Metastatic Breast CancerPhase 1NCT03238196
Fulvestrant, Palbociclib and Erdafitinib in ER+/HER2-/FGFR-amplified Metastatic Breast Cancer
A Phase 1 study testing Erdafitinib, Palbociclib and Fulvestrant in people with Metastatic Breast Cancer, run by Vanderbilt-Ingram Cancer Center at 6 sites in United States.
Trial summary
This is an open-label, multi-institution, phase Ib trial that evaluates the safety and tolerability and preliminary anti-tumor activity of fulvestrant, palbociclib and erdafitinib in patients with ER+/HER2-/FGFR-amplified metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Erdafitinib, Palbociclib and Fulvestrant
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 6 sitesUnited States
- Study dates
- 18 Aug 2017to 20 Mar 2024
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be able to swallow and retain oral medication
- Patients must be ≥ 18 years of age
- Female patients of no childbearing potential must be post-menopausal. Postmenopausal female subjects should be defined prior to protocol enrollment by any of the following:
- Participants at least 60 years of age; OR
- Participants under 60 years of age and naturally (spontaneous, no alternative pathologic or physiological cause) amenorrhea for at least 12 months; OR
- Medical ovarian failure confirmed by follicle-stimulating hormone (FSH) and estradiol levels in the post menopausal range per local institutional normal range; OR
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- Prior bilateral oophorectomy; OR
- Prior radiation castration with amenorrhea for at least 6 months; OR
- Treatment with a luteinizing hormone-releasing hormone (LH-RH) agonist (such as goserelin acetate or leuprolide acetate) is permitted for induction of ovarian suppression as long as it has been initiated at least 28 days prior to study enrollment
- Patients must have ECOG performance status 0 - 1
- Patients must have clinical stage IV or inoperable locoregional recurrent invasive mammary carcinoma that is:
- ER+ and/or PgR+ (≥ 1% positive stained cells) by immunohistochemistry (IHC)
- HER2-negative (by IHC or FISH, per ASCO guidelines)
- FGFR1 - 4 amplified
- Patients must have evaluable (may have either measurable or non-measurable) disease
- Patients must have available tissue for FGFR determination
- Patients must have had at least one line of therapy in the metastatic setting
- Current use of any of the drugs listed on the Cautionary Concomitant Med list has to be approved by the Study Chair
- Patients must have adequate hematologic, hepatic and renal function. All laboratory tests must be obtained within 2 weeks from study drug initiation. These include:
- ANC ≥ 1,500/mm3
- Platelet count ≥ 100,000/mm3
- HgB ≥ 9.0 g/dL
- Creatinine clearance ≥ 40 mL/min/1.73 m2
- SGOT, SGPT ≤ 2.5 x ULN if no liver metastasis present; SGOT, SGPT ≤ 4 x ULN if liver metastasis present
- Albumin ≥ 2.0 g/dL
- Total serum bilirubin ≤ 1.5 x ULN (≤ 3 x ULN or direct bilirubin ≤ 1.5 x ULN if known Gilbert's syndrome)
- Potassium within institutional normal limits
- Phosphorus ≤ institutional upper limit of normal
Who cannot join
- Prior use of an FGFR inhibitor
- More than 2 lines of chemotherapy in the metastatic setting. No limit on endocrine therapy lines. Prior exposure to CDK4/6 inhibitor acceptable.
