Platinum Refractory Epithelial Ovarian CancerPhase 2NCT00543049
Randomized Multicenter Trial With SU11248 Evaluating Dosage,Tolerability,Toxicity and Effectiveness of a Multitargeted Receptor Tyrosine Kinase Inhibitor
A Phase 2 study testing Sunitinib in people with Platinum Refractory Epithelial Ovarian Cancer and Primary Cancer of the Peritoneum, run by AGO Study Group at 16 sites in Germany.
Trial summary
Ovarian cancer is most often recognized in advanced clinical state, the initial therapeutic strategies consist of a platinum containing chemotherapy subsequent to primary surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Platinum Refractory Epithelial Ovarian Cancer, Primary Cancer of the Peritoneum, Cancer of the Fallopian Tube
- What is being tested?
- Sunitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 16 sitesGermany
- Study dates
- Sep 2007to Jun 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Women, 18 years and older, written (signed and dated) informed consent
- Histological confirmed epithelial ovarian cancer, primary cancer of the peritoneum or fallopian tube
- Up to three prior chemotherapies, at least one platinum based chemotherapy
- Platinum refractory or resistant ovarian cancer (defined as stable (SD) or progressive disease (PD) during platinum containing chemotherapy, or treatment free interval < 6 months after stop of platinum based chemotherapy)
- Measurable or non-measurable disease
- Elevated CA°125 level (> 2 x ULN in case of normal CA°125 after prior chemotherapy; or ≥ 2 x nadir CA°125 value after prior chemotherapy, when CA° 125 levels remained elevated above normal) in case of non-measurable disease
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- ECOG performance status 0-2
- Negative pregnancy test within 5 days before randomization and adequate contraception in women with childbearing potential
- Adequate organ function as defined by the following criteria:
- Serum aspartate aminotransferase (AST; serum glutamate-oxalate transferase [SGOT]) and serum alanine aminotransferase (ALT; serum glutamate-pyruvate transferase [SGPT]) <=2.5 x upper limit of normal (ULN). If liver function abnormalities are due to underlying malignancy, then AST and ALT may be <=5x ULN
- Total serum bilirubin <=1.5 x ULN
- Prothrombin time (PT) and partial thromboplastin time (PTT) <=1.5 x ULN
- Serum albumin >= 3.0 g/dL
- Absolute neutrophil count (ANC) >=1500/µl
- Platelets >=100,000/µl
- Hemoglobin >=9.0 g/dL
- Serum creatinine <=1.5 x ULN
- TSH within normal range Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures Resolution of all toxic effects of any prior chemotherapy, surgical procedures, radiotherapy, or other cancer related therapies to NCI CTCAE (Version 3.0) grade >=1 and to the baseline laboratory values as defined in inclusion criterion (see before)
Who cannot join
- Borderline tumor of the ovaries
- Acute or chronic infection
- Any required concurrent cancer chemotherapy or antineoplastic endocrine therapy or radiotherapy
- Exposure to investigational trial medication, cancer chemo- or radiotherapy within the last 28 days prior to start of study treatment
- Known or suspected hypersensitivity to investigational compound
- Second malignancy interfering with prognosis of the patient
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- Cachectic patients with a body weight <45 kg
- Patients requiring parenteral nutrition
- Patients with ileus within the last 28 days
- Any of the following within the 12 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, or other thromboembolic event
- Current treatment with therapeutic doses of anticoagulant
- Current treatment with CYP3A4 inhibitors or -inducers
- Hypertension that cannot be controlled by medications (>150/100 mmHg despite optimal medical therapy)
- Ongoing cardiac dysrhythmias of NCI CTCAE grade >=2, atrial fibrillation of any grade, or prolongation of the QTc interval to >470 msec for females
- Left ventricular ejection fraction (LVEF) <=50% as measured by echocardiogram
- NCI CTCAE Grade 3 hemorrhage within 4 weeks of starting study treatment
- Evidence of neurological signs/symptoms suggestive of brain metastases, spinal cord compression, or new evidence of brain or leptomeningeal disease
- Known human immunodeficiency virus (HIV) positivity or acquired immunodeficiency syndrome (AIDS)-related illness
- Patients with any other severe concurrent disease, which is an undue risk for the patient by participating in the present study
- Any further condition which according to the investigator results in an undue risk of the patient by participating in the present study
- Major surgery, radiation therapy, or systemic therapy within 3 weeks of first study treatment. At least 7 days should elapse from the time of minor surgical procedure including placement of an access device or fine needle aspiration before randomization into this study can occur.
