Ovarian Epithelial Cancer RecurrentPhase 2NCT01735071
Bevacizumab and Trabectedin +/- Carboplatin in Advanced Ovarian Cancer
A Phase 2 study testing bevacizumab and trabectedin and bevacizumab, trabectedin and carboplatin in people with Ovarian Epithelial Cancer Recurrent, run by Mario Negri Institute for Pharmacological Research at 7 sites in Italy.
Trial summary
This study is aimed at assessing the efficacy and the safety of the combination of bevacizumab and trabectedin with or without carboplatin in adult women with epithelial ovarian cancer at first recurrence occurred 6-12 months after the end of the last (first or second) platinum-containing regimen. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Epithelial Cancer Recurrent
- What is being tested?
- bevacizumab and trabectedin and bevacizumab, trabectedin and carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 7 sitesItaly
- Study dates
- Jul 2013to 18 Mar 2018
- 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
- Age≥18years
- Eastern Cooperative Oncology Group (ECOG)- performance status 0-2
- Cytological/histological diagnosis of epithelial ovarian cancer
- Progression free interval between 6-12 months (calculated from the first day of the last cycle of the previous last platinum-based chemotherapy until the date of progression confirmation through radiologic imaging)
- One or two previous platinum-based chemotherapy lines
- Measurable disease according to RECIST version 1.1
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- Life expectancy ≥ 12 weeks
- Patients must be able to receive dexamethasone or its equivalent, as a premedication for trabectedin
- Written informed consents given before the enrolment according to International Conference on Harmonization/ Good Clinical Practice (ICH/GCP).
Who cannot join
- Prior treatment with trabectedin
- Prior progression while on therapy containing bevacizumab or other vascular endothelial growth factor (VEGF) pathway-target therapy
- Pre-existing grade > 1 sensitive/motor neurologic disorder
- Current or recent (within 30 days of first study dosing) treatment with another investigational drug
- Surgery (including open biopsy) within 4 weeks prior to the first planned dose of bevacizumab
- Current or recent (within 10 days prior to the first study drug dose) use of full-dose oral or parenteral anticoagulant or thrombolytic agent for therapeutic purposes (except for line patency, in which case international normalized ratio (INR) must be maintained below 1.5). Post operative prophylaxis with low molecular weight heparin sc is allowed
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- Inadequate bone marrow function: absolute neutrophil count (ANC): <1.5 x 109/l, or platelet count <100 x 109/l or haemoglobin <9 g/dl. Patients may be transfused to maintain haemoglobin values ≥9 g/dl
- Inadequate coagulation parameters: activated partial thromboplastin time (APTT) >1.5 x upper limit of normal (ULN) or INR >1.5
- Inadequate liver function, defined as: serum (total) bilirubin > ULN for the institution AST/serum glutamic-oxaloacetic transaminase (SGOT) or ALT/ serum glutamic-pyruvic transaminase (SGPT) >2.5 x ULN
- Inadequate renal function: serum creatinine >1.5 mg/dL or >132 micromol/L and urine dipstick for proteinuria > or = 2+ and >1g of protein in their 24-hour urine collection
- History or evidence of brain metastases or spinal cord compression
- Pregnant, breastfeeding women and women of child bearing potential, who do not agree to use a medically acceptable method of contraception through the treatment period and for 6 months after discontinuation of treatment
- History or evidence of thrombotic or hemorrhagic disorders; including cerebrovascular accident, stroke or transient ischemic attack or sub-arachnoid haemorrhage within 6 months prior to the first study treatment
- Uncontrolled hypertension (sustained systolic >150 mmHg and/or diastolic >100 mmHg despite antihypertensive therapy) or clinically significant (i.e. active) cardiovascular disease, including: myocardial infarction or unstable angina within 6 months prior to the first study treatment, New York Heart Association grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication
- History of bowel obstruction, including subocclusive disease, related to the underlying disease and history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess. Evidence of recto-sigmoid involvement by pelvic examination or bowel involvement on CT scan or clinical symptoms of bowel obstruction
- Non-healing wound, ulcer or bone fracture
- hepatitis C virus (HCV) positivity
- Other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Italy7 sites
Azienda Ospedaliera Spedali Civili di Brescia
Brescia
Istituto Europeo di Oncologia
Milan
AO Fatebenefratelli e Oftalmico
Milan
Azienda Ospedaliera S. Gerardo
Monza
Istituto Oncologico Veneto
Padova
Policlinico Universitario Agostino Gemelli di Roma
Roma
Mauriziano Hospital
Torino
About this study
Official title: Multicenter, Randomized, Non-comparative, Phase II Trial on the Efficacy and Safety of the Combination of Bevacizumab and Trabectedin With or Without Carboplatin in Adult Women With Platinum Partially Sensitive Recurring Ovarian Cancer.
