GlioblastomaPhase 3RE-GENDNCT02761070
Bevacizumab Alone Versus Dose-dense Temozolomide Followed by Bevacizumab for Recurrent Glioblastoma, Phase III
A Phase 3 study testing Temozolomide and Bevacizumab in people with Glioblastoma and Recurrence, run by Kyorin University at 37 sites in Japan.
Trial summary
The aim of this Phase III study is to evaluate the superiority of dose-dense temozolomide (ddTMZ) followed by bevacizumab at ddTMZ failure for glioblastoma at first recurrence or progression, comparing to bevacizumab alone. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Glioblastoma, Recurrence, Progression
- What is being tested?
- Temozolomide and Bevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 37 sitesJapan
- Study dates
- 11 Jul 2016to 17 Apr 2025
- Phase
- Phase 3
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven diagnosis of glioblastoma (including giant cell glioblastoma and gliosarcoma) by WHO2007 criteria.
- For patients who did not undergo surgery for recurrent disease; pre-registration contrast MRI should confirm; (i)progressive or recurrent glioblastoma; (ii)no evidence of acute or subacute cerebral hemorrhage at enrolment; (iii)presence of a measurable lesion.
- For patients who underwent surgery for recurrent disease; (i)progressive or recurrent glioblastoma must be confirmed on contrast MRI before reoperation; (ii)glioblastoma or anaplastic astrocytoma must be histologically identified in the tissue resected at reoperation; (iii)presence of measurable lesions is not mandatory on pre-registration contrast MRI (more than 4 days after reoperation); (iv)no MRI evidence of aggravating cerebral hemorrhage.
- No evidence of tumors in the cerebellum, brain stem, optic nerve, olfactory nerve, and pituitary gland.
- No evidence of meningeal dissemination or gliomatosis cerebri.
- Prior treatment for newly-diagnosed glioblastoma (or diffuse astrocytoma (Grade II) or anaplastic astrocytoma (Grade III)) with postoperative TMZ administered concomitantly with radiotherapy (>=54 Gy for <=69 years old; >=30 Gy for >=70 years old) and at least for two cycles (5/28d) as an adjuvant treatment have been given.
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- No history of prior treatment with stereotactic radiotherapy (ex. Gamma-knife/Cyberknife), proton beam irradiation, neutron capture therapy, and chemotherapies except standard dose TMZ and immunotherapy (vaccines, immune checkpoint inhibitors, antibodies etc.), bevacizumab (12 weeks or more after termination of prior upfront bevacizumab use) that were combined with TMZ, and intraoperative placement of carmustine wafers, for glioblastoma (including diffuse astrocytoma (Grade II) and anaplastic astrocytoma (Grade III) at onset) diagnosed with WHO2007 criteria.
- Time periods required from the last day of the prior treatment indicated at registration.
- ①Peptide vaccination, immune checkpoint inhibitors, antibodies: 4 weeks.
- ②Bevacizumab: 12 weeks.
- More than 90 days after completion of radiotherapy. For those who underwent reoperation, between 21 and 28 days postoperatively.
- Age between 20 and 75 years at enrolment.
- Karnofsky Performance Status >= 60 within 14 days before enrolment.
- No prior treatment with chemotherapy, molecular targeted therapy, or radiotherapy to head and neck area for other malignancies.
- Adequate organ function.
- Written informed consent.
Who cannot join
- Synchronous or metachronous (within 5 years) malignancy, except for carcinoma in situ or mucosal tumors curatively treated with local therapy
- Active infection requiring systemic therapy
- Body temperature >= 38 degrees Celsius at registration
- Women during pregnancy, possible pregnancy, within 28 days after delivery, or breast-feeding
- Psychosis or with psychotic symptom
- Continuous systemic use of immunosuppressant except for steroid
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- Uncontrolled diabetes mellitus
- Unstable angina within 3 weeks, with a history of myocardial infarction within 6 months, or New York Heart Association (NYHA) class II or greater congestive heart failure
- Inadequately controlled hypertension (cannot be controlled to a systolic pressure of >= 150 mmHg and a diastolic pressure of >= 100 mmHg)
- History of symptomatic cerebrovascular disorder (including subarachnoid hemorrhage, cerebral infarction and transient ischemic attack) within 6 months or history of vascular disorder requiring intervention (including venous/arterial thrombosis or embolism and aortic aneurysm) within 6 moths
- History of grade >= 2 hemoptysis within 28 days
- History of hemorrhagic tendency (e.g., coagulation disorder) or any grade >= 3 hemorrhage within 28 days
- History of gastrointestinal perforation, fistula, abdominal abscess or uncontrolled peptic ulcer within 6 months
- Interstitial pneumonia, pulmonary fibrosis, or severe lung emphysema
- Severe non-healing wound or traumatic fracture at enrolment
- Hypersensitivity to Chinese Hamster Ovary-derived drugs or other recombinant antibodies
- Gadolinium allergy
- Positive HIV antibody
- Positive Hepatitis B (HB)s antigen
Trial locations and contacts
37 sites in 1 country.