- Wounds that have not completely healed, active ulcer(s), or bone fracture(s).
- Prior high-dose chemotherapy requiring hematopoietic stem cell rescue.
- Prior radiation therapy to >25% of the bone marrow.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Germany16 sites
Malterser-Krankenhaus Bonn-Rhein/Sieg, Frauenklinik
Bonn, 53123
Klinikum Bremen-Mitte gGmbH, Frauenklinik
Bremen, 28177
Universitätsklinikum Carl Gustav Carus, Klinik u. Poliklinik für Frauenheilkunde und Geburtshilfe
Dresden, 01307
Universitätsklinikum, Universitätsfrauenklinik
Essen, 45122
Klinikum der JWG Universität Frankfurt, Universitätsfrauenklinik
Frankfurt am Main, 60591
Universitätsklinikum Freiburg, Department Universitäts-Frauenklinik
Freiburg im Breisgau, 79106
Klinikum der Ernst-Moritz-Universität, Klinik u. Poliklinik für Gyn. - u. Geb.Hilfe
Greifswald, 17487
Med. Hochschule Hannover, Frauenklinik
Hanover, 30625
St. Vincentius Kliniken AG, Frauenklinik
Karlsruhe, 76135
Universitätsklinikum Schleswig-Holstein Campus Kiel, Klinik f. Gynäkologie u. Geburtshilfe
Kiel, 24105
Otto-von-Guericke-Universität, Klinik für Frauenheilkunde und Geburtshilfe
Magdeburg, 39108
Universitätsklinikum Gießen u. Marburg, Standort Marburg, Klinik f. Gynäkologie, Gyn. Endokrinologie u. Onkologie
Marburg, 35043
Elblandkliniken Meißen-Radebeul GmbH, Gynäkologie
Radebeul, 01445
Universitätsklinikum Tübingen, Frauenklinik
Tübingen, 72076
Universitätsklinikum, Universitätsfrauenklinik
Ulm, 89075
Dr. Horst Schmidt Kliniken GmbH, Klinik f. Gynäkologie u. Gyn. Onkologie
Wiesbaden, 65199
About this study
Official title: Phase II Trial in Platinum-refractory Ovarian Cancer: A Randomized Multicenter Trial With SU11248 to Evaluate Dosage, Tolerability, Toxicity and Effectiveness of a Multitargeted Receptor Tyrosine Kinase Inhibitor Monotherapy
Ovarian cancer is most often recognized in advanced clinical state, the initial therapeutic strategies consist of a platinum containing chemotherapy subsequent to primary surgery. Although initially responsive to platinum-paclitaxel containing chemotherapy, a significant number of patients will show tumor progression during first line chemotherapy or relapse within six months after completion of first line chemotherapy, therefore being characterized as chemotherapy resistant. Any second line chemotherapy will result in approximately 10% of overall response, underlining the poor prognosis for these patients with an estimated median overall survival of 20 weeks.
In addition to conventional chemotherapeutics, so called small molecules are of high interest to establish new strategies in chemotherapy-refractory ovarian cancer (and in the long run first line chemotherapy). SU11248 is a polytargeting tyrosine kinase inhibitor.
SU11248 has demonstrated clinical efficacy in kidney cancer and GIST, further clinical trials have been initiated in other tumor entities. Growth pattern and biological targets present in ovarian cancer indicate that SU11248 might be a promising compound for the treatment of ovarian cancer. Especially, VEGFR, PDGFR and c-kit are specific targets for SU11248, which are expressed in ovarian cancer. The different targets of SU11248 provide a potential advantage of this compound compared to single-target molecules in chemotherapy-refractory ovarian cancer.
