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
Last Update Posted : December 22, 2017
|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)|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||December 2017|
|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: every 6-12 weeks ]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: every 6-12 weeks ]Defined as the time from the date of randomization until disease progression, or death
- Disease Control Rate (DCR) [ Time Frame: every 6-12 weeks ]Defined as the percentage of patients who have a best-response rating of complete response, partial response, or stable disease
- Duration of Disease Control [ Time Frame: every 6-12 weeks ]Measured from the date of randomization until disease progression, or death due to any cause
- Safety and Toxicity according to NCI-CTCAE criteria (version 4.02) [ Time Frame: every 6-12 weeks ]
- Quality of life (QoL) according to Lung Cancer Symptom Scale [ Time Frame: every 6-12 weeks ]
- Evaluation of medical care utilization in the two treatment arms [ Time Frame: every 6-12 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
Show 49 Study Locations
|Study Director:||Antonio Lambiase, MD||MolMed S.p.A.|