Breast CancerPhase 2NCT02624700
2nd Line Treatment With Pemetrexed and Sorafenib for Recurrent or Metastatic Triple Negative Breast Cancer
A Phase 2 study testing Experimental Arm A: Pemetrexed, Experimental Arm A: Sorafenib and Experimental Arm B: Pemetrexed in people with Breast Cancer and Metastatic Breast Cancer, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
This phase 2 clinical trial will evaluate the efficacy of the combination of pemetrexed and sorafenib in patients with recurrent or metastatic Triple Negative Breast Cancer (TNBC). Candidate pharmacodynamic and predictive biomarkers will also be evaluated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Metastatic Breast Cancer, Recurrent Breast Cancer
- What is being tested?
- Experimental Arm A: Pemetrexed, Experimental Arm A: Sorafenib and Experimental Arm B: Pemetrexed
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2016to 10 Jul 2019
- Phase
- Phase 2
- 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
- Unresectable adenocarcinoma of the breast involving chest wall, regional nodes, or distant site
- Breast cancer determined to be estrogen receptor (ER)-negative and progesterone receptor (PgR)-negative defined for this study as < 10% tumor staining by immunohistochemistry (IHC) (Note: Eligibility should be based on the ER and PgR status reported at the time of the most recent biopsy or resection).
- Breast cancer determined to be HER2-negative per current American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) HER2 Guidelines (Note: Eligibility should be based on the HER2 status reported at the time of the most recent biopsy or resection).
- At least one prior regimen for treatment of recurrent or metastatic disease (Note: Prior regimen for recurrent or metastatic disease is not required if the patient had disease progression or recurrence during or within the first 6 months following completion of adjuvant or neoadjuvant chemotherapy.)
- Measurable disease per RECIST v1.1
- Age ≥ 18 years
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- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Ability to swallow oral medications
- Adequate bone marrow function as defined below:
- Absolute neutrophil count (ANC) ≥ 1,200/mm3
- Platelet count ≥ 100,000/mm3
- Hemoglobin ≥ 9.0 g/dL, which must be stable in the opinion of the investigator without a history of transfusion dependence.
- Adequate renal function as defined below:
- Calculated creatinine clearance ≥ 45 mL/min
- Adequate hepatic function as defined below:
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for the laboratory
- Aspartate aminotransferase (AST) ≤ 3 x ULN for the laboratory, except in the presence of known hepatic metastasis, wherein the AST may be ≤ 5 x ULN
- Alanine aminotransferase (ALT) ≤ 3 x ULN for the laboratory, except in the presence of known hepatic metastasis, wherein the ALT may be ≤ 5 x ULN
- Serum B12 and folate levels ≥ lower limit of normal (LLN) for the laboratory (Note: Patients may begin B12 and folic acid supplementation and be reconsidered for participation in the study when levels are ≥ LLN for the laboratory).
- Ability to take folic acid, vitamin B12, and dexamethasone according to the protocol instructions
- Ability to interrupt chronic non-steroidal anti-inflammatory drugs (NSAIDs) beginning 2 days before (5 days before for long-acting NSAIDs) and continuing for 2 days following administration of each pemetrexed dose
- Toxicities from previous cancer therapies resolved to ≤ grade 1 unless specified otherwise in the inclusion or exclusion criteria
- Women who are not postmenopausal or have not undergone hysterectomy must have a documented negative serum pregnancy test within 7 days prior to initiating study treatment. Note: Postmenopausal is defined as one or more of the following:
- Age ≥ 60 years
- Age < 60 years and amenorrheic for at least 1 year with follicle-stimulating hormone (FSH) and plasma estradiol levels in the postmenopausal range
- Bilateral oophorectomy
- A woman of child-bearing potential (WCBP) and a male patient with partner who is a WCBP must agree to use a medically accepted method for preventing pregnancy for the duration of study treatment and for 2 months following completion of study treatment.
