Prostate CancerPhase 1NCT03478904
Study to Compare Capsule and Liquid Formulations of Enzalutamide After Single Dose Administration Under Fasting Conditions in Prostate Cancer
A Phase 1 study testing Enzalutamide Liquid and Enzalutamide Capsule in people with Prostate Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: Enzalutamide is given to treat metastatic prostate cancer. But it takes 4 pills to deliver the effective dose. This can be difficult for people already taking multiple drugs. And swallowing may be difficult for some people. Researchers want to test out a new way of giving enzalutamide by mouth. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Enzalutamide Liquid and Enzalutamide Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2020to 30 Nov 2020
- Phase
- Phase 1
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically or cytologically confirmed prostate cancer.
- Note: If histopathological documentation is unavailable, a clinical course consistent with prostate cancer is acceptable.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Patients must have adequate organ and marrow function as defined below:
- Hemoglobin greater than or equal to 9 g/dL
- leukocytes greater than or equal to 3000/mcL
Show all 18Show fewer
- absolute neutrophil count greater than or equal to 1500/mcL
- platelets greater than or equal to 150000/mcL
- total bilirubin within normal institutional limits
- Aspartate aminotransferase (AST) serum glutamic oxaloacetic transaminase (SGOT)/ alanine aminotransferase (ALT) serum glutamic pyruvic transaminase (SGPT) less than or equal to X institutional upper limit of normal
- creatinine within normal institutional limits
- OR
- --creatinine clearance greater than or equal to 30 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal (calculated via Cockcroft-Gault equation)
- Patients must not have other concurrent malignancies (within the past 2 years with the exception of non-melanoma skin cancer and Rai Stage 0 chronic lymphocytic leukemia), in situ carcinoma of any site, or life threatening illnesses, including untreated infection (must be at least 1 week off intravenous antibiotic therapy before beginning enzalutamide).
- Ability of subject to understand and the willingness to sign a written informed consent document.
- Willingness to travel to National Institutes of Health (NIH) for follow-up visits.
- Men age greater than or equal to 18 years of age. Children are excluded because prostate cancer is not common in pediatric populations. Women are not eligible because this disease occurs only in men
- The effects of enzalutamide on the developing human fetus are unknown. For this reason men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) throughout the course of the study and for 3 months after the last dose. Should a woman become pregnant or suspect she is pregnant while her partner is participating in this study, she should inform her treating physician immediately.
Who cannot join
- Patients who are receiving any other investigational agents (in the past 28 days) or herbal medications (within 7 days).
- Patients must not be on enzalutamide within five half-lives before the first planned dose of the study drug or anticipating to start enzalutamide within the next 3 months of the first planned dose of study drug
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to enzalutamide or other agents used in study.
- Clinically significant cardiac disease, e.g. New York Heart Association (NYHA) classes III-IV; uncontrolled angina, uncontrolled arrhythmia or uncontrolled hypertension, myocardial infarction in the previous 6 months as confirmed by an electrocardiogram (ECG).
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Patients who are taking medications that may alter the metabolism of enzalutamide. This includes the following: strong or moderate cytochrome P450 family 2 subfamily C member 8 (CYP2C8) inhibitors or inducers; strong cytochrome P450 family 3 subfamily A member 4 (CYP3A4) inhibitors or inducers; or Cytochrome P450 2C9 (CYP2C9), 2C19 or 3A4 substrates with a narrow therapeutic index.
- History of seizure, including any febrile seizure, loss of consciousness, or transient ischemic attach, or any condition that may pre-dispose to seizure (e.g. prior stroke, brain arteriovenous malformation, head trauma with loss of consciousness requiring hospitalization).
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Background:
Enzalutamide is given to treat metastatic prostate cancer. But it takes 4 pills to deliver the effective dose. This can be difficult for people already taking multiple drugs. And swallowing may be difficult for some people. Researchers want to test out a new way of giving enzalutamide by mouth. They want to see if giving a person the liquid taken from inside the standard 4 gelatin capsules is handled by the body in the same way as giving them the capsules whole.
Read more
Objectives:
To compare how capsule and liquid forms of enzalutamide are handled by people with prostate cancer.
Eligibility:
Men at least 18 years old with prostate cancer
Design:
Participants will be screened with a heart test (electrocardiogram), medical history, and physical exam. A tissue sample or lab reports will be reviewed.
During the study, participants will repeat screening tests and have urine tests.
Participants will be randomly assigned to get the study drug in one of two orders: either the as capsules then the liquid form (Arm A) or as the liquid form then the capsule form (Arm B).
