Breast Cancer MetastaticPhase 1NCT01876251
A Study Evaluating The PF-03084014 In Combination With Docetaxel In Patients With Advanced Breast Cancer
A Phase 1 study testing PF-03084014 and Docetaxel in people with Breast Cancer Metastatic, run by Pfizer at 16 sites in 4 countries.
Trial summary
This study is aimed to determine the tolerability of the PF-03084014 plus docetaxel combination in patients with advanced breast cancer. Preliminary information about the efficacy of the combination will also be collected. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Metastatic
- What is being tested?
- PF-03084014 and Docetaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 16 sitesin 4 countries
- Study dates
- 4 Nov 2013to 24 Dec 2015
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of breast cancer with evidence of a) metastatic or b) locally recurrent/advanced disease.
Who cannot join
- Prior treatment with a gamma secretase inhibitors or other Notch signaling inhibitors.
Trial locations and contacts
16 sites in 4 countries.
16 sites in 4 countries
United States11 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35233
University of Alabama at Birmingham, IDS Pharmacy
Birmingham, Alabama, 35249
University of Alabama at Birmingham
Birmingham, Alabama, 35249
UNC Cancer Hospital Infusion Pharmacy
Chapel Hill, North Carolina, 27514
UNC Hospitals, The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7600
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
Karmanos Cancer Institute (KCI)
Detroit, Michigan, 48201
Stanford Cancer Institute
Stanford, California, 94305
Stanford Hospital & Clinics-DRUG SHIPMENT ADDRESS only
Stanford, California, 94305
Stanford Hospital & Clinics
Stanford, California, 94305
Stanford Women's Cancer Center
Stanford, California, 94305
Belgium2 sites
Jules Bordet Institut
Brussels, 1000
Grand Hopital de Charleroi
Charleroi, 6000
Spain2 sites
Instituto Catalan de Oncologia de L'Hospitalet de Llobregat(ICO)
Barcelona, 08908
Hospital Universitario 12 de Octubre
Madrid, 28041
About this study
Official title: Phase 1b Study Of Docetaxel + Pf 03084014 In Metastatic Or Locally Recurrent/Advanced Triple Negative Breast Cancer
This study is aimed to determine the tolerability of the PF-03084014 plus docetaxel combination in patients with advanced breast cancer. Preliminary information about the efficacy of the combination will also be collected.
- Conditions
- Breast Cancer Metastatic
- Being tested
- PF-03084014, Docetaxel
- Keywords
- Breast cancer metastatic, docetaxel, PF-03084014
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-03084014Drug
Tablet, 10 mg, twice a day
PF-03084014Drug
Tablet, 50 mg, twice a day
PF-03084014Drug
Tablet, 100 mg, twice a day
DocetaxelDrug
Also called Taxotere
Solution for IV infusion 75 mg/m^2, every 3 weeks
DocetaxelDrug
Solution for IV infusion 100 mg/m^2, every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| PF-03084014 plus docetaxel | Experimental | PF 03084014 will be administered orally, continuously, twice daily at doses from 80 to 150 mg in combination with docetaxel given every 3 weeks at doses from 75 to 100 mg/m^2 Receives: Drug: PF-03084014; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Dose-limiting Toxicities (DLTs) in Cycle 1
Any DLT event in Cycle 1: Grade 4 neutropenia lasting more than (>)7 days; febrile neutropenia (Grade more than or equal to [>=] 3 and body temperature >=38.5 degrees Celsius); Grade >=3 neutropenic infection; Grade >=3 thrombocytopenia with bleeding; Grade 4 thrombocytopenia without bleeding; Grade >=3 toxicities (except those that had not been maximally treated); Grade 3 prolongation of time from electrocardiogram (ECG) Q wave to the end of the T wave corresponding to electrical systole (QT) corrected for heart rate (QTc) which persisted after correction of reversible causes; delay of 2 weeks in receiving next scheduled cycle due to persisting treatment-related toxicities; and failure to deliver at least 80% of planned dose during first cycle due to treatment-related toxicities.
Measured: Cycle 1 Days 1-21
Progression-free Survival (PFS) at 6 Months - Expansion Cohort
The period from study entry until disease progression, death or date of last contact. Assessment of response was made using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Measured: Baseline till 6 months post-dose
Secondary outcomes (19)
Number of Participants With All Causality and Treatment-related Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs
An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent AEs (TEAEs) are defined as newly occurring AEs or those worsening after first dose. AEs comprised both SAEs and non-SAEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Causality assessment was made by the investigator. Grading was per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) version 3.0: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening, Grade 5=death related to AE.
