Recurrent Ovarian CancerPhase 2/3STAPOVERNCT03458221
Signal TrAnsduction Pathway Activity Analysis in OVarian cancER
A Phase 2/3 study testing Letrozole Oral Product, Bicalutamide Oral Product and Everolimus Oral Product in people with Recurrent Ovarian Cancer and Signal Transduction Pathway Deregulation, run by Gynaecologisch Oncologisch Centrum Zuid at 6 sites in Netherlands.
Trial summary
The purpose of this prospective, parallel-group, cohort study is to implement phenotype-guided targeted therapy based on functional signal transduction pathway (STP) activity in recurrent ovarian cancer patients using a novel mRNA-based assay. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Recurrent Ovarian Cancer, Signal Transduction Pathway Deregulation, Therapy-Associated Cancer
- What is being tested?
- Letrozole Oral Product, Bicalutamide Oral Product and Everolimus Oral Product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 6 sitesNetherlands
- Study dates
- 31 Jan 2023to 1 Oct 2026
- Phase
- Phase 2/3
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female, age > 18 years
- Patients with recurrent ovarian cancer who meet one of the following criteria:
- Platinum-resistant disease, defined as disease recurrence or progression within six months of last platinum-based chemotherapy or;
- Patient refrains from standard therapy or;
- Asymptomatic patient who is not yet eligible for standard palliative chemotherapy but has an increase of CA125 tumour marker at two consecutive time points 28 days apart with a value of two times nadir above 35 U/ml.
- Progressive disease after at least one prior line of systemic treatment for recurrent disease.
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- Radiologically evaluable disease according to RECIST 1.1 criteria (36).
- Ability and willingness to obtain a tumour biopsy after the last course of standard treatment and before start of the study.
- Ability and willingness to provide written and oral consent.
- Able to speak and understand the Dutch language.
- WHO performance status 0-II.
- Adequate renal and liver function to start matched targeted therapy (according to the local clinician).
- Adequate use of contraceptives in case of patients with childbearing potential.
Who cannot join
- Age < 18 years.
- Patient is receiving any other anti-cancer therapy (e.g. cytotoxic or targeted drug or radiation) or is chemotherapy naïve. The required wash out period prior to start of matched targeted therapy is at least three weeks.
- Patient is diagnosed with or treated for a second primary tumour (except non-melanoma skin tumour) one year prior to study inclusion.
- Inability to obtain (sufficient) tumour material.
- Previous use of the selected targeted drug as anti-cancer agent.
- Physical condition WHO III-IV.
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- Pregnant or lactating women.
- Simultaneous participation in another treatment-related clinical trial.
- Patients with any other clinically significant medical condition which, in the opinion of the local clinician, makes it undesirable for the patient to participate in this study or which could jeopardize compliance with study requirements including, but not limited to: ongoing or active infection, severe psychiatric illness, or complicated social situations.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Netherlands6 sites, 6 recruiting
- Not yet recruiting
Amphia Hospital
Breda, 4818 CK
H.M. Westgeest, MD, PhD, hwestgeest@amphia.nl
H.P.M. Smedts
- Recruiting
Catharina Ziekenhuis
Eindhoven, North Brabant, 5623EJ
Jurgen M Piek, MD. PhD., +31(0)40 239 9111, jurgen.piek@catharinaziekenhuis.nl
A.M.J. Thijs, MD, PhD
- Not yet recruiting
Maastricht UMC+
Maastricht, 6229 HX
Sandrina Lambrechts, MD,PhD, sandrina.lambrechts@mumc.nl
- Not yet recruiting
Radboudumc
Nijmegen, Gelderland
L Massuger, Prof, l.massuger@obgyn.umcn.nl
N. Ottevanger, Prof
- Not yet recruiting
Erasmus MC
Rotterdam
I Boere, MD., PhD., i.boere@erasmusmc.nl
- Not yet recruiting
Elisabeth-Tweesteden Hospital
Tilburg, 5022 GC
M.C. Vos, MD, PhD
About this study
The purpose of this prospective, parallel-group, cohort study is to implement phenotype-guided targeted therapy based on functional signal transduction pathway (STP) activity in recurrent ovarian cancer patients using a novel mRNA-based assay. Existing targeted drugs with tolerable toxicity profiles are used to investigate the therapeutic value beyond their approved indication, which are deemed beneficial in the select group of patients with a relevant predominantly active functional STP, in order to improve survival and maintain quality of life.
