carcinoma of Head and Neck, run by University of Colorado, Denver 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 40 inclusion and 20 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 24 Feb 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?
The primary endpoint is whether a dose-limiting toxicity (DLT) occurs (time frame: 13 weeks). 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 24 Feb 2025.