Participants will be counseled about birth control.
The study will have 2 periods with a minimum 42 day break in between.
On Day 1 of Period 1 and Day 1 of Period 2, participants will be admitted to the hospital. They will get one dose of the study drug. They cannot eat or drink anything except water for at least 10 hours before and for 4 hours after the study drug. Their blood will be sampled over 24 hours. Lunch and dinner will be served. Participants will answer questions after taking the liquid form.
Participants will have blood drawn on Day 3, Day 8, and Day 42.
Read the detailed description
Background:
- Enzalutamide is currently approved for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC)
- The marketed (reference) formulation of enzalutamide is a liquid-filled, soft gelatin capsule containing 40 mg enzalutamide dissolved in Labrasol; four such capsules are required to deliver a 160 mg dose
- The four-capsule regimen is inconvenient because of the number of capsules that must be taken, particularly in light of the fact that cancer patients usually have to take multiple drugs.
- Additionally, some patients may not be able to swallow pills; therefore, alternate methods of oral administration are necessary
Objectives:
-To evaluate the bioequivalence, safety, and tolerability of two oral formulations of enzalutamide following a single 160 mg dose in male subjects with prostate cancer under fasting conditions.
Eligibility:
-Male subjects with prostate cancer
Design:
- Comparative, randomized, open-label, single-dose, 2-way crossover bioavailability, safety and tolerability study
- Subjects will be randomized in Period 1 to one of two sequences: AB or BA. Following a minimum 42-day washout period, subjects will be crossed over in Period 2 to receive the treatment that they did not receive in Period 1.
- Treatment A will be the standard capsule (reference) formulation; Treatment B will be the liquid formulation (test product)
- Blood samples will be collected for pharmacokinetic analysis
- Conditions
- Prostate Cancer
- Being tested
- Enzalutamide Liquid, Enzalutamide Capsule
- Keywords
- Castration Resistant Prostate Cancer, Androgen Receptor
- Medical subject headings
- Prostatic Neoplasms, Bulbo-Spinal Atrophy, X-Linked
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enzalutamide LiquidDrug
Also called ASP-9785
Enzalutamide liquid formulation given orally (160mg)
Enzalutamide CapsuleDrug
Also called ASP-9785
Enzalutamide gel capsule (4X 40mg)
| Study group | Role | What they receive |
|---|---|---|
| 4x40mg Enzalutamide Capsule Followed by 160mg Enzalutamide Liquid | Experimental | Enzalutamide capsule (Treatment A) followed by enzalutamide liquid (Treatment B) Receives: Drug: Enzalutamide Liquid; Drug: Enzalutamide Capsule |
| 160mg Enzalutamide Liquid Followed by 4x40mg Enzalutamide Capsule | Experimental | Enzalutamide liquid (Treatment B) followed by enzalutamide capsule (Treatment A) Receives: Drug: Enzalutamide Liquid; Drug: Enzalutamide Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under Curve (AUC) for the First Period of Administration and Second Period of Administration of Two Formulations of Enzalutamide and the Active Metabolite of Enzalutamide Following a Single 160mg Dose
AUC is the cumulative drug exposure (drug concentration * time) for this single dose over a 42-day sampling period. Participants were randomized to receive Enzalutamide gel capsule 4x40mg (Treatment A) followed by enzalutamide liquid 160mg orally (Treatment B), or Enzalutamide liquid 160mg orally (Treatment B) followed by enzalutamide gel capsule 4x40mg (Treatment A). The difference in the AUCs were calculated following a published non-parametric and noncompartmental approach. A difference of less than 20% difference in the AUC for the test version vs. the standard formulation would permit the two formulations to be considered bioequivalent."
*The calculated AUC values for N-Desmethyl Enzalutamide of the "4x40mg Enzalutamide Capsule" formulation was influenced by detectable concentrations of N-Desmethyl Enzalutamide (an active metabolite of Enzalutamide) following the 42 Day washout period between the two doses.
Measured: Day 42
Secondary outcomes (3)
Number of Episodes of Grades 1-5 Nausea and Vomiting on 160mg Enzalutamide Liquid Followed by 4x40mg Enzalutamide Gel Capsule
Nausea and vomiting adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe or medically significant but not immediately life-threatening, Grade 4 is life threatening consequences, and Grade 5 is death related to adverse event.
Measured: Day 1, 3, 8, and 42
Number of Participants With Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0
Here is the number of participants with non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence.
Measured: Date treatment consent signed to date off study, approximately 7 months and 24 days.
