Malignant Pleural MesotheliomaPhase 3NCT01098266
NGR015: Study in Second Line for Patient With Advanced Malignant Pleural Mesothelioma Pretreated With Pemetrexed
A Phase 3 study testing NGR-hTNF plus Best Investigator's Choice (BIC) in people with Malignant Pleural Mesothelioma, run by AGC Biologics S.p.A. at 49 sites in 12 countries.
Trial summary
The main objective of the trial is to document the efficacy of NGR-hTNF administered at low dose weekly in advanced Malignant Pleural Mesothelioma patients previously treated with a pemetrexed-based chemotherapy regimen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Pleural Mesothelioma
- What is being tested?
- NGR-hTNF plus Best Investigator's Choice (BIC)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 49 sitesin 12 countries
- Study dates
- 12 Apr 2010to Dec 2017
- Phase
- Phase 3
- 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
- Age ≥ 18 years
- Histologically or cytological confirmed malignant pleural mesothelioma of any of the following subtype: epithelial, sarcomatoid, mixed, or unknown
- Prior treatment with no more than one systemic pemetrexed-based chemotherapy regimen administered for advanced or metastatic disease. Prior use of a biological agent in combination with a pemetrexed-based regimen and prior administration of intrapleural cytotoxic agents are allowed. Patients who have previously received anthracyclines should not receive doxorubicin
- ECOG Performance Status 0 - 2
- Life expectancy of ≥ 12 weeks
- Adequate baseline bone marrow, hepatic and renal function, defined as follows:
Show all 15Show fewer
- Neutrophils ≥ 1.5 x 109/L; platelets ≥ 100 x 109/L; hemoglobin ≥ 9 g/dL
- Bilirubin ≤ 1.5 x ULN
- AST and/or ALT ≤ 2.5 x ULN in absence of liver metastasis or ≤ 5 x ULN in presence of liver metastasis
- Serum creatinine < 1.5 x ULN
- Measurable or non-measurable disease according to MPM-modified RECIST criteria
- Patients may have had prior therapy providing the following conditions are met:
- Surgery: wash-out period of 14 days
- Systemic and radiation anti-tumor therapy: wash-out period of 28 days
- Patients must give written informed consent to participate in the study
Who cannot join
- Patients must not receive any other investigational agents while on study
- Patients with myocardial infarction within the last six months, unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication
- Uncontrolled hypertension
- QTc interval (congenital or acquired) > 450 ms
- History or evidence upon physical examination of CNS disease unless adequately treated (e.g., primary brain tumor, any brain metastasis, seizure not controlled with standard medical therapy, or history of stroke)
- Patients with active or uncontrolled systemic disease/infections or with serious illness or medical conditions, which is incompatible with the protocol
Show all 9Show fewer
- Known hypersensitivity/allergic reaction to human albumin preparations or to any of the excipients
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol
- Pregnancy or lactation
Trial locations and contacts
49 sites in 12 countries.
49 sites in 12 countries
Italy15 sites
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Alessandria, 15100
Centro di Riferimento Oncologico
Aviano
Ospedale Santo Spirito
Casale Monferrato, Alessandria, 15033
Ospedale Valduce
Como
Azienda Ospedaliero-Universitaria Careggi di Firenze
Florence
Istituto Nazionale per la Ricerca sul Cancro
Genoa, 16132
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori-IRST
Meldola, 47014
Fondazione San Raffaele del Monte Tabor
Milan, 20132
Azienda Ospedaliera San Gerardo
Monza, 20052
Azienda Ospedaliera Universitaria San Luigi Gonzaga
Orbassano, Torino, 10043
Istituto Oncologico Veneto
Padova
Azienda Ospedaliero Universitaria di Parma
Parma
Azienda Unità Sanitaria locale di Ravenna
Ravenna, 48100
A.O. Salvini Garbagnate, Ospedale di Rho
Rho
Azienda Ospedaliera Senese
Siena, 53100
United Kingdom10 sites
Castle Hill Hospital
Cottingham, Yorkshire, HU16 5JQ
Edinburgh Cancer Centre, Western General Hospital
Edinburgh, Scotland, EH4 2XU
The Beatson West of Scotland Cancer Centre
Glasgow, Scotland, G12
University Hospitals of Leicester
Leicester, Leicestershire, LE0116
Guy's Hospital
London, SE1 9RT
The Royal Marsden Hospital
London, SW3 6JJ
Kent Oncology Centre Maidstone Hospital
Maidstone, Kent, ME16 9QQ
Chest Clinic, Wythenshawe Hospital
Manchester, Greater Manchester, M23 9LT
Mount Vernon Cancer Centre
Middlesex, Northwood, HA6 2RN
The Royal Marsden Hospital
Sutton, Surrey
United States7 sites
Johns Hopkins
Baltimore, Maryland, 21231
Wilshire Oncology Medical Group
Corona, California, 92879
UTsouthwestern medical center
Dallas, Texas, 75390
City of Hope-Comprehensive Cancer Cente
Duarte, California, 91010
Columbia University
New York, New York, 10032
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
H. Lee Moffitt ancer Center and Research Institute
Tampa, Florida, 33612
Belgium5 sites
Institut Jules Bordet
Brussels, 1000
Cliniques Universitarie St. Luc
Brussels, 1200
Antwerp University Hospital
Edegem, Antwerp, B-2650
Universitair Ziekenhuis
Ghent, 9000
Centre Hospitalier Universitaire de Liège
Liège, Liege, 4000
Canada2 sites
UAB - Alberta Cancer Board - Cross Cancer Institute
Edmonton, Alberta, T6G1Z2
University Health Network, Princess Margaret Hospital
Toronto, Ontario, M5G2C4
Netherlands2 sites
St. Jansdal Hospital
Harderwijk, Gelderland, 3840
St. Antonius Hospital
Nieuwegein, Utrecht, 3435
