This page shows what was measured, who it was measured in, and what that does not settle.
What Irinotecan does in the body
Irinotecan and its active metabolite SN-38 bind to the topoisomerase I-DNA complex and prevent religation of these single-strand breaks.
From the FDA-approved label: Irinotecan is a derivative of camptothecin. Camptothecins interact specifically with the enzyme topoisomerase I, which relieves torsional strain in DNA by inducing reversible single-strand breaks. Current research suggests that the cytotoxicity of irinotecan is due to double-strand DNA damage produced during DNA synthesis when replication enzymes interact with the ternary complex formed by topoisomerase I, DNA, and either irinotecan or SN-38. Mammalian cells cannot efficiently repair these double-strand breaks.
Why people take it. Metastatic pancreatic adenocarcinoma after disease progression following gemcitabine-based therapy
What happened in people
RNAWiki has not yet published a reviewed conclusion for this use.
§ A fixed RNAWiki sentence
Where this came from
Wording RNAWiki always uses, not a finding about this substance.
No reviewed claim names a result for any goal on this record.
No source is stored against this line.
The limit that matters most
Not recorded.
Where it acts
Not recorded.
Kind of result
No result is published, so no kind of result applies yet
Supervision
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.
What the registries record it as
The substance registry classes this as chemical.
FDA substance registry · 7673326042 · read 2026-08-29
Its recorded molecular formula is C33H38N4O6•HCl, weighing 677.19.
US prescribing information · d04f2471-3085-4fc8-a657-bb3918d48e6e · read 2026-08-30
Where each sentence above came from
A person wrote this explanation into the record, with the studies named in the path below.
The recorded use, written for a reader without medical training. Not signed off.
No statement of the main limit is recorded.
The four opening statements run to 112 words.
Words this page uses
Four words worth knowing first
Chosen from what this page shows, with each one explained before the word it depends on.
Biomarker
A biomarker is a number from a test that stands in for something about health.
A picture of it, and where the picture fails
A biomarker is like a fuel gauge.
Where that stops being true. A gauge is wired to the tank. Many biomarkers are only loosely tied to health.
What people get wrong. A better number is read as a better life. Several medicines improved a number and helped nobody.
A measurable indicator used as a substitute for a clinical outcome of interest.
Placebo
A placebo is a dummy treatment given so the real one can be compared with it.
A picture of it, and where the picture fails
A placebo is like a blank control in an experiment.
Where that stops being true. A blank does nothing. People given a placebo often do get better.
What people get wrong. A placebo effect is read as imaginary. The improvement is measured and real.
An inactive intervention matched in appearance to the test intervention, used to control for non-specific effects.
Comparator
A comparator is whatever the treatment was measured against.
A picture of it, and where the picture fails
It is like the other runner in a race.
Where that stops being true. A race has one winner. A study can show both arms improved.
What people get wrong. Results are read without asking what the other group got. Beating nothing is not beating a treatment.
The control condition against which the experimental intervention is assessed.
What happened in people◇Read from sources, not yet reviewed
What happened in people
Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.
Determine whether adding experimental agents to standard neoadjuvant medications increases the probability of pathologic complete response (pCR) over standard neoadjuvant chemotherapy for each biomarker signature established at trial entry.
✗ The study did not show it
Who was studied
NCT01042379
How many people
5000
Study design
Phase 2
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Injection
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Disease-free Survival (Arms A and D: Wild-type KRAS Patients)
✗ The study did not show it
Who was studied
NCT00079274
How many people
3397
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Injection
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Topoisomerase-1 (topo-1) and K-ras, BRAF results obtained within 10 working days after registration
✗ The study did not show it
Who was studied
NCT00975897
How many people
3240
Study design
Phase 2/Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Injection
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Non-inferiority of 6-month CAPE vs 3-month CAPOX ACT in terms of 3-year Disease Free Survival ctDNA-negative cohort
✗ The study did not show it
Who was studied
NCT07340567
How many people
2450
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Injection
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Overall Survival
✗ The study did not show it
Who was studied
NCT00265850
How many people
2334
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Injection
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Disease-free survival at 5 years
✗ The study did not show it
Who was studied
NCT00091312
How many people
1976
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Injection
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
What we know
RNAWiki holds 6 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.
What is missing or unclear◇Read from sources, not yet reviewed
Were people like you studied?
RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.
Who was studied
People similar to this profile were included.
ONIVYDE is indicated, in combination with oxaliplatin, fluorouracil and leucovorin for the first-line treatment of adult patients with metastatic pancreatic adenocarcinoma. ONIVYDE is indicated, in combination with fluorouracil and leucovorin, for the treatment of adult patients with metastatic pancreatic adenocarcinoma after disease progression following gemcitabine-based therapy.
Who is missing from the studies
Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What the label states about particular groups
On pediatric, the label states: “The effectiveness of irinotecan in pediatric patients has not been established.”
US prescribing information · d04f2471-3085-4fc8-a657-bb3918d48e6e · read 2026-08-30
On older people, the label states: “Patients greater than 65 years of age should be closely monitored because of a greater risk of early and late diarrhea in this population [see Clinical Pharmacology (12.3) and Adverse Reactions (6.1) ] .”
US prescribing information · d04f2471-3085-4fc8-a657-bb3918d48e6e · read 2026-08-30
On people who are pregnant, the label states: “5.9 Embryo-Fetal Toxicity Based on its mechanism of action and findings in animals, irinotecan hydrochloride injection can cause fetal harm when administered to a pregnant woman.”
US prescribing information · d04f2471-3085-4fc8-a657-bb3918d48e6e · read 2026-08-30
On people who are breastfeeding, the label states: “8.3 Females and Males of Reproductive Potential Pregnancy Testing Verify the pregnancy status in female patients of reproductive potential prior to initiating irinotecan hydrochloride injection.”
US prescribing information · d04f2471-3085-4fc8-a657-bb3918d48e6e · read 2026-08-30
On people with reduced liver function, the label states: “Irinotecan clearance is diminished in patients with hepatic impairment while exposure to the active metabolite SN-38 is increased relative to that in patients with normal hepatic function.”
US prescribing information · d04f2471-3085-4fc8-a657-bb3918d48e6e · read 2026-08-30
On people with reduced kidney function, the label states: “The influence of renal impairment on the pharmacokinetics of irinotecan has not been evaluated.”
US prescribing information · d04f2471-3085-4fc8-a657-bb3918d48e6e · read 2026-08-30
Where the result stopped carrying
This is a scope explorer, not a diagnosis engine.
It shows who was studied so you can see whether people similar to you were included.
RNAWiki cannot tell whether a study fits you. It can show who was in it.
What it would be like to take◇Read from sources, not yet reviewed
Why it might seem to do nothing
A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.
It was studied in different people
The people in the studies were not much like the reader.
On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
The evidence may simply be wrong
Small early studies often do not hold up.
On this record: RNAWiki has not yet published a reviewed conclusion for this use.
Other reasons RNAWiki checked and found nothing for (11)
It was studied for a different goal
The studies measured something else entirely. Nothing in this record points to this reason.
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.
None of these is a reason to take more. Taking more is not a step this page ever suggests.
What it would be like to take◇Read from sources, not yet reviewed
What taking it involves
The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.
How it is supplied
Prescription only
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Read from the recorded approval status.
No source is stored against this line.
Form and route
Injection
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form and route recorded on this substance.
No source is stored against this line.
Who oversees it
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Suppression classes recorded: S1, S3, S4, S6.
No source is stored against this line.
What is in the pack
Sold as injectable, injectable, liposomal, injection, solution, injection, given by the injection, intravenous route.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on how this is sold and what that means for what is in the pack.
No source is stored against this line.
Where it is registered
Regulatory records are listed in the technical disclosure at the foot of this page.
# Counted from records
Where this came from
A count of rows RNAWiki holds. It describes our records, not your body.
Register entries are stored per jurisdiction and shown with their dates.
No source is stored against this line.
Why people stop
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
No record of why people stopped taking it is stored for this substance.
No source is stored against this line.
What it would be like to take∅Nothing found in the sources checked
What can go wrong
Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.
∅Nothing found in the sources checked
No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.
The sources listed were searched and held nothing. That is not the same as nothing existing.
Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.
Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What is missing or unclear◇Read from sources, not yet reviewed
Does the exact form matter?
Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.
The form that was studied
Injection
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form used in the studies cited on this page.
No source is stored against this line.
What is sold
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
Nothing further is recorded about which forms are sold.
No source is stored against this line.
