GT1A1 genotype-guided dosing of irinoteca
Suspended
- Conditions
- irinotecan<br />UGT1A1<br />toxicity<br /><br />irinotecan<br />UGT1A1<br />toxiciteit
- Registration Number
- NL-OMON22175
- Lead Sponsor
- Catharina Hospital Eindhoven
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 388
Inclusion Criteria
1. Pathologically confirmed malignancy for which treatment with irinotecan is indicated at a dosing regimen of ≥ 180 mg/m2 or 450-600mg flat dose in 2- or 3-weekly treatment schedules (see table 1)
2. Age ≥ 18 years
Exclusion Criteria
1. Prior treatment with irinotecan
2. Patients with known substance abuse, psychotic disorders, and/or other diseases expected to interfere with study or the patient’s safety
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method incidence of febrile neutropenia (amendment 2019)
- Secondary Outcome Measures
Name Time Method •Incidence of grade ≥3 toxicity other than neutropenia<br /><br>•Incidence of toxicity-related hospital admissions<br /><br>•Number of patients with treatment delay, defined as a delay of more than 2 days<br /><br>•Incidence of early treatment withdrawal<br /><br>•Pharmacokinetics of irinotecan and its metabolite SN-38 in UGT1A1*28 and/or *93 homozygous variant allele carriers. <br /><br>•Incidence of treatment delay due to prospective screening of UGT1A1<br /><br>•Direct medical costs of irinotecan-based treatment<br /><br>•Progression free survival and overall survival<br /><br>•Bilirubin / conjugated bilirubin concentration ratio <br /><br>•The effect of additional polymorphisms other than UGT1A1*28 and *93 on treatment outcome in terms of toxicity and efficacy (survival and progression-free survival)