Poland2 sites
Medical University of Gdansk
Gdansk, 80211
Maria Sklodowska Memorial Cancer Center and Institute of Oncology
Warsaw, 02-781
Spain2 sites
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital Vall d'Hebron
Barcelona, 08035
About this study
Official title: NGR015: Randomized Double-blind Phase III Study of NGR-hTNF Plus Best Investigator's Choice (BIC) Versus Placebo Plus BIC in Previously Treated Patients With Advanced Malignant Pleural Mesothelioma (MPM)
The main objective of the trial is to document the efficacy of NGR-hTNF administered at low dose weekly in advanced Malignant Pleural Mesothelioma patients previously treated with a pemetrexed-based chemotherapy regimen.
Read the detailed description
Currently, there are no regulatory-approved or widely accepted treatment options for patients failing a standard pemetrexed-based chemotherapy regimen.
For this reason, the best supportive care (BSC) alone might be considered as a standard reference for a randomized phase III trial in this setting.
However, single-agent chemotherapeutic agents (such as doxorubicin,gemcitabine, or vinorelbine) with a well-documented safety profile and antitumor activity are also used in clinical practice.
Therefore, the best investigator's choice (BIC) between either best supportive care alone or combined with a few selected single-agent chemotherapy (including doxorubicin, gemcitabine, or vinorelbine) might be considered as an acceptable reference arm as well in this setting.
The current phase III study aims to show a superior efficacy in terms of overall survival duration of NGR-hTNF 0.8 µg/mq weekly plus BIC versus placebo plus BIC in advanced MPM patients progressing after a standard pemetrexed-based chemotherapy.
- Conditions
- Malignant Pleural Mesothelioma
- Being tested
- NGR-hTNF plus Best Investigator's Choice (BIC), Placebo plus Best Investigator's Choice (BIC)
- Keywords
- MPM, NGR-hTNF, NGR-hTNF plus BIC, Randomized double-blind phase III study
- Medical subject headings
- Mesothelioma, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NGR-hTNF plus Best Investigator's Choice (BIC)Drug
Also called NGR-hTNF+BIC
- NGR-hTNF: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs.
- Best Supportive Care: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis
- Investigator's Choice: one of the following single-agent chemotherapy might be administered in combination:
- Doxorubicin: 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles
- Gemcitabine: 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles
- Vinorelbine: 25 mg/m2 iv (or 60 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 weeks)
Placebo plus Best Investigator's Choice (BIC)Drug
Also called Placebo+BIC
- Placebo: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs.
- Best Supportive Care: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis
- Investigator's Choice: one of the following single-agent chemotherapy might be administered in combination:
- Doxorubicin: 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles
- Gemcitabine: 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles
- Vinorelbine: 25 mg/m2 iv (or 60 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 weeks)
| Study group | Role | What they receive |
|---|---|---|
| A: NGR-hTNF + BIC | Experimental | NGR-hTNF plus Best Investigator's Choice Receives: Drug: NGR-hTNF plus Best Investigator's Choice (BIC) |
| B: Placebo+BIC | Placebo comparator | Placebo plus Best Investigator's Choice Receives: Drug: Placebo plus Best Investigator's Choice (BIC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Defined as the time from the date of randomization until the date of death due to any cause or the last date the patient was known to be alive
Measured: From date of randomization until the date of first documented progression or date of death from any cause, wichever came first, assesed up to 48 months
Secondary outcomes (6)
Progression-Free Survival (PFS)
Defined as the time from the date of randomization until disease progression, or deathdue to any couse or the last patient was konwn to be alive. Progression is defined usind Response Evaluation Criteria In Solid Tumors Criteria (Recist v1.1), as a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition torelative increase of 20% the sum must also demonstrate an absolute increase of at least 5 mm. In addition the appearance of one or more new lesions was also considered progression
Measured: From the date of randomization until the date of first documented progression or date of death from any cause, wichever came first, assessed up to 48 months
Disease Control Rate (DCR)
Disease control rate (DCR), defined as the percentage of patients who have a best-response rating of complete or partial response or stable disease, according to MPM-modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria
Measured: Assessed every 6-12 weeks, up to 100 weeks
Number of Partecipants With Disease Control for ≥ 6 Months
Measured from the date of randomization until disease progression, or death due to any cause
Measured: Assessed every 6-12 weeks, up to 100 weeks
Number of Partecipants With Adverse Events
All adverse events will be recorded according to CTC version 4.02 (CTC reference: http://ctep.cancer.gov/reporting/ctc.html) on the case report forms (CRFs); the investigator will decide if those events are drug related and his decision will be recorded on the forms for all adverse events.
