Aneurysmal Bone CystsPhase 2NCT03605199
Denosumab in Subjects With Giant Cell Rich Tumors of Bone
A Phase 2 study testing Denosumab in people with Aneurysmal Bone Cysts and Giant Cell Granuloma, run by Leiden University Medical Center at 3 sites in 3 countries.
Trial summary
An open-label, multi-center, phase 2 study of the efficacy of denosumab in subjects with giant cell rich tumors of bone. The population will consist of subjects with the following tumor types: aneurysmal bone cysts (ABC), giant cell granuloma (GCG) and other giant cell rich lesions (primary bone, non-malignant). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aneurysmal Bone Cysts, Giant Cell Granuloma, Osteoblastoma
- What is being tested?
- Denosumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 18 Jun 2018to Jun 2023
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically proven giant cell rich tumor:
- Aneurysmal bone cysts (ABC)
- Giant cell granuloma (GCG)
- Other giant cell rich lesions (primary bone, non-malignant, pathology and radiology to be reviewed during multidisciplinary meeting LUMC)
- Patients with surgically unsalvageable disease (e.g., sacral, spinal giant cell rich tumors, or multiple lesions including pulmonary metastases) OR patients whose planned surgery includes joint resection, limb amputation, hemipelvectomy or surgical procedure resulting in severe morbidity
- Measurable evidence of active disease within 1 year before study enrollment
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- Albumin-adjusted serum calcium level ≥ 2.0 mmol/L (8.0 mg/dL)
- Aged 18 years and up and skeletally mature
- ECOG performance status 0, 1 or 2
- Written signed informed consent
Who cannot join
- Known or suspected current diagnosis of classic GCTB
- Known or suspected current diagnosis of underlying malignancy including but not limited to high-grade sarcoma, osteosarcoma, fibrosarcoma, malignant giant cell sarcoma
- Known or suspected current diagnosis of brown cell tumor of hyperparathyroidism, Paget's disease or cherubism
- Known or suspected current diagnosis of primary soft tissue tumor with invasion of the bone
- Known diagnosis of other malignancy within the past 5 years (patients with definitively treated basal cell carcinoma and cervical carcinoma in situ are permitted)
- Previous treatment with denosumab (with the exception of patients eligible for re-treatment with denosumab after completing this study)
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- Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw
- Active dental or jaw condition which requires oral surgery, including tooth extraction
- Non-healed dental/oral surgery
- Planned invasive dental procedure for the course of the study
- Known hypersensitivity to denosumab
- Known hypersensitivity to products to be administered during the study (calcium and/or vitamin D)
- Currently receiving other specific treatment for giant cell rich tumors of bone (e.g., radiation, chemotherapy or embolization)
- Concurrent bisphosphonate treatment
- Major surgery less than 4 weeks prior to start of treatment
- Treatment with other investigational device or drug 30 days prior to study enrollment
- Unstable systemic disease including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months before enrollment
- Patient is pregnant or breast feeding, or planning to become pregnant within 5 months after the EOT visit
- Female patient of child bearing potential is not willing to use a highly effective method of contraception during treatment and for 5 months after the EOT visit
- Patient has any kind of disorder that compromises the ability of the patient to give written informed consent and/or to comply with study procedures
Trial locations and contacts
3 sites in 3 countries.
A Lipplaa, MD contact
AJ Gelderblom contact
3 sites in 3 countries
Italy1 site, 1 recruiting
- Not yet recruiting
Istituto Ortopedico Rizzoli
Bologna
E Palmerini
Netherlands1 site, 1 recruiting
- Recruiting
Leiden University Medical Center
Leiden
H Gelderblom, Prof
About this study
Official title: An Open-label, Multi-center, Phase 2 Study of Denosumab in Subjects With Giant Cell Rich Tumors of Bone
An open-label, multi-center, phase 2 study of the efficacy of denosumab in subjects with giant cell rich tumors of bone. The population will consist of subjects with the following tumor types: aneurysmal bone cysts (ABC), giant cell granuloma (GCG) and other giant cell rich lesions (primary bone, non-malignant).