What is recorded as being sold
41 products list this as an active ingredient in the United States drug directory. 41 of them contain it and nothing else.
FDA National Drug Code directory · 0143-9701 · read 2026-08-29
They are sold as injection, injection, powder, for solution, injection, solution, powder and powder, for suspension, taken intravenous.
FDA National Drug Code directory · 0143-9701 · read 2026-08-29
The regulator's established pharmacologic class for it is topoisomerase inhibitor [epc] and topoisomerase inhibitors [moa].
FDA National Drug Code directory · 0143-9701 · read 2026-08-29
17 published labels name it as an active ingredient. 17 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · d04f2471-3085-4fc8-a657-bb3918d48e6e · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · d04f2471-3085-4fc8-a657-bb3918d48e6e · read 2026-08-29
Irinotecan Hydrochloride is intravenous at 3 DOSAGE FORMS AND STRENGTHS Injection: 40 mg/2 mL (20 mg/mL) and 100 mg/5 mL (20 mg/mL) solution in a single-dose vial., recorded as fda label in effect 2026-03-07 in the United States.
US prescribing information · d04f2471-3085-4fc8-a657-bb3918d48e6e · read 2026-08-30
Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.
What it would be like to take◇Read from sources, not yet reviewed
What you could measure
This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.
Self-experiment planning is not offered for a prescription or clinician-supervised medicine. The questions below are for a clinician or pharmacist.
Questions worth asking
Which of the trials of Irinotecan studied people like me?
What was measured, and for how long?
Was the result a laboratory value or a health outcome?
What would we watch for, and when would we stop?
Tracking can show whether something changed for you. It cannot show what caused it.
RNAWiki records evidence. It does not say whether this substance is right for you.
What is missing or unclear◇Read from sources, not yet reviewed
What nobody knows yet
Open questions, each with why it is open and what would close it.
Missing populations
Which groups were under-represented in the studies has not been recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing long-term data
No completed tested study window is recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
No reviewed conclusion
RNAWiki has not yet published a reviewed conclusion for this use.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing interaction studies
No interaction was found in the registers checked. Not finding one is not the same as showing there is none.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Formulation uncertainty
Several salts, forms or products of Irinotecan are recorded. Results from one form may not transfer to another.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Mechanism not reviewed
No reviewed mechanism story exists for this substance.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
What happened in people◇Read from sources, not yet reviewed
Check any of this yourself
Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.
How many documents were read
16 documents were read for this substance.
RNAWiki source record
15 of them state the same halfLife, and they agree.
RNAWiki source record
Where else this substance is registered
FDA substance identifier (UNII)
7673326042
CAS registry number
97682-44-5
PubChem compound
60838
ChEMBL
CHEMBL481
ChEBI
80630
WHO international nonproprietary name list entry
6694
RxNorm concept
51499
EMA substance identifier
100000083374
DrugBank
DB00762
Checks this page had to pass
✓ Passed
Identity resolved
no open identity hold
✓ Passed
No unresolved merge across substance families
no quarantine open
✓ Passed
Every public sentence names a source
The opening statement carries the origin: Written into the record, not signed off.
✗ Not passed
Trial roles classified for highlighted evidence
No registered study is classified as testing this substance.
✓ Passed
No internal keys in reader text
enforced by the copy-contract test over the rendered page
✓ Passed
Safety mode resolved
Suppression classes recorded: S1, S3, S4, S6.
✓ Passed
Canonical metadata present
slug and display name present
What is missing or unclear◇Read from sources, not yet reviewed
How this medicine reached us
Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.
What the approval register records
29 approved applications cover products containing this substance. The earliest was NDA020571, approved 19960614 to PFIZER INC.
This order is fixed in code and does not count clicks or time on the page.
What is not here
9 questions this page could not answer
These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.
What was measured, goal by goal — found nothing in the sources checked.
How close this is to real life — found nothing in the sources checked.
The path through the body — found nothing in the sources checked.
Felt, measured, or meaningful — found nothing in the sources checked.
How long anything takes — found nothing in the sources checked.
What it may clash with — found nothing in the sources checked.
Other ways to the same goal — found nothing in the sources checked.
Claims that go past the evidence — found nothing in the sources checked.
What changed on this page — found nothing in the sources checked.
The record as stored
The full record, for auditing
Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.
