Status:
COMPLETED
Cytochrom p450 3A4 and 1A2 Phenotyping for the Individualization of Treatment With Sunitinib or Erlotinib in Cancer Patients
Lead Sponsor:
Markus Joerger
Collaborating Sponsors:
University of Basel
Conditions:
Non Small-cell Lung Cancer
Renal-cell Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 ...
Detailed Description
Objectives: The primary objective of this study is to show that the individual CYP3A4 and CYP1A2-phenotype as assessed by probe drugs predicts drug exposure to sunitinib and erlotinib. Secondary obje...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT01402089
Start Date
January 1 2012
End Date
November 1 2015
Last Update
February 2 2016
Active Locations (1)
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1
Cantonal Hospital St.Gallen
Sankt Gallen, Switzerland, 9007