Adenoid Cystic Carcinomas of the Salivary GlandsPhase 2ACC-LEN14NCT02860936
Lenvatinib in Recurrent and/or Metastatic Adenoid Cystic Carcinomas of the Salivary Glands: ACC-LEN14
A Phase 2 study testing Lenvatinib in people with Adenoid Cystic Carcinomas of the Salivary Glands, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.
Trial summary
ACC is rare and represent approximately 25% of salivary gland carcinomas. The standard treatment is surgical excision followed by radiotherapy in selected cases. The disease is characterized by a progressive course with local and distant recurrences. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Adenoid Cystic Carcinomas of the Salivary Glands
- What is being tested?
- Lenvatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2015to Jun 2019
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven relapsed and/or metastatic adenoid cystic carcinoma for which potentially curative options such as surgery or radiotherapy are not indicated.
- Archival tissue samples or unstained 20 slides from primary tumor or metastasis for translational biological research.
- Subjects with at least one uni-dimensional measurable lesion by CT-scan or MRI according to RECIST criteria 1.1 (target lesion). A previously treated lesion by radiotherapy or loco-regional therapies such as radiofrequency (RF) can be chosen as target lesion only if progression in the respective lesion has been demonstrated during or following radiotherapy.
- Clinical or radiological progression of disease within 6 months at study entry. Progression of disease by RECIST is not required.
- Age ≥ 18 years
- ECOG Performance Status < 2
Show all 19Show fewer
- Life expectancy of > 3 months
- Adequately controlled blood pressure with or without antihypertensive medications, defined as BP < 150/90 mmHg at screening and no change in antihypertensive medications within 1 week prior to Cycle 1 Day 1
- Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
- Hemoglobin >9.0 g/dl
- Neutrophil count (ANC) >1,000/mm3
- Platelet count 75,000/μl
- Total bilirubin <1.5 times the upper limit of normal
- ALT and AST <2.5 x upper limit of normal (<5 x upper limit of normal for patients with liver metastases)
- Serum creatinine <1.5 x upper limit of normal
- Alkaline phosphatase <4 x ULN
- PT-INR/PTT <1.5 x upper limit of normal (Patients who are being therapeutically anticoagulated with an agent such as heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists)
- Previous systemic therapy for metastatic disease is allowed for a maximum of 1 previous line of chemotherapy and/or 1 previous line of TKI
- Signed written informed consent
Who cannot join
- Symptomatic metastatic brain or meningeal tumors unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry
- Subjects having > 1+ proteinuria on urine dipstick testing will undergo 24h urine collection for quantitative assessment of proteinuria. Subjects with urine protein ≥ 1 g/24h will be ineligible
- History of cardiac disease: congestive heart failure >NYHA class 2; active CAD (MI more than 6 mo prior to study entry is allowed); cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
- Gastrointestinal abnormalities (i.e. inability to take oral medication; malabsorption syndrome)
- Requirement for anticoagulant therapy with oral vitamin K antagonists (LMWH therapy is accepted)
- Prolongation of QTc interval to > 480 msec
Show all 23Show fewer
- Known allergic reaction to any of the components of the treatment
- Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
- Legal incapacity or limited legal capacity
- Active clinically serious infections (> grade 2 NCI-CTC version 4.0)
- Medical or psychological condition which, in the opinion of the investigator, would not enable the patient to complete the study or knowingly sign the Informed Consent
- Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and two weeks after the completion of trial
- Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis \& T1] or any cancer curatively treated > 3 years prior to study entry.
- Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
- History of organ allograft.
- Patients with evidence or history of bleeding diathesis
- Patients undergoing renal dialysis
- Anticancer chemotherapy or immunotherapy during the study or within 4 weeks of study entry.
