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Recurrent Fallopian Tube CarcinomaPhase 2NCT01305213

Bevacizumab With or Without Fosbretabulin Tromethamine in Treating Patients With Recurrent or Persistent Ovarian Epithelial, Fallopian Tube, or Peritoneal Cavity Cancer

A Phase 2 study testing Bevacizumab, Fosbretabulin Tromethamine and Laboratory Biomarker Analysis in people with Recurrent Fallopian Tube Carcinoma and Recurrent Ovarian Carcinoma, run by National Cancer Institute (NCI) at 51 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This randomized phase II trial studies how well bevacizumab with or without fosbretabulin tromethamine works in treating patients with ovarian epithelial, fallopian tube, or peritoneal cavity cancer that has come back or is persistent. Monoclonal antibodies, such as bevacizumab, find tumor cells and help kill them. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Bevacizumab, Fosbretabulin Tromethamine and Laboratory Biomarker Analysis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
107 participants
Where
51 sitesUnited States
Study dates
21 Mar 2011to 3 Nov 2016
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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma; histologic documentation of the original primary tumor is required via the pathology report
  • Patients must have measurable disease or detectable (non-measurable) disease:
  • Measurable disease defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded); each lesion must be >= 10 mm when measured by computed tomography (CT) scan, magnetic resonance imaging (MRI) or caliper measurement by clinical exam, or >= 20 mm when measured by chest x-ray; lymph nodes must be >= 15 mm in short axis when measured by CT or MRI
  • Detectable disease in a patient is defined as one who does not have measurable disease but has at least one of the following conditions:
  • Baseline values of CA-125 at least 2 x upper limit of normal (ULN)
  • Ascites and/or pleural effusion attributed to tumor
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  • Solid and/or cystic abnormalities on radiographic imaging that do not meet RECIST 1.1 definition for target lesions
  • Patients in the measurable disease cohort must have at least one ?target lesion? to be used to assess response on this protocol as defined by RECIST 1.1; tumors within a previously irradiated field will be designated as ?non-target? lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
  • Patients must not be eligible for a higher priority Gynecologic Oncology Group (GOG) protocol, if one exists; in general, this would refer to any active GOG phase 3 protocol or rare tumor protocol for the same patient population
  • Patients who have had one prior treatment must have a performance status of 0, 1, or 2
  • Patients who have had two or three prior treatments must have a performance status of 0 or 1
  • Patients should be free of acute hepatitis and active infection requiring parenteral antibiotics (with the exception of uncomplicated urinary tract infection [UTI])
  • Recovery from the effects of recent surgery, radiotherapy, or chemotherapy
  • Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration
  • Any other prior therapy directed at the malignant tumor, including chemotherapy, biological/targeted and immunologic agents, must be discontinued at least 3 weeks prior to registration (including small molecules and murine monoclonal antibodies); chimeric or human or humanized monoclonal antibodies (including bevacizumab) or vascular endothelial growth factor (VEGF) receptor fusion protein (including VEGF Trap/aflibercept) must be discontinued for at least 12 weeks prior to registration; no investigational therapy within 30 days prior to the first date of study treatment
  • Any prior radiation therapy must be discontinued at least 4 weeks prior to registration
  • Prior therapy:
  • Patients must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound; this initial treatment may have included intraperitoneal therapy, consolidation, non-cytotoxic (biologic/targeted agents, such as bevacizumab) or extended therapy administered after surgical or non-surgical assessment
  • Patients are allowed to receive, but are not required to receive, two additional cytotoxic regimens for management of recurrent or persistent disease, with no more than 1 non-platinum, non-taxane regimen
  • Patients are allowed to receive, but are not required to receive, non-cytotoxic (biologic/targeted agents, such as bevacizumab) therapy as part of their primary treatment regimen; patients must have NOT received any non-cytotoxic therapy (biologic/targeted agents) for management of recurrent or persistent disease (e.g., GOG protocol 170 series drugs or bevacizumab)
  • For the purposes of this study, poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitors will be considered ?cytotoxic?, and prior treatment with PARP inhibitors for primary or recurrent disease WILL be allowed (either alone or in combination with chemotherapy)
  • Patients with both platinum-sensitive and platinum-resistant disease are eligible; patients with platinum-refractory disease are NOT eligible; platinum-refractory disease is defined as patients who have progression of disease during the preceding platinum treatment
  • Definitions:
  • Platinum-free interval (PFI) is the period of time from the date of last platinum therapy to the date of progression (recurrence by CA-125, CT, etc.; CT is preferred) of disease or initiation of subsequent therapy (whichever occurs first); non-platinum maintenance therapy (e.g., extending taxane treatment) is excluded as a ?subsequent therapy;? if the patient?s last regimen used platinum, and she has NOT progressed before enrolling onto this study, then her PFI will be calculated from the date of last platinum therapy to the date of registration onto this study
  • PFI for the most recent platinum therapy will need to be calculated before enrollment onto this study for stratification purposes (i.e. balanced randomization)
  • Patients who have a PFI =< 182 days (26 weeks) are defined as ?platinum resistant;? patients who have 182 < PFI =< 365 days are defined as ?GOG platinum sensitive;? finally, patients with PFI > 365 days are defined as ?platinum sensitive?
  • ANC greater than or equal to 1,500/mcl
  • Platelets greater than or equal to 100,000/mcl
  • Hemoglobin greater than or equal to 9 g/dL
  • Creatinine less than or equal to 1.5 x institutional upper limit of normal (ULN)
  • Potassium within the normal reference range for the laboratory; correction with supplements is acceptable
  • Magnesium within the normal reference range for the laboratory; correction with supplements is acceptable
  • Calcium within the normal reference range for the laboratory; correction with supplements is acceptable
  • Bilirubin less than or equal to 1.5 x ULN
  • Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< less than or equal to 3 x ULN
  • Alkaline phosphatase less than or equal to 2.5 x ULN
  • Prothrombin time (PT) such that international normalized ratio (INR) is less than or equal to 1.5 x ULN (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin) and a partial thromboplastin time (PTT) less than or equal to 1.5 x ULN
  • Urine protein should be screened by urine analysis; if protein is 2+ or higher, a 24-hour urine protein should be obtained and the level must be < 1,000 mg (< 1.0 g/24 hrs) for patient enrollment
  • Patients of childbearing potential must have a negative serum pregnancy test prior to the study entry and be practicing an effective form of contraception
  • Patients must have signed an approved informed consent and authorization permitting the release of personal health information
  • Patients must meet pre-entry requirements

Who cannot join

  • Patients who have received prior fosbretabulin tromethamine or any other vascular disrupting agent (VDA)
  • Patients with other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies as noted below, are excluded if there is any evidence of other malignancy being present within the last three years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
  • Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis OTHER THAN for the treatment of ovarian, fallopian tube or primary peritoneal cancer within the last three years are excluded; prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease
  • Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of ovarian, fallopian tube or primary peritoneal cancer within the last three years are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease
  • Patients with serious non-healing wound, ulcer, or bone fracture; this includes history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 90 days prior to the first date of study treatment
  • Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels
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  • Patients with history or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months prior to the first date of treatment on this study
  • Patients with clinically significant cardiovascular disease; this includes:
  • Uncontrolled hypertension, defined as systolic > 150 mm Hg or diastolic > 90 mm Hg despite antihypertensive medications
  • History of torsade de pointes, ventricular tachycardia or fibrillation, pathologic sinus bradycardia (< 60 beats per minute [bpm]), heart block (excluding 1st degree block being, PR interval prolongation only), congenital long QT syndrome, new ST segment elevation or depression, or new Q waves on electrocardiogram (ECG)
  • Patients with corrected QT interval (QTc) > 470 msec
  • Requirement for receiving any drug known to prolong the QTc interval, including anti-arrhythmic medications; stable regimen of antidepressants of the selective serotonin reuptake inhibitor (SSRI) class is allowed
  • Myocardial infarction or unstable angina within 6 months prior to registration
  • New York Heart Association (NYHA) class II or greater congestive heart failure
  • Serious cardiac arrhythmia requiring medication; this does not include asymptomatic, atrial fibrillation with controlled ventricular rate
  • Patients who have received prior treatment with an anthracycline (including doxorubicin and or pegylated liposomal doxorubicin [Doxil; PLD]) must have an echocardiogram assessment and are excluded if they have an ejection fraction < 50%
  • Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or greater peripheral vascular disease (at least brief [< 24 hrs] episodes of ischemia managed non-surgically and without permanent deficit)
  • Known hypersensitivity to any of the components of fosbretabulin tromethamine or bevacizumab
  • Major surgery within 28 days prior to the first date of study treatment
  • Anticipation of need for major surgical procedures during the course of the study
  • Core biopsy within 7 days prior to the first date of study treatment
  • Patients with clinical symptoms or signs of gastrointestinal obstruction and patients who require parenteral hydration and/or nutrition; patients with bowel involvement on CT scan
  • Patients with medical history or conditions not otherwise previously specified which in the opinion of the investigator should exclude participation in this study; the investigator can consult the Study Chair or Study Co-Chairs for uncertainty in this regard
  • Patients who are pregnant or nursing

Trial locations and contacts

51 sites in 1 country.