Read the detailed description
In this phase 2 single arm trial subjects with giant cell rich tumors that would require morbid surgery OR with tumors that have recurred after previous surgery will be treated with denosumab. The primary objectives of the study are to evaluate avoidance of surgery and performance of less morbid surgical procedure compared with the planned surgical procedure at baseline in subjects with salvageable giant cell rich tumors during the study. For subjects with unsalvageable tumors the objective is to evaluate disease control (radiological response assessed by combined RECIST, PET, inverse Choi when available and/or no progression at 1 year (based on disease assessment) in combination with stable pain score defined as ≤ 1 point increase on 'worst pain' question in BPI-SF).
Surgical resection may occur at any time during the study based on the clinical judgement of the Investigator. For subjects that undergo surgical tumor resection, denosumab treatment will be discontinued after surgery. In all other cases, denosumab treatment continues for a maximum of up to 3 years, or until confirmation of disease progression, the Investigator's or Sponsor's recommendation of discontinuation, the subject's decision to discontinue for any reason or administration of any of the prohibited therapies listed in the study protocol. For subjects that continue to show clinical benefit after 3 years of treatment with denosumab, ongoing treatment outside of study protocol is optional after discussion with Amgen.
For assessment of histopathological response and for translational research purposes a tumor sample will be requested either during study or at the EOT (surgical sample only for the subject group that has undergone surgery).
During the time the study is still open, re-treatment may be allowed for subjects who demonstrated a response to denosumab and are currently not receiving denosumab treatment (e.g., in the case of recurrent disease while subject is in the safety follow-up phase or subjects that have completed the study and have later experienced disease progression). The re-treatment decision including the use of the loading dose and discontinuation of therapy will be handled on a case-by-case basis; prior authorization from the Sponsor is required. Subjects must meet all inclusion/exclusion criteria prior to being considered for re-treatment, with the exception of the exclusion criterium of previous denosumab treatment. The same subject number will be assigned to avoid bias.
Overall in total approximately 60 subjects with giant cell rich tumors that would require morbid surgery or with tumors that have recurred after previous surgery will be included. The investigators expect 50% of subjects will have salvageable giant cell rich tumors and the remaining 50% of subjects to have unsalvageable giant cell rich tumors.
The population will consist of subjects with the following cohorts according to tumor type:
- Aneurysmal bone cysts (ABC), ~ approximately 40 subjects
- Giant Cell Granuloma (GCG) and other giant cell rich lesions (primary bone, non-malignant), ~ approximately 20 subjects
- Conditions
- Aneurysmal Bone Cysts, Giant Cell Granuloma, Osteoblastoma, Chondroblastoma, Chondromyxoid Fibroma
- Being tested
- Denosumab
- Keywords
- denosumab, giant cell rich tumor of bone
- Medical subject headings
- Bone Cysts, Aneurysmal, Granuloma, Giant Cell, Osteoblastoma, Chondroblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DenosumabDrug
Also called Xgeva
Denosumab will be given in a dose of 120mg subcutaneously (SC) on day 1 of every 4 week cycle with a loading dose of 120mg SC on days 8 and 15 of the first cycle.
| Study group | Role | What they receive |
|---|---|---|
| Denosumab active treatment | Experimental | Denosumab active treatment Receives: Drug: Denosumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy (proportion of subjects who do not require surgery during the study)
(For subgroup of subjects with salvageable tumors):The proportion of subjects who do not require surgery during the study.
Measured: Continuous monitoring until surgery of max treatment duration of 3 years.
Efficacy (proportion of subjects undergoing the planned versus performed type of surgery during the study)
(For subgroup of subjects with salvageable tumors): The proportion of subjects undergoing the planned versus performed type of surgery during the study.
Measured: Continuous monitoring until surgery of max treatment duration of 3 years.
Efficacy (Radiological response)
(For subgroup of subjects with UNsalvageable tumors) Combined endpoint: 1. Disease control:
- Radiological response assessed by combined RECIST, PET, inverse Choi criteria when available
Measured: Imaging to be performed every 3 months. Up to maximum duration of treatment of 3 years.
Efficacy (disease progression based on clinical disease assessment)
(For subgroup of subjects with UNsalvageable tumors) Combined endpoint: 2. Disease control:
- No progression at 1 year (based on clinical disease assessment)
Measured: Clinical disease assessment performed every 4 weeks. Up to maximum duration of treatment of 3 years.
Efficacy (combined pain scores)
(For subgroup of subjects with UNsalvageable tumors) Combined endpoint: 3. Stable pain score, defined as ≤ 1 point increase on 'worst pain' question in Brief Pain Inventory - Short Form (BPI-SF, measures pain severity on a scale of 0 to 10 [10 being worse pain], and pain interference on a scale of 0 to 10 [10 being complete interference], scores are averaged in total test score).
Measured: Questionnaires on pain to be performed every 4 weeks. Up to maximum duration of treatment of 3 years.
Secondary outcomes (8)
Toxicity according to CTCAE v 4.03
- Frequency of adverse events (AEs), as determined by Common Terminology Criteria for Adverse Events (CTCAE) v. 4.03 criteria
Measured: Assessed every 4 weeks up to 3 years.
Disease recurrence after denosumab followed by surgery.
The proportion of subjects with disease recurrence after denosumab followed by surgery during the study.
Measured: Follow-up every 6-12 months after end of treatment, up to 5 years max.
Symptomatic improvement.
Symptomatic improvement in the Brief Pain Inventory - Short Form (BPI-SF, measures pain severity on a scale of 0 to 10 [10 being worse pain], and pain interference on a scale of 0 to 10 [10 being complete interference], scores are averaged in total test score).
Measured: Questionnaires to be performed every 4 weeks during first 6 months on treatment, after 6 months assessment is every 12 weeks. Up to 3 years.
Symptomatic improvement.
Symptomatic improvement in the European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire C30 (EORTC QLC-30, 28 questions regarding interference of disease with QoL ranging from 1 'not at all' to 4 'very much', 2 questions regarding QoL raging from 1 'very poor' to 7 'excellent', scores are averaged in total test score)
Measured: Questionnaires to be performed every 4 weeks during first 6 months on treatment, after 6 months assessment is every 12 weeks. Up to 3 years.
Time to surgery
Time in months
Measured: Continuous monitoring, clinical assessment every 4 weeks during treatment and every 6-12 months after end of treatment up to max of 5 years.
Time to recurrence after surgery (for patients with salvageable disease)
Time in months
Measured: Continuous monitoring, clinical assessment every 4 weeks during treatment and every 6-12 months after end of treatment up to max of 5 years
Progression free survival
Time in months
Measured: Continuous monitoring, clinical assessment every 4 weeks during treatment and every 6-12 months after end of treatment up to max of 5 years
Overall survival.
Time in months
Measured: Continuous monitoring, clinical assessment every 4 weeks during treatment and every 6-12 months after end of treatment up to max of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2018
- Study start18 Jun 2018
- Primary completionJun 2021 (estimated)
- Study completionJun 2023 (estimated)
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 Aneurysmal Bone CystsStudies of the same condition, open and under way.
- More trials run by Leiden University Medical 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Principal investigator, HansGelderblom, Leiden University Medical Center
- Investigators
- AJ Gelderblom, Prof, Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03605199
- Sponsor's protocol ID
- 20159990
- Status last verified
- Aug 2019
- First submitted
- 15 Jun 2018
- Last updated
- 26 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lipplaa A, Schreuder WH, Pichardo SEC, Gelderblom H. Denosumab in Giant Cell Rich Tumors of Bone: An Open-Label Multicenter Phase II Study. Oncologist. 2023 Nov 2;28(11):1005-e1104. doi: 10.1093/oncolo/oyad196.
PubMed 37449658
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-center, Phase 2 Study of Denosumab in Subjects With Giant Cell Rich Tumors of Bone
- ClinicalTrials.gov ID
- NCT03605199
- Acronym / sponsor ID
- 20159990
- Conditions
- Aneurysmal Bone Cysts, Giant Cell Granuloma, Osteoblastoma, Chondroblastoma, Chondromyxoid Fibroma
- Keywords
- denosumab, giant cell rich tumor of bone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- 18 Jun 2018 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 30 Jul 2018 (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.
