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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-016879-29 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: NGR-hTNF + BIC | Experimental | NGR-hTNF plus Best Investigator's Choice |
|
| B: Placebo+BIC | Placebo Comparator | Placebo plus Best Investigator's Choice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NGR-hTNF plus Best Investigator's Choice (BIC) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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:
Measurable or non-measurable disease according to MPM-modified RECIST criteria
Patients may have had prior therapy providing the following conditions are met:
Patients must give written informed consent to participate in the study
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Lambiase, MD | AGC Biologics S.p.A. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wilshire Oncology Medical Group | Corona | California | 92879 | United States | ||
| City of Hope-Comprehensive Cancer Cente |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29753703 | Derived | 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. |
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Before randomization, the physician had to decide for each patient if he/she was candidate to either Best Supportive Care (BSC) alone or combined with single-agent chemotherapy.
Study Period: April 12th, 2010(First enrolment); January 21st, 2013 (date of last enrolment); April 29th, 2014 (cut-off date). 15 clinical sites in Italy, 10 in UK, 7 in USA, 4 in Belgium, 2 in Canada, 2 in Netherland, 2 in Poland, 1 in Egypt, 1 in Ireland;1 in Sweden
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| ID | Title | Description |
|---|---|---|
| FG000 | A: NGR-hTNF + BIC | NGR-hTNF plus Best Investigator's Choice NGR-hTNF plus Best Investigator's Choice (BIC): - NGR-hTNF: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs.
|
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
|
| Placebo plus Best Investigator's Choice (BIC) | Drug |
|
|
|
| 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 | 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 | 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. | 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%. | 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. | Assessed every 6-12 weeks, up to 100 weeks |
| Duarte |
| California |
| 91010 |
| United States |
| H. Lee Moffitt ancer Center and Research Institute | Tampa | Florida | 33612 | United States |
| Johns Hopkins | Baltimore | Maryland | 21231 | United States |
| Columbia University | New York | New York | 10032 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| UTsouthwestern medical center | Dallas | Texas | 75390 | United States |
| Antwerp University Hospital | Edegem | Antwerp | B-2650 | Belgium |
| Centre Hospitalier Universitaire de Liège | Liège | Liege | 4000 | Belgium |
| Institut Jules Bordet | Brussels | 1000 | Belgium |
| Cliniques Universitarie St. Luc | Brussels | 1200 | Belgium |
| Universitair Ziekenhuis | Ghent | 9000 | Belgium |
| UAB - Alberta Cancer Board - Cross Cancer Institute | Edmonton | Alberta | T6G1Z2 | Canada |
| University Health Network, Princess Margaret Hospital | Toronto | Ontario | M5G2C4 | Canada |
| National Cancer Institute | Cairo | 11796 | Egypt |
| Hôpitaux de Marseille Hôpital Nord | Marseille | Cedex 20 | France |
| St James's Hospital | Dublin | Ireland |
| Ospedale Santo Spirito | Casale Monferrato | Alessandria | 15033 | Italy |
| Azienda Ospedaliera Universitaria San Luigi Gonzaga | Orbassano | Torino | 10043 | Italy |
| Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria | Alessandria | 15100 | Italy |
| Centro di Riferimento Oncologico | Aviano | Italy |
| Ospedale Valduce | Como | Italy |
| Azienda Ospedaliero-Universitaria Careggi di Firenze | Florence | Italy |
| Istituto Nazionale per la Ricerca sul Cancro | Genoa | 16132 | Italy |
| Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori-IRST | Meldola | 47014 | Italy |
| Fondazione San Raffaele del Monte Tabor | Milan | 20132 | Italy |
| Azienda Ospedaliera San Gerardo | Monza | 20052 | Italy |
| Istituto Oncologico Veneto | Padova | Italy |
| Azienda Ospedaliero Universitaria di Parma | Parma | Italy |
| Azienda Unità Sanitaria locale di Ravenna | Ravenna | 48100 | Italy |
| A.O. Salvini Garbagnate, Ospedale di Rho | Rho | Italy |
| Azienda Ospedaliera Senese | Siena | 53100 | Italy |
| St. Jansdal Hospital | Harderwijk | Gelderland | 3840 | Netherlands |
| St. Antonius Hospital | Nieuwegein | Utrecht | 3435 | Netherlands |
| Medical University of Gdansk | Gdansk | 80211 | Poland |
| Maria Sklodowska Memorial Cancer Center and Institute of Oncology | Warsaw | 02-781 | Poland |
| Hospital Universitari Germans Trias i Pujol | Badalona | Barcelona | 08916 | Spain |
| Hospital Vall d'Hebron | Barcelona | 08035 | Spain |
| The University Hospital | Linköping | 581 85 | Sweden |
| Chest Clinic, Wythenshawe Hospital | Manchester | Greater Manchester | M23 9LT | United Kingdom |
| Kent Oncology Centre Maidstone Hospital | Maidstone | Kent | ME16 9QQ | United Kingdom |
| University Hospitals of Leicester | Leicester | Leicestershire | LE0116 | United Kingdom |
| Mount Vernon Cancer Centre | Middlesex | Northwood | HA6 2RN | United Kingdom |
| Edinburgh Cancer Centre, Western General Hospital | Edinburgh | Scotland | EH4 2XU | United Kingdom |
| The Beatson West of Scotland Cancer Centre | Glasgow | Scotland | G12 | United Kingdom |
| The Royal Marsden Hospital | Sutton | Surrey | United Kingdom |
| Castle Hill Hospital | Cottingham | Yorkshire | HU16 5JQ | United Kingdom |
| Guy's Hospital | London | SE1 9RT | United Kingdom |
| The Royal Marsden Hospital | London | SW3 6JJ | United Kingdom |
| FG001 | B: Placebo+BIC | Placebo plus Best Investigator's Choice Placebo plus Best Investigator's Choice (BIC): - Placebo: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs.