Read the detailed description
This study in patients with ovarian cancer refractory to platinum based chemotherapy is designed as a randomized, 2-schedule and dose-level, open-label, multicenter phase II study to select the better dose and schedule arm for further investigation.
72 patients will be randomized in a 1:1 ratio to receive oral SU11248 therapy either 37.5 mg/day continuously or 50mg/day for 4 weeks followed by 14 days off.
Patients will get outpatients treatment. At screening the patients' eligibility will be assessed, their baseline and demographic characteristics obtained, and the baseline values for the effect variables collected. Patients with measurable lesions as well as non-measurable disease will be included into this trial. Measurable lesion will be documented by CT or MRI scan and CA-125 values, non-measurable lesions will be monitored by analysis of CA°125 levels.
The patients' safety will be monitored during and up to 30 days after termination of SU11248 therapy.
In patients with measurable lesions at baseline, the (post)-treatment values for effect according to the RECIST criteria will be collected as shown in table 6. In case of CR or PR, a confirmatory CT or MRI scan is required after an interval of at least four weeks. Antitumor effects according to CA°125 levels will be determined in the same time intervals and, in addition, 28 days after last SU11248 application in patients with CA°125 response according to GCIG guidelines during therapy.
For post study follow-up, patients and/or their physicians will be contacted via phone for overall survival and TTP (including the method of diagnosis and additional treatment) every 2 months for their life time.
- Conditions
- Platinum Refractory Epithelial Ovarian Cancer, Primary Cancer of the Peritoneum, Cancer of the Fallopian Tube
- Being tested
- Sunitinib
- Keywords
- platinum refractory, epithelial ovarian cancer, primary cancer of the peritoneum, cancer of the fallopian tube
- Medical subject headings
- Fallopian Tube Neoplasms, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SunitinibDrug
Also called Sutent, Sunitinib, SU011248
Sunitinib, oral, 50mg once daily, 28 days then paused for 14 days, for up to one year
SUNITINIBDrug
Also called SUTENT, Sunitinib, SU011248
Sunitinib, oral, 37,5 mg once daily continuously, up to one year
| Study group | Role | What they receive |
|---|---|---|
| 1 non-continuous | Other | Subjects will receive open-label sunitinib = SU11248 at a dose of 50.0 mg once daily. After 28 days, treatment will be paused for 14 days and cycle one is completed, followed by resumption of therapy as cycle one for up to one year (therapy can be continued in case of tumor response and benefit for the patient for more than one year). Receives: Drug: Sunitinib |
| 2 continuous | Other | Subjects will receive open-label sunitinib = SU11248 at a dose of 37.5 mg once daily continuously. Treatment period up to one year (therapy can be continued in case of tumor response and benefit for the patient for more than one year). Receives: Drug: SUNITINIB |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate
Measured: one year
Secondary outcomes (1)
tolerability and toxicity, overall survival, duration of response, time to progression, stable disease
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2007 (estimated)
- Study startSep 2007
- Primary completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Platinum Refractory Epithelial Ovarian 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- AGO Study Group
- Sponsor type
- University, hospital or other
- Collaborators
- Philipps University Marburg, HSK Reasearch GmbH Wiesbaden
- Responsible party
- Sponsor
- Investigators
- Uwe Wagner, MD, PhD, Principal investigator, Universitätsklinikum Gießen u. Marburg, Klinik f. Gynäkologie, Gyn. Endokrinologie u. Onkologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00543049
- Sponsor's protocol ID
- AGO-OVAR 2.11
- Status last verified
- Mar 2014
- First submitted
- 10 Oct 2007
- Last updated
- 7 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Baumann KH, du Bois A, Meier W, Rau J, Wimberger P, Sehouli J, Kurzeder C, Hilpert F, Hasenburg A, Canzler U, Hanker LC, Hillemanns P, Richter B, Wollschlaeger K, Dewitz T, Bauerschlag D, Wagner U. A phase II trial (AGO 2.11) in platinum-resistant ovarian cancer: a randomized multicenter trial with sunitinib (SU11248) to evaluate dosage, schedule, tolerability, toxicity and effectiveness of a multitargeted receptor tyrosine kinase inhibitor monotherapy. Ann Oncol. 2012 Sep;23(9):2265-2271. doi: 10.1093/annonc/mds003. Epub 2012 Feb 29.