- Previous therapy with lenvatinib (E7080)
- Radiotherapy during study or within 3 weeks of start of study drug. (Palliative radiotherapy will be allowed)
- Major surgery within 2 weeks of start of study
- Use of biologic response modifiers, such as G-CSF, within 3 week of study entry [G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity such as febrile neutropenia when clinically indicated or at the discretion of the investigator, however they may not be substituted for a required dose reduction; patients taking chronic erythropoietin are permitted provided no dose adjustment is undertaken within 2 months prior to the study or during the study]
- Investigational drug therapy outside of this trial during or within 4 weeks of study entry
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study on Lenvatinib in Recurrent and/or Metastatic Adenoid Cystic Carcinomas of the Salivary Glands of the Upper Aerodigestive Tract
ACC is rare and represent approximately 25% of salivary gland carcinomas. The standard treatment is surgical excision followed by radiotherapy in selected cases. The disease is characterized by a progressive course with local and distant recurrences. First-line treatment is palliative chemotherapy that had modest results. Expression of the epidermal growth factor receptor in ACC of salivary origin has been reported. Several papers report that a high percentage of ACCs carries a chromosome translocation that results in the overexpression of the oncogene MYB, which is involved in cell proliferation, apoptosis, differentiation and in upregulation of several growth and angiogenetic factors contributing to the autocrine activation of the FGFR and VEGFR-mediated angiogenesis. Recently two whole genome sequencing of several ACC tumor/normal pairs have found mutations in genes involved in the FGF/IGF/PI3K pathway corroborating the hypothesis that this subset might benefit from inhibitors of this pathway. Based on these premises several antiangiogenic drugs and FGFR inhibitors are currently under investigation and a response rate of 11% was observed in ACC. Lenvatinib is an oral multiple RTK inhibitor targeting VEGFR-1-3, FGFR-1-4, RET, c-KIT, and PDGFR. On February 13, 2015 the drug has been approved by FDA for the treatment of patients with locally recurrent or metastatic, radioactive iodine-refractory differentiated thyroid cancer. Based on preclinical and clinical data, the investigators believe that targeting angiogenesis, FGFR pathway and tumor microenvironment might represent a rational basis to test Lenvatinib in patients with relapsed and/or metastatic ACC.
Read the detailed description
Carcinomas of the salivary glands (SGCs) are rare, (less than 1% of all cancers of the head and neck and include more than 20 malignant histotypes. They can occur both in major and minor salivary glands, are locally aggressive, demonstrating invasiveness that leads to involvement of the facial nerve, skin, bone and surrounding soft tissue. The standard treatment is surgical excision, followed by radiotherapy in selected cases such as high-grade histotypes, advanced disease and neck nodes diffusion. Loco-regional recurrence occurs in 16% to 85%, it can be managed in very selected cases with further surgery and/or radiotherapy, although the prognosis of these patients remains poor. Adenoid cystic cancer (ACC) is the most common SGC histotype observed in metastatic subjects (60%) and distant metastases are the principal cause of failure, being diagnosed in 25-55% of the patients. First-line treatment is palliative chemotherapy that is typically not associated with any benefit neither in response rate nor in outcome. In preclinical models, VEGF seems to contribute to tumor aggressiveness as well as to distant metastasization, in particular in ACC. Moreover, about 80% of ACC are characterized by MYB-NFIB fusion gene. Deregulation of MYB involves several genes including those associated with apoptosis, cell cycle control and angiogenesis. Clinical evidences support the use of antiangiogenic compounds in ACC. Sorafenib a multi-tyrosine kinase inhibitor (TKI) (VEGFR1-3; PDGFR, RET, cKIT FLT3) and axitinib a potent TKI anti VEGFR1-3 have been tested in advanced ACC, obtaining a 1% of response rate, suggesting some activity agents of this class of drug.
Recently two whole genome sequencing of ACC tumor/normal pairs have found mutations in genes involved in the FGF/IGF/PI3K pathway (up to 30% of the cases) corroborating the hypothesis that this subset might benefit from agents targeting this pathway. Dovitinib, a small molecule that inhibits FGFR, is currently under investigation. Preliminary results indicate that the drug produces objective partial responses and prolonged tumor stabilization in patients with progressive ACCs. Lenvatinib has a stronger antiangiogenic effect compared to sorafenib and axitinib and has also a higher potency with regard to inhibition of FGFR-1, offering a potential opportunity to block one of the well known mechanisms of resistance to VEGF/VEGFR inhibitors. Lenvatinib also has a direct oncogenic effect of controlling tumor cell proliferation by inhibiting RET, c-KIT, and PDGFR beta, as well as an effect on the tumor microenvironment by blocking FGFR and PDGFR beta.
Lenvatinib has been investigated in thyroid cancer and hepatocellular carcinoma (phase III trials) and in other malignancies, showing high rates of activity.
Based on preclinical and clinical data, the investigators believe that targeting angiogenesis, FGFR pathway and tumor microenvironment might represent a rational basis to test lenvatinib in patients with relapsed and/or metastatic ACC.
- Being tested
- Lenvatinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenvatinibDrug
Also called Lenvima
Lenvatinib will be self orally administered at 24 mg daily, on a continuous basis in 4 week cycles until tumour progression, unacceptable toxicity or other criteria for discontinuation is met. Study drug should be taken at approximately the same time each morning.
| Study group | Role | What they receive |
|---|---|---|
| Lenvatinib | Experimental | 24 mg of lenvatinib will be administered daily to patients until progression of disease or intolerable toxicity or other criteria for discontinuation is met. Receives: Drug: Lenvatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (CR+PR)
Objective response rate (CR+PR) will be evaluated according to RECIST response evaluation criteria 1.1 at any subsequent re-evaluation
Measured: 2 years and 5 months
Secondary outcomes (4)
Progression free survival
PFS according to RECIST criteria 1.1
Measured: 2 years and 5 months
Overall survival
After study drug treatment ends, patients will be contacted each 6 months to determine survival
Measured: 2 years and 5 months
Safety and toxicity profile of lenvatinib (according to CTCAE v 4.0)
Incidence of adverse events (AEs), will be graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4.0, laboratory values, physical examinations, vital signs.
