Infiltrating Bladder Urothelial CarcinomaPhase 2NCT01616875
Bristol Bladder Trial
A Phase 2 study testing Cabazitaxel + Cisplatin chemotherapy in people with Infiltrating Bladder Urothelial Carcinoma, run by University Hospitals Bristol and Weston NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
26 patients with invasive primary transitional cell carcinoma of the bladder will receive 4 cycles of combination chemotherapy consisting of Cabazitaxel and Cisplatin both given intravenously on day 1 of each 3 weekly cycle prior to radical cystectomy, to evaluate the overall response rate and to determine whether… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infiltrating Bladder Urothelial Carcinoma
- What is being tested?
- Cabazitaxel + Cisplatin chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Jul 2012to 4 Jan 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age ≥18 years
- Histologically confirmed primary transitional cell carcinoma (TCC) of the urinary bladder
- T2 to T4 disease, N0 M0 determined by computerised tomography (CT) imaging and biopsy or transurethral resection
- Eastern Co-operative Oncology Group (ECOG) Performance status 0 or 1
- Glomerular filtration rate (GFR) ≥60ml/min.
- Written, informed consent
Who cannot join
- ECOG Performance Status ≥ 2
- Lymph node involvement or metastatic disease
- Prior surgery (except transurethral resection of bladder tumour), radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior to enrolment
- Active Grade ≥2 peripheral neuropathy
- Active secondary cancers
- History of severe hypersensitivity reaction (≥Grade 3) to polysorbate 80 containing drugs
Show all 17Show fewer
- Other concurrent serious illness or medical conditions
- Inadequate organ function as evidenced by peripheral blood counts at enrolment:
- Electrocardiogram (ECG) evidence of uncontrolled cardiac arrhythmias, angina pectoris, and/or hypertension, history of congestive heart failure, or myocardial infarction within last 6 months.
- Uncontrolled diabetes mellitus.
- Active uncontrolled gastro-oesophageal reflux disease (GORD).
- Active infection requiring systemic antibiotic or anti-fungal medication
- Participation in another clinical trial with any investigational drug within 30 days prior to study enrolment.
- Concurrent or planned treatment with strong inhibitors of cytochrome P450 3A4/5. A 1-week washout period is necessary for patients who are already on these treatments.
- Concurrent or planned treatment with strong inducers of cytochrome P450 3A4/5. A 1-week washout period is necessary for patients who are already on these treatments.
- Contraindications to cisplatin.
- Patient with reproductive potential not implementing an accepted and effective method of contraception.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Bristol Haematology + Oncology Centre, Horfield Road
Bristol, BS2 8ED
About this study
Official title: A Phase II Trial of Combination Cabazitaxel and Cisplatin Chemotherapy in the Neo-adjuvant Treatment of Transitional Cell Carcinoma of the Urinary Bladder
26 patients with invasive primary transitional cell carcinoma of the bladder will receive 4 cycles of combination chemotherapy consisting of Cabazitaxel and Cisplatin both given intravenously on day 1 of each 3 weekly cycle prior to radical cystectomy, to evaluate the overall response rate and to determine whether this approach warrants further research of a phase II/III study.Participation in 2 sub studies will also be offered to the participants.
- Contrast Magnetic resonance imaging (MRI ) scans will be taken at baseline and after cycle 1 and cycle 3.
- A pilot sub study involving the circulating tumour cell concentration from blood samples taken at baseline, prior to each cycle of chemotherapy and prior to surgery
- Being tested
- Cabazitaxel + Cisplatin chemotherapy
- Keywords
- Bladder cancer, Transitional cell carcinoma, Urothelial cancer, Cisplatin, Cabazitaxel, Chemotherapy, Neo adjuvant chemotherapy
- Medical subject headings
- Urinary Bladder Neoplasms, Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cabazitaxel + Cisplatin chemotherapyDrug
Also called Jevtana
Cabazitaxel 15mg/m2 followed by cisplatin 70mg/m2 given intravenously on day 1 of each 3 weekly cycle for 4 cycles prior to radical cystectomy.
