drugset
drugset / Trial / NCT01402089

Cytochrom p450 3A4 and 1A2 Phenotyping for the Individualization of Treatment With Sunitinib or Erlotinib in Cancer Patients

NCT01402089 ↗

Phase 4 Completed 54 enrolled Markus Joerger University of Basel · collab
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2012-01
Primary completion
2015-07
Completion
2015-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Erlotinib Small molecule 150 mg Oral
Subject Sunitinib Small molecule 37.5 mg Oral
Subject Sunitinib Small molecule 50 mg Oral
Background Caffeine Small molecule 100 mg Oral
Background Midazolam Small molecule 2 mg Oral

Indications

gastrointestinal stromal tumor non-small cell lung carcinoma renal cell carcinoma