This study is aimed at assessing the efficacy and the safety of the combination of bevacizumab and trabectedin with or without carboplatin in adult women with epithelial ovarian cancer at first recurrence occurred 6-12 months after the end of the last (first or second) platinum-containing regimen. According to the Bryant and Day design the primary endpoints will be the proportion of progression-free patients at 6 months for the efficacy, and the proportion of patients with severe toxicity for the safety at the same time-point.
- Conditions
- Ovarian Epithelial Cancer Recurrent
- Being tested
- bevacizumab and trabectedin, bevacizumab, trabectedin and carboplatin
- Keywords
- ovarian cancer, bevacizumab, trabectedin, carboplatin, randomized trial, phase II
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bevacizumab and trabectedinDrug
Also called Avastin, Yondelis
Arm A: bevacizumab (15 mg/kg) given as 1 hour infusion will be followed by trabectedin (1.1 mg/sqm) 3 hour iv infusion; to be repeated every 21 days until progression, unacceptable toxicity, patient or physician decision to discontinue, or death patients
bevacizumab, trabectedin and carboplatinDrug
Also called Avastin, Yondelis, Carboplatin
Arm B: cycle 1- 6, bevacizumab given as 1 hour infusion will be followed by carboplatin AUC 4 and trabectedin 3 hour iv infusion.
Cycle 7- end of treatment, bevacizumab given as 1 hour infusion will be followed by trabectedin 3 hour iv infusion.
Patient enrolled in arm B will receive (cycle 1-6): trabectedin 0.8 mg/m2 ,carboplatin AUC 4 day 1 every 28 days and bevacizumab 10 mg/kg iv on day 1 and day 15.
From cycle 7 to disease progression, unacceptable toxicity, patient or physician decision to discontinue, or death patients will receive bevacizumab 15 mg/kg iv and trabectedin 1.1 mg/m2 day 1 every 21 days
| Study group | Role | What they receive |
|---|---|---|
| bevacizumab and trabectedin | Experimental | Arm A: bevacizumab (15 mg/kg) given as 1 hour infusion will be followed by trabectedin (1.1 mg/sqm) 3 hour iv infusion; to be repeated every 21 days until progression, unacceptable toxicity, patient or physician decision to discontinue, or death patients Receives: Drug: bevacizumab and trabectedin |
| bevacizumab, trabectedin and carboplatin | Experimental | Arm B: cycle 1-6, bevacizumab given as 1 hour infusion will be followed by carboplatin area under curve 4 (AUC 4) and trabectedin 3 hour iv infusion.
Cycle 7- end of treatment, bevacizumab given as 1 hour infusion will be followed by trabectedin 3 hour iv infusion.
Patient enrolled in arm B will receive (cycle 1-6): trabectedin 0.8 mg/m2 ,carboplatin AUC 4 day 1 every 28 days and bevacizumab 10 mg/kg iv on day 1 and day 15.
From cycle 7 to disease progression, unacceptable toxicity, patient or physician decision to discontinue, or death patients will receive bevacizumab 15 mg/kg iv and trabectedin 1.1 mg/m2 day 1 every 21 days Receives: Drug: bevacizumab, trabectedin and carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival at 6 months (PFS-6)
The PFS-6, defined as the percentage of patients who are alive and progression free at 6 months after the randomization.
Measured: from randomization up to 6 months
Proportion of patients with severe toxicity within 6 months from randomization.