Read the detailed description
Rationale: Ovarian cancer is one of the most lethal cancers in the world. Standard therapy consists of debulking surgery and chemotherapy. However, despite this aggressive treatment, recurrent disease almost invariably occurs resulting in a five-year survival rate of approximately 30%. Tumour growth is driven by several signal transduction pathways (STPs), and twelve major STPs have been identified as important for carcinogenesis. Currently, several targeted therapy drugs are available and new targeted drugs are being developed. With a newly developed technique, Signal Transduction Activation (STA) analysis, it is possible to assess which pathway is predominant in a specific (ovarian) cancer sample. Therefore, we hypothesize that specifically targeting the predominant STP might impair tumour growth and improve survival.
Objective: This study aims to investigate the progression-free survival (PFS) according to RECIST 1.1 criteria on matched targeted therapy by STA-analysis (PFS2) in comparison to the PFS recorded on the therapy administered immediately prior to enrolment (PFS1) in women with recurrent ovarian cancer.
Study design: A multi-centre prospective, parallel-group, cohort study. Study population: Recurrent ovarian cancer patients with platinum-resistant disease, patients who refrain from standard therapy and patients who are not yet eligible for standard palliative chemotherapy, including all histological subtypes.
Intervention: STA-analysis will be performed on a biopsy taken from the recurrent tumour. Patients will be included if a predominant pathway is identified for which a matched targeted drug is available and deemed adequate by the multidisciplinary tumour board. We will start with targeted therapy in patients with oestrogen receptor, androgen receptor, phosphoinositide 3-kinase and Hedgehog pathway active tumours, since targeted therapy interceding these pathways are easily available with tolerable side effects.
Main study parameters/endpoints: The primary outcome is therapy response defined as PFS2/PFS1 ratio according to RECIST 1.1 criteria. Secondary outcomes include the proportion of patients with an actionable active pathway and the proportion of patients receiving matched targeted therapy, best overall response (according to RECIST 1.1 criteria), one-year survival, overall survival, predictive value of STA-analysis results, side effects, quality of life, cost-effectiveness and change in STP activity score comparing the score before treatment and after disease progression.
- Conditions
- Recurrent Ovarian Cancer, Signal Transduction Pathway Deregulation, Therapy-Associated Cancer
- Being tested
- Letrozole Oral Product, Bicalutamide Oral Product, Everolimus Oral Product, Itraconazole Oral Product
- Keywords
- Ovarian Cancer, Signal Transduction Pathway, Targeted therapy, Drug repurposing
- Medical subject headings
- Ovarian Neoplasms, Neoplasms, Second Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Letrozole Oral ProductDrug
Letrozole 2.5mg tablet - 2.5mg once dailty until progression of disease.
Bicalutamide Oral ProductDrug
Bicalutatmide 150mg tablet - 150mg once daily until progression of disease.
Everolimus Oral ProductDrug
Everolimus 10mg tablet - 10mg once daily until progression of disease.
Itraconazole Oral ProductDrug
Itraconazole 100mg capsule - 300mg twice daily until progression of disease.
| Study group | Role | What they receive |
|---|---|---|
| A - ER active tumors | Experimental | In case of an aberrantly active Estrogen Receptor (ER) pathway, patients will be treated with Letrozole 2.5mg daily orally until progression of disease. Receives: Drug: Letrozole Oral Product |
| B - AR active tumors | Experimental | In case of an aberrantly active androgen receptor (AR) pathway, patients will be treated with Bicalutamide 150mg daily orally until progression of disease. Receives: Drug: Bicalutamide Oral Product |
| C - PI3K active tumors | Experimental | In case of an aberrantly active phosphoinositide 3-kinase (PI3K) pathway, patients will be treated with Everolimus 10mg daily orally until progression of disease. Receives: Drug: Everolimus Oral Product |
| D - HH and/or PI3K active tumors | Experimental | In case of an aberrantly active Hedgehog (HH) or PI3K pathway, patients will be treated with Itraconazole 300mg twice daily orally until progression of disease. Receives: Drug: Itraconazole Oral Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival on matched targeted therapy determined by STP-activity (PFS2) in comparison to the PFS recorded on the therapy administered immediately prior to enrolment (PFS1).
PFS on matched targeted therapy (PFS2) is defined as the time from start of matched targeted therapy to disease progression, defined by RECIST 1.1 criteria, or death from any cause. PFS on prior therapy (PFS1) is defined as the time from start of the prior treatment to disease progression defined by RECIST 1.1 criteria
Measured: From baseline until the date of documented disease progression or 12 months after the start of targeted therapy.
Secondary outcomes (10)
Proportion of patients with an actionable active pathway for which targeted therapy is recommended in relation to the number of patients who underwent a biopsy.
Measured: From date of biopsy until the date of the result from Multi-disciplinary Tumor Board Meeting, up 14 days after biopsy date.
Proportion of patients who receive matched targeted therapy in relation to the number of patients included in each study arm.
Proportion of patients included in arm A, B, C, D.
Measured: From start date matched targeted therapy until the end of the study enrollment, up to 36 months.
Best overall response defined by RECIST 1.1 criteria based on radiological imaging.
Measured: From baseline, radiological evaluation every 12 weeks after the start of targeted therapy until the date of documented disease progression or death, whichever comes first, assessed up to 12 months.
One-year survival
One-year survival is defined as the time from start matched targeted therapy till death or the end of the one-year follow-up period.
Measured: From start date of targeted therapy until date of death or one year follow-up, whichever comes first.
Overall survival
Defined as the time from start matched targeted therapy till death.
Measured: From start date of targeted therapy until the date of death, assessed up to 36 months.
Predictive value of STA-analysis results on matched targeted therapy response.
Measured: From start date targeted therapy until response evaluation at 12 weeks after start of targeted therapy.
Side effects
Assessed according to the PRO-CTCAE and NCI CTCAE 5.0
Measured: From start date of targeted therapy after two weeks, every 12 weeks from targeted therapy start date, until 12 weeks after end of treatment.
Health Related Quality of Life
HRQoL is assessed using standardized questionnaires from the EORTC QLQ-C30 and QLQ-OV28.
Measured: From baseline, every 12 weeks after start date of treatment until 12 weeks after end of treatment.
Cost-effectiveness
Standardized EuroQol 5D (EQ-5D-5L) questionnaire is used to calculated the cost-effectiveness.
Measured: From baseline, every 12 weeks after start date of targeted therapy until 12 weeks after end of treatment.
Change in pathway activity score after disease progression compared to pathway activity score before start of matched therapy.
If pathway activity scores are available from a second (voluntary) biopsy for after treatment has ended and before standard (palliative) treatment has started, change in pathway scores are assessed.
Measured: From date of biopsy until 4 weeks after date of documented progression of disease.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2018
- Study start31 Jan 2023
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Ovarian CancerStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Targeted therapy based on functional signal transduction pathway activation in patients with recurrent ovarian cancer.
- Masking
- None (open label)
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gynaecologisch Oncologisch Centrum Zuid
- Sponsor type
- University, hospital or other
- Collaborators
- Radboud University Medical Center, Erasmus Medical Center, Maastricht University Medical Center, InnoSIGN, Eurofins
- Responsible party
- Principal investigator, Jurgen M.J. Piek, Catharina Ziekenhuis Eindhoven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03458221
- Sponsor's protocol ID
- STAPOVER
- Other IDs
- 2020-005091-36
- Acronym
- STAPOVER
- Status last verified
- Apr 2023
- First submitted
- 23 Feb 2018
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Signal TrAnsduction Pathway Activity Analysis in OVarian cancER
- ClinicalTrials.gov ID
- NCT03458221
- Acronym / sponsor ID
- STAPOVER / STAPOVER
- Conditions
- Recurrent Ovarian Cancer, Signal Transduction Pathway Deregulation, Therapy-Associated Cancer
- Keywords
- Ovarian Cancer, Signal Transduction Pathway, Targeted therapy, Drug repurposing
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Gynaecologisch Oncologisch Centrum ZuidUniversity, hospital or other
- Collaborators
- Radboud University Medical Center, Erasmus Medical Center, Maastricht University Medical Center, InnoSIGN, Eurofins
- Study start
- 31 Jan 2023 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 8 Mar 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.
