First Line Metastatic Colorectal CancerPhase 2IriGenNCT01963182
Individualization of Dosage of Irinotecan in the FOLFIRI According to the Genetic Polymorphism of UGT1A1 in the First Line Treatment of Metastatic Colorectal Cancer
A Phase 2 study testing Irinotecan in people with First Line Metastatic Colorectal Cancer, run by Centre Jean Perrin at 3 sites in France.
Trial summary
This prospective, non randomized multicenter phase II study, will determine the feasibility of individualized dose of irinotecan with the UGT1A1 polymorphism, in patients with metastatic colorectal cancer treated with FOLFIRI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- First Line Metastatic Colorectal Cancer
- What is being tested?
- Irinotecan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 3 sitesFrance
- Study dates
- Oct 2013to 9 Dec 2019
- Phase
- Phase 2
- 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
- Colorectal cancer histologically or cytologically proven
- Indication of treatment according to the FOLFIRI + / - bevacizumab or cetuximab or panitumumab
- Age> 18 years
- Presence of at least one measurable target by RECIST
- Life expectancy> 3 months
- Satisfactory biological functions (renal, hepatic and hematologic)
- Affiliation to a social security scheme (or be the beneficiary of such a plan) under the terms of the Act of August 9, 2004
- Patient has signed, after informing the informed consent form
Who cannot join
- Patients of childbearing age and not using effective contraception during treatment and for at least three months after the end of treatment with irinotecan and at least six months after the end of treatment with bevacizumab, cetuximab or panitumumab and patient pregnant or nursing
- Patient with another pathology deemed incompatible with the entry in the protocol
- Prior treatment in metastatic
- Patients taking antiepileptic
- Allergic reaction or intolerance to irinotecan
- Heart failure , kidney , bone marrow , liver or respiratory
Show all 14Show fewer
- Higher bilirubin 1.5 times the upper limit of normal
- Significant psychiatric or neurological abnormality
- Infectious syndrome requiring treatment with antibiotics or antiviral long-term
- Patients with chronic inflammatory bowel disease and / or bowel obstruction
- Contraindication Association St. John's wort and yellow fever vaccine
- Against Heart indication 5-FU
- Concurrent treatment with a drug test , participation in a clinical trial within <30 days
- Patient refused to sign the consent
Trial locations and contacts
3 sites in 1 country.
France3 sites
Clinique de la Châtaigneraie
Beaumont, 63110
Centre Jean Perrin
Clermont-Ferrand, 63011
CHU Estaing
Clermont-Ferrand, 63011
About this study
Official title: Phase II Study: Individualization of Dosage of Irinotecan in the FOLFIRI According to the Genetic Polymorphism of UGT1A1 in the First Line Treatment of Metastatic Colorectal Cancer
This prospective, non randomized multicenter phase II study, will determine the feasibility of individualized dose of irinotecan with the UGT1A1 polymorphism, in patients with metastatic colorectal cancer treated with FOLFIRI.
- Conditions
- First Line Metastatic Colorectal Cancer
- Being tested
- Irinotecan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IrinotecanDrug
| Study group | Role | What they receive |
|---|---|---|
| irinotecan dose based on genetic polymorphism of UGT1A1 | Experimental | Not described Receives: Drug: Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
severe toxicity (according to NCI-CTC cotation) and response with adapted dose of irinotecan
Measured: during the treatment (an expected average of 7 months)
Secondary outcomes (2)
Study of the blood concentration (pharmacokinetic) of irinotecan, the SN38 and SN38-G, and bevacizumab
Measured: during the first 24 hours of the first cure
evaluation of treatment efficacy (progression-free survival, duration of response)
Measured: to progression (1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2019
- Study completion9 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for First Line 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Jean Perrin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hervé DEVAUD, MD, Principal investigator, Centre Jean Perrin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01963182
- Sponsor's protocol ID
- 2013-001275-21
- Acronym
- IriGen
- Status last verified
- Dec 2019
- First submitted
- 10 Oct 2013
- Last updated
- 26 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Ginzac A, Thivat E, Petorin C, Richard D, Herviou P, Molnar I, Devaud H, Creveaux I, Ferrer F, Authier N, Jary M, Pezet D, Durando X. A phase-II study based on dose adjustment according to UGT1A1 polymorphism: is irinotecan underdosed in first-line FOLFIRI regimen for mCRC? Cancer Chemother Pharmacol. 2024 Mar;93(3):225-236. doi: 10.1007/s00280-023-04603-x. Epub 2023 Nov 7.