Measured: 2 years and 5 months
Duration of response
The duration of response will be evaluated to assess the duration of activity of lenvatinib (CR+PR+SD)
Measured: 2 years and 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2016 (estimated)
- Study startJun 2015
- Primary completionJun 2019
- Study completionJun 2019
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 Adenoid Cystic Carcinomas of the Salivary GlandsStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoThe 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
- 26 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa Licitra, Principal investigator, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02860936
- Sponsor's protocol ID
- INT 38/15
- Acronym
- ACC-LEN14
- Status last verified
- Aug 2019
- First submitted
- 2 Aug 2016
- Last updated
- 3 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Only study results will be shared through publication on scientific indexed journals
Publications
Locati LD, Galbiati D, Calareso G, Alfieri S, Singer S, Cavalieri S, Bergamini C, Bossi P, Orlandi E, Resteghini C, Platini F, Granata R, Quattrone P, Mancinelli M, Mariani L, Lo Vullo S, Licitra LF. Patients with adenoid cystic carcinomas of the salivary glands treated with lenvatinib: Activity and quality of life. Cancer. 2020 Jan 1;126(9):1888-1894. doi: 10.1002/cncr.32754. Epub 2020 Feb 7.
PubMed 32031693
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study on Lenvatinib in Recurrent and/or Metastatic Adenoid Cystic Carcinomas of the Salivary Glands of the Upper Aerodigestive Tract
- ClinicalTrials.gov ID
- NCT02860936
- Acronym / sponsor ID
- ACC-LEN14 / INT 38/15
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 10 Aug 2016 (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.
ACC is rare and represent approximately 25% of salivary gland carcinomas. The standard treatment is surgical excision followed by radiotherapy in selected cases. The disease is characterized by a progressive course with local and distant recurrences. First-line treatment is palliative chemotherapy that had modest results. Expression of the epidermal growth factor receptor in ACC of salivary origin has been reported. Several papers report that a high percentage of ACCs carries a chromosome translocation that results in the overexpression of the oncogene MYB, which is involved in cell proliferation, apoptosis, differentiation and in upregulation of several growth and angiogenetic factors contributing to the autocrine activation of the FGFR and VEGFR-mediated angiogenesis. Recently two whole genome sequencing of several ACC tumor/normal pairs have found mutations in genes involved in the FGF/IGF/PI3K pathway corroborating the hypothesis that this subset might benefit from inhibitors of this pathway. Based on these premises several antiangiogenic drugs and FGFR inhibitors are currently under investigation and a response rate of 11% was observed in ACC. Lenvatinib is an oral multiple RTK inhibitor targeting VEGFR-1-3, FGFR-1-4, RET, c-KIT, and PDGFR. On February 13, 2015 the drug has been approved by FDA for the treatment of patients with locally recurrent or metastatic, radioactive iodine-refractory differentiated thyroid cancer. Based on preclinical and clinical data, the investigators believe that targeting angiogenesis, FGFR pathway and tumor microenvironment might represent a rational basis to test Lenvatinib in patients with relapsed and/or metastatic ACC.
Detailed description
Carcinomas of the salivary glands (SGCs) are rare, (less than 1% of all cancers of the head and neck and include more than 20 malignant histotypes. They can occur both in major and minor salivary glands, are locally aggressive, demonstrating invasiveness that leads to involvement of the facial nerve, skin, bone and surrounding soft tissue. The standard treatment is surgical excision, followed by radiotherapy in selected cases such as high-grade histotypes, advanced disease and neck nodes diffusion. Loco-regional recurrence occurs in 16% to 85%, it can be managed in very selected cases with further surgery and/or radiotherapy, although the prognosis of these patients remains poor. Adenoid cystic cancer (ACC) is the most common SGC histotype observed in metastatic subjects (60%) and distant metastases are the principal cause of failure, being diagnosed in 25-55% of the patients. First-line treatment is palliative chemotherapy that is typically not associated with any benefit neither in response rate nor in outcome. In preclinical models, VEGF seems to contribute to tumor aggressiveness as well as to distant metastasization, in particular in ACC. Moreover, about 80% of ACC are characterized by MYB-NFIB fusion gene. Deregulation of MYB involves several genes including those associated with apoptosis, cell cycle control and angiogenesis. Clinical evidences support the use of antiangiogenic compounds in ACC. Sorafenib a multi-tyrosine kinase inhibitor (TKI) (VEGFR1-3; PDGFR, RET, cKIT FLT3) and axitinib a potent TKI anti VEGFR1-3 have been tested in advanced ACC, obtaining a 1% of response rate, suggesting some activity agents of this class of drug.
