Clinical trial · Interventional
Cytochrom p450 3A4 and 1A2 Phenotyping for the Individualization of Treatment With Sunitinib or Erlotinib in Cancer Patients
NCT01402089CI-TRIAL-00020750completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Stroma Tumor | — | UNRESOLVED | — |
| Non Small-cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Renal-cell Cancer | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- 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
- timeFrame
- 2 weeks
- description
- Sunitinib or erlotinib area under the concentration-time curve during 24 hours at steady-state conditions, compared with the CYP3A4 or CYP1A2 phenotype activity as assessed by the two probe drugs midazolam (CYP3A4) and/or caffeine (CYP1A2)
Secondary outcomes (2)
- measure
- Sunitinib and Erlotinib-associated toxicity according to the CTC criteria (v.3.0)
- timeFrame
- 12 weeks (end of study)
- measure
- Concentrations of Sunitinib, Erlotinib and probe drugs (Midazolam, Caffeine) in whole blood, sampled from patient's dried blood spots (DBS)
- timeFrame
- 12 weeks (end of study)
- description
- Dried blood spots are a potential alternative to venous blood samples to assess drug exposure in cancer patients.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.