The purpose of this prospective, parallel-group, cohort study is to implement phenotype-guided targeted therapy based on functional signal transduction pathway (STP) activity in recurrent ovarian cancer patients using a novel mRNA-based assay. Existing targeted drugs with tolerable toxicity profiles are used to investigate the therapeutic value beyond their approved indication, which are deemed beneficial in the select group of patients with a relevant predominantly active functional STP, in order to improve survival and maintain quality of life.
Detailed description
Rationale: Ovarian cancer is one of the most lethal cancers in the world. Standard therapy consists of debulking surgery and chemotherapy. However, despite this aggressive treatment, recurrent disease almost invariably occurs resulting in a five-year survival rate of approximately 30%. Tumour growth is driven by several signal transduction pathways (STPs), and twelve major STPs have been identified as important for carcinogenesis. Currently, several targeted therapy drugs are available and new targeted drugs are being developed. With a newly developed technique, Signal Transduction Activation (STA) analysis, it is possible to assess which pathway is predominant in a specific (ovarian) cancer sample. Therefore, we hypothesize that specifically targeting the predominant STP might impair tumour growth and improve survival.
Objective: This study aims to investigate the progression-free survival (PFS) according to RECIST 1.1 criteria on matched targeted therapy by STA-analysis (PFS2) in comparison to the PFS recorded on the therapy administered immediately prior to enrolment (PFS1) in women with recurrent ovarian cancer.
Study design: A multi-centre prospective, parallel-group, cohort study. Study population: Recurrent ovarian cancer patients with platinum-resistant disease, patients who refrain from standard therapy and patients who are not yet eligible for standard palliative chemotherapy, including all histological subtypes.
Intervention: STA-analysis will be performed on a biopsy taken from the recurrent tumour. Patients will be included if a predominant pathway is identified for which a matched targeted drug is available and deemed adequate by the multidisciplinary tumour board. We will start with targeted therapy in patients with oestrogen receptor, androgen receptor, phosphoinositide 3-kinase and Hedgehog pathway active tumours, since targeted therapy interceding these pathways are easily available with tolerable side effects.
Main study parameters/endpoints: The primary outcome is therapy response defined as PFS2/PFS1 ratio according to RECIST 1.1 criteria. Secondary outcomes include the proportion of patients with an actionable active pathway and the proportion of patients receiving matched targeted therapy, best overall response (according to RECIST 1.1 criteria), one-year survival, overall survival, predictive value of STA-analysis results, side effects, quality of life, cost-effectiveness and change in STP activity score comparing the score before treatment and after disease progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Targeted therapy based on functional signal transduction pathway activation in patients with recurrent ovarian cancer.
| Arm | Type | Receives |
|---|---|---|
| A - ER active tumors | Experimental | Drug: Letrozole Oral ProductIn case of an aberrantly active Estrogen Receptor (ER) pathway, patients will be treated with Letrozole 2.5mg daily orally until progression of disease. |
| B - AR active tumors | Experimental | Drug: Bicalutamide Oral ProductIn case of an aberrantly active androgen receptor (AR) pathway, patients will be treated with Bicalutamide 150mg daily orally until progression of disease. |
| C - PI3K active tumors | Experimental | Drug: Everolimus Oral ProductIn case of an aberrantly active phosphoinositide 3-kinase (PI3K) pathway, patients will be treated with Everolimus 10mg daily orally until progression of disease. |
| D - HH and/or PI3K active tumors | Experimental | Drug: Itraconazole Oral ProductIn case of an aberrantly active Hedgehog (HH) or PI3K pathway, patients will be treated with Itraconazole 300mg twice daily orally until progression of disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Female, age > 18 years
- Patients with recurrent ovarian cancer who meet one of the following criteria:
- Platinum-resistant disease, defined as disease recurrence or progression within six months of last platinum-based chemotherapy or;
- Patient refrains from standard therapy or;
- Asymptomatic patient who is not yet eligible for standard palliative chemotherapy but has an increase of CA125 tumour marker at two consecutive time points 28 days apart with a value of two times nadir above 35 U/ml.
