PMID- 23787063
OWN - NLM
STAT- MEDLINE
DCOM- 20140408
LR  - 20211203
IS  - 1872-8332 (Electronic)
IS  - 0169-5002 (Linking)
VI  - 81
IP  - 3
DP  - 2013 Sep
TI  - A phase II clinical trial of the vascular disrupting agent BNC105P as second line 
      chemotherapy for advanced Malignant Pleural Mesothelioma.
PG  - 422-427
LID - S0169-5002(13)00218-3 [pii]
LID - 10.1016/j.lungcan.2013.05.006 [doi]
AB  - 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 16 mg/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.
CI  - Copyright (c) 2013 Elsevier Ireland Ltd. All rights reserved.
FAU - Nowak, Anna K
AU  - Nowak AK
AD  - Department of Medical Oncology, Sir Charles Gairdner Hospital, Hospital Ave, 
      Nedlands, WA 6009, Australia; School of Medicine and Pharmacology, University of 
      Western Australia, M503 35 Stirling Hwy, Crawley, WA 6009, Australia; National 
      Centre for Asbestos Related Diseases, M503 35 Stirling Hwy, Crawley, WA 6009, 
      Australia. Electronic address: anna.nowak@uwa.edu.au.
FAU - Brown, Chris
AU  - Brown C
AD  - NHMRC Clinical Trials Centre, University of Sydney, Medical Foundation Building, 
      92-94 Parramatta Road, Camperdown, NSW 2050, Australia.
FAU - Millward, Michael J
AU  - Millward MJ
AD  - Department of Medical Oncology, Sir Charles Gairdner Hospital, Hospital Ave, 
      Nedlands, WA 6009, Australia; School of Medicine and Pharmacology, University of 
      Western Australia, M503 35 Stirling Hwy, Crawley, WA 6009, Australia.
FAU - Creaney, Jenette
AU  - Creaney J
AD  - School of Medicine and Pharmacology, University of Western Australia, M503 35 
      Stirling Hwy, Crawley, WA 6009, Australia; National Centre for Asbestos Related 
      Diseases, M503 35 Stirling Hwy, Crawley, WA 6009, Australia.
FAU - Byrne, Michael J
AU  - Byrne MJ
AD  - Department of Medical Oncology, Sir Charles Gairdner Hospital, Hospital Ave, 
      Nedlands, WA 6009, Australia; School of Medicine and Pharmacology, University of 
      Western Australia, M503 35 Stirling Hwy, Crawley, WA 6009, Australia; National 
      Centre for Asbestos Related Diseases, M503 35 Stirling Hwy, Crawley, WA 6009, 
      Australia.
FAU - Hughes, Brett
AU  - Hughes B
AD  - The Prince Charles Hospital, Rode Road, Chermside, Queensland 4032, Australia.
FAU - Kremmidiotis, Gabriel
AU  - Kremmidiotis G
AD  - Bionomics Limited, 31 Dalgleish Street, Thebarton, SA 5031, Australia.
FAU - Bibby, David C
AU  - Bibby DC
AD  - Bionomics Limited, 31 Dalgleish Street, Thebarton, SA 5031, Australia.
FAU - Leske, Annabell F
AU  - Leske AF
AD  - Bionomics Limited, 31 Dalgleish Street, Thebarton, SA 5031, Australia.
FAU - Mitchell, Paul L R
AU  - Mitchell PLR
AD  - Austin-Ludwig Medical Oncology Unit, Austin Health, Studley Road, Heidelberg, VIC 
      3084, Australia.
FAU - Pavlakis, Nick
AU  - Pavlakis N
AD  - Department of Medical Oncology, Royal North Shore Hospital, St. Leonards, NSW 
      2065, Australia; Faculty of Medicine, University of Sydney, Camperdown, NSW 2050, 
      Australia.
FAU - Boyer, Michael
AU  - Boyer M
AD  - Royal Prince Alfred Hospital, Missenden Road, Camperdown, NSW 2050, Australia.
FAU - Stockler, Martin R
AU  - Stockler MR
AD  - NHMRC Clinical Trials Centre, University of Sydney, Medical Foundation Building, 
      92-94 Parramatta Road, Camperdown, NSW 2050, Australia.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20130617
PL  - Ireland
TA  - Lung Cancer
JT  - Lung cancer (Amsterdam, Netherlands)
JID - 8800805
RN  - 0 (Antineoplastic Agents)
RN  - 0 (BNC 105P)
RN  - 0 (Benzofurans)
RN  - 0 (Biomarkers)
RN  - 0 (GPI-Linked Proteins)
RN  - 0 (Organophosphates)
RN  - 0 (Tubulin Modulators)
RN  - J27WDC343N (Mesothelin)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Agents/*therapeutic use
MH  - Benzofurans/administration & dosage/adverse effects/*therapeutic use
MH  - Biomarkers/blood/metabolism
MH  - Female
MH  - GPI-Linked Proteins/blood/metabolism
MH  - Humans
MH  - Lung Neoplasms/diagnostic imaging/*drug therapy/mortality/*pathology
MH  - Male
MH  - Mesothelin
MH  - Mesothelioma/diagnostic imaging/*drug therapy/mortality/*pathology
MH  - Mesothelioma, Malignant
MH  - Middle Aged
MH  - Neoplasm Staging
MH  - Organophosphates/administration & dosage/adverse effects/*therapeutic use
MH  - Pleural Neoplasms/diagnostic imaging/*drug therapy/mortality/*pathology
MH  - Radiography
MH  - Treatment Outcome
MH  - Tubulin Modulators/administration & dosage/adverse effects/*therapeutic use
MH  - Tumor Burden
OTO - NOTNLM
OT  - BNC105P
OT  - Biomarkers
OT  - Clinical trial
OT  - Mesothelioma
OT  - Phase II
OT  - Vascular Disrupting Agent
EDAT- 2013/06/22 06:00
MHDA- 2014/04/09 06:00
CRDT- 2013/06/22 06:00
PHST- 2013/01/18 00:00 [received]
PHST- 2013/05/06 00:00 [revised]
PHST- 2013/05/10 00:00 [accepted]
PHST- 2013/06/22 06:00 [entrez]
PHST- 2013/06/22 06:00 [pubmed]
PHST- 2014/04/09 06:00 [medline]
AID - S0169-5002(13)00218-3 [pii]
AID - 10.1016/j.lungcan.2013.05.006 [doi]
PST - ppublish
SO  - Lung Cancer. 2013 Sep;81(3):422-427. doi: 10.1016/j.lungcan.2013.05.006. Epub 
      2013 Jun 17.