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Citation
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HERO ID
1937477
Reference Type
Journal Article
Title
A phase II clinical trial of the Vascular Disrupting Agent BNC105P as second line chemotherapy for advanced Malignant Pleural Mesothelioma
Author(s)
Nowak, AK; Brown, C; Millward, MJ; Creaney, J; Byrne, MJ; Hughes, B; Kremmidiotis, G; Bibby, DC; Leske, AF; Mitchell, PL; Pavlakis, N; Boyer, M; Stockler, MR
Year
2013
Is Peer Reviewed?
1
Journal
Lung Cancer
ISSN:
0169-5002
EISSN:
1872-8332
Volume
81
Issue
3
Page Numbers
422-427
Language
English
PMID
23787063
DOI
10.1016/j.lungcan.2013.05.006
Abstract
BNC105P is a tubulin polymerisation inhibitor that selectively disrupts tumour vasculature and suppresses cancer cell proliferation. This agent has exhibited preclinical and phase I activity in Malignant Pleural Mesothelioma (MPM). This phase II, single arm trial investigated the efficacy and safety of BNC105P as second line therapy in MPM. Participants had progressive MPM after first line pemetrexed/platinum chemotherapy, ECOG PS 0-1, adequate organ function, and measurable disease. BNC105P 16mg/m(2) was administered intravenously on day 1 and 8 every 21 days until progression or undue toxicity. The primary endpoint was centrally reviewed objective response rate (RR). Tumour response was assessed every two cycles using modified RECIST. 30 patients were enrolled in 10 months, predominantly male (90%), ECOG PS 1 (77%), epithelioid histology (67%), and non-metastatic disease (67%). All patients received at least one dose of study drug, with a median of 2 cycles. No significant haematologic, biochemical, or cardiac adverse events (AEs) were observed. Grade 3 or 4 AEs occurred in 10 patients (33%). There were 2 deaths on study: 1 cardiorespiratory, the other to pneumonia. We observed 1 partial response (3%); 13 patients had stable disease (43%). Median progression free survival was 1.5 months (95% CI 1.4-2.4); median overall survival was 8.2 months (95% CI 3.8-11.9). BNC105P was safe and tolerable. The sole response was insufficient to warrant further research as a single agent.
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IRIS
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Libby Amphibole Asbestos (Draft, 2011)
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