An open-label, multi-center, phase 2 study of the efficacy of denosumab in subjects with giant cell rich tumors of bone. The population will consist of subjects with the following tumor types: aneurysmal bone cysts (ABC), giant cell granuloma (GCG) and other giant cell rich lesions (primary bone, non-malignant).
Detailed description
In this phase 2 single arm trial subjects with giant cell rich tumors that would require morbid surgery OR with tumors that have recurred after previous surgery will be treated with denosumab. The primary objectives of the study are to evaluate avoidance of surgery and performance of less morbid surgical procedure compared with the planned surgical procedure at baseline in subjects with salvageable giant cell rich tumors during the study. For subjects with unsalvageable tumors the objective is to evaluate disease control (radiological response assessed by combined RECIST, PET, inverse Choi when available and/or no progression at 1 year (based on disease assessment) in combination with stable pain score defined as ≤ 1 point increase on 'worst pain' question in BPI-SF).
Surgical resection may occur at any time during the study based on the clinical judgement of the Investigator. For subjects that undergo surgical tumor resection, denosumab treatment will be discontinued after surgery. In all other cases, denosumab treatment continues for a maximum of up to 3 years, or until confirmation of disease progression, the Investigator's or Sponsor's recommendation of discontinuation, the subject's decision to discontinue for any reason or administration of any of the prohibited therapies listed in the study protocol. For subjects that continue to show clinical benefit after 3 years of treatment with denosumab, ongoing treatment outside of study protocol is optional after discussion with Amgen.
For assessment of histopathological response and for translational research purposes a tumor sample will be requested either during study or at the EOT (surgical sample only for the subject group that has undergone surgery).
During the time the study is still open, re-treatment may be allowed for subjects who demonstrated a response to denosumab and are currently not receiving denosumab treatment (e.g., in the case of recurrent disease while subject is in the safety follow-up phase or subjects that have completed the study and have later experienced disease progression). The re-treatment decision including the use of the loading dose and discontinuation of therapy will be handled on a case-by-case basis; prior authorization from the Sponsor is required. Subjects must meet all inclusion/exclusion criteria prior to being considered for re-treatment, with the exception of the exclusion criterium of previous denosumab treatment. The same subject number will be assigned to avoid bias.
Overall in total approximately 60 subjects with giant cell rich tumors that would require morbid surgery or with tumors that have recurred after previous surgery will be included. The investigators expect 50% of subjects will have salvageable giant cell rich tumors and the remaining 50% of subjects to have unsalvageable giant cell rich tumors.
The population will consist of subjects with the following cohorts according to tumor type:
- Aneurysmal bone cysts (ABC), ~ approximately 40 subjects
- Giant Cell Granuloma (GCG) and other giant cell rich lesions (primary bone, non-malignant), ~ approximately 20 subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Denosumab active treatment | Experimental | Drug: DenosumabDenosumab active treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Pathologically proven giant cell rich tumor:
- Patients with surgically unsalvageable disease (e.g., sacral, spinal giant cell rich tumors, or multiple lesions including pulmonary metastases) OR patients whose planned surgery includes joint resection, limb amputation, hemipelvectomy or surgical procedure resulting in severe morbidity
- Measurable evidence of active disease within 1 year before study enrollment
- Albumin-adjusted serum calcium level ≥ 2.0 mmol/L (8.0 mg/dL)
- Aged 18 years and up and skeletally mature
Key exclusion criteria (20 listed)
- Known or suspected current diagnosis of classic GCTB
- Known or suspected current diagnosis of underlying malignancy including but not limited to high-grade sarcoma, osteosarcoma, fibrosarcoma, malignant giant cell sarcoma
- Known or suspected current diagnosis of brown cell tumor of hyperparathyroidism, Paget's disease or cherubism
- Known or suspected current diagnosis of primary soft tissue tumor with invasion of the bone
- Known diagnosis of other malignancy within the past 5 years (patients with definitively treated basal cell carcinoma and cervical carcinoma in situ are permitted)
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 |
|---|---|---|
| DenosumabAlso: XgevaDenosumab will be given in a dose of 120mg subcutaneously (SC) on day 1 of every 4 week cycle with a loading dose of 120mg SC on days 8 and 15 of the first cycle. | Drug | Denosumab active treatment |
Primary outcome
Efficacy (proportion of subjects who do not require surgery during the study)
Time frame: Continuous monitoring until surgery of max treatment duration of 3 years.