Measured: Baseline up to 28-35 days after treatment discontinuation (up to Day 280)
Number of Participants With Laboratory Abnormalities
Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters included hematology, coagulation, liver function, renal function, electrolytes, clinical chemistry, and urinalysis (dipstick).
Measured: Baseline up to 28-35 days after treatment discontinuation (up to Day 280)
Percentage of Participants With Objective Response (OR)
OR was based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 millimeters [mm]). No new lesions. PR was defined as more than or equal to (>=) 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.
Measured: Baseline, every 6 weeks from Cycle 2 onwards up to 26 months
Area Under the Concentration-time Curve (AUC) From Time 0 to Time of Last Measured Concentration (AUClast) of PF-03084014 in Dose-finding Cohort
Serum PF-03084014 pharmacokinetic (PK) parameters were calculated following twice daily (BID) doses of PF-03084014 given alone (Cycle 1 Day 21) and in combination with docetaxel (Cycle 1 Day 2 and Cycle 2 Day 1).
Measured: Cycle (C) 1 Days (D) 1, 2, 8, and 21; Day 1 of subsequent cycles and at EOT (max reached: Cycle 12)
AUClast and AUC From Time 0 Extrapolated to Infinite Time (AUCinf) of Docetaxel in Dose-finding Cohort
Plasma docetaxel PK parameters were calculated following a 1-hr infusion of docetaxel given alone (Cycle 1 Day 1) and in combination with BID dosing of PF-03084014 (Cycle 2 Day 1)
Measured: C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)
Maximum Serum or Plasma Concentration (Cmax) and Predose Concentration (Ctrough) of PF-03084014 in Dose-finding Cohort
Serum PF-03084014 PK parameters were calculated following BID doses of PF-03084014 given alone (Cycle 1 Day 21) and in combination with docetaxel (Cycle 1 Day 2 and Cycle 2 Day 1)
Measured: C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)
Cmax of Docetaxel in Dose-finding Cohort
Plasma docetaxel PK parameters were calculated following a 1-hr infusion of docetaxel given alone (Cycle 1 Day 1) and in combination with BID dosing of PF-03084014 (Cycle 2 Day 1)
Measured: C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)
Time to Cmax (Tmax) of PF-03084014 in Dose-finding Cohort
Serum PF-03084014 PK parameters were calculated following BID doses of PF-03084014 given alone (Cycle 1 Day 21) and in combination with docetaxel (Cycle 1 Day 2 and Cycle 2 Day 1)
Measured: C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)
Tmax of Docetaxel in Dose-finding Cohort
Plasma docetaxel PK parameters were calculated following a 1-hr infusion of docetaxel given alone (Cycle 1 Day 1) and in combination with BID dosing of PF-03084014 (Cycle 2 Day 1)
Measured: C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)
Systemic Clearance (CL) of Docetaxel in Dose-finding Cohort
Plasma docetaxel PK parameters were calculated following a 1-hr infusion of docetaxel given alone (Cycle 1 Day 1) and in combination with BID dosing of PF-03084014 (Cycle 2 Day 1)
Measured: C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)
Terminal Half-life (t1/2) of Docetaxel in Dose-finding Cohort
Plasma docetaxel PK parameters were calculated following a 1-hr infusion of docetaxel given alone (Cycle 1 Day 1) and in combination with BID dosing of PF-03084014 (Cycle 2 Day 1)
Measured: C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)
Volume of Distribution (Vss) of Docetaxel in Dose-finding Cohort
Plasma docetaxel PK parameters were calculated following a 1-hr infusion of docetaxel given alone (Cycle 1 Day 1) and in combination with BID dosing of PF-03084014 (Cycle 2 Day 1)
Measured: C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)
AUClast of PF-03084014 in the Expansion Cohort
Measured: C1D1, C1D21, and Day 1 of subsequent cycles and at EOT (max reached: C12)
Cmax of PF-03084014 in the Expansion Cohort
Measured: C1D1, C1D21, and Day 1 of subsequent cycles and at EOT (max reached: C12)
Tmax of PF-03084014 in the Expansion Cohort
Measured: C1D1, C1D21, and Day 1 of subsequent cycles and at EOT (max reached: C12)
Ctrough of PF-03084014 in the Expansion Cohort
Measured: C1D1, C1D21, and Day 1 of subsequent cycles and at EOT (max reached: C12)
Duration of Response (DR)
Duration of response (DR) defined as time from start of first documented objective tumor response [Complete Response (CR) or Partial Response (PR)] to first documented objective tumor progression or death due to any cause, whichever occurs first. DR = (the end date for DR minus first subsequent confirmed CR or PR plus 1) divided by 7.02. CR: disappearance of all target lesions. PR: at least 30% decrease in the sum of diameters of target lesions.
