Overview

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