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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Sunitinib — DRUG
  Patients with renal-cell cancer or GIST are receiving conventional treatment with sunitinib (50mg/day for 4 out of 6 weeks)
• Erlotinib — DRUG
  Patients with non small-cell lung cancer receive conventional treatment with erlotinib 150mg/day.
• Midazolam — DRUG
  For phenotyping of CYP3A4, all patients receive one-time midazolam 2mg as a drinking solution at the start of study treatment.
• Caffeine — DRUG
  For phenotyping of CYP1A2, patients with non small-cell lung cancer receive additionally one-time caffeine 100mg as a tablet.

Study Details

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.

Key Dates

First listed

Jul 26, 2011

Start date

Jan 31, 2012

Status verified

Jan 2016

Primary completion

Jul 31, 2015

Completion

Nov 30, 2015

Study Design

Enrollment

54 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Primary Outcome Measure

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 [ Time Frame: 2 weeks ]