| Study group | Role | What they receive |
|---|---|---|
| Cabazitaxel + Cisplatin chemotherapy | Experimental | Cabazitaxel 15mg/m2 Intravenous (IV)followed by Cisplatin 70mg/m2 IV on day 1 of each 21 day cycle for 4 cycles Receives: Drug: Cabazitaxel + Cisplatin chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Pathological Response Rate
Pathological stage at diagnosis (T2/T3 - see baseline characteristics) was compared to pathological stage of the surgical specimen at cystectomy. A response is considered as a decrease in T stage from T2/T3 seen at baseline to T1 or less indicating a reduction in tumour size/invasiveness.
The T stage describes how far the primary tumour has spread. The higher the stage the further the tumour has grown through the bladder wall and into the surrounding tissues. The stages are Ta - non-invasive papillary carcinoma, Tis - flat non-invasive carcinoma, T1 - grown through the connective tissue but not into the muscle of the bladder wall, T2 - tumour has grown through the connective tissue and into the muscle of the bladder wall, T3 - tumour has grown through the muscle and into the fatty layer surrounding the bladder and T4 - the cancer has spread to surrounding tissues.
Measured: Histological assessment of radical cystectomy specimen expected to be 15 weeks after commencing study chemotherapy.
Secondary outcomes (12)
Progression Free Survival at 5 Years After Cystectomy
From registration until progression or death from any cause up to 5 years after surgery. Outcome is the percentage of patients who are progression free. After cystectomy patients are tumour free. They are reviewed regularly and CT scans and further tests are requested if it is suspected that the tumour has returned. If there is evidence that the tumour has returned or if the patient dies from any cause this is considered to be progression.
Measured: From registration up to 5 years after surgery
Progression Free Survival of Patients Who Did Not Show Pathological Downstaging
From registration until progression or death from any cause up to 5 years after surgery. Outcome is the median number of months it takes 50% of patients to show progression. After cystectomy patients are tumour free. They are reviewed regularly and CT scans and further tests are requested if it is suspected that the tumour has returned. If there is evidence that the tumour has returned or if the patient dies from any cause this is considered to be progression.
Measured: From registration up to 5 years after surgery
Overall Survival at 5 Years After Cystectomy
From registration until death from any cause up to 5 years after surgery. Outcome is the percentage of patients alive at 5 years after cystectomy.
Measured: From registration up to 5 years after cystectomy
Overall Survival of Patients Who Did Not Show Pathological Downstaging
From registration until death from any cause up to 5 years after surgery. Outcome is the median number of months it takes for 50% of patients to die.
Measured: From registration up to 5 years after cystectomy
Assessment of EQ-5D-5L Quality of Life
EQ-5D-5L will be assessed at baseline, following each cycle of chemotherapy and at the end of chemotherapy prior to surgery. The patients answer 5 questions which have 5 possible answers from no issue to extreme issue. The answers are given a code, 1, 2, 3, 4 or 5 with 1 for no issue through to 5 for extreme issues which results in a 5 digit 'health state' for that time point. Using a formula this is translated into the 'EQ-5D index value' where 1 is full health and 0 is the worst health. This is what is presented here, the lower the score the worse the quality of life.
Measured: Baseline, pre-Cycle 2 (each cycle was 21 days), pre-Cycle 3, pre-Cycle 4, and end of treatment visit (up to 13 weeks)
Assessment of EQ-5D-5L VAS Score
EQ-5D-5L VAS score was assessed at baseline, following each cycle of chemotherapy and at the end of chemotherapy prior to surgery. Patients are asked to score their health on a scale 0-100, the higher the score the better they are feeling
Measured: Baseline, pre-Cycle 2 (each cycle was 21 days), pre-Cycle 3, pre-Cycle 4, and end of treatment visit (up to 13 weeks)
Assessment of EORTC QLQ-C30 Score
EORTC QLQ-C30 questionnaire was completed at baseline, following each cycle of chemotherapy and at the end of chemotherapy prior to surgery. Patients are asked to complete 30 questions and a combined summary score between 0-100 is derived from their answers. The higher the score the better their quality of life.