37 sites in 1 country
Japan37 sites
Tokyo Medical And Dental University, Medical Hospital
Bunkyō-Ku, Tokyo, 113-8519
Chiba University Hospital
Chiba, Chiba, 260-8677
University of Yamanashi
Chuo-shi, Yamanashi, 400-8510
Kusyu University Graduate School of Medical Sciences
Fukuoka, 812-8582
Saitama Medical University International Medical Center
Hidaka, Saitama, 350-1298
Kansai Medical University
Hirakata, Osaka, 573-1191
Hirosaki University School of Medicine
Hirosaki, Aomori, 036-8563
Hiroshima University Hospital
Hiroshima, 734-8551
Kagoshima University Graduate School of Medical and Dental Sciences
Kagoshima, 890-8520
Kitasato University School of Medicine
Kanagawa, 252-0374
Kobe University Hospital
Kobe, Hyōgo, 650-0017
Kumamoto University Hospital
Kumamoto, Kumamoto, 860-8556
Kurume University Hospital
Kurume-shi, Fukuoka, 830-0011
Kyoto University Graduate School of Medicine
Kyoto, 606-8507
Iwate Medical University
Morioka, Iwate, 020-8505
Nagasaki University Hospital
Nagasaki, Nagasaki, 852-8501
Nagoya University Hospital
Nagoya, Aichi-ken, 466-8560
Niigata University Medical & Dental Hospital
Niigata, Niigata, 951-8520
Okayama University Hospital
Okayama, Okayama-ken, 700-8558
Osaka International Cancer Institute
Osaka, 541-8567
Saga University Hospital
Saga, Saga-ken, 849-8501
Sapporo Medical University Hospital
Sapporo, Hokkaido, 060-8543
Nakamura Memorial Hospital
Sapporo, 060-8570
Hokkaido University Graduate School of Medicine
Sapporo, 060-8648
Tohoku University Graduate School of Medicine
Sendai, Miyagi, 980-8574
Dokkyo Medical University
Shimotsuge, Tochigi, 321-0293
Ehime University Graduate School of Medicine
Shizukawa, Ehime, 791-0295
Shizuoka Canser Center Hospital
Shizuoka, 411-8777
Osaka University Graduate School of Medicine
Suita, Osaka, 565-0871
National Cancer Center Hospital
Tokyo, 104-0045
The University of Tokyo Hospital
Tokyo, 113-8655
Keio University Hospital
Tokyo, 160-8582
Nihon University School of Medicine Itabashi Hospital
Tokyo, 173-0032
Kyorin University Faculty of Medicine, Department of Neurosurgery
Tokyo, 181-8611
Fujita Health University Hospital
Toyoake, Aichi-ken, 470-1192
University of Tsukuba Hospital
Tsukuba, Ibaraki, 305-8576
Yamagata University Hospital
Yamagata, Yamagata, 990-9585
About this study
Official title: A Multicenter Randomized Phase III Study for Recurrent Glioblastoma Comparing Bevacizumab Alone With Dose-dense Temozolomide Followed by Bevacizumab (JCOG1308C, RE-GEND-pIII)
The aim of this Phase III study is to evaluate the superiority of dose-dense temozolomide (ddTMZ) followed by bevacizumab at ddTMZ failure for glioblastoma at first recurrence or progression, comparing to bevacizumab alone.