- Ability to understand and willingness to sign the consent form written in English
Who cannot join
- Any investigational agent within 4 weeks prior to initiating study treatment
- Anticancer therapy within 2 weeks prior to initiating study treatment
- Plans for concurrent anticancer therapy except as permitted in Section 6.7.11
- Known or presumed intolerance of pemetrexed or sorafenib
- Known or suspected malabsorption condition or obstruction
- Brain metastases meeting either of the following exclusion criteria:
Show all 39Show fewer
- Untreated brain metastases
- After completion of brain-directed therapy, the patient has not been able to tolerate discontinuation of steroids or a decrease in steroid dose
- Leptomeningeal metastasis
- Any documented history of clinically identifiable thrombotic, embolic, venous, or arterial events such as cerebrovascular accident, transient ischemic attack, deep vein thrombosis, or pulmonary embolism within 6 months prior to initiating study treatment (Note: Patients with an asymptomatic catheter-related thrombus or a tumor-associated thrombus of locally-involved vessels or with incidental asymptomatic filling defects identified on imaging are not excluded.)
- Contraindication to antiangiogenic agents, including:
- Serious non-healing wound, non-healing ulcer, or bone fracture
- Major surgical procedure or significant traumatic injury within 4 weeks prior to initiating study treatment
- Pulmonary hemorrhage/bleeding event ≥ grade 2 (CTCAE v4.0) within 12 weeks prior to initiating study treatment
- Any other hemorrhage/bleeding event ≥ grade 3 (CTCAE v4.0) within 12 weeks prior to initiating study treatment
- Systolic blood pressure (BP) > 160 mmHg or diastolic BP > 100 mmHg despite optimal medical management
- QT interval, corrected (QTc) > 480 ms (≥ grade 2) on a 12-lead electrocardiogram (ECG)
- If baseline QTc on screening ECG is ≥ grade 2:
- Check potassium and magnesium serum levels
- Correct any identified hypokalemia and/or hypomagnesemia and repeat ECG to confirm exclusion of patient due to QTc
- For patients with heart rate < 60 bpm or > 100 bpm, manual read of the QT interval by a cardiologist is required, with Fridericia correction applied to determine QT interval with correction using Fridericia's formula (QTcF) which must be used to determine eligibility (Note: If heart rate is 60-100 bpm, manual read of the QT interval and correction to QTcF is not required).
- Active or clinically significant cardiac disease including any of the following:
- Unstable angina (eg, anginal symptoms at rest) or onset of angina within 3 months prior to initiating study treatment
- Myocardial infarction within 6 months prior to initiating study treatment
- Ventricular arrhythmias requiring anti-arrhythmic therapy other than beta blockers
- New York Heart Association (NYHA) class III or IV congestive heart failure
- Serious (ie, ≥ grade 3) uncontrolled infection
- Uncontrolled effusion
- Known human immunodeficiency virus (HIV) seropositivity (Note: HIV testing is not required)
- Chronic or active hepatitis B or C infection requiring treatment with antiviral therapy
- Seizure disorder requiring enzyme-inducing anti-epileptic drugs (EIAEDs) (Note: If the seizure disorder can be managed with agents that are not EIAEDs (eg, levetiracetam or valproate), the patient should not be excluded).