Measured: Baseline up to 28-35 days after treatment discontinuation (up to Day 280)
Number of Participants With QTc Values Meeting Categorical Summarization Criteria
Criteria for categorical summarization of the time corresponding to the beginning of depolarization to repolarization of the ventricles (QT) corrected for heart rate (QTc) using Bazett's correction (QTcB) or Fridericia's correction (QTcF) included: maximum QTcB or QTcF less than or equal to (<=) 450 milliseconds (msec), 450 to <=480 msec, 480 to <=500 msec, more than (>) 500 msec; maximum QTcB or QTcF changes (increases/decreases) from baseline (BL) less than (<) 30 msec, 30 to <60 msec, more than or equal to (>=) 60 msec.
Measured: Screening, C1D1, C1D21, Day 1 of subsequent cycles, and EOT (maximum reached: C12)
Percentage Change From Baseline in Notch 1 to 4 Ribonucleic Acid (RNA) in Blood
As PF-03084014 acts on the Notch pathway as an inhibitor, it is of interest to investigate its effects, if any, on the Notch family of receptors, mainly Notch 1-4.
Measured: C1D1, C1D2, C1D8, C1D21 and EOT (maximum reached: C12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2013 (estimated)
- Study start4 Nov 2013
- Primary completion24 Dec 2015
- Study completion24 Dec 2015
Why it stopped: The study was terminated on June 24th, 2015 due to change in strategy of PF-03084014 development. There were no safety/efficacy concerns behind the decision.
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.
- Other trials for Breast Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- Treatment
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01876251
- Sponsor's protocol ID
- A8641016
- Other IDs
- 2013-000659-41
- Status last verified
- Mar 2019
- First submitted
- 10 Jun 2013
- Last updated
- 15 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1b Study Of Docetaxel + Pf 03084014 In Metastatic Or Locally Recurrent/Advanced Triple Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT01876251
- Acronym / sponsor ID
- A8641016
- Conditions
- Breast Cancer Metastatic
- Keywords
- Breast cancer metastatic, docetaxel, PF-03084014
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated on June 24th, 2015 due to change in strategy of PF-03084014 development. There were no safety/efficacy concerns behind the decision.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 4 Nov 2013 (actual)
- Primary completion
- 24 Dec 2015 (actual)
- Study completion
- 24 Dec 2015 (actual)
- First posted
- 12 Jun 2013 (estimated)
- Results
- Posted 15 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is aimed to determine the tolerability of the PF-03084014 plus docetaxel combination in patients with advanced breast cancer. Preliminary information about the efficacy of the combination will also be collected.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PF-03084014 plus docetaxel | Experimental | Drug: PF-03084014, Drug: DocetaxelPF 03084014 will be administered orally, continuously, twice daily at doses from 80 to 150 mg in combination with docetaxel given every 3 weeks at doses from 75 to 100 mg/m^2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of breast cancer with evidence of a) metastatic or b) locally recurrent/advanced disease.
Key exclusion criteria (1 listed)
- Prior treatment with a gamma secretase inhibitors or other Notch signaling inhibitors.