Measured: Assessed every 6-12 weeks, up to 100 weeks
Time to LCSS Symptomatic Progression
Quality of life (QoL) assessment was performed by using a questionnaire according to The Lung Cancer Symptom Scale (LCSS) . The LCSS is designed as a disease and site-specific measure of QoL particularly for use in clinical trials. It evaluates six major symptoms (loss of appetite, fatigue, cough, dyspnea, hemoptysis, and pain) associated with lung malignancies and their effect on overall symptomatic distress, functional activities, and global QoL. Within this trial the questionnaire according to LCSS was only recorded by the patient (patient's scale). QoL assessment was performed by using a questionnaire according to LCSS, which consists of nine 100-mm visual analog scales, with scores reported from 0 to 100 (0 representing the best score). The LCSS subscore is the average symptom burden index computed as the mean score for all six major symptoms. Symptomatic progression was defined as a worsening in the average symptom burden index by 25%.
Measured: from the date of randomization to the date of the LCSS assessment on which symptomatic progression was identified, assessed on cycle 2, cycle 4 and cycle 6 (each cycle lasted 21 days)
Evaluation of Medical Care Utilization in the Two Treatment Arms
Medical resource use data collected will be used in health economic analyses where it may be combined with other data from other sources such as cost data or other clinical parameters.
Measured: Assessed every 6-12 weeks, up to 100 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2010 (estimated)
- Study start12 Apr 2010
- Primary completion29 Apr 2014
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant Pleural MesotheliomaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- AGC Biologics S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Antonio Lambiase, MD, Study director, AGC Biologics S.p.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01098266
- Sponsor's protocol ID
- NGR015
- Other IDs
- 2009-016879-29, 2009
- Status last verified
- Aug 2019
- First submitted
- 17 Mar 2010
- Last updated
- 17 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Gregorc V, Gaafar RM, Favaretto A, Grossi F, Jassem J, Polychronis A, Bidoli P, Tiseo M, Shah R, Taylor P, Novello S, Muzio A, Bearz A, Greillier L, Fontana F, Salini G, Lambiase A, O'Brien M. NGR-hTNF in combination with best investigator choice in previously treated malignant pleural mesothelioma (NGR015): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet Oncol. 2018 Jun;19(6):799-811. doi: 10.1016/S1470-2045(18)30193-1. Epub 2018 May 9.
PubMed 29753703
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NGR015: Randomized Double-blind Phase III Study of NGR-hTNF Plus Best Investigator's Choice (BIC) Versus Placebo Plus BIC in Previously Treated Patients With Advanced Malignant Pleural Mesothelioma (MPM)
- ClinicalTrials.gov ID
- NCT01098266
- Acronym / sponsor ID
- NGR015
- Conditions
- Malignant Pleural Mesothelioma
- Keywords
- MPM, NGR-hTNF, NGR-hTNF plus BIC, Randomized double-blind phase III study
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- AGC Biologics S.p.A.Industry (pharma, biotech, devices)
- Study start
- 12 Apr 2010 (actual)
- Primary completion
- 29 Apr 2014 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 2 Apr 2010 (estimated)
- Results
- Posted 17 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of the trial is to document the efficacy of NGR-hTNF administered at low dose weekly in advanced Malignant Pleural Mesothelioma patients previously treated with a pemetrexed-based chemotherapy regimen.
Detailed description
Currently, there are no regulatory-approved or widely accepted treatment options for patients failing a standard pemetrexed-based chemotherapy regimen.
For this reason, the best supportive care (BSC) alone might be considered as a standard reference for a randomized phase III trial in this setting.
However, single-agent chemotherapeutic agents (such as doxorubicin,gemcitabine, or vinorelbine) with a well-documented safety profile and antitumor activity are also used in clinical practice.