Read the detailed description
Glioblastoma (GBM), the most frequent malignant primary brain tumor, has yet been incurable despite recent progress on its standard of care using TMZ as the main trunk of initial therapy in the newly diagnosed setting. One of the main reasons accounting for the dismal prognosis would attribute to lack of active therapeutic regimens at recurrence.
Bevacizumab, a humanized monoclonal antibody against cardinal angiogenic factor vascular endothelial growth factor (VEGF), has recently shown efficacy for recurrent GBM, and has been approved in Japan, thereby being a standard care for recurrent GBM. Since there is no effective drugs or regimens developed at bevacizumab failure, insertion of another active drug prior to bevacizumab induction would enhance survival time for patients with recurrent GBM.
In Japan, there are currently only few chemotherapeutic agents approved and available for GBM. Among them rechallenge with alternating dosing of TMZ have shown certain efficacy with acceptable toxicities for patients with TMZ-pretreated recurrent GBM, thus being a good candidate for the regimen used prior to bevacizumab at recurrence.
The present proposal of sequential administration of dose dense TMZ (7/14d) followed by bevacizumab wishes to define a new standard of care for recurrent disease and hopes to identify the subgroups of patients with progressive or recurrent glioblastoma that respond particularly well to dose-dense temozolomide regimens.
This study is carried out as a JCOG Brain Tumor Study Group multicenter randomized phase III trial under approval by Advanced Medical Care B system, Ministry of Health, Labour and Welfare, Japan.
- Conditions
- Glioblastoma, Recurrence, Progression
- Being tested
- Temozolomide, Bevacizumab
- Keywords
- glioblastoma, recurrent, dose-dense temozolomide, bevacizumab
- Medical subject headings
- Glioblastoma, Recurrence, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TemozolomideDrug
Also called Temodar, Temodal
BevacizumabDrug
Also called Avastin
| Study group | Role | What they receive |
|---|---|---|
| Bevacizumab (BEV) alone | Active comparator | Bevacizumab 10 mg/kg, day 1 div, every 2 weeks Receives: Drug: Bevacizumab |
| Dose Dense Temozolomide Followed by BEV | Experimental | Temozolomide (120 mg/m2, po, 7 days on/7 days off, every 2 weeks per cycle) up to 48 cycles. The dose will be escalated to 150 mg/m2 at 3rd cycle if the defined conditions are met throughout the first 2 cycles. At recurrence or progression, bevacizumab alone(10 mg/kg, day 1 div, every 2 weeks) Receives: Drug: Temozolomide; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Overall survival will be measured from registration until death for any reason. If the patient is alive at last follow-up, the patient will be censored at the last time of confirmation of survival.
Measured: Time to event. Up to 2 years from the last patient in.
Secondary outcomes (11)
Progression-free survival (PFS)
Progression free will be measured from registration until the first occurrence of progression or death.
Measured: Time to event. Up to 2 years from the last patient in.
6-month progression-free survival (6m-PFS)
Number of patients without progression at 6 months from registration divided by number of all registered
Measured: 6 months from registration
Complete response rate
Complete response rate is defined as the rate of complete response after chemotherapy in cases with measurable lesions through completion/termination of the protocol treatment.
Measured: Through study completion, an average of 1 year
Response rate
Response rate is defined as the rate of complete response/partial response after chemotherapy in cases with measurable lesions through completion/termination of the protocol treatment.
Measured: Through study completion, an average of 1 year
Adverse events
Each adverse event must be graded as the worst grade observed during the entire treatment period of each treatment protocol according to Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0) up to 1 year.
Measured: Up to 1 year after completion/termination of the protocol treatment.
Serious adverse events
Each serious adverse event must be recorded according to CTCAE v4.0 up to 1 year.
Measured: Up to 1 year after completion/termination of the protocol treatment.
Progression-free survival (PFS) from bevacizumab (BEV) initiation
Progression free from BEV initiation will be measured from the day of initiation of BEV until the first occurrence of progression or death.
Measured: Time to event from initiation of BEV. Up to 2 years from the last patient in.
6-month progression-free survival (6m-PFS) after initiation of bevacizumab (BEV) (Experimental Arm Only)
Number of patients without progression at 6 months from the day of initiation of BEV divided by number of all second-line (BEV) treated in Experimental Arm
Measured: 6 months from initiation of BEV
Overall survival after initiation of bevacizumab (BEV)
Overall survival from the day of initiation of BEV until death for any reason. If the patient is alive at last follow-up, the patient will be censored at the last time of confirmation of survival.
