Ovarian CancerPhase 2ACTOvNCT05080556
Adaptive ChemoTherapy for Ovarian Cancer in Patients With Replased Platinum-sensitive High Grade Serous or High Grade Endometrioid Ovarian Cancer
A Phase 2 study testing Carboplatin in people with Ovarian Cancer and Relapsed Ovarian Cancer, run by University College, London at 1 site in United Kingdom.
Trial summary
ACTOv will compare standard 3-weekly carboplatin (AUC5), to carboplatin delivered according to an AT regimen. The AT regimen will modify carboplatin dose according to changes in the clinical-standard serum biomarker CA125 as a proxy measure of total tumour burden and an individual patient's response to the most recent… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Relapsed Ovarian Cancer, Fallopian Tube Cancer
- What is being tested?
- Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 May 2023to 1 Nov 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 patients aged ≥18 years
- ECOG performance status 0-2
- Histologically proven diagnosis of high grade serous or high grade endometrioid carcinoma of the ovary, fallopian tube or peritoneum
- Most recent regimen must have included platinum (cisplatin or carboplatin)
- Must have previously received a PARP inhibitor
- 6. Must have responded to most recent platinum treatment by CT or MRI or by GCIG CA125 response criteria
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- Pre-trial CT or MRI-confirmed disease relapse ≥ 6 months after day 1 of the last cycle of platinum-containing chemotherapy (cisplatin or carboplatin) and requiring treatment with further platinum-based chemotherapy
- Measurable disease by RECIST v1.1 on a CT scan conducted within 28 days prior to randomisation (Patient with non-measurable disease could be eligible if they meet GCIG CA125 progression criteria)
- CA125 ≥ 100iU/l at screening
- Agree to provide additional research blood samples at the same time as blood draws prior to each carboplatin treatment, 6-weekly during surveillance and at 12- weekly follow-up visit
- Expected to be able to commence treatment within 28 days post randomisation
- Adequate bone marrow function
- Adequate liver function
- Adequate renal function
- Postmenopausal or women of child-bearing potential (WOCBP) must agree to have an urine or serum pregnancy test at screening for evidence of non-childbearing status and prior to trial treatment and use adequate contraception for duration of trial
- Willing and able to give consent and able to comply with treatment and follow up schedule
Who cannot join
- Non-epithelial ovarian cancer, carcinosarcoma, low-grade serous and endometrioid carcinomas, mucinous \& clear-cell carcinomas
- Patients requiring treatment with combination chemotherapy regimens
- Patients with a known hypersensitivity to carboplatin
- Persisting ≥ grade 2 CTCAE v5 adverse events/ toxicity (except alopecia and neuropathy) from previous anti-cancer treatment.
- Treatment with any other investigational agent, or participation in another interventional clinical trial within 28 days prior to randomisation.
- Major surgery within 14 days before anticipated start of treatment and patients must have recovered from any effects of major surgery.
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- Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contra-indicated the use of an investigation drug or puts the patients at high risk for treatment-related complications.
- Other psychological, psychiatric, social or medical condition, physical examination finding or a laboratory abnormality that the Investigator considers would make the patient a poor trial candidate or could interfere with protocol compliance or the interpretation of trial results.
- Malignancy treated within the last 5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS) of the breast, Stage 1, grade 1 endometrial carcinoma.
- Patients with symptomatic uncontrolled brain or meningeal metastases. A scan to confirm the absence of brain metastases is not required. The patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least 4 weeks prior to treatment.
- Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days prior to randomisation.
- Pregnant or breast-feeding women are excluded. Women of childbearing potential will be excluded unless effective methods of contraception are used from signing of the informed consent, throughout the period of taking study treatment and for at least 6 months after last dose of trial drug(s).
- Inability to attend or comply with treatment or follow-up scheduling.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University College London Hospitals
London
Michelle Lockley, michellelockley@nhs.net
Michelle Lockley
About this study
Official title: A Multicentre Phase II Randomised Controlled Trial to Evaluate the Efficacy of Adaptive Therapy (AT) With Carboplatin, Based on Changes in CA125, in Patients With Relapsed Platinum-sensitive High Grade Serous or High Grade Endometrioid Ovarian Cancer
ACTOv will compare standard 3-weekly carboplatin (AUC5), to carboplatin delivered according to an AT regimen. The AT regimen will modify carboplatin dose according to changes in the clinical-standard serum biomarker CA125 as a proxy measure of total tumour burden and an individual patient's response to the most recent chemotherapy treatment. AT could prolong sensitivity to carboplatin and extend tumour control, while simultaneously reducing chemotherapy dose and drug-induced toxicity. Carboplatin is a low cost and low toxicity drug that has an enduring and central role in ovarian cancer treatment.