- Planned ongoing treatment with other drugs thought to potentially have adverse interactions with either of the study drugs; if such drugs have been used, patients must have discontinued these agents at least 2 weeks (or as noted below) prior to initiating study treatment. Examples include:
- STRONG CYP3A4 inducers
- Note: Examples of clinical inducers of cytochrome p450 (CYP) isozymes and classification of strong, moderate, and weak interactions are available through the FDA website (Table 3-3 of website:): http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/DrugInteractionsLabeling/ucm093664.htm
- Immunosuppressants (eg, tacrolimus, leflunomide, tofacitinib, roflumilast, pimecrolimus)
- NSAIDs (Note: NSAIDs must be discontinued within 5 days prior to initiating study treatment)
- Pregnancy or breastfeeding
- Previous malignancy with the following exceptions: adequately treated basal cell carcinoma or squamous cell carcinoma of the skin; any in situ malignancy; adequately treated Stage 1 and Stage 2 cancer from which the patient is currently in remission; any other cancer from which the patient has been disease-free for 3 years
- Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298
About this study
Official title: Phase 2 Study of Pemetrexed and Sorafenib for Treatment of Recurrent or Metastatic Triple Negative Breast Cancer
This phase 2 clinical trial will evaluate the efficacy of the combination of pemetrexed and sorafenib in patients with recurrent or metastatic Triple Negative Breast Cancer (TNBC). Candidate pharmacodynamic and predictive biomarkers will also be evaluated.
Read the detailed description
This study is a single-arm, open-label, phase 2 study of a regimen of dose-dense pemetrexed and sorafenib to determine the objective response rate in patients with recurrent or metastatic TNBC. Eligible patients will be those who have had disease progression during or after treatment for recurrent or metastatic disease with one previous cytotoxic chemotherapy regimen. Additionally, patients with disease progression or recurrence during or within 6 months of completion of adjuvant or neoadjuvant therapy are also eligible. Correlative studies will be conducted using blood samples and archived tumor samples.
Simon's two-stage design will be utilized in this study. In the first stage, if there are ≤ 3 patients of the first 18 efficacy-evaluable patients who have a partial or complete response, then the trial will end for futility. If ≥ 4 patients have a partial or complete response, patient accrual will continue in the second stage to add 10 more efficacy-evaluable patients.
The total sample size for the Simon's two-stage design is 35 patients. Based on enrollment of 2-3 patients per month, the expected enrollment period will be about 12-18 months.
Patients were enrolled in 2 sequential groups, referred to as "arms" for the purposes of reporting results by group. The initial group of patients were enrolled in what is referred to here as Arm A. After a study amendment patients were enrolled in what is referred to here as Arm B.
- Being tested
- Experimental Arm A: Pemetrexed, Experimental Arm A: Sorafenib, Experimental Arm B: Pemetrexed, Experimental Arm B: Sorafenib
- Keywords
- ER-negative, PgR-negative, Human epidermal growth factor receptor 2 (HER2-negative), Triple Negative Breast Cancer, HER2-negative
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Arm A: PemetrexedDrug
Also called Alimta
Treatment schedule is administered on day 1 of each 14-day cycle by Intravenous infusion over 10 minutes with a dose of 500 mg/m2. If necessary, the duration of the pemetrexed infusion may be extended to a maximum of 20 minutes.
Experimental Arm A: SorafenibDrug
Also called Nexavar
Treatment schedule is administered twice daily by mouth on an empty stomach on days 1-5 of each 14-day cycle with a dose of 400 mg.
Experimental Arm B: PemetrexedDrug
Also called Alimta
Treatment schedule is administered on day 1 of each 21-day cycle by Intravenous infusion over 10 minutes with a dose of 375 mg/m2. If necessary, the duration of the pemetrexed infusion may be extended to a maximum of 20 minutes.
Experimental Arm B: SorafenibDrug
Also called Nexavar
Treatment schedule is administered twice daily by mouth on an empty stomach on days 1-5 of each 21-day cycle with a dose of 200 mg.
| Study group | Role | What they receive |
|---|---|---|
| A: Pemetrexed + Sorafenib | Experimental | Pemetrexed 500 mg/m2 IV Day 1 + Sorafenib 400mg PO twice each day on Days 1-5 of each 14-day cycle Receives: Drug: Experimental Arm A: Pemetrexed; Drug: Experimental Arm A: Sorafenib |
| B: Pemetrexed + Sorafenib | Experimental | Pemetrexed 375mg/m2 intravenously (IV) Day 1 + Sorafenib 200mg by mouth twice daily on days 1-5, every 21 days of each cycle. Receives: Drug: Experimental Arm B: Pemetrexed; Drug: Experimental Arm B: Sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percentage of Patients With Objective Response Either Partial Response (PR) or Complete Response(CR).
The primary endpoint is the percentage of patients with HER2-negative metastatic breast cancer achieving an objective response (either PR or CR). Overall Response = CR+PR, based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
Measured: 2 years 3 months
Secondary outcomes (3)
The Duration of Progression-free Survival (PFS).
Progression-free survival (PFS) defined as the time (in days) from initiation of study treatment until documented disease progression or death, whichever occurs first.
Measured: 2 years 3 months
The 2-year Survival Rate After Initial Study Treatment.
The proportion of patients who are alive at 2 years following initiation of study treatment.
Measured: 2 years 3 months
Number of Participants at Risk and Affected by Adverse Events (AEs)
To further characterize the safety and side effect profile of the combination. All participants' AEs will be listed and summary descriptive statistics will be calculated.The Adverse events (AEs) are reported using criteria in the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0).
Measured: 2 years 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2015 (estimated)
- Study start28 Jan 2016
- Primary completion10 Jul 2019
- Study completion10 Jul 2019
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 CancerStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company, Bayer
- Responsible party
- Sponsor
- Investigators
- Andrew S Poklepovic, MD, Principal investigator, Massey Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02624700
- Sponsor's protocol ID
- MCC-14-10790
- Other IDs
- HM20005967, NCI-2015-02190
- Status last verified
- Jun 2020
- First submitted
- 3 Dec 2015
- Last updated
- 14 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Pemetrexed and Sorafenib for Treatment of Recurrent or Metastatic Triple Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT02624700
- Acronym / sponsor ID
- MCC-14-10790
- Keywords
- ER-negative, PgR-negative, Human epidermal growth factor receptor 2 (HER2-negative), Triple Negative Breast Cancer, HER2-negative
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Eli Lilly and Company, Bayer
- Study start
- 28 Jan 2016 (actual)
- Primary completion
- 10 Jul 2019 (actual)
- Study completion
- 10 Jul 2019 (actual)
- First posted
- 8 Dec 2015 (estimated)
- Results
- Posted 14 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase 2 clinical trial will evaluate the efficacy of the combination of pemetrexed and sorafenib in patients with recurrent or metastatic Triple Negative Breast Cancer (TNBC). Candidate pharmacodynamic and predictive biomarkers will also be evaluated.
Detailed description
This study is a single-arm, open-label, phase 2 study of a regimen of dose-dense pemetrexed and sorafenib to determine the objective response rate in patients with recurrent or metastatic TNBC. Eligible patients will be those who have had disease progression during or after treatment for recurrent or metastatic disease with one previous cytotoxic chemotherapy regimen. Additionally, patients with disease progression or recurrence during or within 6 months of completion of adjuvant or neoadjuvant therapy are also eligible. Correlative studies will be conducted using blood samples and archived tumor samples.
Simon's two-stage design will be utilized in this study. In the first stage, if there are ≤ 3 patients of the first 18 efficacy-evaluable patients who have a partial or complete response, then the trial will end for futility. If ≥ 4 patients have a partial or complete response, patient accrual will continue in the second stage to add 10 more efficacy-evaluable patients.
The total sample size for the Simon's two-stage design is 35 patients. Based on enrollment of 2-3 patients per month, the expected enrollment period will be about 12-18 months.
Patients were enrolled in 2 sequential groups, referred to as "arms" for the purposes of reporting results by group. The initial group of patients were enrolled in what is referred to here as Arm A. After a study amendment patients were enrolled in what is referred to here as Arm B.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: Pemetrexed + Sorafenib | Experimental | Drug: Experimental Arm A: Pemetrexed, Drug: Experimental Arm A: SorafenibPemetrexed 500 mg/m2 IV Day 1 + Sorafenib 400mg PO twice each day on Days 1-5 of each 14-day cycle |
| B: Pemetrexed + Sorafenib | Experimental | Drug: Experimental Arm B: Pemetrexed, Drug: Experimental Arm B: SorafenibPemetrexed 375mg/m2 intravenously (IV) Day 1 + Sorafenib 200mg by mouth twice daily on days 1-5, every 21 days of each cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Unresectable adenocarcinoma of the breast involving chest wall, regional nodes, or distant site
- Breast cancer determined to be estrogen receptor (ER)-negative and progesterone receptor (PgR)-negative defined for this study as < 10% tumor staining by immunohistochemistry (IHC) (Note: Eligibility should be based on the ER and PgR status reported at the time of the most recent biopsy or resection).
- Breast cancer determined to be HER2-negative per current American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) HER2 Guidelines (Note: Eligibility should be based on the HER2 status reported at the time of the most recent biopsy or resection).
- At least one prior regimen for treatment of recurrent or metastatic disease (Note: Prior regimen for recurrent or metastatic disease is not required if the patient had disease progression or recurrence during or within the first 6 months following completion of adjuvant or neoadjuvant chemotherapy.)
- Measurable disease per RECIST v1.1
Key exclusion criteria (39 listed)
- Any investigational agent within 4 weeks prior to initiating study treatment
- Anticancer therapy within 2 weeks prior to initiating study treatment
- Plans for concurrent anticancer therapy except as permitted in Section 6.7.11
- Known or presumed intolerance of pemetrexed or sorafenib
- Known or suspected malabsorption condition or obstruction
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 |
|---|---|---|
| Experimental Arm A: PemetrexedAlso: AlimtaTreatment schedule is administered on day 1 of each 14-day cycle by Intravenous infusion over 10 minutes with a dose of 500 mg/m2. If necessary, the duration of the pemetrexed infusion may be extended to a maximum of 20 minutes. | Drug | A: Pemetrexed + Sorafenib |
| Experimental Arm A: SorafenibAlso: NexavarTreatment schedule is administered twice daily by mouth on an empty stomach on days 1-5 of each 14-day cycle with a dose of 400 mg. | Drug | A: Pemetrexed + Sorafenib |
| Experimental Arm B: PemetrexedAlso: AlimtaTreatment schedule is administered on day 1 of each 21-day cycle by Intravenous infusion over 10 minutes with a dose of 375 mg/m2. If necessary, the duration of the pemetrexed infusion may be extended to a maximum of 20 minutes. | Drug | B: Pemetrexed + Sorafenib |
| Experimental Arm B: SorafenibAlso: NexavarTreatment schedule is administered twice daily by mouth on an empty stomach on days 1-5 of each 21-day cycle with a dose of 200 mg. | Drug | B: Pemetrexed + Sorafenib |
Primary outcome
The Percentage of Patients With Objective Response Either Partial Response (PR) or Complete Response(CR).
Time frame: 2 years 3 months
The primary endpoint is the percentage of patients with HER2-negative metastatic breast cancer achieving an objective response (either PR or CR). Overall Response = CR+PR, based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
3 secondary outcomes
The Duration of Progression-free Survival (PFS).
Time frame: 2 years 3 months
The 2-year Survival Rate After Initial Study Treatment.
Time frame: 2 years 3 months
Number of Participants at Risk and Affected by Adverse Events (AEs)
Time frame: 2 years 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Andrew S Poklepovic, MD principal investigator
Massey Cancer Center
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 Experimental Arm A: Pemetrexed, Experimental Arm A: Sorafenib and Experimental Arm B: Pemetrexed in people with Breast Cancer and Metastatic Breast Cancer, run by Virginia Commonwealth University 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 28 inclusion and 39 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 14 Jul 2020. 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 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?
Yes. Results are posted in the registry (first posted 14 Jul 2020). 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?
The Percentage of Patients With Objective Response Either Partial Response (PR) or Complete Response(CR). (time frame: 2 years 3 months). 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 14 Jul 2020.