NGR015: Study in Second Line for Patient With Advanced Malignant Pleural Mesothelioma Pretreated With Pemetrexed

Phase 3 Completed 400 enrolled AGC Biologics S.p.A.

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2010-04-12
Primary completion: 2014-04-29
Completion: 2017-12

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	NGR-hTNF	Protein / enzyme biologic	0.8 ug/m2	Intravenous
Background	Doxorubicin	Other / unclassified	60 mg/m2	Intravenous
Background	Doxorubicin	Other / unclassified	75 mg/m2	Intravenous
Background	Gemcitabine	Small molecule	1000 mg/m2	Intravenous
Background	Gemcitabine	Small molecule	1250 mg/m2	Intravenous
Background	Vinorelbine	Small molecule	25 mg/m2	Intravenous
Background	Vinorelbine	Small molecule	60 mg/m2	Intravenous

NGR015: Study in Second Line for Patient With Advanced Malignant Pleural Mesothelioma Pretreated With Pemetrexed

Summary

Timeline

Publications

Drugs

Indications