Recently two whole genome sequencing of ACC tumor/normal pairs have found mutations in genes involved in the FGF/IGF/PI3K pathway (up to 30% of the cases) corroborating the hypothesis that this subset might benefit from agents targeting this pathway. Dovitinib, a small molecule that inhibits FGFR, is currently under investigation. Preliminary results indicate that the drug produces objective partial responses and prolonged tumor stabilization in patients with progressive ACCs. Lenvatinib has a stronger antiangiogenic effect compared to sorafenib and axitinib and has also a higher potency with regard to inhibition of FGFR-1, offering a potential opportunity to block one of the well known mechanisms of resistance to VEGF/VEGFR inhibitors. Lenvatinib also has a direct oncogenic effect of controlling tumor cell proliferation by inhibiting RET, c-KIT, and PDGFR beta, as well as an effect on the tumor microenvironment by blocking FGFR and PDGFR beta.
Lenvatinib has been investigated in thyroid cancer and hepatocellular carcinoma (phase III trials) and in other malignancies, showing high rates of activity.
Based on preclinical and clinical data, the investigators believe that targeting angiogenesis, FGFR pathway and tumor microenvironment might represent a rational basis to test lenvatinib in patients with relapsed and/or metastatic ACC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lenvatinib | Experimental | Drug: Lenvatinib24 mg of lenvatinib will be administered daily to patients until progression of disease or intolerable toxicity or other criteria for discontinuation is met. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Histologically proven relapsed and/or metastatic adenoid cystic carcinoma for which potentially curative options such as surgery or radiotherapy are not indicated.
- Archival tissue samples or unstained 20 slides from primary tumor or metastasis for translational biological research.
- Subjects with at least one uni-dimensional measurable lesion by CT-scan or MRI according to RECIST criteria 1.1 (target lesion). A previously treated lesion by radiotherapy or loco-regional therapies such as radiofrequency (RF) can be chosen as target lesion only if progression in the respective lesion has been demonstrated during or following radiotherapy.
- Clinical or radiological progression of disease within 6 months at study entry. Progression of disease by RECIST is not required.
- Age ≥ 18 years
Key exclusion criteria (23 listed)
- Symptomatic metastatic brain or meningeal tumors unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry
- Subjects having > 1+ proteinuria on urine dipstick testing will undergo 24h urine collection for quantitative assessment of proteinuria. Subjects with urine protein ≥ 1 g/24h will be ineligible
- History of cardiac disease: congestive heart failure >NYHA class 2; active CAD (MI more than 6 mo prior to study entry is allowed); cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
- Gastrointestinal abnormalities (i.e. inability to take oral medication; malabsorption syndrome)
- Requirement for anticoagulant therapy with oral vitamin K antagonists (LMWH therapy is accepted)
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 |
|---|---|---|
| LenvatinibAlso: LenvimaLenvatinib will be self orally administered at 24 mg daily, on a continuous basis in 4 week cycles until tumour progression, unacceptable toxicity or other criteria for discontinuation is met. Study drug should be taken at approximately the same time each morning. | Drug | Lenvatinib |
Primary outcome
Objective response rate (CR+PR)
Time frame: 2 years and 5 months
Objective response rate (CR+PR) will be evaluated according to RECIST response evaluation criteria 1.1 at any subsequent re-evaluation
4 secondary outcomes
Progression free survival
Time frame: 2 years and 5 months
Overall survival
Time frame: 2 years and 5 months
Safety and toxicity profile of lenvatinib (according to CTCAE v 4.0)
Time frame: 2 years and 5 months
Duration of response
Time frame: 2 years and 5 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 3 Sep 2019.
- Derived from this study: PubMed 32031693Locati LD, Galbiati D, Calareso G, Alfieri S, Singer S, Cavalieri S, Bergamini C, Bossi P, Orlandi E, Resteghini C, Platini F, Granata R, Quattrone P, Mancinelli M, Mariani L, Lo Vullo S, Licitra LF. Patients with adenoid cystic carcinomas of the salivary glands treated with lenvatinib: Activity and quality of life. Cancer. 2020 Jan 1;126(9):1888-1894. doi: 10.1002/cncr.32754. Epub 2020 Feb 7.
- Individual participant dataSharing planned: No. Only study results will be shared through publication on scientific indexed journals
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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.
Lisa Licitra principal investigator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lenvatinib in people with Adenoid Cystic Carcinomas of the Salivary Glands, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.
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 19 inclusion and 23 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 3 Sep 2019. 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 Italy. 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?
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?
Objective response rate (CR+PR) (time frame: 2 years and 5 months). 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 NCT02860936, 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 3 Sep 2019; AzTrials last refreshed its copy on 8 Nov 2026.