- Radiation therapy ≤ 2 weeks prior to study entry. Patients who have received prior radiotherapy must have recovered from toxicity (≤ grade 1) induced by this treatment (except for alopecia)
- Prior cancer therapy (except for endocrine therapy) must have been discontinued for 1 week prior to initiation of study drugs
- Concurrent anti-cancer therapy other than the ones specified in the protocol is not permitted during study participation. Bisphosphonates or denosumab are allowed
- Major surgery within 4 weeks of enrollment
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- Herbal preparations are not allowed throughout the study, and should be discontinued 14 days prior to initiation of study treatment
- Any corneal or retinal abnormality likely to increase the risk of eye toxicity, such as:
- Current corneal pathology such as keratitis, keratoconjunctivitis, keratopathy, corneal abrasion, inflammation or ulceration
- Uncontrolled glaucoma despite standard of care therapy
- Diabetic retinopathy with macular edema
- Known active wet, age-related macular degeneration (AMD)
- Known central serous retinopathy (CSR) or retinal vascular occlusion (RVO)
- Uncontrolled intercurrent illness including, but not limited to:
- Malabsorption syndrome significantly affecting gastrointestinal function
- Ongoing or active infection requiring antibiotics/antivirals
- Impairment of lung function (COPD > grade 2, lung conditions requiring oxygen therapy)
- Symptomatic congestive heart failure
- Unstable angina pectoris, angioplasty, stenting, or myocardial infarction within 6 months
- Clinically significant cardiac arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia that is symptomatic or requires treatment [National Cancer Institute -Common Terminology Criteria for Adverse Events, Version 4.03, grade 3]
- QTcF ≥ 480 msec on screening EKG
- Known history of clinically significant QT/QTc prolongation or Torsades de Pointes(TdP)
- ST depression or elevation of ≥ 1.5 mm in 2 or more leads
- Diarrhea of any cause ≥ CTCAE grade 2 that does not resolve within a few days when adequately treated with anti-diarrhea medications
- Psychiatric illness/social situations that would compromise patient safety or limit compliance with study requirements including maintenance of a compliance/pill diary
- Symptomatic brain metastases (patients with a history of brain metastases must be clinically stable for more than 4 weeks from completion of radiation treatment and be off steroids)
- Known history of chronic liver or chronic renal failure
- Poor wound healing capacity
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Alabama
Birmingham, Alabama, 35233
University of Texas Southwestern Simmons Comprehensive Cancer Center
Dallas, Texas, 75235
Baptist Memorial Hospital MEMPHIS
Memphis, Tennessee, 38120
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: A Phase Ib Trial of Fulvestrant, Palbociclib (CDK4/6 Inhibitor) and Erdafitinib (JNJ- 42756493,Pan-FGFR Tyrosine Kinase Inhibitor) in ER+/HER2-/FGFR-Amplified Metastatic Breast Cancer (MBC)
This is an open-label, multi-institution, phase Ib trial that evaluates the safety and tolerability and preliminary anti-tumor activity of fulvestrant, palbociclib and erdafitinib in patients with ER+/HER2-/FGFR-amplified metastatic breast cancer.
Read the detailed description
Primary Objectives
To determine the safety and tolerability of fulvestrant, palbociclib and erdafitinib in patients with ER+/HER2-/FGFR-amplified MBC.
Secondary Objectives
- To determine the anti-tumor effect of fulvestrant, palbociclib and erdafitinib in patients with ER+/HER2-/FGFR-amplified MBC.