Proportion of Participants With Grade 3 Vomiting Compared Between Two Formulations of Enzalutamide at Each Time Point Using Fishers Exact Test
Proportion of participants with Grade 3 vomiting assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0., compared between two formulations of enzalutamide at each time point using Fishers exact test.
Measured: Day 1, 3, 8, and 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start10 Mar 2020
- Primary completion30 Nov 2020
- Study completion30 Nov 2020
Why it stopped: Study drug is now commercially available in tablet format
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 Prostate CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, William Figg, National Cancer Institute (NCI)
- Investigators
- William D Figg, Pharm.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03478904
- Sponsor's protocol ID
- 180070
- Other IDs
- 18-C-0070
- Status last verified
- Apr 2021
- First submitted
- 21 Mar 2018
- Last updated
- 10 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cordes LM, Schmidt KT, Peer CJ, Chau CH, Redmond E, Francis D, Karzai F, Madan RA, Figg WD. Study to Compare Capsule and Liquid Formulations of Enzalutamide After Single-Dose Administration Under Fasting Conditions in Prostate Cancer. Oncologist. 2021 Sep;26(9):729-e1493. doi: 10.1002/onco.13919. Epub 2021 Aug 14.
PubMed 34333820
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Compare Capsule and Liquid Formulations of Enzalutamide After Single Dose Administration Under Fasting Conditions in Prostate Cancer
- ClinicalTrials.gov ID
- NCT03478904
- Acronym / sponsor ID
- 180070
- Conditions
- Prostate Cancer
- Keywords
- Castration Resistant Prostate Cancer, Androgen Receptor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study drug is now commercially available in tablet format
- Enrolment
- 1 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 27 Mar 2018 (actual)
- Results
- Posted 10 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Enzalutamide is given to treat metastatic prostate cancer. But it takes 4 pills to deliver the effective dose. This can be difficult for people already taking multiple drugs. And swallowing may be difficult for some people. Researchers want to test out a new way of giving enzalutamide by mouth. They want to see if giving a person the liquid taken from inside the standard 4 gelatin capsules is handled by the body in the same way as giving them the capsules whole.
Objectives:
To compare how capsule and liquid forms of enzalutamide are handled by people with prostate cancer.
Eligibility:
Men at least 18 years old with prostate cancer
Design:
Participants will be screened with a heart test (electrocardiogram), medical history, and physical exam. A tissue sample or lab reports will be reviewed.
During the study, participants will repeat screening tests and have urine tests.
Participants will be randomly assigned to get the study drug in one of two orders: either the as capsules then the liquid form (Arm A) or as the liquid form then the capsule form (Arm B).
Participants will be counseled about birth control.
The study will have 2 periods with a minimum 42 day break in between.
On Day 1 of Period 1 and Day 1 of Period 2, participants will be admitted to the hospital. They will get one dose of the study drug. They cannot eat or drink anything except water for at least 10 hours before and for 4 hours after the study drug. Their blood will be sampled over 24 hours. Lunch and dinner will be served. Participants will answer questions after taking the liquid form.
Participants will have blood drawn on Day 3, Day 8, and Day 42.
Detailed description
Background:
- Enzalutamide is currently approved for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC)
- The marketed (reference) formulation of enzalutamide is a liquid-filled, soft gelatin capsule containing 40 mg enzalutamide dissolved in Labrasol; four such capsules are required to deliver a 160 mg dose
- The four-capsule regimen is inconvenient because of the number of capsules that must be taken, particularly in light of the fact that cancer patients usually have to take multiple drugs.
- Additionally, some patients may not be able to swallow pills; therefore, alternate methods of oral administration are necessary
Objectives:
-To evaluate the bioequivalence, safety, and tolerability of two oral formulations of enzalutamide following a single 160 mg dose in male subjects with prostate cancer under fasting conditions.
Eligibility:
-Male subjects with prostate cancer
Design:
- Comparative, randomized, open-label, single-dose, 2-way crossover bioavailability, safety and tolerability study
- Subjects will be randomized in Period 1 to one of two sequences: AB or BA. Following a minimum 42-day washout period, subjects will be crossed over in Period 2 to receive the treatment that they did not receive in Period 1.