51 sites in 1 country

United States51 sites

  • Summa Akron City Hospital/Cooper Cancer Center

    Akron, Ohio, 44304

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215

  • MedStar Franklin Square Medical Center/Weinberg Cancer Institute

    Baltimore, Maryland, 21237

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

  • Providence Saint Joseph Medical Center/Disney Family Cancer Center

    Burbank, California, 91505

  • Novant Health Presbyterian Medical Center

    Charlotte, North Carolina, 28204

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

  • University of Cincinnati/Barrett Cancer Center

    Cincinnati, Ohio, 45219

  • Cleveland Clinic Cancer Center/Fairview Hospital

    Cleveland, Ohio, 44111

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

  • John Muir Medical Center-Concord Campus

    Concord, California, 94520

  • Presbyterian - Saint Lukes Medical Center - Health One

    Denver, Colorado, 80218

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Northeast Georgia Medical Center-Gainesville

    Gainesville, Georgia, 30501

  • Green Bay Oncology at Saint Vincent Hospital

    Green Bay, Wisconsin, 54301-3526

  • Saint Vincent Hospital Cancer Center Green Bay

    Green Bay, Wisconsin, 54301

  • Green Bay Oncology Limited at Saint Mary's Hospital

    Green Bay, Wisconsin, 54303

  • Greenville Health System Cancer Institute-Eastside

    Greenville, South Carolina, 29615

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • Sudarshan K Sharma MD Limited-Gynecologic Oncology

    Hinsdale, Illinois, 60521

  • Indiana University/Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • Saint Vincent Hospital and Health Care Center

    Indianapolis, Indiana, 46260

  • University of Iowa/Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242

  • Saint Dominic-Jackson Memorial Hospital

    Jackson, Mississippi, 39216

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Borgess Medical Center

    Kalamazoo, Michigan, 49048

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

  • Women's Cancer Center of Nevada

    Las Vegas, Nevada, 89169

  • Beebe Medical Center

    Lewes, Delaware, 19958

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

  • Holy Family Memorial Hospital

    Manitowoc, Wisconsin, 54221

  • Bay Area Medical Center

    Marinette, Wisconsin, 54143

  • Hillcrest Hospital Cancer Center

    Mayfield Heights, Ohio, 44124

  • Mercy Hospital

    Miami, Florida, 33133

  • Christiana Care Health System-Christiana Hospital

    Newark, Delaware, 19718

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Saint Joseph's Hospital and Medical Center

    Phoenix, Arizona, 85013

  • Maine Medical Center-Bramhall Campus

    Portland, Maine, 04102

  • Women and Infants Hospital

    Providence, Rhode Island, 02905

  • Virginia Commonwealth University/Massey Cancer Center

    Richmond, Virginia, 23298

  • Sutter Medical Center Sacramento

    Sacramento, California, 95816

  • Memorial Health University Medical Center

    Savannah, Georgia, 31404

  • Sanford Cancer Center Oncology Clinic

    Sioux Falls, South Dakota, 57104

  • Sanford USD Medical Center - Sioux Falls

    Sioux Falls, South Dakota, 57117-5134

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • SCL Health Lutheran Medical Center

    Wheat Ridge, Colorado, 80033

  • University of Massachusetts Memorial Health Care

    Worcester, Massachusetts, 01605

Other trials in United States

About this study

Official title: A Randomized Phase II Evaluation of Single-Agent Bevacizumab (NSC #704865) and Combination Bevacizumab With Fosbretabulin Tromethamine (CA4P) (NSC #752293) in the Treatment of Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma

This randomized phase II trial studies how well bevacizumab with or without fosbretabulin tromethamine works in treating patients with ovarian epithelial, fallopian tube, or peritoneal cavity cancer that has come back or is persistent. Monoclonal antibodies, such as bevacizumab, find tumor cells and help kill them. Bevacizumab and fosbretabulin tromethamine may stop the growth of ovarian cancer by blocking blood flow to the tumor. It is not yet known whether bevacizumab is more effective with or without fosbretabulin tromethamine in treating ovarian epithelial, fallopian tube, and peritoneal cavity cancer.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To estimate the progression-free survival hazard ratio of the combination of bevacizumab and fosbretabulin tromethamine (CA4P) compared to bevacizumab alone in patients with persistent or recurrent ovarian, fallopian tube, or primary peritoneal cancer.

SECONDARY OBJECTIVES:

  1. To determine the nature and degree of toxicity of fosbretabulin tromethamine plus bevacizumab.

II. To characterize and compare progression-free survival in patients with measurable disease (Response Evaluation Criteria in Solid Tumors [RECIST] criteria) and patients with detectable (non-measurable) disease between regimens.

III. To determine the overall survival for both regimens. IV. To estimate the proportion of patients with measurable disease who have objective tumor responses by treatment.

  1. To provide descriptive information about cancer antigen (CA)-125 responses by regimen and where possible by objective tumor responses.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive bevacizumab intravenously (IV) over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive bevacizumab IV over 30-90 minutes and fosbretabulin tromethamine IV over 10-20 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Being tested
Bevacizumab, Fosbretabulin Tromethamine, Laboratory Biomarker Analysis
Medical subject headings
Fallopian Tube Neoplasms, Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BevacizumabBiological

    Also called Anti-VEGF, Anti-VEGF Humanized Monoclonal Antibody, Anti-VEGF rhuMAb, Avastin

    Given IV

  • Fosbretabulin TromethamineDrug

    Also called CA4P, Zybrestat

    Given IV

  • Laboratory Biomarker AnalysisOther

    Correlative studies

Study groups in NCT01305213
Study groupRoleWhat they receive
Arm I (bevacizumab)Active comparatorPatients receive bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Receives: Biological: Bevacizumab; Other: Laboratory Biomarker Analysis
Arm II (bevacizumab, fosbretabulin tromethamine)ExperimentalPatients receive bevacizumab IV over 30-90 minutes and fosbretabulin tromethamine IV over 10-20 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Receives: Biological: Bevacizumab; Drug: Fosbretabulin Tromethamine; Other: Laboratory Biomarker Analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival (PFS)

    The time from randomization until disease progression, death, or date of last contact. Endpoints are progression or death. Patients who are not observed with an endpoint are censored.

    Measured: For those patients whose disease can be evaluated by physical examination, progression was assessed prior to each 21 day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle, up to 5 years

Secondary outcomes (5)

  1. Incidence of Adverse Events (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 4.0

    Toxicities will be characterized by their frequency and severity. Differences in the level of toxicities by treatment regimen will be assessed by classifying them as severe or not severe and examining the relative proportion of severe toxicities.

    Measured: Up to 5 years

  2. Measurable Disease by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria and Progression Free Survival (PFS)

    Differences between measurable versus non-measurable disease status on PFS and OS will be examined with plots of survival curves, estimates of quartiles and hazard ratios.

    Measured: Up to 5 years

  3. Tumor Response

    Complete and Partial Tumor Response by RECIST 1.0

    Measured: for those patients whose disease can be evaluated by physical examination, response wa assessed prior to each 21 day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle, up to 5 years

  4. Overall Survival (OS)

    Differences between measurable versus non-measurable disease status on PFS and OS will be examined with plots of survival curves, estimates of quartiles and hazard ratios.

    Measured: Up to 5 years

  5. Response by CA-125

    The effects of treatment on the proportion responding by CA125 will be examined.

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2011 (estimated)
  2. Study start21 Mar 2011
  3. Primary completion20 Aug 2016
  4. Study completion3 Nov 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
107 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01305213
Sponsor's protocol ID
NCI-2011-02666
Other IDs
NCI-2011-02666, CDR0000696220, GOG-0186I, GOG-0186I, U10CA180868, U10CA027469
Status last verified
Jul 2019
First submitted
25 Feb 2011
Last updated
30 Jul 2019
Data monitoring committee
Yes

Publications

  • Monk BJ, Sill MW, Walker JL, Darus CJ, Sutton G, Tewari KS, Martin LP, Schilder JM, Coleman RL, Balkissoon J, Aghajanian C. Randomized Phase II Evaluation of Bevacizumab Versus Bevacizumab Plus Fosbretabulin in Recurrent Ovarian, Tubal, or Peritoneal Carcinoma: An NRG Oncology/Gynecologic Oncology Group Study. J Clin Oncol. 2016 Jul 1;34(19):2279-86. doi: 10.1200/JCO.2015.65.8153. Epub 2016 May 23.

    PubMed 27217446

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bevacizumab, Fosbretabulin Tromethamine and Laboratory Biomarker Analysis in people with Recurrent Fallopian Tube Carcinoma and Recurrent Ovarian Carcinoma, run by National Cancer Institute (NCI) at 51 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 41 inclusion and 24 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 30 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 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 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 12 Jul 2017). 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?

Progression-free Survival (PFS) (time frame: For those patients whose disease can be evaluated by physical examination, progression was assessed prior to each 21 day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle, up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01305213, 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 30 Jul 2019.

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