NCT00634205|CompletedPhase 2DMC
Phase II Study of Valproate and Doxorubicin in Malignant Mesothelioma
A Phase II Study Assessing the Activity of Valproate Acid Plus Doxorubicin in Refractory or Recurrent Malignant Mesothelioma
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Sponsor study identifier
interventional
45
2 countries
8
Study Start
July 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2009
Actual (reported)Study Completion
June 2010
Actual (reported)The purpose of this study is to determine the response rate to the combination of doxorubicin and valproate acid in patients with MM failing after at least one previous chemotherapy regimen including platinum derivatives .
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2010
Actual (reported)Click 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.
July 2006
Date type not reportedThis date has not been verified as actual or estimated.
March 5, 2008
Actual (reported)March 12, 2008
Actual (reported)March 2009
Actual (reported)June 2010
Actual (reported)Response rate
Every 3 courses
Survival
Survival will be dated from the day of registration until death or last follow up
Toxicity
After each course of chemotherapy and at the end of treatment
Continuous oral administration of valproate plus every 3 weeks, intravenous administration of doxorubicin
Valproate 20-30 mg/kg orally (in order to obtain serum concentration between 50-100 mcg/ml) Doxorubicin 60 mg/m² intravenously every 3 weeks
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Treatment programme
Valproate plus doxorubicin
The registry describes a treatment programme. Individual components, doses and actual administration are not established by this entry.
View registry recordDepartment of Pneumology CHR St joseph - Warquignies
Boussu, 7360, Belgium
Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
Brussels, 1000, Belgium
Department of Pneumology Hôpital Ixelles-Molière
Brussels, Belgium
Department of Pneumology CHU Charleroi
Charleroi, 6000, Belgium
Department of Pneumology Hôpital Saint-Joseph
Gilly, 6060, Belgium
Hôpital Ambroise Paré
Mons, 7000, Belgium
CH Peltzer-La Tourelle
Verviers, 4800, Belgium
Scherpereel A, Berghmans T, Lafitte JJ, Colinet B, Richez M, Bonduelle Y, Meert AP, Dhalluin X, Leclercq N, Paesmans M, Willems L, Sculier JP; European Lung Cancer Working Party (ELCWP). Valproate-doxorubicin: promising therapy for progressing mesothelioma. A phase II study. Eur Respir J. 2011 Jan;37(1):129-35. doi: 10.1183/09031936.00037310. Epub 2010 Jun 7.
Thierry Berghmans, MD
European Lung Cancer Working Party
45 participants (actual enrollment reported by the registry).
First Submitted
March 5, 2008
First Posted
March 12, 2008
Study Start
July 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.
Department of Pneumology CHRU Lille
Lille, France
Primary Completion
March 2009
Actual (reported)Study Completion
June 2010
Actual (reported)Last Updated
February 12, 2015
Record last verified: 2015-02
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.
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