Therefore, the best investigator's choice (BIC) between either best supportive care alone or combined with a few selected single-agent chemotherapy (including doxorubicin, gemcitabine, or vinorelbine) might be considered as an acceptable reference arm as well in this setting.
The current phase III study aims to show a superior efficacy in terms of overall survival duration of NGR-hTNF 0.8 µg/mq weekly plus BIC versus placebo plus BIC in advanced MPM patients progressing after a standard pemetrexed-based chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: NGR-hTNF + BIC | Experimental | Drug: NGR-hTNF plus Best Investigator's Choice (BIC)NGR-hTNF plus Best Investigator's Choice |
| B: Placebo+BIC | Placebo comparator | Drug: Placebo plus Best Investigator's Choice (BIC)Placebo plus Best Investigator's Choice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age ≥ 18 years
- Histologically or cytological confirmed malignant pleural mesothelioma of any of the following subtype: epithelial, sarcomatoid, mixed, or unknown
- Prior treatment with no more than one systemic pemetrexed-based chemotherapy regimen administered for advanced or metastatic disease. Prior use of a biological agent in combination with a pemetrexed-based regimen and prior administration of intrapleural cytotoxic agents are allowed. Patients who have previously received anthracyclines should not receive doxorubicin
- ECOG Performance Status 0 - 2
- Life expectancy of ≥ 12 weeks
Key exclusion criteria (9 listed)
- Patients must not receive any other investigational agents while on study
- Patients with myocardial infarction within the last six months, unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication
- Uncontrolled hypertension
- QTc interval (congenital or acquired) > 450 ms
- History or evidence upon physical examination of CNS disease unless adequately treated (e.g., primary brain tumor, any brain metastasis, seizure not controlled with standard medical therapy, or history of stroke)
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 |
|---|---|---|
| NGR-hTNF plus Best Investigator's Choice (BIC)Also: NGR-hTNF+BIC* NGR-hTNF: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs. * Best Supportive Care: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis * Investigator's Choice: one of the following single-agent chemotherapy might be administered in combination: 1. Doxorubicin: 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles 2. Gemcitabine: 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles 3. Vinorelbine: 25 mg/m2 iv (or 60 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 weeks) | Drug | A: NGR-hTNF + BIC |
| Placebo plus Best Investigator's Choice (BIC)Also: Placebo+BIC* Placebo: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs. * Best Supportive Care: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis * Investigator's Choice: one of the following single-agent chemotherapy might be administered in combination: 1. Doxorubicin: 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles 2. Gemcitabine: 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles 3. Vinorelbine: 25 mg/m2 iv (or 60 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 weeks) | Drug | B: Placebo+BIC |
Primary outcome
Overall Survival (OS)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, wichever came first, assesed up to 48 months
Defined as the time from the date of randomization until the date of death due to any cause or the last date the patient was known to be alive
6 secondary outcomes
Progression-Free Survival (PFS)
Time frame: From the date of randomization until the date of first documented progression or date of death from any cause, wichever came first, assessed up to 48 months
Disease Control Rate (DCR)
Time frame: Assessed every 6-12 weeks, up to 100 weeks
Number of Partecipants With Disease Control for ≥ 6 Months
Time frame: Assessed every 6-12 weeks, up to 100 weeks
Number of Partecipants With Adverse Events
Time frame: Assessed every 6-12 weeks, up to 100 weeks
Time to LCSS Symptomatic Progression
Time frame: from the date of randomization to the date of the LCSS assessment on which symptomatic progression was identified, assessed on cycle 2, cycle 4 and cycle 6 (each cycle lasted 21 days)
Evaluation of Medical Care Utilization in the Two Treatment Arms
Time frame: Assessed every 6-12 weeks, up to 100 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29753703Gregorc V, Gaafar RM, Favaretto A, Grossi F, Jassem J, Polychronis A, Bidoli P, Tiseo M, Shah R, Taylor P, Novello S, Muzio A, Bearz A, Greillier L, Fontana F, Salini G, Lambiase A, O'Brien M. NGR-hTNF in combination with best investigator choice in previously treated malignant pleural mesothelioma (NGR015): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet Oncol. 2018 Jun;19(6):799-811. doi: 10.1016/S1470-2045(18)30193-1. Epub 2018 May 9.
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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.
Antonio Lambiase, MD study director
AGC Biologics S.p.A.
49 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NGR-hTNF plus Best Investigator's Choice (BIC) in people with Malignant Pleural Mesothelioma, run by AGC Biologics S.p.A. at 49 sites in 12 countries.
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 15 inclusion and 9 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 17 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in Italy, United Kingdom, United States, Belgium, Canada and 7 more countries. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 17 Sep 2019). 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?
Overall Survival (OS) (time frame: From date of randomization until the date of first documented progression or date of death from any cause, wichever came first, assesed up to 48 months). 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 NCT01098266, 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 17 Sep 2019.