- Treatment A will be the standard capsule (reference) formulation; Treatment B will be the liquid formulation (test product)
- Blood samples will be collected for pharmacokinetic analysis
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4x40mg Enzalutamide Capsule Followed by 160mg Enzalutamide Liquid | Experimental | Drug: Enzalutamide Liquid, Drug: Enzalutamide CapsuleEnzalutamide capsule (Treatment A) followed by enzalutamide liquid (Treatment B) |
| 160mg Enzalutamide Liquid Followed by 4x40mg Enzalutamide Capsule | Experimental | Drug: Enzalutamide Liquid, Drug: Enzalutamide CapsuleEnzalutamide liquid (Treatment B) followed by enzalutamide capsule (Treatment A) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Patients must have histologically or cytologically confirmed prostate cancer.
- Note: If histopathological documentation is unavailable, a clinical course consistent with prostate cancer is acceptable.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Patients must have adequate organ and marrow function as defined below:
- OR
Key exclusion criteria (7 listed)
- Patients who are receiving any other investigational agents (in the past 28 days) or herbal medications (within 7 days).
- Patients must not be on enzalutamide within five half-lives before the first planned dose of the study drug or anticipating to start enzalutamide within the next 3 months of the first planned dose of study drug
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to enzalutamide or other agents used in study.
- Clinically significant cardiac disease, e.g. New York Heart Association (NYHA) classes III-IV; uncontrolled angina, uncontrolled arrhythmia or uncontrolled hypertension, myocardial infarction in the previous 6 months as confirmed by an electrocardiogram (ECG).
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
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 |
|---|---|---|
| Enzalutamide LiquidAlso: ASP-9785Enzalutamide liquid formulation given orally (160mg) | Drug | 160mg Enzalutamide Liquid Followed by 4x40mg Enzalutamide Capsule, 4x40mg Enzalutamide Capsule Followed by 160mg Enzalutamide Liquid |
| Enzalutamide CapsuleAlso: ASP-9785Enzalutamide gel capsule (4X 40mg) | Drug | 160mg Enzalutamide Liquid Followed by 4x40mg Enzalutamide Capsule, 4x40mg Enzalutamide Capsule Followed by 160mg Enzalutamide Liquid |
Primary outcome
Area Under Curve (AUC) for the First Period of Administration and Second Period of Administration of Two Formulations of Enzalutamide and the Active Metabolite of Enzalutamide Following a Single 160mg Dose
Time frame: Day 42
AUC is the cumulative drug exposure (drug concentration * time) for this single dose over a 42-day sampling period. Participants were randomized to receive Enzalutamide gel capsule 4x40mg (Treatment A) followed by enzalutamide liquid 160mg orally (Treatment B), or Enzalutamide liquid 160mg orally (Treatment B) followed by enzalutamide gel capsule 4x40mg (Treatment A). The difference in the AUCs were calculated following a published non-parametric and noncompartmental approach. A difference of less than 20% difference in the AUC for the test version vs. the standard formulation would permit the two formulations to be considered bioequivalent." *The calculated AUC values for N-Desmethyl Enzalutamide of the "4x40mg Enzalutamide Capsule" formulation was influenced by detectable concentrations of N-Desmethyl Enzalutamide (an active metabolite of Enzalutamide) following the 42 Day washout period between the two doses.
3 secondary outcomes
Number of Episodes of Grades 1-5 Nausea and Vomiting on 160mg Enzalutamide Liquid Followed by 4x40mg Enzalutamide Gel Capsule
Time frame: Day 1, 3, 8, and 42
Number of Participants With Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0
Time frame: Date treatment consent signed to date off study, approximately 7 months and 24 days.
Proportion of Participants With Grade 3 Vomiting Compared Between Two Formulations of Enzalutamide at Each Time Point Using Fishers Exact Test
Time frame: Day 1, 3, 8, and 42
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34333820Cordes LM, Schmidt KT, Peer CJ, Chau CH, Redmond E, Francis D, Karzai F, Madan RA, Figg WD. Study to Compare Capsule and Liquid Formulations of Enzalutamide After Single-Dose Administration Under Fasting Conditions in Prostate Cancer. Oncologist. 2021 Sep;26(9):729-e1493. doi: 10.1002/onco.13919. Epub 2021 Aug 14.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- 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.
William D Figg, Pharm.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Enzalutamide Liquid and Enzalutamide Capsule in people with Prostate Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
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 18 inclusion and 7 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: stopped early, as of the sponsor's last update on 10 May 2021. 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 States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 10 May 2021). 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?
Area Under Curve (AUC) for the First Period of Administration and Second Period of Administration of Two Formulations of Enzalutamide and the Active Metabolite of Enzalutamide Following a Single 160mg Dose (time frame: Day 42). 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 NCT03478904, 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 10 May 2021.