- Pharmacokinetic assessments of erdafitinib
Correlative Objectives
- To determine the therapeutic predictive role of FGFR1-4, CCND1-2, CDK4 and CDK6 amplifications, and RB1 and ESR1 mutations on clinical outcome
- To determine if the FGFR1 amplification levels is an early surrogate of response
- To determine if the cfDNA results at disease progression show new genomic alterations potentially associated with resistance to CDK4/6 and FGFR inhibition
- To determine pharmacodynamic biomarkers of FGFR inhibition
- Conditions
- Metastatic Breast Cancer
- Being tested
- Erdafitinib, Palbociclib, Fulvestrant
- Keywords
- FGFR inhibitor, ER+ metastatic breast cancer, CDK4/6 inhibitor, Endocrine therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErdafitinibDrug
Also called JNJ-42756493
4mg - 8mg
PalbociclibDrug
Also called Ibrance
125 mg
FulvestrantDrug
Also called Faslodex
500 mg
| Study group | Role | What they receive |
|---|---|---|
| Escalation | Experimental | Fulvestrant - injection into muscle 1 time per month
Palbociclib capsule taken by mouth 1 time per day every 21 days followed by 1 week of rest (no drug taken)
Erdafitinib tablet taken by mouth 1 time per day Receives: Drug: Erdafitinib; Drug: Palbociclib; Drug: Fulvestrant |
| Expansion | Experimental | Fulvestrant - injection into muscle 1 time per month
Palbociclib capsule taken by mouth 1 time per day every 21 days followed by 1 week of rest (no drug taken)
Erdafitinib tablet taken by mouth 1 time per day Receives: Drug: Erdafitinib; Drug: Palbociclib; Drug: Fulvestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Dose Limiting Toxicities (DLT) in the First Cycle for the Determination of the Maximum Tolerated Dose (MTD)
Number of participants with DLT in the first cycle for the determination of the MTD.
Measured: From the time of randomization up to 4 weeks of treatment (cycle 1), for each patient
Secondary outcomes (8)
Progression-free Survival
Assessment of clinical impact [anti-tumor effect] of the combination of erdafitinib, palbociclib and fulvestrant in patients with ER+/ FGFR amplified metastatic breast cancer will be assessed by measuring the interval (in months) between treatment initiation and disease progression. Progression-free survival (PFS) time is defined as the time from treatment initiation to progression date or death (whichever comes first). Those alive without prpgression is censored at the last date of known alive. Median PFS time and 95% confidence intervals are obtained using Kaplan-meier method.
Measured: Imaging studies will be performed every 8 weeks from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
Overall Response Rate
Assessment of clinical impact [anti-tumor effect] of the combination of erdafitinib, palbociclib and fulvestrant in patients with ER+/ FGFR amplified metastatic breast cancer by measure the rate (%) of complete and partial responses seen in patients with measurable disease. The response of a patient will be evaluated using Solid Tumor Response Criteria RECIST v1.1.
Measured: Imaging studies will be performed every 8 weeks from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
Clinical Benefit Rate (CBR; Complete Response + Partial Response + Stable Disease Without Disease Progression at 6 Months)
Assessment of clinical impact [anti-tumor effect] of the combination of erdafitinib, palbociclib and fulvestrant in patients with ER+/ FGFR amplified metastatic breast cancer by measure the rate (%) of complete and partial responses + stability of disease at 6 months seen in patients with measurable disease. Response of a patient was evaluated using Solid Tumor Response Criteria -RECIST v1.1.
Measured: From the time of randomization up to 6 months for each patient
Pharmacokinetic Assessment of Erdafitinib - Area Under the Curve (AUC)
The area under the plasma concentration-time curve from time zero to the last measurable concentration
Measured: From the time of randomization up to 4 weeks of treatment for each patient
Pharmacokinetic Assessment of Erdafitinib - Cmax (Maximum Plasma Concentration)
The maximum (peak) observed plasma drug concentration after oral dose administration
Measured: From the time of randomization up to 4 weeks of treatment for each patient
Pharmacokinetic Assessment of Erdafitinib - Tmax
Time to reach maximum (Cmax) plasma drug concentration after oral dose administration (time)
Measured: From the time of randomization up to 4 weeks of treatment for each patient
Pharmacokinetic Assessment of Erdafitinib - CL/F
Apparent total body clearance of drug from the plasma after oral administration
Measured: From the time of randomization up to 4 weeks of treatment for each patient
Incidence of Treatment-Emergent Adverse Events [Tolerability]
Assessment of adverse events throughout the study. The number of patients who had any grade of adverse events were reported.