Measured: Baseline, pre-Cycle 2 (each cycle was 21 days), pre-Cycle 3, pre-Cycle 4, and end of treatment visit (up to 13 weeks)
Assessment of BLM30 Urinary Score
EORTC BLM30 questionnaire was completed at baseline, following each cycle of chemotherapy and at the end of chemotherapy prior to surgery. Patients are asked to complete questions which are split into 5 categories Urinary, Future perspectives, Bloating/flatulence, Body image and Sexual functioning. Each question has 4 possible answers from 'not at all' scored 1, to 'very much' scored 4. The scores for each different question in a category are combined and an overall score between 0-100 is derived from the answers. The higher the score the worse the symptom. In this outcome the score for the combined urinary questions is shown.
Measured: Baseline, pre-Cycle 2 (each cycle was 21 days), pre-Cycle 3, pre-Cycle 4, and end of treatment visit (up to 13 weeks)
Assessment of BLM30 Future Perspectives Score
EORTC BLM30 questionnaire was completed at baseline, following each cycle of chemotherapy and at the end of chemotherapy prior to surgery. Patients are asked to complete questions which are split into 5 categories Urinary, Future perspectives, Bloating/flatulence, Body image and Sexual functioning. Each question has 4 possible answers from 'not at all' scored 1, to 'very much' scored 4. The scores for each different question in a category are combined and an overall score between 0-100 is derived from the answers. The higher the score the worse the symptom. In this outcome the score for the combined future perspectives questions is shown.
Measured: Baseline, pre-Cycle 2 (each cycle was 21 days), pre-Cycle 3, pre-Cycle 4, and end of treatment visit (up to 13 weeks)
Assessment of BLM30 Bloating/Flatulence Score
EORTC BLM30 questionnaire was completed at baseline, following each cycle of chemotherapy and at the end of chemotherapy prior to surgery. Patients are asked to complete questions which are split into 5 categories Urinary, Future perspectives, Bloating/flatulence, Body image and Sexual functioning. Each question has 4 possible answers from 'not at all' scored 1, to 'very much' scored 4. The scores for each different question in a category are combined and an overall score between 0-100 is derived from the answers. The higher the score the worse the symptom. In this outcome the score for the combined bloating/flatulence questions is shown.
Measured: Baseline, pre-Cycle 2 (each cycle was 21 days), pre-Cycle 3, pre-Cycle 4, and end of treatment visit (up to 13 weeks)
Assessment of BLM30 Body Image Score
EORTC BLM30 questionnaire was completed at baseline, following each cycle of chemotherapy and at the end of chemotherapy prior to surgery. Patients are asked to complete questions which are split into 5 categories Urinary, Future perspectives, Bloating/flatulence, Body image and Sexual functioning. Each question has 4 possible answers from 'not at all' scored 1, to 'very much' scored 4. The scores for each different question in a category are combined and an overall score between 0-100 is derived from the answers. The higher the score the worse the symptom. In this outcome the score for the combined Body Image questions is shown.
Measured: Baseline, pre-Cycle 2 (each cycle was 21 days), pre-Cycle 3, pre-Cycle 4, and end of treatment visit (up to 13 weeks)
Assessment of BLM30 Sexual Function Score
EORTC BLM30 questionnaire was completed at baseline, following each cycle of chemotherapy and at the end of chemotherapy prior to surgery. Patients are asked to complete questions which are split into 5 categories Urinary, Future perspectives, Bloating/flatulence, Body image and Sexual functioning. Each question has 4 possible answers from 'not at all' scored 1, to 'very much' scored 4. The scores for each different question in a category are combined and an overall score between 0-100 is derived from the answers. The higher the score the worse the symptom. In this outcome the score for the combined sexual functioning questions is shown.
Measured: Baseline, pre-Cycle 2 (each cycle was 21 days), pre-Cycle 3, pre-Cycle 4, and end of treatment visit (up to 13 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2012 (estimated)
- Study start25 Jul 2012
- Primary completionNov 2017
- Study completion4 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infiltrating Bladder Urothelial CarcinomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Bristol and Weston NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Amit K Bahl, Principal investigator, University Hospitals Bristol and Weston NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01616875
- Sponsor's protocol ID
- ON/2011/3775
- Other IDs
- 2011-004090-82
- Status last verified
- Dec 2025
- First submitted
- 17 May 2012
- Last updated
- 6 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Challapalli A, Masson S, White P, Dailami N, Pearson S, Rowe E, Koupparis A, Oxley J, Abdelaziz A, Ash-Miles J, Bravo A, Foulstone E, Perks C, Holly J, Persad R, Bahl A. A Single-arm Phase II Trial of Neoadjuvant Cabazitaxel and Cisplatin Chemotherapy for Muscle-Invasive Transitional Cell Carcinoma of the Urinary Bladder. Clin Genitourin Cancer. 2021 Aug;19(4):325-332. doi: 10.1016/j.clgc.2021.02.001. Epub 2021 Feb 18.
PubMed 33727028
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Combination Cabazitaxel and Cisplatin Chemotherapy in the Neo-adjuvant Treatment of Transitional Cell Carcinoma of the Urinary Bladder
- ClinicalTrials.gov ID
- NCT01616875
- Acronym / sponsor ID
- ON/2011/3775
- Keywords
- Bladder cancer, Transitional cell carcinoma, Urothelial cancer, Cisplatin, Cabazitaxel, Chemotherapy, Neo adjuvant chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University Hospitals Bristol and Weston NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- 25 Jul 2012 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- 4 Jan 2023 (actual)
- First posted
- 12 Jun 2012 (estimated)
- Results
- Posted 6 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
26 patients with invasive primary transitional cell carcinoma of the bladder will receive 4 cycles of combination chemotherapy consisting of Cabazitaxel and Cisplatin both given intravenously on day 1 of each 3 weekly cycle prior to radical cystectomy, to evaluate the overall response rate and to determine whether this approach warrants further research of a phase II/III study.Participation in 2 sub studies will also be offered to the participants.
- Contrast Magnetic resonance imaging (MRI ) scans will be taken at baseline and after cycle 1 and cycle 3.
- A pilot sub study involving the circulating tumour cell concentration from blood samples taken at baseline, prior to each cycle of chemotherapy and prior to surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cabazitaxel + Cisplatin chemotherapy | Experimental | Drug: Cabazitaxel + Cisplatin chemotherapyCabazitaxel 15mg/m2 Intravenous (IV)followed by Cisplatin 70mg/m2 IV on day 1 of each 21 day cycle for 4 cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years
- Histologically confirmed primary transitional cell carcinoma (TCC) of the urinary bladder
- T2 to T4 disease, N0 M0 determined by computerised tomography (CT) imaging and biopsy or transurethral resection
- Eastern Co-operative Oncology Group (ECOG) Performance status 0 or 1
- Glomerular filtration rate (GFR) ≥60ml/min.
Key exclusion criteria (17 listed)
- ECOG Performance Status ≥ 2
- Lymph node involvement or metastatic disease
- Prior surgery (except transurethral resection of bladder tumour), radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior to enrolment
- Active Grade ≥2 peripheral neuropathy
- Active secondary cancers
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 |
|---|---|---|
| Cabazitaxel + Cisplatin chemotherapyAlso: JevtanaCabazitaxel 15mg/m2 followed by cisplatin 70mg/m2 given intravenously on day 1 of each 3 weekly cycle for 4 cycles prior to radical cystectomy. | Drug | Cabazitaxel + Cisplatin chemotherapy |
Primary outcome
Overall Pathological Response Rate
Time frame: Histological assessment of radical cystectomy specimen expected to be 15 weeks after commencing study chemotherapy.
Pathological stage at diagnosis (T2/T3 - see baseline characteristics) was compared to pathological stage of the surgical specimen at cystectomy. A response is considered as a decrease in T stage from T2/T3 seen at baseline to T1 or less indicating a reduction in tumour size/invasiveness. The T stage describes how far the primary tumour has spread. The higher the stage the further the tumour has grown through the bladder wall and into the surrounding tissues. The stages are Ta - non-invasive papillary carcinoma, Tis - flat non-invasive carcinoma, T1 - grown through the connective tissue but not into the muscle of the bladder wall, T2 - tumour has grown through the connective tissue and into the muscle of the bladder wall, T3 - tumour has grown through the muscle and into the fatty layer surrounding the bladder and T4 - the cancer has spread to surrounding tissues.
12 secondary outcomes
Progression Free Survival at 5 Years After Cystectomy
Time frame: From registration up to 5 years after surgery
Progression Free Survival of Patients Who Did Not Show Pathological Downstaging
Time frame: From registration up to 5 years after surgery
Overall Survival at 5 Years After Cystectomy
Time frame: From registration up to 5 years after cystectomy
Overall Survival of Patients Who Did Not Show Pathological Downstaging
Time frame: From registration up to 5 years after cystectomy
Assessment of EQ-5D-5L Quality of Life
Time frame: Baseline, pre-Cycle 2 (each cycle was 21 days), pre-Cycle 3, pre-Cycle 4, and end of treatment visit (up to 13 weeks)
Assessment of EQ-5D-5L VAS Score
Time frame: Baseline, pre-Cycle 2 (each cycle was 21 days), pre-Cycle 3, pre-Cycle 4, and end of treatment visit (up to 13 weeks)
Assessment of EORTC QLQ-C30 Score
Time frame: Baseline, pre-Cycle 2 (each cycle was 21 days), pre-Cycle 3, pre-Cycle 4, and end of treatment visit (up to 13 weeks)
Assessment of BLM30 Urinary Score
Time frame: Baseline, pre-Cycle 2 (each cycle was 21 days), pre-Cycle 3, pre-Cycle 4, and end of treatment visit (up to 13 weeks)
Assessment of BLM30 Future Perspectives Score
Time frame: Baseline, pre-Cycle 2 (each cycle was 21 days), pre-Cycle 3, pre-Cycle 4, and end of treatment visit (up to 13 weeks)
Assessment of BLM30 Bloating/Flatulence Score
Time frame: Baseline, pre-Cycle 2 (each cycle was 21 days), pre-Cycle 3, pre-Cycle 4, and end of treatment visit (up to 13 weeks)
Assessment of BLM30 Body Image Score
Time frame: Baseline, pre-Cycle 2 (each cycle was 21 days), pre-Cycle 3, pre-Cycle 4, and end of treatment visit (up to 13 weeks)
Assessment of BLM30 Sexual Function Score
Time frame: Baseline, pre-Cycle 2 (each cycle was 21 days), pre-Cycle 3, pre-Cycle 4, and end of treatment visit (up to 13 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 33727028Challapalli A, Masson S, White P, Dailami N, Pearson S, Rowe E, Koupparis A, Oxley J, Abdelaziz A, Ash-Miles J, Bravo A, Foulstone E, Perks C, Holly J, Persad R, Bahl A. A Single-arm Phase II Trial of Neoadjuvant Cabazitaxel and Cisplatin Chemotherapy for Muscle-Invasive Transitional Cell Carcinoma of the Urinary Bladder. Clin Genitourin Cancer. 2021 Aug;19(4):325-332. doi: 10.1016/j.clgc.2021.02.001. Epub 2021 Feb 18.
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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.
Amit K Bahl principal investigator
University Hospitals Bristol and Weston NHS Foundation Trust
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 Cabazitaxel + Cisplatin chemotherapy in people with Infiltrating Bladder Urothelial Carcinoma, run by University Hospitals Bristol and Weston NHS Foundation Trust at 1 site in United Kingdom.
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 6 inclusion and 17 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 6 Mar 2026. 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 Kingdom. 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?
Yes. Results are posted in the registry (first posted 6 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Pathological Response Rate (time frame: Histological assessment of radical cystectomy specimen expected to be 15 weeks after commencing study chemotherapy.). 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 NCT01616875, 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 6 Mar 2026.