Clinical trial · Interventional
Study of Genetic Polymorphisms of Drug Transporters and Orphan Nuclear Receptors on Treatment Effects of Irinotecan
A Clinical Study for the Evaluation of Genetic Polymorphisms of Drug Transporters and Orphan Nuclear Receptors on the Pharmacokinetics and Treatment Effects of Irinotecan in Patients With Colorectal and Gastric Cancer
- 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)
From 100 colorectal cancer patients being treated with FOLFIRI regimen or any kind of irinotecan containing regimen, blood samples for irinotecan and its metabolites levels and genotypes related with its metabolism will be collected. The association of their levels and genotypes and treatment effects will be evaluated.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Secondary | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| irinotecan | Drug | Irinotecan | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- SLCO1B1 and PXR genotypes and maximal response rate
- timeFrame
- Before & during treatment
- measure
- SLCO1B1 and PXR genotypes and pharmacokinetics of SN-38
- timeFrame
- Before and 1st cycle
Secondary outcomes (1)
- measure
- SLCO1B1 and PXR genotypes and response duration, time to progression and overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically diagnosed unresectable or metastatic colorectal cancer * Performance status of 0, 1 and 2 on the ECOG criteria * Disease status must be that of measurable disease as defined by RECIST criteria (For genotype-PD study only) Only non-target lesions are allowed for PK study * No previous chemotherapy, radiotherapy on the target lesion, immunotherapy; adjuvant chemotherapy with fluoropyrimidines completed at least 6 months ago is allowed (For genotype-PD study only) Previously treated patients are allowed for PK study * Life expectancy of more than 3 months (For genotype-PD study only) * Adequate major organ functions * Compliant patient who can be followed-up adequately * Informed consent Exclusion Criteria: * Active or uncontrolled infection * Pregnant or breast-feeding women * Patients with systemic disease, especially cardiovascular disease, who cannot tolerate systemic chemotherapy * Patients with brain metastasis (For genotype-PD study only) * Patients treated with radiotherapy within 2 weeks (For genotype-PD study only)
References
Publications (0)
Data not yet available