Measured: From date of randomization until 28 days post treatment discontinuation from any cause, assessed up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2017
- Study start18 Aug 2017
- Primary completion30 Apr 2021
- Study completion20 Mar 2024
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 Metastatic Breast 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Brent Rexer, Vanderbilt-Ingram Cancer Center
- Investigators
- Brent Rexer, MD, PhD, Principal investigator, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03238196
- Sponsor's protocol ID
- VICC BRE 16126
- Status last verified
- Oct 2024
- First submitted
- 24 Jul 2017
- Last updated
- 14 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gonzalez-Ericsson PI, Unni N, Jhaveri K, Stringer-Reasor E, Liu Q, Wang Y, Sanchez V, Garcia G, Sanders ME, Lehmann BD, Balko JM, Park B, Rexer BN, Mayer IA, Arteaga CL. Phase Ib Trial of Fulvestrant, Palbociclib, and Erdafitinib, a pan-FGFR Tyrosine Kinase Inhibitor, in HR+/HER2- Metastatic Breast Cancer. Clin Cancer Res. 2025 Sep 2;31(17):3652-3661. doi: 10.1158/1078-0432.CCR-24-3803.
PubMed 40627530
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Trial of Fulvestrant, Palbociclib (CDK4/6 Inhibitor) and Erdafitinib (JNJ- 42756493,Pan-FGFR Tyrosine Kinase Inhibitor) in ER+/HER2-/FGFR-Amplified Metastatic Breast Cancer (MBC)
- ClinicalTrials.gov ID
- NCT03238196
- Acronym / sponsor ID
- VICC BRE 16126
- Conditions
- Metastatic Breast Cancer
- Keywords
- FGFR inhibitor, ER+ metastatic breast cancer, CDK4/6 inhibitor, Endocrine therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 18 Aug 2017 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 20 Mar 2024 (actual)
- First posted
- 3 Aug 2017 (actual)
- Results
- Posted 16 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, multi-institution, phase Ib trial that evaluates the safety and tolerability and preliminary anti-tumor activity of fulvestrant, palbociclib and erdafitinib in patients with ER+/HER2-/FGFR-amplified metastatic breast cancer.
Detailed description
Primary Objectives
To determine the safety and tolerability of fulvestrant, palbociclib and erdafitinib in patients with ER+/HER2-/FGFR-amplified MBC.
Secondary Objectives
- To determine the anti-tumor effect of fulvestrant, palbociclib and erdafitinib in patients with ER+/HER2-/FGFR-amplified MBC.
- Pharmacokinetic assessments of erdafitinib
Correlative Objectives
- To determine the therapeutic predictive role of FGFR1-4, CCND1-2, CDK4 and CDK6 amplifications, and RB1 and ESR1 mutations on clinical outcome
- To determine if the FGFR1 amplification levels is an early surrogate of response
- To determine if the cfDNA results at disease progression show new genomic alterations potentially associated with resistance to CDK4/6 and FGFR inhibition
- To determine pharmacodynamic biomarkers of FGFR inhibition
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Escalation | Experimental | Drug: Erdafitinib, Drug: Palbociclib, Drug: FulvestrantFulvestrant - injection into muscle 1 time per month Palbociclib capsule taken by mouth 1 time per day every 21 days followed by 1 week of rest (no drug taken) Erdafitinib tablet taken by mouth 1 time per day |
| Expansion | Experimental | Drug: Erdafitinib, Drug: Palbociclib, Drug: FulvestrantFulvestrant - injection into muscle 1 time per month Palbociclib capsule taken by mouth 1 time per day every 21 days followed by 1 week of rest (no drug taken) Erdafitinib tablet taken by mouth 1 time per day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Patients must be able to swallow and retain oral medication
- Patients must be ≥ 18 years of age
- Female patients of no childbearing potential must be post-menopausal. Postmenopausal female subjects should be defined prior to protocol enrollment by any of the following:
- Participants at least 60 years of age; OR
- Participants under 60 years of age and naturally (spontaneous, no alternative pathologic or physiological cause) amenorrhea for at least 12 months; OR
Key exclusion criteria (28 listed)
- Prior use of an FGFR inhibitor
- More than 2 lines of chemotherapy in the metastatic setting. No limit on endocrine therapy lines. Prior exposure to CDK4/6 inhibitor acceptable.
