A Study to Identify a Biomarker Predictive for Response on Everolimus in Solid Tumors (CPCT-03) (CPCT-03)
|ClinicalTrials.gov Identifier: NCT01566279|
Recruitment Status : Unknown
Verified February 2014 by Martijn P. Lolkema, UMC Utrecht.
Recruitment status was: Recruiting
First Posted : March 29, 2012
Last Update Posted : February 25, 2014
|Condition or disease||Intervention/treatment|
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: Everolimus|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Two Parts, Biomarker Study to Identify Genetic Aberrations Predictive for Response on Everolimus in Solid Tumors Without Regular Treatment Options (CPCT-03)|
|Study Start Date :||August 2012|
|Estimated Primary Completion Date :||June 2014|
|Estimated Study Completion Date :||June 2015|
All patients in first part will receive everolimus 10mg q.d.
All patients will receive everolimus 10mg q.d.
Other Name: Affinitor
- analyse a set of 1951 genes for prediction of response measured by time to progression (TTP) ratio (defined as the TTP without drug: TTP on drug) on mTOR inhibition. [ Time Frame: An expected average of 5 months ]Inclusion until earliest date of disease progression (defined as a 30% volumetric increase in tumorvolume or appearance of new lesions)
- Progression free survival [ Time Frame: An expected average of 4 months ]Time from initiation of everolimus to, either radiological (RECIST 1.1) or clinical disease progression or death from any cause.
- Disease control rate (DCR) [ Time Frame: At 3 months after initiation of everolimus ]Disease control rate (DCR) (DC = CR or PR or SD) as defined by RECIST 1.1 3 months after initiation of Everolimus.
- Toxicity [ Time Frame: An expected average of 6 months ]Toxicity will be assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version v4.03: June 14, 2010
- Median overall survival [ Time Frame: An expected average of one year ]The (median) time from initiation of Everolimus to time of death or censored at the date of last follow-up. First analysis of overall survival will be performed within one year after inclusion of last subject.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01566279
|Contact: G.A. Cirkel, MD||+3188 75 55 555 ext pager firstname.lastname@example.org|
|Contact: R. Kronemeijer||+3188 75 56 email@example.com|
|NKI-AVL||Not yet recruiting|
|Amsterdam, Noord Holland, Netherlands, 1066 CX|
|Erasmus Medical Center||Not yet recruiting|
|Rotterdam, Zuid Holland, Netherlands, 3075 EA|
|University medical center Utrecht||Recruiting|
|Utrecht, Netherlands, 3584 CX|
|Sub-Investigator: G.A. Cirkel, MD|
|Principal Investigator:||M.P.J.K. Lolkema, MD/PhD||UMC Utrecht|
|Principal Investigator:||N. Steeghs, MD/PhD||NKI-AvL|
|Principal Investigator:||A. Matthijssen, MD/PhD||Erasmus MC|