NCT01402089|CompletedPhase 4DMC
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Sponsor study identifier
interventional
54
1 country
1
Study Start
January 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2015
Actual (reported)Study Completion
November 2015
Actual (reported)It is well known that substantial interindividual variability of CYP3A4/1A2-phenotype activity is an important contributor to individual differences in the sensitivity to the frequently used tyrosine kinase inhibitors sunitinib and erlotinib. This study tests the potential for CYP-phenotyping to predict individual pharmacology and derive dosing algorithms for more tailored treatment of these drugs.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2015
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 20, 2011
Actual (reported)July 26, 2011
Actual (reported)January 2012
Date type not reportedThis date has not been verified as actual or estimated.
July 2015
Actual (reported)November 2015
Actual (reported)Steady-state partial area-under the plasma concentration-time curve over 24 hours (AUC24h) of sunitinib and erlotinib and CYP3A4/1A2-phenotype activity as defined in the protocol
Sunitinib or erlotinib area under the concentration-time curve during 24 hours at steady-state conditions, compared with the CYP3A4 or CYP1A2 phenotype activity as assessed by the two probe drugs midazolam (CYP3A4) and/or caffeine (CYP1A2)
2 weeks
Sunitinib and Erlotinib-associated toxicity according to the CTC criteria (v.3.0)
12 weeks (end of study)
Concentrations of Sunitinib, Erlotinib and probe drugs (Midazolam, Caffeine) in whole blood, sampled from patient's dried blood spots (DBS)
Patients with renal-cell cancer or GIST are receiving conventional treatment with sunitinib (50mg/day for 4 out of 6 weeks)
Patients with non small-cell lung cancer receive conventional treatment with erlotinib 150mg/day.
Cantonal Hospital St.Gallen
Sankt Gallen, 9007, Switzerland
Markus Joerger, MD PhD
Cantonal Hospital of St. Gallen
54 participants (actual enrollment reported by the registry).
First Submitted
July 20, 2011
First Posted
July 26, 2011
Study Start
January 2012
Date type not reportedThis date has not been verified as actual or estimated.
12 weeks (end of study)
For phenotyping of CYP3A4, all patients receive one-time midazolam 2mg as a drinking solution at the start of study treatment.
For phenotyping of CYP1A2, patients with non small-cell lung cancer receive additionally one-time caffeine 100mg as a tablet.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
July 2015
Actual (reported)Study Completion
November 2015
Actual (reported)Last Updated
February 2, 2016
Record last verified: 2016-01
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Source: ClinicalTrials.gov.
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