MedTrace Logo

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

NCT01402089 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2016-02-02

No results posted yet for this study

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.

Conditions

  • Non Small-cell Lung Cancer
  • Renal-cell Cancer
  • Gastrointestinal Stroma Tumor

Interventions

DRUG

Sunitinib

Patients with renal-cell cancer or GIST are receiving conventional treatment with sunitinib (50mg/day for 4 out of 6 weeks)

DRUG

Erlotinib

Patients with non small-cell lung cancer receive conventional treatment with erlotinib 150mg/day.

DRUG

Midazolam

For phenotyping of CYP3A4, all patients receive one-time midazolam 2mg as a drinking solution at the start of study treatment.

DRUG

Caffeine

For phenotyping of CYP1A2, patients with non small-cell lung cancer receive additionally one-time caffeine 100mg as a tablet.

Sponsors & Collaborators

  • University of Basel

    collaborator OTHER

  • Markus Joerger

    lead OTHER

Principal Investigators

  • Markus Joerger, MD PhD · Cantonal Hospital St. Gallen, Switzerland

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2015-07-31
Completion
2015-11-30

Countries

  • Switzerland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01402089 on ClinicalTrials.gov