Recorded evidence blocks (11)
Q2
On the Irinotecan label: indicated for what?
"Irinotecan hydrochloride injection is indicated as a component of first-line therapy in combination with 5-fluorouracil (5-FU) and leucovorin (LV) for patients with metastatic carcinoma of the colon or rectum. Irinotecan hydrochloride injection is indicated for patients with metastatic carcinoma of the colon or rectum…": indications and usage on Irinotecan's label. DailyMed label · b66dbd6d-6ccb-ce9d-e053-2995a90a4c3c · 2026-08-26
Q3
1139 registered trials of Irinotecan — at which phases?
Registered studies posting no result
898 of 1139
1139 registered studies of Irinotecan: 700 phase2, 363 phase1, 166 phase3, 18 na, 12 phase4, 11 na or unstated, 9 early phase1. CLINICALTRIALS_SNAPSHOT · 2026-09-01
"Study terminated due to poor accrual"; 145 of 1139 registered studies
Show the evidence
Trial
NCT00003843
terminated; "Study terminated due to poor accrual"
NCT00006037
terminated; "Drug not available"
NCT00023868
terminated; "redesign"
NCT00052585
terminated; "Administratively complete."
NCT00053833
terminated; "lack of accrual"
NCT00070434
withdrawn; "poor accrual"
14 further recorded trials
NCT00077233
terminated; "Poor accrual"
NCT00089102
terminated; "Low accrual"
NCT00089128
terminated; "Low accrual"
NCT00100828
terminated; "Closed due to early stopping rule"
NCT00106262
terminated; "Lack of accrual"
NCT00109850
terminated; "Closed due to poor accrual"
NCT00177853
terminated; "terminated"
NCT00209612
withdrawn; "due to strong side effect"
NCT00216086
terminated; "Funding withdrawn"
NCT00256269
terminated; "Study was terminated by funding entity"
NCT00271011
terminated; "The study was discontinued due to the death of a co-investigator and a second co-investigator leaving the institution."
NCT00276744
terminated; "Because there was no longer an active laboratory component to this study."
NCT00290719
terminated; "low enrollment"
NCT00296062
terminated; "Trial did not move to Phase II portion due to poor tolerance of treatment"
recorded 2026-09-01 · last checked 2026-09-04
Q5
Human studies of Irinotecan used Irinotecan 125mg — over how long?
studies of Irinotecan used the recorded amount. ClinicalTrials.gov · 2026-09-01
3 recorded entries; human; also "Irinotecan 125mg", "Irinotecan liposome（40mg/m2）", "Irinotecan Liposome（60mg/m2）"
Show the evidence
human
NCT02934529
Irinotecan 125mg
NCT06513455
Irinotecan liposome（40mg/m2）
NCT06513455
Irinotecan Liposome（60mg/m2）
recorded 2026-09-01 · last checked 2026-09-04
Q6
Irinotecan's half-life is 6 to 12 hours — which schedules were studied?
6 to 12 hours, the half-life Irinotecan's label states: "After intravenous infusion of irinotecan in humans, irinotecan plasma concentrations decline in a multiexponential manner, with a mean terminal elimination half-life of about 6 to 12 hours." DailyMed label · b66dbd6d-6ccb-ce9d-e053-2995a90a4c3c · 2026-08-26
Show the evidence
half lifepharmacokinetics
6 to 12 hours; After intravenous infusion of irinotecan in humans, irinotecan plasma concentrations decline in a multiexponential manner, with a mean terminal elimination half-life of about 6 to 12 hours.
metabolismpharmacokinetics
Elimination Metabolism Irinotecan is subject to extensive metabolic conversion by various enzyme systems, including esterases that form an active metabolite SN-38, and UGT1A1 which mediates the glucuronidation of SN-38 to form an inactive metabolite.
recorded 2026-08-26 · last checked 2026-09-04
Q7
Which running trial of Irinotecan could settle lifespan?
NCT04117945 measures Overall Survival (OS), reading out 2025-03-31.
83 open trials; n 22; "Regorafenib, With Cetuximab or Panitumumab, for the Treatment of Unresectable, Locally Advanced, or Metastatic Colorectal Cancer"
Show the evidence
Trial
NCT04117945
"Regorafenib, With Cetuximab or Panitumumab, for the Treatment of Unresectable, Locally Advanced, or Metastatic Colorectal Cancer"; n 22; "Overall Survival (OS)"; 2025-03-31
NCT03709680
"Study Of Palbociclib Combined With Chemotherapy In Pediatric Patients With Recurrent/Refractory Solid Tumors"; n 128; "Phase 2 open-label, randomized: Event-free survival (EFS) based on Investigator assessment."; 2025-10-18
NCT04821284
"Sonoporation and Chemotherapy for the Treatment of Pancreatic Cancer"; n 120; "Progression-free survival"; 2026-02-28
NCT02919787
"Nordic Pancreatic Cancer Trial (NorPACT) - 1"; n 140; "Overall survival 18 month after randomization"; 2026-04-30
NCT04390399
"Combination Immunotherapy Plus Standard-of-Care Chemotherapy Versus Standard-of-Care Chemotherapy for the Treatment of Locally Advanced or Metastatic Pancreatic Cancer"; n 328; "Progression Free Survival (PFS)"; 2026-05-31
NCT04094688
"Vitamin D3 With Chemotherapy and Bevacizumab in Treating Patients With Advanced or Metastatic Colorectal Cancer"; n 455; "Progression-free Survival (PFS)"; 2026-07-01
14 further recorded trials
NCT04753879
"Multi-agent Low Dose Chemotherapy GAX-CI Followed by Olaparib and Pembro in Metastatic Pancreatic Ductal Cancer."; n 38; "Progression-free Survival (PFS) after 6 months according to RECIST 1.1 criteria."; 2026-07-01
NCT03829462
"Assessing a Regorafenib-irinotecan Combination Versus Regorafenib Alone in Metastatic Colorectal Cancer Patients"; n 377; "Overall Survival"; 2026-09
NCT04342910
"Study to Evaluate the Efficacy and Safety of Camrelizumab and Apatinib in Patients With GC/GEJC"; n 550; "Overall Survival (OS) in PD-L1 Positive Participants."; 2026-09-01
NCT06346392
"AZD0901 Compared With Investigator's Choice of Therapy in Participants With Second- or Later-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2"; n 594; "Progression Free Survival (PFS) in all randomized participants"; 2026-10-14
NCT02567435
"Combination Chemotherapy With or Without Temsirolimus in Treating Patients With Intermediate Risk Rhabdomyosarcoma"; n 325; "Event-free Survival (EFS)"; 2026-10-27
NCT05427383
"KN026 in Combination With Chemotherapy in HER2 Positive Gastric Cancer Subjects Who Have Failed First-line Therapy"; n 286; "Progression Free Survival (PFS) according to RECIST 1.1 by IRC"; 2026-11
NCT04776655
"Study in mCRC Patients RAS/BRAF wt Tissue and RAS Mutated LIquid BIopsy to Compare FOLFIRI Plus CetuxiMAb or BevacizumaB"; n 280; "Progression free survival (PFS) in patients with RASmut at liquid biopsy and RASwt on tissue."; 2026-12
NCT05440786
"CAMPFIRE: A Study of Abemaciclib (LY2835219) in Participants With Ewing's Sarcoma"; n 46; "Progression Free Survival (PFS) Assessed by Blinded Independent Review Committee (BIRC) by Bayesian Analysis"; 2026-12
NCT06242067
"Second-line Treatment of Metastatic Colorectal Cancer"; n 50; "progression-free survival(PFS)"; 2026-12
NCT06351020
"LM-302 for the Treatment of Subjects With Claudin18.2-Positive Gastric and Gastroesophageal Junction Adenocarcinoma."; n 387; "Overall Survival (OS)"; 2026-12-15
NCT03303495
"A Study of 2nd-line FOLFIRI ± Bevacizumab vs. Irinotecan ± Bevacizumab in mCRC"; n 280; "Progression-free survival (PFS)"; 2026-12-31
NCT04233866
"Comparing Two Treatment Combinations, Gemcitabine and Nab-Paclitaxel With 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan for Older Patients With Pancreatic Cancer That Has Spread"; n 176; "Overall survival (OS)"; 2026-12-31
NCT06463548
"Irinotecan Hydrochloride Liposome Combined With Capecitabine and Lenvatinib in Patients With Biliary Tract Carcinoma"; n 30; "Progression-free survival (PFS)"; 2026-12-31
NCT05062317
"ctDNA-Directed Post-Hepatectomy Chemotherapy for Patients With Resectable Colorectal Liver Metastases"; n 120; "To establish the 1-year recurrence-free survival rate following liver resection of CLM with curative intent among ctDNA-negative patients who receive risk-stratified postoperative chemotherapy"; 2027-02-28
Q8
Which 332 trials of Irinotecan posted no result?