Key exclusion criteria (9 listed)
- Age < 18 years.
- Patient is receiving any other anti-cancer therapy (e.g. cytotoxic or targeted drug or radiation) or is chemotherapy naïve. The required wash out period prior to start of matched targeted therapy is at least three weeks.
- Patient is diagnosed with or treated for a second primary tumour (except non-melanoma skin tumour) one year prior to study inclusion.
- Inability to obtain (sufficient) tumour material.
- Previous use of the selected targeted drug as anti-cancer agent.
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 |
|---|---|---|
| Letrozole Oral ProductLetrozole 2.5mg tablet - 2.5mg once dailty until progression of disease. | Drug | A - ER active tumors |
| Bicalutamide Oral ProductBicalutatmide 150mg tablet - 150mg once daily until progression of disease. | Drug | B - AR active tumors |
| Everolimus Oral ProductEverolimus 10mg tablet - 10mg once daily until progression of disease. | Drug | C - PI3K active tumors |
| Itraconazole Oral ProductItraconazole 100mg capsule - 300mg twice daily until progression of disease. | Drug | D - HH and/or PI3K active tumors |
Primary outcome
Progression free survival on matched targeted therapy determined by STP-activity (PFS2) in comparison to the PFS recorded on the therapy administered immediately prior to enrolment (PFS1).
Time frame: From baseline until the date of documented disease progression or 12 months after the start of targeted therapy.
PFS on matched targeted therapy (PFS2) is defined as the time from start of matched targeted therapy to disease progression, defined by RECIST 1.1 criteria, or death from any cause. PFS on prior therapy (PFS1) is defined as the time from start of the prior treatment to disease progression defined by RECIST 1.1 criteria
10 secondary outcomes
Proportion of patients with an actionable active pathway for which targeted therapy is recommended in relation to the number of patients who underwent a biopsy.
Time frame: From date of biopsy until the date of the result from Multi-disciplinary Tumor Board Meeting, up 14 days after biopsy date.
Proportion of patients who receive matched targeted therapy in relation to the number of patients included in each study arm.
Time frame: From start date matched targeted therapy until the end of the study enrollment, up to 36 months.
Best overall response defined by RECIST 1.1 criteria based on radiological imaging.
Time frame: From baseline, radiological evaluation every 12 weeks after the start of targeted therapy until the date of documented disease progression or death, whichever comes first, assessed up to 12 months.
One-year survival
Time frame: From start date of targeted therapy until date of death or one year follow-up, whichever comes first.
Overall survival
Time frame: From start date of targeted therapy until the date of death, assessed up to 36 months.
Predictive value of STA-analysis results on matched targeted therapy response.
Time frame: From start date targeted therapy until response evaluation at 12 weeks after start of targeted therapy.
Side effects
Time frame: From start date of targeted therapy after two weeks, every 12 weeks from targeted therapy start date, until 12 weeks after end of treatment.
Health Related Quality of Life
Time frame: From baseline, every 12 weeks after start date of treatment until 12 weeks after end of treatment.
Cost-effectiveness
Time frame: From baseline, every 12 weeks after start date of targeted therapy until 12 weeks after end of treatment.
Change in pathway activity score after disease progression compared to pathway activity score before start of matched therapy.
Time frame: From date of biopsy until 4 weeks after date of documented progression of disease.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: Undecided
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Letrozole Oral Product, Bicalutamide Oral Product and Everolimus Oral Product in people with Recurrent Ovarian Cancer and Signal Transduction Pathway Deregulation, run by Gynaecologisch Oncologisch Centrum Zuid at 6 sites in Netherlands.
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 13 inclusion and 9 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 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in 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 combined 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jurgen M Piek, MD, PhD (+31(0)40 239 91 11, jurgen.piek@catharinaziekenhuis.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival on matched targeted therapy determined by STP-activity (PFS2) in comparison to the PFS recorded on the therapy administered immediately prior to enrolment (PFS1). (time frame: From baseline until the date of documented disease progression or 12 months after the start of targeted therapy.). 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 18 Apr 2023.