NCT00513877|CompletedPhase 2
Bortezomib in Treating Patients With Malignant Pleural Mesothelioma
An Open Label Phase II Multicentre Clinical Trial of Single Agent Bortezomib in Patients With Malignant Pleural Mesothelioma
Loading search results
An Open Label Phase II Multicentre Clinical Trial of Single Agent Bortezomib in Patients With Malignant Pleural Mesothelioma
Sponsor study identifier
Secondary identifiers
interventional
33
4 countries
13
Study Start
May 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2009
Actual (reported)Study Completion
Not reported
Date not reportedRATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying the side effects of bortezomib and how well it works in treating patients with malignant pleural mesothelioma.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
Date not reportedClick on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2006
Date type not reportedThis date has not been verified as actual or estimated.
August 8, 2007
Actual (reported)August 9, 2007
Actual (reported)December 2009
Actual (reported)Objective tumor response rate (complete response or partial response) as assessed by modified RECIST criteria
The objective tumour response rate is a primary endpoint of the study. This will be a proportion of evaluable subjects who achieve a confirmed CR or PR per modified RECIST guidelines within four cycles (20 weeks) of treatment.
28 days prior to baseline, at 10 weeks and at end of treatment
Time to disease progression
Time to disease progression is measured from first treatment until the date of PD or death whichever is first reported. Subjects who did not progress or die will be censored at the day of their last tumour assessment.
Overall survival
Overall Survival is measured from the date of first treatment to the date of the subject's death. If the subject is alive or the vital status is unknown, the date of death will be censored at the date that the subject is last known to be alive.
Safety
The assessment of safety will be based mainly on the frequency of adverse events and on the number of laboratory values that fall outside of the pre-determined normal ranges.
Quality of life
Week 1, Week 10 and end of treatment
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Universitair Ziekenhuis Gent
Ghent, B-9000, Belgium
Cork University Hospital
Cork, Ireland
Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital
Dublin, 24, Ireland
St. Vincent's University Hospital
Dublin, 4, Ireland
Mater Misericordiae University Hospital
Dublin, 7, Ireland
St. James's Hospital
Dublin, 8, Ireland
Beaumont Hospital
Dublin, 9, Ireland
Walter RFH, Sydow SR, Berg E, Kollmeier J, Christoph DC, Christoph S, Eberhardt WEE, Mairinger T, Wohlschlaeger J, Schmid KW, Mairinger FD. Bortezomib sensitivity is tissue dependent and high expression of the 20S proteasome precludes good response in malignant pleural mesothelioma. Cancer Manag Res. 2019 Sep 24;11:8711-8720. doi: 10.2147/CMAR.S194337. eCollection 2019.
Dean A. Fennell, MD, PhD
Centre for Cancer Research and Cell Biology at Queen's University Belfast
33 participants (actual enrollment reported by the registry).
First Submitted
August 8, 2007
First Posted
August 9, 2007
Study Start
May 2006
Date type not reportedThis date has not been verified as actual or estimated.
A Clinical Study With Tremelimumab as Monotherapy in Malignant Mesothelioma
Contact the study team to confirm eligibility.
Galway University Hospital
Galway, Ireland
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Amsterdam, 1066 BE, Netherlands
Saint Bartholomew's Hospital
London, England, EC1A 7BE, United Kingdom
Royal Marsden - Surrey
Sutton, England, SM2 5PT, United Kingdom
Centre for Cancer Research and Cell Biology at Queen's University Belfast
Belfast, Northern Ireland, BT9 7BL, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, Scotland, G11 6NT, United Kingdom
Primary Completion
December 2009
Actual (reported)Last Updated
December 31, 2014
Record last verified: 2013-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: