A Study to Identify a Biomarker Predictive for Response on Everolimus in Solid Tumors (CPCT-03) (CPCT-03)
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|ClinicalTrials.gov Identifier: NCT01566279|
Recruitment Status : Completed
First Posted : March 29, 2012
Last Update Posted : March 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: Everolimus||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||73 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|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||November 2016|
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01566279
|Amsterdam, Noord Holland, Netherlands, 1066 CX|
|Erasmus Medical Center|
|Rotterdam, Zuid Holland, Netherlands, 3075 EA|
|University Medical Center Utrecht|
|Utrecht, Netherlands, 3584 CX|
|Principal Investigator:||M.H.G. Langenberg, MD/PhD||UMC Utrecht|
|Principal Investigator:||N. Steeghs, MD/PhD||NKI-AvL|
|Principal Investigator:||M.J.A. de Jonge, MD/PhD||Erasmus MC|