PubMed 22377563Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.
PubMed 37185961
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial in Platinum-refractory Ovarian Cancer: A Randomized Multicenter Trial With SU11248 to Evaluate Dosage, Tolerability, Toxicity and Effectiveness of a Multitargeted Receptor Tyrosine Kinase Inhibitor Monotherapy
- ClinicalTrials.gov ID
- NCT00543049
- Acronym / sponsor ID
- AGO-OVAR 2.11
- Conditions
- Platinum Refractory Epithelial Ovarian Cancer, Primary Cancer of the Peritoneum, Cancer of the Fallopian Tube
- Keywords
- platinum refractory, epithelial ovarian cancer, primary cancer of the peritoneum, cancer of the fallopian tube
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- AGO Study GroupUniversity, hospital or other
- Collaborators
- Philipps University Marburg, HSK Reasearch GmbH Wiesbaden
- Study start
- Sep 2007
- Primary completion
- Jun 2012 (actual)
- First posted
- 12 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ovarian cancer is most often recognized in advanced clinical state, the initial therapeutic strategies consist of a platinum containing chemotherapy subsequent to primary surgery. Although initially responsive to platinum-paclitaxel containing chemotherapy, a significant number of patients will show tumor progression during first line chemotherapy or relapse within six months after completion of first line chemotherapy, therefore being characterized as chemotherapy resistant. Any second line chemotherapy will result in approximately 10% of overall response, underlining the poor prognosis for these patients with an estimated median overall survival of 20 weeks.
In addition to conventional chemotherapeutics, so called small molecules are of high interest to establish new strategies in chemotherapy-refractory ovarian cancer (and in the long run first line chemotherapy). SU11248 is a polytargeting tyrosine kinase inhibitor.
SU11248 has demonstrated clinical efficacy in kidney cancer and GIST, further clinical trials have been initiated in other tumor entities. Growth pattern and biological targets present in ovarian cancer indicate that SU11248 might be a promising compound for the treatment of ovarian cancer. Especially, VEGFR, PDGFR and c-kit are specific targets for SU11248, which are expressed in ovarian cancer. The different targets of SU11248 provide a potential advantage of this compound compared to single-target molecules in chemotherapy-refractory ovarian cancer.
Detailed description
This study in patients with ovarian cancer refractory to platinum based chemotherapy is designed as a randomized, 2-schedule and dose-level, open-label, multicenter phase II study to select the better dose and schedule arm for further investigation.
72 patients will be randomized in a 1:1 ratio to receive oral SU11248 therapy either 37.5 mg/day continuously or 50mg/day for 4 weeks followed by 14 days off.
Patients will get outpatients treatment. At screening the patients' eligibility will be assessed, their baseline and demographic characteristics obtained, and the baseline values for the effect variables collected. Patients with measurable lesions as well as non-measurable disease will be included into this trial. Measurable lesion will be documented by CT or MRI scan and CA-125 values, non-measurable lesions will be monitored by analysis of CA°125 levels.
The patients' safety will be monitored during and up to 30 days after termination of SU11248 therapy.
In patients with measurable lesions at baseline, the (post)-treatment values for effect according to the RECIST criteria will be collected as shown in table 6. In case of CR or PR, a confirmatory CT or MRI scan is required after an interval of at least four weeks. Antitumor effects according to CA°125 levels will be determined in the same time intervals and, in addition, 28 days after last SU11248 application in patients with CA°125 response according to GCIG guidelines during therapy.