PubMed 37932443
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study: Individualization of Dosage of Irinotecan in the FOLFIRI According to the Genetic Polymorphism of UGT1A1 in the First Line Treatment of Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01963182
- Acronym / sponsor ID
- IriGen / 2013-001275-21
- Conditions
- First Line Metastatic Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Centre Jean PerrinUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2019 (actual)
- Study completion
- 9 Dec 2019 (actual)
- First posted
- 16 Oct 2013 (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.
This prospective, non randomized multicenter phase II study, will determine the feasibility of individualized dose of irinotecan with the UGT1A1 polymorphism, in patients with metastatic colorectal cancer treated with FOLFIRI.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| irinotecan dose based on genetic polymorphism of UGT1A1 | Experimental | Drug: Irinotecan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Colorectal cancer histologically or cytologically proven
- Indication of treatment according to the FOLFIRI + / - bevacizumab or cetuximab or panitumumab
- Age> 18 years
- Presence of at least one measurable target by RECIST
- Life expectancy> 3 months
Key exclusion criteria (14 listed)
- Patients of childbearing age and not using effective contraception during treatment and for at least three months after the end of treatment with irinotecan and at least six months after the end of treatment with bevacizumab, cetuximab or panitumumab and patient pregnant or nursing
- Patient with another pathology deemed incompatible with the entry in the protocol
- Prior treatment in metastatic
- Patients taking antiepileptic
- Allergic reaction or intolerance to irinotecan
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 |
|---|---|---|
| Irinotecan | Drug | irinotecan dose based on genetic polymorphism of UGT1A1 |
Primary outcome
severe toxicity (according to NCI-CTC cotation) and response with adapted dose of irinotecan
Time frame: during the treatment (an expected average of 7 months)
2 secondary outcomes
Study of the blood concentration (pharmacokinetic) of irinotecan, the SN38 and SN38-G, and bevacizumab
Time frame: during the first 24 hours of the first cure
evaluation of treatment efficacy (progression-free survival, duration of response)
Time frame: to progression (1 year)
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 26 Dec 2019.
- Derived from this study: PubMed 37932443Ginzac A, Thivat E, Petorin C, Richard D, Herviou P, Molnar I, Devaud H, Creveaux I, Ferrer F, Authier N, Jary M, Pezet D, Durando X. A phase-II study based on dose adjustment according to UGT1A1 polymorphism: is irinotecan underdosed in first-line FOLFIRI regimen for mCRC? Cancer Chemother Pharmacol. 2024 Mar;93(3):225-236. doi: 10.1007/s00280-023-04603-x. Epub 2023 Nov 7.
Related trials for First Line Metastatic Colorectal Cancer
Active, not recruitingPhase 3
A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer
Neoplasms
RecruitingPhase 3
Phase III Study of Ivonescimab or Bevacizumab Combined With FOLFOX in Patients With Metastatic Colorectal Cancer
Metastatic Colorectal Cancer (CRC)
Not yet recruitingObservational study
Real-World Study: Panitumumab N01 vs Cetuximab Plus FOLFOX in First-Line RAS Wild-Type mCRC
Colorectal Cancer Metastatic
RecruitingPhase 3
A Clinical Study of Calderasib (MK-1084) With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012)
Colon Adenocarcinoma, Rectal Adenocarcinoma
RecruitingPhase 3
Study of Petosemtamab Plus Chemotherapy Versus Cetuximab Plus Chemotherapy in RAS and BRAF Wild-type, Unresectable or Metastatic, Left-sided Colorectal Cancer (LiGeR-CRC1)
Left-sided Colorectal Cancer
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.
Hervé DEVAUD, MD principal investigator
Centre Jean Perrin
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Irinotecan in people with First Line Metastatic Colorectal Cancer, run by Centre Jean Perrin at 3 sites in France.
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 8 inclusion and 14 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 26 Dec 2019. 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 France. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
severe toxicity (according to NCI-CTC cotation) and response with adapted dose of irinotecan (time frame: during the treatment (an expected average of 7 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01963182, which also lists 1 linked publication.
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 26 Dec 2019.