Metastatic Colorectal CancerNCT02547480
LifePearl-Iri Pharmacokinetic Study
A study testing TACE with irinotecan loaded LifePearl in people with Metastatic Colorectal Cancer and mCRC, run by Terumo Europe N.V. at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer, mCRC
- What is being tested?
- TACE with irinotecan loaded LifePearl
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Nov 2015to 19 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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)
Who cannot join
- 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)
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Germany2 sites
SLK-Kliniken Heilbronn GmbH
Heilbronn
Klinikum Bogenhausen, Städt. Klinikum München GmbH
Munich
About this study
Official title: Pharmacokinetic Study In Patients With Liver Predominant Unresectable mCRC Receiving Treatment With LifePearl Microspheres Loaded With Irinotecan
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
- Being tested
- TACE with irinotecan loaded LifePearl
- Keywords
- liver, metastatic
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TACE with irinotecan loaded LifePearlDevice
Also called TACE
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: TACE with irinotecan loaded LifePearl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax)
Maximum observed plasma concentrations of Irinotecan and its active metabolite SN38
Measured: 2 days
Time to reach Cmax (Tmax)
Tmax will be estimated directly from concentration-time data
Measured: 2 days
Area Under the Curve (AUC)
The trapezoidal rule will be used to calculate the area under the curve over 24 hours
Measured: 1 day
Secondary outcomes (6)
Adverse Events (AE) (grade ≥3) and Serious AEs related with study treatment up to 30 days post initial treatment
Measured: 1 month
Overall Survival
Measured: 12 months
Progression-Free Survival
Measured: 12 months
Response rate
Response rate (mRECIST criteria) 3 months after the first treatment
Measured: 3 months
Technical success - treatment delivery
Ability to deliver ≥75% of the planned dose during the first chemoembolization
Measured: 1 day
Technical success - total dose delivered
Sum of all doses delivered during the course of the study
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2015 (estimated)
- Study startNov 2015
- Primary completion28 Apr 2017
- Study completion19 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Terumo Europe N.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Federation Francophone de Cancerologie Digestive, Universitaire Ziekenhuizen KU Leuven
- Responsible party
- Sponsor
- Investigators
- Hans Prenen, MD, Principal investigator, Universitair Ziekenhuis LeuvenPhilippe Pereira, MD, Principal investigator, SLK Kliniken Heilbronn GmbHJulien Taieb, MD, Principal investigator, Hôpital Georges Pompidou Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02547480
- Sponsor's protocol ID
- T126E2
- Status last verified
- Nov 2017
- First submitted
- 27 Aug 2015
- Last updated
- 27 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Study In Patients With Liver Predominant Unresectable mCRC Receiving Treatment With LifePearl Microspheres Loaded With Irinotecan
- ClinicalTrials.gov ID
- NCT02547480
- Acronym / sponsor ID
- T126E2
- Conditions
- Metastatic Colorectal Cancer, mCRC
- Keywords
- liver, metastatic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Terumo Europe N.V.Industry (pharma, biotech, devices)
- Collaborators
- Federation Francophone de Cancerologie Digestive, Universitaire Ziekenhuizen KU Leuven
- Study start
- Nov 2015
- Primary completion
- 28 Apr 2017 (actual)
- Study completion
- 19 Sep 2017 (actual)
- First posted
- 11 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TACE with irinotecan loaded LifePearl | Experimental | Device: TACE with irinotecan loaded LifePearl10 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TACE with irinotecan loaded LifePearlAlso: TACEArterial 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. | Device | TACE with irinotecan loaded LifePearl |
Primary outcome
Maximum Observed Plasma Concentration (Cmax)
Time frame: 2 days
Maximum observed plasma concentrations of Irinotecan and its active metabolite SN38
Time to reach Cmax (Tmax)
Time frame: 2 days
Tmax will be estimated directly from concentration-time data
Area Under the Curve (AUC)
Time frame: 1 day
The trapezoidal rule will be used to calculate the area under the curve over 24 hours
6 secondary outcomes
Adverse Events (AE) (grade ≥3) and Serious AEs related with study treatment up to 30 days post initial treatment
Time frame: 1 month
Overall Survival
Time frame: 12 months
Progression-Free Survival
Time frame: 12 months
Response rate
Time frame: 3 months
Technical success - treatment delivery
Time frame: 1 day
Technical success - total dose delivered
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans Prenen, MD principal investigator
Universitair Ziekenhuis Leuven
Philippe Pereira, MD principal investigator
SLK Kliniken Heilbronn GmbH
Julien Taieb, MD principal investigator
Hôpital Georges Pompidou Paris
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TACE with irinotecan loaded LifePearl in people with Metastatic Colorectal Cancer and mCRC, run by Terumo Europe N.V. at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Observed Plasma Concentration (Cmax) (time frame: 2 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2017.