- Conditions
- Ovarian Cancer, Relapsed Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer, Endometrioid Carcinoma, High Grade Serous Carcinoma
- Being tested
- Carboplatin
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms, Carcinoma, Endometrioid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarboplatinDrug
Treatment in both arms will be administered intravenously (IV) every 21 days (q21D) and for a maximum of 6 cycles in Arm 1 and 12 cycles in Arm 2.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (control) - standard dosing carboplatin | Active comparator | Arm 1 (Standard Dosing): Carboplatin AUC5 based on nuclear medicine renal clearance. Receives: Drug: Carboplatin |
| Arm 2 (experimental) - adaptive therapy carboplatin according to CA125 | Experimental | Arm 2 (Adaptive Therapy): Carboplatin dose will be calculated according to the CA125 value. Receives: Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Progression Free Survival (mPFS)
Measured from the date of randomisation to the date of objective progression (investigator assessed using RECIST v1.1) but comparing CT scans to the baseline CT rather than the radiological nadir), clinical progression or death from any cause (in the absence of progression)
Measured: From the date of randomisation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 years.
Secondary outcomes (15)
Acceptability (1/2)
the number of eligible patients approached who accept randomisation and continue to receive treatment
Measured: From the date of randomisation to the first dose of treatment (within 28 days from randomisation)received by patient. Measured as the number of patients approached who accept randomisation.
Acceptability (2/2)
the proportion of eligible patients approached who accept randomisation and continue to receive treatment
Measured: From the date of randomisation to the first dose of treatment (within 28 days from randomisation)received by patient. Measured as the percent of patients approached who accept randomisation.
Deliverability (1/2)
the number of treatment cycles that are delivered as per protocol, described by trial arm
Measured: Measured as the number of treatment cycles that are delivered as per protocol, described by trial arm (maximum of 6 cycles in control arm and 12 in experimental arm, approx.. 18 weeks and 36 weeks respectively). Treatment delays, reductions and omissions
Deliverability (2/2)
the proportion of treatment cycles that are delivered as per protocol, described by trial arm
Measured: Measured as the number of treatment cycles that are delivered as per protocol, described by trial arm (maximum of 6 cycles in control arm and 12 in experimental arm, approx.. 18 weeks and 36 weeks respectively). Treatment delays, reductions and omissions
Compliance
total cumulative carboplatin dose will be calculated for each patient over time on treatment, and described by trial arm
Measured: Total cumulative carboplatin dose will be calculated for each patient over time on treatment (max. of 6 cycles in control arm and 12 cycles in experimental arm, approximately 18 weeks and 36 weeks respectively
Adverse events (1/2)
adverse events will be categorised using the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5. The number of patients who suffer a grade 3 or 4 toxicity at any time, and the maximum grade of toxicity for each adverse event term, will be described by trial arm
Measured: Adverse events will be reported between informed consent and 30 calendar days post last IMP (i.e. max. of 6 cycles in control arm and 12 cycles in experimental arm, approximately 30 days after 18 weeks or 36 weeks respectively)
Adverse events (2/2)
adverse events will be categorised using the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5. The percentage of patients who suffer a grade 3 or 4 toxicity at any time, and the maximum grade of toxicity for each adverse event term, will be described by trial arm
Measured: Adverse events will be reported between informed consent and 30 calendar days post last IMP (i.e. max. of 6 cycles in control arm and 12 cycles in experimental arm, approximately 30 days after 18 weeks or 36 weeks respectively)
Quality of life (1/2) - EORTC questionnaire (assessing the quality of life of patients with ovarian cancer)
measured using European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC questionnaires): Quality of Life cancer 30 (QLQ-C30) (suitable for all cancer types) and Qualify of life questionnaire (QLQ-OV28 (ovarian cancer-specific)) in scale of 4 (1 is not very much and 4 very much)
Measured: At baseline, during treatment and follow up until the first documented progression or date of death (estimate 6 or 12 months but can be up to 4 years)
Quality of life (2/2) - EQ-5D ((mobility, self-care, usual activities, pain/discomfort, anxiety/depression, a single summary index and a visual analogue scale)
measured using European Quality of life questionnaire five dimensions (EQ-5D (descriptive profile of health state)) in scale of 5 (1 is no problem and 5 is extreme problem)
Measured: At baseline, during treatment and follow up until the first documented progression or date of death (estimate 6 or 12 months but can be up to 4 years)
Fear of progression
measured using Fear of progression questionnaire (FOP-Q SF) in scale of 1 to 5 where 1 is never and 5 is very often
Measured: At baseline, during treatment and follow up until the first documented progression or date of death (estimate 6 or 12 months but can be up to 4 years)
CA125
measured at baseline, 3-weekly during treatment, 6-weekly during surveillance and 12-weekly during follow-up
Measured: Measured at baseline, 3 weekly during treatment, 6-weekly during surveillance and 12-weekly during follow-up, through study completion, an average of 1 year.