Posted no result
332 of 332 completed trials
Registrations
NCT00003344, NCT00004182, NCT00001495, NCT00002988, NCT00002933 and NCT00003109, and 326 more
Completion dates
oldest 2000-01; newest 2024-06-05
Show the evidence
Trial
NCT00003344
2000-01
NCT00004182
2000-04
NCT00001495
2000-10
NCT00002988
2000-11
NCT00002933
2001-01
NCT00003109
2001-01
14 further recorded trials
NCT00003276
2001-03
NCT00003544
2001-03
NCT00003055
2001-04
NCT00003710
2001-05
NCT00003225
2001-06
NCT00003742
2001-08
NCT00003345
2001-10
NCT00002939
2002-04
NCT00003427
2002-04
NCT00006103
2002-04
NCT00004922
2002-06
NCT00003463
2002-07
NCT00004870
2002-09
NCT00024141
2003-01
Q9
At the median, Irinotecan's trials enrolled 51 people — anything larger?
Median enrolment
51
Largest enrolment
3397
Registered trials counted
1079
Q10
What do 8 spontaneous reports say about Irinotecan — and not say?
These are reports people sent to a regulator. They do not show the medicine caused the reaction. Nobody counted how many people took the medicine and reported nothing. The same event can be reported more than once, and many reports are incomplete. News coverage, lawsuits and new warnings change how often people report. A count is not a rate and not a risk.
Irinotecan appears in spontaneous reports to regulators. Across the 4 most-reported reaction terms, 8 reaction mentions were counted: stomatitis 3; enterocolitis 2; metastases to lung 2; reexpansion pulmonary oedema 1. FAERS via Open Targets · CHEMBL1200512 · 2026-06-24
Show the evidence
stomatitis
3
enterocolitis
2
metastases to lung
2
reexpansion pulmonary oedema
1
recorded 2026-06-24 · last checked 2026-09-04
Q11
Which 4 reactions does Irinotecan's label not list?
• Strong CYP3A4 Inducers: Do not administer strong CYP3A4 inducers with irinotecan hydrochloride injection.
drug_interactions
( 7.2 ) • Strong CYP3A4 Inhibitors: Do not administer strong CYP3A4 inhibitors with irinotecan hydrochloride injection.
drug_interactions
7.2 Strong CYP3A4 Inducers Exposure to irinotecan or its active metabolite SN-38 is substantially reduced in adult and pediatric patients concomitantly receiving the CYP3A4 enzyme-inducing anticonvulsants phenytoin, phenobarbital, carbamazepine, or St.
drug_interactions
Do not administer strong CYP3A4 inducers with irinotecan hydrochloride injection unless there are no therapeutic alternatives.
drug_interactions
7.3 Strong CYP3A4 or UGT1A1 Inhibitors Irinotecan and its active metabolite, SN-38, are metabolized via the human cytochrome P450 3A4 isoenzyme (CYP3A4) and uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1), respectively, [see Clinical Pharmacology (12.3) ].
drug_interactions
Patients receiving concomitant ketoconazole, a CYP3A4 and UGT1A1 inhibitor, have increased exposure to irinotecan and its active metabolite SN-38.
2 more recorded rows
Interaction statementdrug_interactions
Coadministration of irinotecan hydrochloride injection with other inhibitors of CYP3A4 (e.g., clarithromycin, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telaprevir, voriconazole) or UGT1A1 (e.g., atazanavir, gemfibrozil, indinavir) may increase systemic exposure to irinotecan or SN-38.
Interaction statementdrug_interactions
Discontinue strong CYP3A4 inhibitors at least 1 week prior to starting irinotecan hydrochloride injection therapy.
ClinicalTrials.gov — US Government work · Open Targets 26.06 — CC0 · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work
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✓ public claims reviewed: 0 reviewed claim(s); drafts are never rendered
✓ source coverage passed: 6 source rows
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