- Radiation therapy ≤ 2 weeks prior to study entry. Patients who have received prior radiotherapy must have recovered from toxicity (≤ grade 1) induced by this treatment (except for alopecia)
- Prior cancer therapy (except for endocrine therapy) must have been discontinued for 1 week prior to initiation of study drugs
- Concurrent anti-cancer therapy other than the ones specified in the protocol is not permitted during study participation. Bisphosphonates or denosumab are allowed
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 |
|---|---|---|
| ErdafitinibAlso: JNJ-427564934mg - 8mg | Drug | Escalation, Expansion |
| PalbociclibAlso: Ibrance125 mg | Drug | Escalation, Expansion |
| FulvestrantAlso: Faslodex500 mg | Drug | Escalation, Expansion |
Primary outcome
Number of Participants With Dose Limiting Toxicities (DLT) in the First Cycle for the Determination of the Maximum Tolerated Dose (MTD)
Time frame: From the time of randomization up to 4 weeks of treatment (cycle 1), for each patient
Number of participants with DLT in the first cycle for the determination of the MTD.
8 secondary outcomes
Progression-free Survival
Time frame: Imaging studies will be performed every 8 weeks from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
Overall Response Rate
Time frame: Imaging studies will be performed every 8 weeks from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
Clinical Benefit Rate (CBR; Complete Response + Partial Response + Stable Disease Without Disease Progression at 6 Months)
Time frame: From the time of randomization up to 6 months for each patient
Pharmacokinetic Assessment of Erdafitinib - Area Under the Curve (AUC)
Time frame: From the time of randomization up to 4 weeks of treatment for each patient
Pharmacokinetic Assessment of Erdafitinib - Cmax (Maximum Plasma Concentration)
Time frame: From the time of randomization up to 4 weeks of treatment for each patient
Pharmacokinetic Assessment of Erdafitinib - Tmax
Time frame: From the time of randomization up to 4 weeks of treatment for each patient
Pharmacokinetic Assessment of Erdafitinib - CL/F
Time frame: From the time of randomization up to 4 weeks of treatment for each patient
Incidence of Treatment-Emergent Adverse Events [Tolerability]
Time frame: From date of randomization until 28 days post treatment discontinuation from any cause, assessed up to 48 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40627530Gonzalez-Ericsson PI, Unni N, Jhaveri K, Stringer-Reasor E, Liu Q, Wang Y, Sanchez V, Garcia G, Sanders ME, Lehmann BD, Balko JM, Park B, Rexer BN, Mayer IA, Arteaga CL. Phase Ib Trial of Fulvestrant, Palbociclib, and Erdafitinib, a pan-FGFR Tyrosine Kinase Inhibitor, in HR+/HER2- Metastatic Breast Cancer. Clin Cancer Res. 2025 Sep 2;31(17):3652-3661. doi: 10.1158/1078-0432.CCR-24-3803.
- Clinical Trials Webpage - Vanderbilt-Ingram Cancer CenterLink provided by the sponsor.
- Mycancergenome - FGFR1 WebpageLink 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.
Brent Rexer, MD, PhD principal investigator
Vanderbilt-Ingram Cancer Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Erdafitinib, Palbociclib and Fulvestrant in people with Metastatic Breast Cancer, run by Vanderbilt-Ingram Cancer Center at 6 sites 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 28 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2024. 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 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 16 Feb 2023). 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 (DLT) in the First Cycle for the Determination of the Maximum Tolerated Dose (MTD) (time frame: From the time of randomization up to 4 weeks of treatment (cycle 1), for each patient). 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 NCT03238196, 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 14 Nov 2024.