Further treatment (1/3)
of patients who progress will be described by trial arm including the time-to-next treatment (measured from randomisation)
Measured: Additional treatment of patients who progress will be described by trial arm, this will include the time-to-next treatment (measured from randomisation).
Further treatment (2/3)
of patients who progress will be described by trial arm including the time treatment received (measured from randomisation)
Measured: Additional treatment of patients who progress will be described by trial arm, this will include the time treatment received (measured from randomisation)
Further treatment (3/3)
of patients who progress will be described by trial arm including the time response to this treatment (measured from randomisation)
Measured: Additional treatment of patients who progress will be described by trial arm, this will include the time response to this treatment (measured from randomisation)
Overall survival
measured from the date of randomisation to the date of death from any cause. Patients who are event-free will be censored at the date last seen
Measured: Measured from the date of randomisation to the date of death from any cause, censored at the date last seen (estimate 2 years but can be up to 4 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start24 May 2023
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by University College, LondonThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Anticancer Fund, Belgium, JP Moulton Charitable Foundation, Barts & The London NHS Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05080556
- Sponsor's protocol ID
- 136618
- Acronym
- ACTOv
- Status last verified
- Nov 2023
- First submitted
- 16 Jun 2021
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mukherjee UA, Hockings H, Counsell N, Patel A, Narayanan P, Wilkinson K, Dhanda H, Robinson K, McNeish I, Anderson ARA, Miller R, Gourley C, Graham T, Lockley M. Study protocol for Adaptive ChemoTherapy for Ovarian cancer (ACTOv): a multicentre phase II randomised controlled trial to evaluate the efficacy of adaptive therapy (AT) with carboplatin, based on changes in CA125, in patients with relapsed platinum-sensitive high-grade serous or high-grade endometrioid ovarian cancer. BMJ Open. 2024 Dec 22;14(12):e091262. doi: 10.1136/bmjopen-2024-091262.
PubMed 39806715
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Phase II Randomised Controlled Trial to Evaluate the Efficacy of Adaptive Therapy (AT) With Carboplatin, Based on Changes in CA125, in Patients With Relapsed Platinum-sensitive High Grade Serous or High Grade Endometrioid Ovarian Cancer
- ClinicalTrials.gov ID
- NCT05080556
- Acronym / sponsor ID
- ACTOv / 136618
- Conditions
- Ovarian Cancer, Relapsed Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer, Endometrioid Carcinoma, High Grade Serous Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Anticancer Fund, Belgium, JP Moulton Charitable Foundation, Barts & The London NHS Trust
- Study start
- 24 May 2023 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 15 Oct 2021 (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.
ACTOv will compare standard 3-weekly carboplatin (AUC5), to carboplatin delivered according to an AT regimen. The AT regimen will modify carboplatin dose according to changes in the clinical-standard serum biomarker CA125 as a proxy measure of total tumour burden and an individual patient's response to the most recent chemotherapy treatment. AT could prolong sensitivity to carboplatin and extend tumour control, while simultaneously reducing chemotherapy dose and drug-induced toxicity. Carboplatin is a low cost and low toxicity drug that has an enduring and central role in ovarian cancer treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (control) - standard dosing carboplatin | Active comparator | Drug: CarboplatinArm 1 (Standard Dosing): Carboplatin AUC5 based on nuclear medicine renal clearance. |
| Arm 2 (experimental) - adaptive therapy carboplatin according to CA125 | Experimental | Drug: CarboplatinArm 2 (Adaptive Therapy): Carboplatin dose will be calculated according to the CA125 value. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Female patients aged ≥18 years
- ECOG performance status 0-2
- Histologically proven diagnosis of high grade serous or high grade endometrioid carcinoma of the ovary, fallopian tube or peritoneum
- Most recent regimen must have included platinum (cisplatin or carboplatin)
- Must have previously received a PARP inhibitor
Key exclusion criteria (13 listed)
- Non-epithelial ovarian cancer, carcinosarcoma, low-grade serous and endometrioid carcinomas, mucinous \& clear-cell carcinomas
- Patients requiring treatment with combination chemotherapy regimens
- Patients with a known hypersensitivity to carboplatin
- Persisting ≥ grade 2 CTCAE v5 adverse events/ toxicity (except alopecia and neuropathy) from previous anti-cancer treatment.
- Treatment with any other investigational agent, or participation in another interventional clinical trial within 28 days prior to randomisation.