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Patients ≥ 18 years with advanced malignant pleural mesothelioma previously treated with a pemetrexed based chemotherapy regimen for advanced or metastatic disease.
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| ID | Title | Description |
|---|---|---|
| BG000 | A: NGR-hTNF + BIC | NGR-hTNF plus Best Investigator's Choice NGR-hTNF plus Best Investigator's Choice (BIC): - NGR-hTNF: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs.
|
| BG001 | B: Placebo+BIC | Placebo plus Best Investigator's Choice Placebo plus Best Investigator's Choice (BIC): - Placebo: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs.
|
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Median | 95% Confidence Interval | months | 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 | 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 | Posted | Median | 95% Confidence Interval | months | 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 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | Posted | Count of Participants | Participants | Assessed every 6-12 weeks, up to 100 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Partecipants With Disease Control for ≥ 6 Months | Measured from the date of randomization until disease progression, or death due to any cause | Duration of disease control ≥ 6 months | Posted | Count of Participants | Participants | Assessed every 6-12 weeks, up to 100 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The safety data referred to patients of both arms who received at least one treatment and is termed as safety population (n=386) | Posted | Number | participants | Assessed every 6-12 weeks, up to 100 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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%. | Participants with a worsening in the average symptom burden index by 25%. | Posted | Median | 95% Confidence Interval | months | 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) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Count of Participants | Participants | Assessed every 6-12 weeks, up to 100 weeks |
|
Through study completation, an average of 2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | A: NGR-hTNF + BIC | NGR-hTNF plus Best Investigator's Choice NGR-hTNF plus Best Investigator's Choice (BIC): - NGR-hTNF: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs.
| 12 | 193 | 56 | 193 | 190 | 193 |
| EG001 | B: Placebo+BIC | Placebo plus Best Investigator's Choice Placebo plus Best Investigator's Choice (BIC): - Placebo: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs.
| 13 | 193 | 54 | 193 | 185 | 193 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Paraneoplastic fever | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Brain mets | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Brain mets | Immune system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Mucositis | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hyperpyrexia | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Ischaemic ulcer to left heel | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Deterioration of clinical status | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Admitted for pain control | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Uncertain study medication dose delivered | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Drug infusion reaction | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Occipital trauma | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cardiac disorder | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Infection (chest) with normal ANC | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pleural pain | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Neutropenic fever | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Superior sagittal sinus thrombosis | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Right hemispheric cerebrovascular accident | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Abdominal ascites | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Acute hepatitis | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Abnormal renal function | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pain right chest wall + right shoulder | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Appendiceal abscess | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Infection - source unknown | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Viral gastroenteritis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Cardiac arresr | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Condition aggraveted | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Lower Respiratory Tract Infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Lung Infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| . Respiratory Tract Infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pleural Mesothelioma | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Jacksonian seizure | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dysponoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pheripheral neuropathy | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
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| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Transaminases Increased | Investigations | MedDRA 18.1 | Systematic Assessment |
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| Abdominal disconfort | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operations | Molmed S.p.A | 003902212771 | clinical.operations@molmed.com |
| ID | Term |
|---|---|
| D000086002 | Mesothelioma, Malignant |
| ID | Term |
|---|---|
| D008654 | Mesothelioma |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018301 | Neoplasms, Mesothelial |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D010997 | Pleural Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C464839 | tumor necrosis factor-alpha, CNGRC fusion protein, human |
Not provided
Not provided
Not provided
| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Netherlands |
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| Sweden |
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| Belgium |
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| United States |
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| Ireland |
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| Egypt |
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| Poland |
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| Italy |
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| United Kingdom |
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| France |
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| Spain |
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| Superiority |
| OG001 | B: Placebo+BIC | Placebo plus Best Investigator's Choice Placebo plus Best Investigator's Choice (BIC): - Placebo: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs.
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Placebo plus Best Investigator's Choice
Placebo plus Best Investigator's Choice (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:
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| OG001 | B: Placebo+BIC | Placebo plus Best Investigator's Choice Placebo plus Best Investigator's Choice (BIC): - Placebo: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs.
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