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

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Markus Joerger
• Collaborator: University of Basel
• Treatments: Caffeine; Erlotinib Hydrochloride; Midazolam; Sunitinib

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed renal-cell cancer or gastrointestinal stromal tumor (for sunitinib) or non small-cell lung cancer (for erlotinib)

• Both early or advanced tumor stage

• Indication for the therapeutic use of either sunitinib or erlotinib

• Written informed consent and willing to undergo PK-sampling

• Patients > 18 years of age

• ECOG performance status or ≤2

• Adequate laboratory parameters:

i. Serum creatinine and serum bilirubin ≤ 1.5 X ULN ii. Serum ALT and AST ≤ 2.5 X ULN (or ≤ 5 in case of liver metastases) iii. Serum calcium ≤ 11,6 mg/dl (2.9 mmol/L)

Exclusion Criteria:

• Previous treatment with sunitinib or erlotinib

• Known hypersensitivity to trial drug or any compounds of the drug

• Concurrent radiotherapy

• Concurrent systemic anticancer treatment with the exception of bisphosphonates and bevacizumab in patients with non small-cell lung cancer