The following conditions will be considered as severe toxicity:
- absolute neutrophil count (ANC) < 0.5x109/L lasting > 7 days and/or with fever
- platelets < 25x109/L
- any other grade 3-4 (evaluated by the National Cancer Institute-Common Terminology Criteria for Adverse Events [NCI-CTCAE] version 4.0) non-hematological toxicities except for reversible nausea/vomiting, diarrhea, hypersensitivity reactions, and alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevation reversible to grade 1 by day 28
- any toxicity causing a delay of >14 days in the following cycle
Measured: from randomization up to 6 months
Secondary outcomes (14)
Progression Free Survival (PFS)
Defined for each patient as the time from the date of randomization to the date of first progression, second primary malignancy or death for any cause, whichever comes first. Subjects not progressed or died at the time of the analysis will be censored at the last disease assessment date.
Measured: from randomization up to 30 months
Overall survival at 12 months (OS-12)
Defined as the percentage of patients who are alive at 12 months after the randomization.
Measured: one year
Clinical Benefit (CB)
clinical benefit, defined as the percentage of patients who are judged by the Investigators to have a complete response (CR), or partial response (PR) or stable disease (SD) according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria, version 1.1 after 12 weeks from the date of randomization.
Measured: from randomization up to 30 months
Incidence of Adverse Events (AEs)
Incidence of AEs, according to NCI-CTCAE, version 4.0
Measured: from randomization up to 30 months
Maximum toxicity grade
Maximum toxicity grade experienced by each patient for each specific toxicity
Measured: from randomization up to 30 months
Percentage of patients experiencing grade 3-4 toxicity for each specific toxicity
Percentage of patients experiencing grade 3-4 toxicity for each specific toxicity during the study
Measured: from randomization up to 30 months
Patients with at least a Serious Adverse Drug Reaction (SADR)
Patients with at least a SADR during the study
Measured: from randomization up to 30 months
Patients with at least a Suspect Unexpected Serious Adverse Reaction (SUSAR).
Patients with at least a suspect unexpected serious adverse reaction during the study
Measured: from randomization up to 30 months
Percentage of patients with dose and/or time modifications
Percentage of patients with dose and/or time modifications of the study drugs
Measured: from randomization up to 30 months
Percentage of premature withdrawals
Percentage of premature withdrawals of the enrolled patients
Measured: from randomization up to 30 months
Patients with at least a Serious Adverse Event (SAE)
Patients with at least a SAE during the study
Measured: from randomization up to 30 months
Nature of AEs
Nature of AEs, according to NCI-CTCAE, version 4.0
Measured: from randomization up to 30 months
Severity of AEs
Severity of AEs, according to NCI-CTCAE, version 4.0
Measured: from randomization up to 30 months
Seriousness of AEs
Seriousness of AEs according to NCI-CTCAE, version 4.0
Measured: from randomization up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2012 (estimated)
- Study startJul 2013
- Primary completion18 Mar 2018
- Study completion18 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian Epithelial Cancer RecurrentStudies of the same condition, open and under way.
- More trials run by Mario Negri Institute for Pharmacological ResearchThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a multicentre, randomized, non-comparative phase II study aimed at assessing efficacy and safety of two regimens according to a Bryant and Day two-stage design
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- PharmaMar, Hoffmann-La Roche
- Responsible party
- Sponsor
- Investigators
- Nicoletta Colombo, Medical D, Principal investigator, IRCCS Istituto Europeo di Oncologia di Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01735071
- Sponsor's protocol ID
- IRFMN-OVA-6152
- Status last verified
- Nov 2019
- First submitted
- 13 Nov 2012
- Last updated
- 19 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Colombo N, Zaccarelli E, Baldoni A, Frezzini S, Scambia G, Palluzzi E, Tognon G, Lissoni AA, Rubino D, Ferrero A, Farina G, Negri E, Pesenti Gritti A, Galli F, Biagioli E, Rulli E, Poli D, Gerardi C, Torri V, Fossati R, D'Incalci M. Multicenter, randomised, open-label, non-comparative phase 2 trial on the efficacy and safety of the combination of bevacizumab and trabectedin with or without carboplatin in women with partially platinum-sensitive recurrent ovarian cancer. Br J Cancer. 2019 Oct;121(9):744-750. doi: 10.1038/s41416-019-0584-5. Epub 2019 Sep 20.