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 |
|---|---|---|
| CarboplatinTreatment in both arms will be administered intravenously (IV) every 21 days (q21D) and for a maximum of 6 cycles in Arm 1 and 12 cycles in Arm 2. | Drug | Arm 1 (control) - standard dosing carboplatin, Arm 2 (experimental) - adaptive therapy carboplatin according to CA125 |
Primary outcome
Modified Progression Free Survival (mPFS)
Time frame: From the date of randomisation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 years.
Measured from the date of randomisation to the date of objective progression (investigator assessed using RECIST v1.1) but comparing CT scans to the baseline CT rather than the radiological nadir), clinical progression or death from any cause (in the absence of progression)
15 secondary outcomes
Acceptability (1/2)
Time frame: From the date of randomisation to the first dose of treatment (within 28 days from randomisation)received by patient. Measured as the number of patients approached who accept randomisation.
Acceptability (2/2)
Time frame: From the date of randomisation to the first dose of treatment (within 28 days from randomisation)received by patient. Measured as the percent of patients approached who accept randomisation.
Deliverability (1/2)
Time frame: Measured as the number of treatment cycles that are delivered as per protocol, described by trial arm (maximum of 6 cycles in control arm and 12 in experimental arm, approx.. 18 weeks and 36 weeks respectively). Treatment delays, reductions and omissions
Deliverability (2/2)
Time frame: Measured as the number of treatment cycles that are delivered as per protocol, described by trial arm (maximum of 6 cycles in control arm and 12 in experimental arm, approx.. 18 weeks and 36 weeks respectively). Treatment delays, reductions and omissions
Compliance
Time frame: Total cumulative carboplatin dose will be calculated for each patient over time on treatment (max. of 6 cycles in control arm and 12 cycles in experimental arm, approximately 18 weeks and 36 weeks respectively
Adverse events (1/2)
Time frame: Adverse events will be reported between informed consent and 30 calendar days post last IMP (i.e. max. of 6 cycles in control arm and 12 cycles in experimental arm, approximately 30 days after 18 weeks or 36 weeks respectively)
Adverse events (2/2)
Time frame: Adverse events will be reported between informed consent and 30 calendar days post last IMP (i.e. max. of 6 cycles in control arm and 12 cycles in experimental arm, approximately 30 days after 18 weeks or 36 weeks respectively)
Quality of life (1/2) - EORTC questionnaire (assessing the quality of life of patients with ovarian cancer)
Time frame: At baseline, during treatment and follow up until the first documented progression or date of death (estimate 6 or 12 months but can be up to 4 years)
Quality of life (2/2) - EQ-5D ((mobility, self-care, usual activities, pain/discomfort, anxiety/depression, a single summary index and a visual analogue scale)
Time frame: At baseline, during treatment and follow up until the first documented progression or date of death (estimate 6 or 12 months but can be up to 4 years)
Fear of progression
Time frame: At baseline, during treatment and follow up until the first documented progression or date of death (estimate 6 or 12 months but can be up to 4 years)
CA125
Time frame: Measured at baseline, 3 weekly during treatment, 6-weekly during surveillance and 12-weekly during follow-up, through study completion, an average of 1 year.
Further treatment (1/3)
Time frame: Additional treatment of patients who progress will be described by trial arm, this will include the time-to-next treatment (measured from randomisation).
Further treatment (2/3)
Time frame: Additional treatment of patients who progress will be described by trial arm, this will include the time treatment received (measured from randomisation)
Further treatment (3/3)
Time frame: Additional treatment of patients who progress will be described by trial arm, this will include the time response to this treatment (measured from randomisation)
Overall survival
Time frame: Measured from the date of randomisation to the date of death from any cause, censored at the date last seen (estimate 2 years but can be up to 4 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Derived from this study: PubMed 39806715Mukherjee UA, Hockings H, Counsell N, Patel A, Narayanan P, Wilkinson K, Dhanda H, Robinson K, McNeish I, Anderson ARA, Miller R, Gourley C, Graham T, Lockley M. Study protocol for Adaptive ChemoTherapy for Ovarian cancer (ACTOv): a multicentre phase II randomised controlled trial to evaluate the efficacy of adaptive therapy (AT) with carboplatin, based on changes in CA125, in patients with relapsed platinum-sensitive high-grade serous or high-grade endometrioid ovarian cancer. BMJ Open. 2024 Dec 22;14(12):e091262. doi: 10.1136/bmjopen-2024-091262.
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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.
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 Carboplatin in people with Ovarian Cancer and Relapsed Ovarian Cancer, run by University College, London 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 16 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 12 Apr 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ACTOv Trial Coordinator (02076794466, ctc.actov@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Progression Free Survival (mPFS) (time frame: From the date of randomisation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 years.). 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 NCT05080556, 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 12 Apr 2024.