For post study follow-up, patients and/or their physicians will be contacted via phone for overall survival and TTP (including the method of diagnosis and additional treatment) every 2 months for their life time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 non-continuous | Other | Drug: SunitinibSubjects will receive open-label sunitinib = SU11248 at a dose of 50.0 mg once daily. After 28 days, treatment will be paused for 14 days and cycle one is completed, followed by resumption of therapy as cycle one for up to one year (therapy can be continued in case of tumor response and benefit for the patient for more than one year). |
| 2 continuous | Other | Drug: SUNITINIBSubjects will receive open-label sunitinib = SU11248 at a dose of 37.5 mg once daily continuously. Treatment period up to one year (therapy can be continued in case of tumor response and benefit for the patient for more than one year). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Women, 18 years and older, written (signed and dated) informed consent
- Histological confirmed epithelial ovarian cancer, primary cancer of the peritoneum or fallopian tube
- Up to three prior chemotherapies, at least one platinum based chemotherapy
- Platinum refractory or resistant ovarian cancer (defined as stable (SD) or progressive disease (PD) during platinum containing chemotherapy, or treatment free interval < 6 months after stop of platinum based chemotherapy)
- Measurable or non-measurable disease
Key exclusion criteria (24 listed)
- Borderline tumor of the ovaries
- Acute or chronic infection
- Any required concurrent cancer chemotherapy or antineoplastic endocrine therapy or radiotherapy
- Exposure to investigational trial medication, cancer chemo- or radiotherapy within the last 28 days prior to start of study treatment
- Known or suspected hypersensitivity to investigational compound
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 |
|---|---|---|
| SunitinibAlso: Sutent, Sunitinib, SU011248Sunitinib, oral, 50mg once daily, 28 days then paused for 14 days, for up to one year | Drug | 1 non-continuous |
| SUNITINIBAlso: SUTENT, Sunitinib, SU011248Sunitinib, oral, 37,5 mg once daily continuously, up to one year | Drug | 2 continuous |
Primary outcome
objective response rate
Time frame: one year
1 secondary outcome
tolerability and toxicity, overall survival, duration of response, time to progression, stable disease
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2014.
- Results publication: PubMed 22377563Baumann KH, du Bois A, Meier W, Rau J, Wimberger P, Sehouli J, Kurzeder C, Hilpert F, Hasenburg A, Canzler U, Hanker LC, Hillemanns P, Richter B, Wollschlaeger K, Dewitz T, Bauerschlag D, Wagner U. A phase II trial (AGO 2.11) in platinum-resistant ovarian cancer: a randomized multicenter trial with sunitinib (SU11248) to evaluate dosage, schedule, tolerability, toxicity and effectiveness of a multitargeted receptor tyrosine kinase inhibitor monotherapy. Ann Oncol. 2012 Sep;23(9):2265-2271. doi: 10.1093/annonc/mds003. Epub 2012 Feb 29.
- Derived from this study: PubMed 37185961Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.
Related trials for Platinum Refractory Epithelial Ovarian Cancer
RecruitingPhase 1/2
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High Grade Epithelial Ovarian Cancer, High Grade Serous Ovarian Cancer
RecruitingPhase 2
ONC201 Plus Weekly Paclitaxel in Patients With Platinum Refractory or Resistant Ovarian Cancer
Malignant Ovarian Epithelial Tumor, Platinum-Resistant Fallopian Tube Carcinoma
Not yet recruitingPhase 2
Etoposide Capsules Combined With Bevacizumab and Iparomlimab and Tuvonralimab in the Treatment of Platinum Resistant or Platinum Refractory Ovarian Cancer
Platinum Resistant Ovarian Cancer, Platinum Refractory Epithelial Ovarian Cancer
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.
Uwe Wagner, MD, PhD principal investigator
Universitätsklinikum Gießen u. Marburg, Klinik f. Gynäkologie, Gyn. Endokrinologie u. Onkologie
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sunitinib in people with Platinum Refractory Epithelial Ovarian Cancer and Primary Cancer of the Peritoneum, run by AGO Study Group at 16 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 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 7 Mar 2014. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
objective response rate (time frame: one year). 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 NCT00543049, which also lists 2 linked publications.
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 7 Mar 2014; AzTrials last refreshed its copy on 4 Nov 2026.