Measured: Time to event from initiation of BEV. Up to 2 years from the last patient in.
MMSE non-deterioration rate
The MMSE (Mini Mental Status Examination) non-deterioration rate is calculated from the number of patients who underwent baseline MMSE evaluation prior to initiation of protocol treatment as a denominator and the number of those whose MMSE score (normal (30-24), mild decrease (23-20), intermediate decrease (19-10), severe decrease (9-0)) at 16 weeks improved or maintained from that at baseline as a numerator among all eligible patients.
Measured: MMSE non-deterioration rates will be calculated at 8 and 24 weeks after initiation of protocol treatment
KPS non-deterioration rate
The KPS non-deterioration rate is calculated from the number of patients whose KPS was recorded prior to initiation of protocol treatment as a denominator and the number of those whose KPS score at 16 weeks improved or maintained from that at baseline as a numerator among all eligible patients. In case KPS is not recorded, it is considered as deterioration.
Measured: KPS non-deterioration rates will be calculated at 8 and 24 weeks after initiation of protocol treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study start11 Jul 2016
- Primary completion17 Apr 2025
- Study completion17 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyorin University
- Sponsor type
- University, hospital or other
- Collaborators
- Japan Clinical Oncology Group
- Responsible party
- Principal investigator, Motoo Nagane, Kyorin University
- Investigators
- Motoo Nagane, M.D., Ph.D., Study chair, Kyorin University Faculty of Medicine, Department of Neurosurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02761070
- Sponsor's protocol ID
- JCOG1308C
- Acronym
- RE-GEND
- Status last verified
- Aug 2026
- First submitted
- 28 Apr 2016
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Phase III Study for Recurrent Glioblastoma Comparing Bevacizumab Alone With Dose-dense Temozolomide Followed by Bevacizumab (JCOG1308C, RE-GEND-pIII)
- ClinicalTrials.gov ID
- NCT02761070
- Acronym / sponsor ID
- RE-GEND / JCOG1308C
- Conditions
- Glioblastoma, Recurrence, Progression
- Keywords
- glioblastoma, recurrent, dose-dense temozolomide, bevacizumab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Kyorin UniversityUniversity, hospital or other
- Collaborators
- Japan Clinical Oncology Group
- Study start
- 11 Jul 2016 (actual)
- Primary completion
- 17 Apr 2025 (actual)
- Study completion
- 17 Apr 2025 (actual)
- First posted
- 4 May 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.
The aim of this Phase III study is to evaluate the superiority of dose-dense temozolomide (ddTMZ) followed by bevacizumab at ddTMZ failure for glioblastoma at first recurrence or progression, comparing to bevacizumab alone.
Detailed description
Glioblastoma (GBM), the most frequent malignant primary brain tumor, has yet been incurable despite recent progress on its standard of care using TMZ as the main trunk of initial therapy in the newly diagnosed setting. One of the main reasons accounting for the dismal prognosis would attribute to lack of active therapeutic regimens at recurrence.
Bevacizumab, a humanized monoclonal antibody against cardinal angiogenic factor vascular endothelial growth factor (VEGF), has recently shown efficacy for recurrent GBM, and has been approved in Japan, thereby being a standard care for recurrent GBM. Since there is no effective drugs or regimens developed at bevacizumab failure, insertion of another active drug prior to bevacizumab induction would enhance survival time for patients with recurrent GBM.
In Japan, there are currently only few chemotherapeutic agents approved and available for GBM. Among them rechallenge with alternating dosing of TMZ have shown certain efficacy with acceptable toxicities for patients with TMZ-pretreated recurrent GBM, thus being a good candidate for the regimen used prior to bevacizumab at recurrence.
The present proposal of sequential administration of dose dense TMZ (7/14d) followed by bevacizumab wishes to define a new standard of care for recurrent disease and hopes to identify the subgroups of patients with progressive or recurrent glioblastoma that respond particularly well to dose-dense temozolomide regimens.