(For subgroup of subjects with salvageable tumors):The proportion of subjects who do not require surgery during the study.
Efficacy (proportion of subjects undergoing the planned versus performed type of surgery during the study)
Time frame: Continuous monitoring until surgery of max treatment duration of 3 years.
(For subgroup of subjects with salvageable tumors): The proportion of subjects undergoing the planned versus performed type of surgery during the study.
Efficacy (Radiological response)
Time frame: Imaging to be performed every 3 months. Up to maximum duration of treatment of 3 years.
(For subgroup of subjects with UNsalvageable tumors) Combined endpoint: 1. Disease control: o Radiological response assessed by combined RECIST, PET, inverse Choi criteria when available
Efficacy (disease progression based on clinical disease assessment)
Time frame: Clinical disease assessment performed every 4 weeks. Up to maximum duration of treatment of 3 years.
(For subgroup of subjects with UNsalvageable tumors) Combined endpoint: 2. Disease control: o No progression at 1 year (based on clinical disease assessment)
Efficacy (combined pain scores)
Time frame: Questionnaires on pain to be performed every 4 weeks. Up to maximum duration of treatment of 3 years.
(For subgroup of subjects with UNsalvageable tumors) Combined endpoint: 3. Stable pain score, defined as ≤ 1 point increase on 'worst pain' question in Brief Pain Inventory - Short Form (BPI-SF, measures pain severity on a scale of 0 to 10 [10 being worse pain], and pain interference on a scale of 0 to 10 [10 being complete interference], scores are averaged in total test score).
8 secondary outcomes
Toxicity according to CTCAE v 4.03
Time frame: Assessed every 4 weeks up to 3 years.
Disease recurrence after denosumab followed by surgery.
Time frame: Follow-up every 6-12 months after end of treatment, up to 5 years max.
Symptomatic improvement.
Time frame: Questionnaires to be performed every 4 weeks during first 6 months on treatment, after 6 months assessment is every 12 weeks. Up to 3 years.
Symptomatic improvement.
Time frame: Questionnaires to be performed every 4 weeks during first 6 months on treatment, after 6 months assessment is every 12 weeks. Up to 3 years.
Time to surgery
Time frame: Continuous monitoring, clinical assessment every 4 weeks during treatment and every 6-12 months after end of treatment up to max of 5 years.
Time to recurrence after surgery (for patients with salvageable disease)
Time frame: Continuous monitoring, clinical assessment every 4 weeks during treatment and every 6-12 months after end of treatment up to max of 5 years
Progression free survival
Time frame: Continuous monitoring, clinical assessment every 4 weeks during treatment and every 6-12 months after end of treatment up to max of 5 years
Overall survival.
Time frame: Continuous monitoring, clinical assessment every 4 weeks during treatment and every 6-12 months after end of treatment up to max of 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2019.
- Derived from this study: PubMed 37449658Lipplaa A, Schreuder WH, Pichardo SEC, Gelderblom H. Denosumab in Giant Cell Rich Tumors of Bone: An Open-Label Multicenter Phase II Study. Oncologist. 2023 Nov 2;28(11):1005-e1104. doi: 10.1093/oncolo/oyad196.
- Individual participant dataSharing planned: Undecided
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.
A Lipplaa, MD contact
AJ Gelderblom contact
AJ Gelderblom, Prof principal investigator
Leiden University Medical Center
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Denosumab in people with Aneurysmal Bone Cysts and Giant Cell Granuloma, run by Leiden University Medical Center at 3 sites in 3 countries.
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 10 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: status not confirmed, as of the sponsor's last update on 26 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France, Italy, Netherlands. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact A Lipplaa, MD (a.lipplaa@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy (proportion of subjects who do not require surgery during the study) (time frame: Continuous monitoring until surgery of max treatment duration of 3 years.). The study lists 5 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 NCT03605199, 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 26 Aug 2019.