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 |
|---|---|---|
| PF-03084014Tablet, 10 mg, twice a day | Drug | PF-03084014 plus docetaxel |
| PF-03084014Tablet, 50 mg, twice a day | Drug | PF-03084014 plus docetaxel |
| PF-03084014Tablet, 100 mg, twice a day | Drug | PF-03084014 plus docetaxel |
| DocetaxelAlso: TaxotereSolution for IV infusion 75 mg/m^2, every 3 weeks | Drug | PF-03084014 plus docetaxel |
| DocetaxelSolution for IV infusion 100 mg/m^2, every 3 weeks | Drug | PF-03084014 plus docetaxel |
Primary outcome
Number of Participants With Dose-limiting Toxicities (DLTs) in Cycle 1
Time frame: Cycle 1 Days 1-21
Any DLT event in Cycle 1: Grade 4 neutropenia lasting more than (>)7 days; febrile neutropenia (Grade more than or equal to [>=] 3 and body temperature >=38.5 degrees Celsius); Grade >=3 neutropenic infection; Grade >=3 thrombocytopenia with bleeding; Grade 4 thrombocytopenia without bleeding; Grade >=3 toxicities (except those that had not been maximally treated); Grade 3 prolongation of time from electrocardiogram (ECG) Q wave to the end of the T wave corresponding to electrical systole (QT) corrected for heart rate (QTc) which persisted after correction of reversible causes; delay of 2 weeks in receiving next scheduled cycle due to persisting treatment-related toxicities; and failure to deliver at least 80% of planned dose during first cycle due to treatment-related toxicities.
Progression-free Survival (PFS) at 6 Months - Expansion Cohort
Time frame: Baseline till 6 months post-dose
The period from study entry until disease progression, death or date of last contact. Assessment of response was made using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
19 secondary outcomes
Number of Participants With All Causality and Treatment-related Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs
Time frame: Baseline up to 28-35 days after treatment discontinuation (up to Day 280)
Number of Participants With Laboratory Abnormalities
Time frame: Baseline up to 28-35 days after treatment discontinuation (up to Day 280)
Percentage of Participants With Objective Response (OR)
Time frame: Baseline, every 6 weeks from Cycle 2 onwards up to 26 months
Area Under the Concentration-time Curve (AUC) From Time 0 to Time of Last Measured Concentration (AUClast) of PF-03084014 in Dose-finding Cohort
Time frame: Cycle (C) 1 Days (D) 1, 2, 8, and 21; Day 1 of subsequent cycles and at EOT (max reached: Cycle 12)
AUClast and AUC From Time 0 Extrapolated to Infinite Time (AUCinf) of Docetaxel in Dose-finding Cohort
Time frame: C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)
Maximum Serum or Plasma Concentration (Cmax) and Predose Concentration (Ctrough) of PF-03084014 in Dose-finding Cohort
Time frame: C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)
Cmax of Docetaxel in Dose-finding Cohort
Time frame: C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)
Time to Cmax (Tmax) of PF-03084014 in Dose-finding Cohort
Time frame: C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)
Tmax of Docetaxel in Dose-finding Cohort
Time frame: C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)
Systemic Clearance (CL) of Docetaxel in Dose-finding Cohort
Time frame: C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)
Terminal Half-life (t1/2) of Docetaxel in Dose-finding Cohort
Time frame: C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)
Volume of Distribution (Vss) of Docetaxel in Dose-finding Cohort
Time frame: C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)
AUClast of PF-03084014 in the Expansion Cohort
Time frame: C1D1, C1D21, and Day 1 of subsequent cycles and at EOT (max reached: C12)
Cmax of PF-03084014 in the Expansion Cohort
Time frame: C1D1, C1D21, and Day 1 of subsequent cycles and at EOT (max reached: C12)
Tmax of PF-03084014 in the Expansion Cohort
Time frame: C1D1, C1D21, and Day 1 of subsequent cycles and at EOT (max reached: C12)
Ctrough of PF-03084014 in the Expansion Cohort
Time frame: C1D1, C1D21, and Day 1 of subsequent cycles and at EOT (max reached: C12)
Duration of Response (DR)
Time frame: Baseline up to 28-35 days after treatment discontinuation (up to Day 280)
Number of Participants With QTc Values Meeting Categorical Summarization Criteria
Time frame: Screening, C1D1, C1D21, Day 1 of subsequent cycles, and EOT (maximum reached: C12)
Percentage Change From Baseline in Notch 1 to 4 Ribonucleic Acid (RNA) in Blood
Time frame: C1D1, C1D2, C1D8, C1D21 and EOT (maximum reached: C12)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
16 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PF-03084014 and Docetaxel in people with Breast Cancer Metastatic, run by Pfizer at 16 sites in 4 countries.
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 1 inclusion and 1 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 15 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Belgium, Spain, Italy. 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 15 Mar 2019). 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?
Number of Participants With Dose-limiting Toxicities (DLTs) in Cycle 1 (time frame: Cycle 1 Days 1-21). The study lists 2 primary outcomes in all. 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 15 Mar 2019.