This study is carried out as a JCOG Brain Tumor Study Group multicenter randomized phase III trial under approval by Advanced Medical Care B system, Ministry of Health, Labour and Welfare, Japan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab (BEV) alone | Active comparator | Drug: BevacizumabBevacizumab 10 mg/kg, day 1 div, every 2 weeks |
| Dose Dense Temozolomide Followed by BEV | Experimental | Drug: Temozolomide, Drug: BevacizumabTemozolomide (120 mg/m2, po, 7 days on/7 days off, every 2 weeks per cycle) up to 48 cycles. The dose will be escalated to 150 mg/m2 at 3rd cycle if the defined conditions are met throughout the first 2 cycles. At recurrence or progression, bevacizumab alone(10 mg/kg, day 1 div, every 2 weeks) |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Histologically proven diagnosis of glioblastoma (including giant cell glioblastoma and gliosarcoma) by WHO2007 criteria.
- For patients who did not undergo surgery for recurrent disease; pre-registration contrast MRI should confirm; (i)progressive or recurrent glioblastoma; (ii)no evidence of acute or subacute cerebral hemorrhage at enrolment; (iii)presence of a measurable lesion.
- For patients who underwent surgery for recurrent disease; (i)progressive or recurrent glioblastoma must be confirmed on contrast MRI before reoperation; (ii)glioblastoma or anaplastic astrocytoma must be histologically identified in the tissue resected at reoperation; (iii)presence of measurable lesions is not mandatory on pre-registration contrast MRI (more than 4 days after reoperation); (iv)no MRI evidence of aggravating cerebral hemorrhage.
- No evidence of tumors in the cerebellum, brain stem, optic nerve, olfactory nerve, and pituitary gland.
- No evidence of meningeal dissemination or gliomatosis cerebri.
Key exclusion criteria (19 listed)
- Synchronous or metachronous (within 5 years) malignancy, except for carcinoma in situ or mucosal tumors curatively treated with local therapy
- Active infection requiring systemic therapy
- Body temperature >= 38 degrees Celsius at registration
- Women during pregnancy, possible pregnancy, within 28 days after delivery, or breast-feeding
- Psychosis or with psychotic symptom
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 |
|---|---|---|
| TemozolomideAlso: Temodar, Temodal | Drug | Dose Dense Temozolomide Followed by BEV |
| BevacizumabAlso: Avastin | Drug | Bevacizumab (BEV) alone, Dose Dense Temozolomide Followed by BEV |
Primary outcome
Overall survival
Time frame: Time to event. Up to 2 years from the last patient in.
Overall survival will be measured from registration until death for any reason. If the patient is alive at last follow-up, the patient will be censored at the last time of confirmation of survival.
11 secondary outcomes
Progression-free survival (PFS)
Time frame: Time to event. Up to 2 years from the last patient in.
6-month progression-free survival (6m-PFS)
Time frame: 6 months from registration
Complete response rate
Time frame: Through study completion, an average of 1 year
Response rate
Time frame: Through study completion, an average of 1 year
Adverse events
Time frame: Up to 1 year after completion/termination of the protocol treatment.
Serious adverse events
Time frame: Up to 1 year after completion/termination of the protocol treatment.
Progression-free survival (PFS) from bevacizumab (BEV) initiation
Time frame: Time to event from initiation of BEV. Up to 2 years from the last patient in.
6-month progression-free survival (6m-PFS) after initiation of bevacizumab (BEV) (Experimental Arm Only)
Time frame: 6 months from initiation of BEV
Overall survival after initiation of bevacizumab (BEV)
Time frame: Time to event from initiation of BEV. Up to 2 years from the last patient in.
MMSE non-deterioration rate
Time frame: MMSE non-deterioration rates will be calculated at 8 and 24 weeks after initiation of protocol treatment
KPS non-deterioration rate
Time frame: KPS non-deterioration rates will be calculated at 8 and 24 weeks after initiation of protocol treatment
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 7 Aug 2026.
- 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.
Motoo Nagane, M.D., Ph.D. study chair
Kyorin University Faculty of Medicine, Department of Neurosurgery
37 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Temozolomide and Bevacizumab in people with Glioblastoma and Recurrence, run by Kyorin University at 37 sites in Japan.
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 16 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in Japan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Overall survival (time frame: Time to event. Up to 2 years from the last patient in.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.