LifePearl-Iri Pharmacokinetic Study

NCT02547480 | Completed DMC

• 1 other identifier: T126E2
• Study Type: interventional
• Target: 15
• Locations: 2 countries
• Sites: 3

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.

Conditions

Metastatic Colorectal Cancer; mCRC

Keywords

liver; metastatic

Outcome Measures

Primary Outcomes (3)

• Maximum Observed Plasma Concentration (Cmax)

  Maximum observed plasma concentrations of Irinotecan and its active metabolite SN38

  2 days

• Time to reach Cmax (Tmax)

  Tmax will be estimated directly from concentration-time data

  2 days

• Area Under the Curve (AUC)

  The trapezoidal rule will be used to calculate the area under the curve over 24 hours

  1 day

Secondary Outcomes (6)

• Adverse Events (AE) (grade ≥3) and Serious AEs related with study treatment up to 30 days post initial treatment

  1 month

• Overall Survival

  12 months

• Progression-Free Survival

  12 months

• Response rate

  3 months

• Technical success - treatment delivery

  1 day

Study Arms (1)

TACE with irinotecan loaded LifePearl

EXPERIMENTAL

10 patients receiving unilobar treatment: day 1=chemoembolization of first lobe of liver, day 14=chemoembolization of second lobe of liver, day 30=chemoembolization of first lobe of liver, day 44= chemoembolization of second lobe of liver; AND 10 patient receiving bilobar treatment: day 1=chemoembolization of both lobes of the liver, day 30=chemoembolization of both lobes of the liver

Device: TACE with irinotecan loaded LifePearl

Interventions

TACE with irinotecan loaded LifePearl DEVICE

Arterial embolization will be performed through lobar infusion and using a microcatheter. LifePearl microspheres of 200 µm will be used as preferred beads. They will be loaded with the appropriate dose of irinotecan hydrochloride injectable solution, mixed with the contrast media and distributed to the targeted lobe. The targeted dose is 100 mg of irinotecan per lobe treated, meaning that when treated unilobarly at baseline the total dose received will be 100 mg ( all in one lobe) and in during bilobar treatment, 200 mg in both lobes.

Also known as: TACE

TACE with irinotecan loaded LifePearl

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Terumo Europe N.V.: lead
• Federation Francophone de Cancerologie Digestive: collaborator
• Universitaire Ziekenhuizen KU Leuven: collaborator

Study Sites (3)

KUL

Leuven, Belgium

Location

SLK-Kliniken Heilbronn GmbH

Heilbronn, Germany

Location

Klinikum Bogenhausen, Städt. Klinikum München GmbH

Munich, Germany

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hans Prenen, MD

  Universitair Ziekenhuis Leuven

  PRINCIPAL INVESTIGATOR

• Philippe Pereira, MD

  SLK Kliniken Heilbronn GmbH

  PRINCIPAL INVESTIGATOR

• Julien Taieb, MD

  Hôpital Georges Pompidou Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2015
• First Posted: September 11, 2015
• Study Start: November 1, 2015
• Primary Completion: April 28, 2017
• Study Completion: September 19, 2017
• Last Updated: November 27, 2017

Record last verified: 2017-11

Locations

DE (2); BE (1)