PubMed 31537908
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Non-comparative, Phase II Trial on the Efficacy and Safety of the Combination of Bevacizumab and Trabectedin With or Without Carboplatin in Adult Women With Platinum Partially Sensitive Recurring Ovarian Cancer.
- ClinicalTrials.gov ID
- NCT01735071
- Acronym / sponsor ID
- IRFMN-OVA-6152
- Conditions
- Ovarian Epithelial Cancer Recurrent
- Keywords
- ovarian cancer, bevacizumab, trabectedin, carboplatin, randomized trial, phase II
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Mario Negri Institute for Pharmacological ResearchUniversity, hospital or other
- Collaborators
- PharmaMar, Hoffmann-La Roche
- Study start
- Jul 2013 (actual)
- Primary completion
- 18 Mar 2018 (actual)
- Study completion
- 18 Mar 2018 (actual)
- First posted
- 28 Nov 2012 (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.
This study is aimed at assessing the efficacy and the safety of the combination of bevacizumab and trabectedin with or without carboplatin in adult women with epithelial ovarian cancer at first recurrence occurred 6-12 months after the end of the last (first or second) platinum-containing regimen. According to the Bryant and Day design the primary endpoints will be the proportion of progression-free patients at 6 months for the efficacy, and the proportion of patients with severe toxicity for the safety at the same time-point.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a multicentre, randomized, non-comparative phase II study aimed at assessing efficacy and safety of two regimens according to a Bryant and Day two-stage design
| Arm | Type | Receives |
|---|---|---|
| bevacizumab and trabectedin | Experimental | Drug: bevacizumab and trabectedinArm A: bevacizumab (15 mg/kg) given as 1 hour infusion will be followed by trabectedin (1.1 mg/sqm) 3 hour iv infusion; to be repeated every 21 days until progression, unacceptable toxicity, patient or physician decision to discontinue, or death patients |
| bevacizumab, trabectedin and carboplatin | Experimental | Drug: bevacizumab, trabectedin and carboplatinArm B: cycle 1-6, bevacizumab given as 1 hour infusion will be followed by carboplatin area under curve 4 (AUC 4) and trabectedin 3 hour iv infusion. Cycle 7- end of treatment, bevacizumab given as 1 hour infusion will be followed by trabectedin 3 hour iv infusion. Patient enrolled in arm B will receive (cycle 1-6): trabectedin 0.8 mg/m2 ,carboplatin AUC 4 day 1 every 28 days and bevacizumab 10 mg/kg iv on day 1 and day 15. From cycle 7 to disease progression, unacceptable toxicity, patient or physician decision to discontinue, or death patients will receive bevacizumab 15 mg/kg iv and trabectedin 1.1 mg/m2 day 1 every 21 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age≥18years
- Eastern Cooperative Oncology Group (ECOG)- performance status 0-2
- Cytological/histological diagnosis of epithelial ovarian cancer
- Progression free interval between 6-12 months (calculated from the first day of the last cycle of the previous last platinum-based chemotherapy until the date of progression confirmation through radiologic imaging)
- One or two previous platinum-based chemotherapy lines
Key exclusion criteria (18 listed)
- Prior treatment with trabectedin
- Prior progression while on therapy containing bevacizumab or other vascular endothelial growth factor (VEGF) pathway-target therapy
- Pre-existing grade > 1 sensitive/motor neurologic disorder
- Current or recent (within 30 days of first study dosing) treatment with another investigational drug
- Surgery (including open biopsy) within 4 weeks prior to the first planned dose of bevacizumab
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 |
|---|---|---|
| bevacizumab and trabectedinAlso: Avastin, YondelisArm A: bevacizumab (15 mg/kg) given as 1 hour infusion will be followed by trabectedin (1.1 mg/sqm) 3 hour iv infusion; to be repeated every 21 days until progression, unacceptable toxicity, patient or physician decision to discontinue, or death patients | Drug | bevacizumab and trabectedin |
| bevacizumab, trabectedin and carboplatinAlso: Avastin, Yondelis, CarboplatinArm B: cycle 1- 6, bevacizumab given as 1 hour infusion will be followed by carboplatin AUC 4 and trabectedin 3 hour iv infusion. Cycle 7- end of treatment, bevacizumab given as 1 hour infusion will be followed by trabectedin 3 hour iv infusion. Patient enrolled in arm B will receive (cycle 1-6): trabectedin 0.8 mg/m2 ,carboplatin AUC 4 day 1 every 28 days and bevacizumab 10 mg/kg iv on day 1 and day 15. From cycle 7 to disease progression, unacceptable toxicity, patient or physician decision to discontinue, or death patients will receive bevacizumab 15 mg/kg iv and trabectedin 1.1 mg/m2 day 1 every 21 days | Drug | bevacizumab, trabectedin and carboplatin |
Primary outcome
Progression Free Survival at 6 months (PFS-6)
Time frame: from randomization up to 6 months
The PFS-6, defined as the percentage of patients who are alive and progression free at 6 months after the randomization.
Proportion of patients with severe toxicity within 6 months from randomization.
Time frame: from randomization up to 6 months
The following conditions will be considered as severe toxicity: * absolute neutrophil count (ANC) < 0.5x109/L lasting > 7 days and/or with fever * platelets < 25x109/L * any other grade 3-4 (evaluated by the National Cancer Institute-Common Terminology Criteria for Adverse Events [NCI-CTCAE] version 4.0) non-hematological toxicities except for reversible nausea/vomiting, diarrhea, hypersensitivity reactions, and alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevation reversible to grade 1 by day 28 * any toxicity causing a delay of >14 days in the following cycle
14 secondary outcomes
Progression Free Survival (PFS)
Time frame: from randomization up to 30 months
Overall survival at 12 months (OS-12)
Time frame: one year
Clinical Benefit (CB)
Time frame: from randomization up to 30 months
Incidence of Adverse Events (AEs)
Time frame: from randomization up to 30 months
Maximum toxicity grade
Time frame: from randomization up to 30 months
Percentage of patients experiencing grade 3-4 toxicity for each specific toxicity
Time frame: from randomization up to 30 months
Patients with at least a Serious Adverse Drug Reaction (SADR)
Time frame: from randomization up to 30 months
Patients with at least a Suspect Unexpected Serious Adverse Reaction (SUSAR).
Time frame: from randomization up to 30 months
Percentage of patients with dose and/or time modifications
Time frame: from randomization up to 30 months
Percentage of premature withdrawals
Time frame: from randomization up to 30 months
Patients with at least a Serious Adverse Event (SAE)
Time frame: from randomization up to 30 months
Nature of AEs
Time frame: from randomization up to 30 months
Severity of AEs
Time frame: from randomization up to 30 months
Seriousness of AEs
Time frame: from randomization up to 30 months
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 19 Nov 2019.
- Results publication: PubMed 31537908Colombo N, Zaccarelli E, Baldoni A, Frezzini S, Scambia G, Palluzzi E, Tognon G, Lissoni AA, Rubino D, Ferrero A, Farina G, Negri E, Pesenti Gritti A, Galli F, Biagioli E, Rulli E, Poli D, Gerardi C, Torri V, Fossati R, D'Incalci M. Multicenter, randomised, open-label, non-comparative phase 2 trial on the efficacy and safety of the combination of bevacizumab and trabectedin with or without carboplatin in women with partially platinum-sensitive recurrent ovarian cancer. Br J Cancer. 2019 Oct;121(9):744-750. doi: 10.1038/s41416-019-0584-5. Epub 2019 Sep 20.
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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.
Nicoletta Colombo, Medical D principal investigator
IRCCS Istituto Europeo di Oncologia di Milano
7 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 bevacizumab and trabectedin and bevacizumab, trabectedin and carboplatin in people with Ovarian Epithelial Cancer Recurrent, run by Mario Negri Institute for Pharmacological Research at 7 sites in Italy.
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 9 inclusion and 18 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 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 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?
Progression Free Survival at 6 months (PFS-6) (time frame: from randomization up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01735071, 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 19 Nov 2019.