LifePearl-Iri Pharmacokinetic Study
- Conditions
- mCRCMetastatic Colorectal Cancer
- Registration Number
- NCT02547480
- Lead Sponsor
- Terumo Europe N.V.
- Brief Summary
The primary purpose of the study is to evaluate the pharmacokinetic profile, safety, and efficacy of LifePearl microspheres loaded with irinotecan in the treatment of liver predominant mCRC by chemoembolization.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
- Patient is at least 18 years old
- Histologically proven mCRC
- At least 1 measurable liver metastasis > 1 cm (mRECIST) Liver predominant disease ( ≥ 80% of metastatic disease confined to the liver)
- No portal vein involvement
- Performance status 0 or 1
- Life Expectancy ≥ 3m
- Adequate Hematologic function (ANC≥1.5 10^9/l; PLT≥75 10^9/l; INR (international normalized ratio) ≤1.3)
- Adequate liver and renal function (Total bilirubin ≤2.0 mg/dl; ALBUMINE 2.5g/dl; Serum creatinine ≤2.0 mg/dl; ALT (alanine transaminase),AST (aspartate transaminase) ≤5 times ULN)
- Less than 50% liver tumor replacement
- Patient has provided written informed consent
- Patient is affiliated to social security or equivalent system (France only)
- Eligible for curative treatment (resection/RFA) History of hepaticocholangiojejunostomy or obstructive biliary disease (with/without previous treatment)
- Previous liver embolization
- Contraindication for intra-arterial embolization and local irinotecan administration
- Allergy to contrast media
- Patient is co-treated with potent CYP3A4/UGT1A1 (cytochrome P450 3A4/uridine diphosphate glucuronosyltransferase 1A1) inducers, i.e. rifampin, rifabutin, phenytoin, phenobarbital, carbamazepine and St John's Wort
- Patient is currently participating in a clinical trial with an investigational drug or a device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints
- In the Investigator's opinion patient has (a) co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study
- Patient is under judicial protection (France only)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Area Under the Curve (AUC) 1 day The trapezoidal rule will be used to calculate the area under the curve over 24 hours
Maximum Observed Plasma Concentration (Cmax) 2 days Maximum observed plasma concentrations of Irinotecan and its active metabolite SN38
Time to reach Cmax (Tmax) 2 days Tmax will be estimated directly from concentration-time data
- Secondary Outcome Measures
Name Time Method Progression-Free Survival 12 months Overall Survival 12 months Adverse Events (AE) (grade ≥3) and Serious AEs related with study treatment up to 30 days post initial treatment 1 month Response rate 3 months Response rate (mRECIST criteria) 3 months after the first treatment
Technical success - treatment delivery 1 day Ability to deliver ≥75% of the planned dose during the first chemoembolization
Technical success - total dose delivered 6 weeks Sum of all doses delivered during the course of the study
Trial Locations
- Locations (3)
KUL
🇧🇪Leuven, Belgium
SLK-Kliniken Heilbronn GmbH
🇩🇪Heilbronn, Germany
Klinikum Bogenhausen, Städt. Klinikum München GmbH
🇩🇪Munich, Germany
KUL🇧🇪Leuven, Belgium