NGR015: Study in Second Line for Patient With Advanced Malignant Pleural Mesothelioma Pretreated With Pemetrexed
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|ClinicalTrials.gov Identifier: NCT01098266|
Recruitment Status : Completed
First Posted : April 2, 2010
Results First Posted : September 17, 2019
Last Update Posted : September 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Malignant Pleural Mesothelioma||Drug: NGR-hTNF plus Best Investigator's Choice (BIC) Drug: Placebo plus Best Investigator's Choice (BIC)||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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)|
|Actual Study Start Date :||April 12, 2010|
|Actual Primary Completion Date :||April 29, 2014|
|Actual Study Completion Date :||December 2017|
Experimental: A: NGR-hTNF + BIC
NGR-hTNF plus Best Investigator's Choice
Drug: NGR-hTNF plus Best Investigator's Choice (BIC)
Other Name: NGR-hTNF+BIC
Placebo Comparator: B: Placebo+BIC
Placebo plus Best Investigator's Choice
Drug: Placebo plus Best Investigator's Choice (BIC)
Other Name: Placebo+BIC
- 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
- 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 ]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) [ Time Frame: Assessed every 6-12 weeks, up to 100 weeks ]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
- Number of Partecipants With Disease Control for ≥ 6 Months [ Time Frame: Assessed every 6-12 weeks, up to 100 weeks ]Measured from the date of randomization until disease progression, or death due to any cause
- Number of Partecipants With Adverse Events [ Time Frame: Assessed every 6-12 weeks, up to 100 weeks ]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 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) ]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%.
- Evaluation of Medical Care Utilization in the Two Treatment Arms [ Time Frame: Assessed every 6-12 weeks, up to 100 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01098266
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|Study Director:||Antonio Lambiase, MD||MolMed S.p.A.|