TriangleNCT01098266 · STUDY IN CONTEXT
NGR015: Study in Second Line for Patient With Advanced Malignant Pleural Mesothelioma Pretreated With Pemetrexed
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
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
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
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 from the date of randomization until disease progression, or death due to any cause
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.
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%.
Reported safety
Quality of life and patient-reported measures
Unnamed quality-of-life measure · Time to LCSS Symptomatic Progression
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT01098266
- qol key
- qol-0005
- source section id
- NCT01098266-om-0005
- source outcome index
- 5
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Time to LCSS Symptomatic Progression
- measure definition
- 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%.
- 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)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Participants with a worsening in the average symptom burden index by 25%.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT01098266
- trial label
- NGR015: Study in Second Line for Patient With Advanced Malignant Pleural Mesothelioma Pretreated With Pemetrexed
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 6
- harms Count
- 2
- qol Count
- 1
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT01098266
- outcome key
- om-0000
- source section id
- NCT01098266-om-0000
- source outcome index
- 0
- endpoint
- Overall Survival (OS)
- endpoint definition
- 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
- time origin
- 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
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT01098266
- outcome key
- om-0001
- source section id
- NCT01098266-om-0001
- source outcome index
- 1
- endpoint
- Progression-Free Survival (PFS)
- endpoint definition
- 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
- time origin
- 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
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT01098266
- outcome key
- om-0002
- source section id
- NCT01098266-om-0002
- source outcome index
- 2
- endpoint
- Disease Control Rate (DCR)
- endpoint definition
- 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
- time origin
- Assessed every 6-12 weeks, up to 100 weeks
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT01098266
- outcome key
- om-0003
- source section id
- NCT01098266-om-0003
- source outcome index
- 3
- endpoint
- Number of Partecipants With Disease Control for ≥ 6 Months
- endpoint definition
- Measured from the date of randomization until disease progression, or death due to any cause
- time origin
- Assessed every 6-12 weeks, up to 100 weeks
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Duration of disease control ≥ 6 months
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT01098266
- outcome key
- om-0004
- source section id
- NCT01098266-om-0004
- source outcome index
- 4
- endpoint
- Number of Partecipants With Adverse Events
- endpoint definition
- 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.
- time origin
- Assessed every 6-12 weeks, up to 100 weeks
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The safety data referred to patients of both arms who received at least one treatment and is termed as safety population (n=386)
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT01098266
- outcome key
- om-0005
- source section id
- NCT01098266-om-0005
- source outcome index
- 5
- endpoint
- Time to LCSS Symptomatic Progression
- endpoint definition
- 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%.
- time origin
- 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)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Participants with a worsening in the average symptom burden index by 25%.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT01098266
- outcome key
- om-0000
- arm key
- OG000
- arm label
- A: NGR-hTNF + BIC
- regimen
- 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. * 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)
- analyzed count
- 200
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01098266-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT01098266
- outcome key
- om-0000
- arm key
- OG001
- arm label
- B: Placebo+BIC
- regimen
- 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: 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)
- analyzed count
- 200
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01098266-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT01098266
- outcome key
- om-0001
- arm key
- OG000
- arm label
- A: NGR-hTNF + BIC
- regimen
- 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. * 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)
- analyzed count
- 200
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01098266-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT01098266
- outcome key
- om-0001
- arm key
- OG001
- arm label
- B: Placebo+BIC
- regimen
- 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: 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)
- analyzed count
- 200
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01098266-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT01098266
- outcome key
- om-0002
- arm key
- OG000
- arm label
- A: NGR-hTNF + BIC
- regimen
- 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. * 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)
- analyzed count
- 200
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01098266-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT01098266
- outcome key
- om-0002
- arm key
- OG001
- arm label
- B: Placebo+BIC
- regimen
- 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: 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)
- analyzed count
- 200
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01098266-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT01098266
- outcome key
- om-0003
- arm key
- OG000
- arm label
- A: NGR-hTNF + BIC
- regimen
- 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. * 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)
- analyzed count
- 200
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01098266-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT01098266
- outcome key
- om-0003
- arm key
- OG001
- arm label
- B: Placebo+BIC
- regimen
- 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: 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)
- analyzed count
- 200
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01098266-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT01098266
- outcome key
- om-0004
- arm key
- OG000
- arm label
- A: NGR-hTNF + BIC
- regimen
- 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. * 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)
- analyzed count
- 193
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01098266-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT01098266
- outcome key
- om-0004
- arm key
- OG001
- arm label
- B: Placebo+BIC
- regimen
- 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: 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)
- analyzed count
- 193
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01098266-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT01098266
- outcome key
- om-0005
- arm key
- OG000
- arm label
- A: NGR-hTNF + BIC
- regimen
- 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. * 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)
- analyzed count
- 175
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01098266-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT01098266
- outcome key
- om-0005
- arm key
- OG001
- arm label
- B: Placebo+BIC
- regimen
- 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: 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)
- analyzed count
- 185
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01098266-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT01098266
- harm key
- EG000
- source section id
- NCT01098266-ae
- event group key
- EG000
- event group label
- A: NGR-hTNF + BIC
- serious affected
- 56
- serious at risk
- 193
- other affected
- 190
- other at risk
- 193
- frequency threshold
- 5
- collection period
- Through study completation, an average of 2 years
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT01098266
- harm key
- EG001
- source section id
- NCT01098266-ae
- event group key
- EG001
- event group label
- B: Placebo+BIC
- serious affected
- 54
- serious at risk
- 193
- other affected
- 185
- other at risk
- 193
- frequency threshold
- 5
- collection period
- Through study completation, an average of 2 years
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-mesothelioma
- nct id
- NCT01098266
- qol key
- qol-0005
- source section id
- NCT01098266-om-0005
- source outcome index
- 5
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Time to LCSS Symptomatic Progression
- measure definition
- 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%.
- 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)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Participants with a worsening in the average symptom burden index by 25%.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- setting source links
Preserved source evidence · Not medical advice