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
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Tracking Information | ||||
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First Submitted Date ICMJE | March 17, 2010 | |||
First Posted Date ICMJE | April 2, 2010 | |||
Results First Submitted Date ICMJE | June 5, 2019 | |||
Results First Posted Date ICMJE | September 17, 2019 | |||
Last Update Posted Date | September 17, 2019 | |||
Actual Study Start Date ICMJE | April 12, 2010 | |||
Actual Primary Completion Date | April 29, 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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
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Original Primary Outcome Measures ICMJE |
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
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Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | NGR015: Study in Second Line for Patient With Advanced Malignant Pleural Mesothelioma Pretreated With Pemetrexed | |||
Official Title ICMJE | 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) | |||
Brief 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. | |||
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. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Malignant Pleural Mesothelioma | |||
Intervention ICMJE |
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Study Arms ICMJE |
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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. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
400 | |||
Original Estimated Enrollment ICMJE |
390 | |||
Actual Study Completion Date ICMJE | December 2017 | |||
Actual Primary Completion Date | April 29, 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Belgium, Canada, Egypt, France, Ireland, Italy, Netherlands, Poland, Spain, Sweden, United Kingdom, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01098266 | |||
Other Study ID Numbers ICMJE | NGR015 2009-016879-29 ( EudraCT Number ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | AGC Biologics S.p.A. | |||
Original Responsible Party | MolMed | |||
Current Study Sponsor ICMJE | AGC Biologics S.p.A. | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | AGC Biologics S.p.A. | |||
Verification Date | August 2019 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |