This page shows what was measured, who it was measured in, and what that does not settle.
What Capecitabine does in the body
Capecitabine tablets are a nucleoside metabolic inhibitor indicated for: Colorectal Cancer adjuvant treatment of patients with Stage III colon cancer as a single agent or as a component of a combination chemotherapy regimen.
From the FDA-approved label: Capecitabine is metabolized to fluorouracil in vivo . Both normal and tumor cells metabolize fluorouracil to 5-fluoro-2’- deoxyuridine monophosphate (FdUMP) and 5- fluorouridine triphosphate (FUTP). These metabolites cause cell injury by two different mechanisms. First, FdUMP and the folate cofactor, N 5-10 - methylenetetrahydrofolate, bind to thymidylate synthase (TS) to form a covalently bound ternary complex. This binding inhibits the formation of thymidylate from 2’-deoxyuridylate. Thymidylate is the necessary precursor of thymidine triphosphate, which is essential for the synthesis of DNA, so that a deficiency of this compound can inhibit cell division.
Why people take it. Capecitabine tablets are a nucleoside metabolic inhibitor indicated for: Colorectal Cancer adjuvant treatment of patients with Stage III colon cancer as a single agent or as a component of a combination chemotherapy regimen.
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 · 6804DJ8Z9U · read 2026-08-29
Its recorded molecular formula is C15H22FN3O6, weighing 359.35.
US prescribing information · 4ec2cfc1-e8ca-4109-8b90-1aab07cbab21 · read 2026-08-30
Where each sentence above came from
The use the label states, quoted from it. No plain-language version of this sentence has been written.
The use the label states, quoted from it. It is written for a clinician, not for a reader without medical training.
No statement of the main limit is recorded.
The four opening statements run to 172 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.
To determine the objective response rate of patients with metastatic colorectal cancer received the combination of drugs
✗ The study did not show it
Who was studied
NCT01196260
How many people
8000
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. Oral
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
Distant metastasis-free survival at 5 years
✗ The study did not show it
Who was studied
NCT00433589
How many people
6600
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. Oral
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
3-year disease-free survival
✗ The study did not show it
Who was studied
NCT00749450
How many people
6088
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. Oral
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 (DFS)
✗ The study did not show it
Who was studied
NCT04089631
How many people
4812
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. Oral
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 (DFS) at 5 years
✗ The study did not show it
Who was studied
NCT00301925
How many people
4400
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. Oral
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 (DFS)
✗ The study did not show it
Who was studied
NCT00646607
How many people
3756
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. Oral
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.
Capecitabine tablets are a nucleoside metabolic inhibitor indicated for: Colorectal Cancer adjuvant treatment of patients with Stage III colon cancer as a single agent or as a component of a combination chemotherapy regimen. ( 1.1 ) perioperative treatment of adults with locally advanced rectal cancer as a component of chemoradiotherapy.
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 safety and effectiveness of capecitabine tablets in pediatric patients have not been established.”
US prescribing information · 4ec2cfc1-e8ca-4109-8b90-1aab07cbab21 · read 2026-08-30
On older people, the label states: “Of 7,938 patients with colorectal cancer who were treated with capecitabine tablets, 33% were older than 65 years.”
US prescribing information · 4ec2cfc1-e8ca-4109-8b90-1aab07cbab21 · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary Based on findings in animal reproduction studies and its mechanism of action [see Clinical Pharmacology ( 12.1 )] , capecitabine tablets can cause fetal harm when administered to a pregnant woman.”
US prescribing information · 4ec2cfc1-e8ca-4109-8b90-1aab07cbab21 · read 2026-08-30
On people who are breastfeeding, the label states: “8.3 Females and Males of Reproductive Potential Capecitabine tablets can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations ( 8.1 )] .”
US prescribing information · 4ec2cfc1-e8ca-4109-8b90-1aab07cbab21 · read 2026-08-30
On people with reduced liver function, the label states: “The exposure of capecitabine increases in patients with mild to moderate hepatic impairment.”
US prescribing information · 4ec2cfc1-e8ca-4109-8b90-1aab07cbab21 · read 2026-08-30
On people with reduced kidney function, the label states: “The exposure of capecitabine and its inactive metabolites (5-DFUR and FBAL) increases in patients with CLcr <50 mL/min as determined by Cockcroft-Gault [see Clinical Pharmacology ( 12.3 )] .”
US prescribing information · 4ec2cfc1-e8ca-4109-8b90-1aab07cbab21 · 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
Oral
✎ 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 tablet, tablet, film coated, given by the oral 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
Oral
✎ 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
54 products list this as an active ingredient in the United States drug directory. 54 of them contain it and nothing else.
FDA National Drug Code directory · 72205-006 · read 2026-08-29
They are sold as crystal, powder, tablet and tablet, film coated, taken oral.
FDA National Drug Code directory · 72205-006 · read 2026-08-29
The regulator's established pharmacologic class for it is nucleic acid synthesis inhibitors [moa] and nucleoside metabolic inhibitor [epc].
FDA National Drug Code directory · 72205-006 · read 2026-08-29
21 published labels name it as an active ingredient. 21 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 4ec2cfc1-e8ca-4109-8b90-1aab07cbab21 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 4ec2cfc1-e8ca-4109-8b90-1aab07cbab21 · read 2026-08-29
5 marketed supplement labels list this ingredient, classed as other combinations and vitamin.
Those labels carry all other and nutrient claims. A claim of that kind is written by the manufacturer and is not assessed by any regulator, so its presence says nothing about whether it is true.
Capecitabine is oral at 3 DOSAGE FORMS AND STRENGTHS Tablets, film-coated: 150 mg: Light Peach color, oval shaped with 'A015' on the one side and '150' on the other side 500 mg: Light Peach color, oval shaped with 'A016' on the one side and '5…, recorded as fda label in effect 2025-06-25 in the United States.
US prescribing information · 4ec2cfc1-e8ca-4109-8b90-1aab07cbab21 · read 2026-08-30
Recorded price in US: 0.36154–0.46793 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 28 priced products whose strengths and pack forms differ, as of 2026-08-26, paid by retail pharmacies buying the product, as surveyed by the Centers for Medicare & Medicaid Services. It is not a list price, an insurance price, or what anyone pays at a counter..
Recorded source · 2026-08-26 · read 2026-08-28
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 Capecitabine 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 Capecitabine 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
21 documents were read for this substance.
RNAWiki source record
3 of them state the same halfLife, and they agree.
RNAWiki source record
21 of them state the same proteinBinding, and they agree.
RNAWiki source record
Where else this substance is registered
FDA substance identifier (UNII)
6804DJ8Z9U
RxNorm concept
200327
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: Quoted from a stored source.
✗ 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
15 approved applications cover products containing this substance. The earliest was NDA020896, approved 19980430 to CHEPLAPHARM.
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 Capecitabine label: indicated for what?
"Capecitabine is a nucleoside metabolic inhibitor indicated for: Colorectal Cancer • adjuvant treatment of patients with Stage III colon cancer as a single agent or as a component of a combination chemotherapy regimen. ( 1.1 ) • perioperative treatment of adults with locally advanced rectal cancer as a component of…": indications and usage on Capecitabine's label. DailyMed label · 0b59e98c-5b34-4b93-90f6-20526f4d4f88 · 2026-07-21
Q3
1503 registered trials of Capecitabine — at which phases?
Registered studies posting no result
1168 of 1503
1503 registered studies of Capecitabine: 918 phase2, 360 phase3, 325 phase1, 39 na or unstated, 34 na, 20 phase4, 4 early phase1. CLINICALTRIALS_SNAPSHOT · 2026-09-01
terminated; "The study was terminated due to poor recruitment (after enrolling 62 of planned 300 patients in 20 months"
NCT00087334
terminated; "Withdrawn due to poor/low accrual"
14 further recorded trials
NCT00095641
withdrawn; "no longer studying this disease site"
NCT00101075
terminated; "Slow Accrual"
NCT00107315
terminated; "Terminated due to low accrual"
NCT00118105
withdrawn; "Budget Constraints"
NCT00118300
withdrawn; "Competing studies"
NCT00119314
withdrawn; "slow accrual"
NCT00130507
terminated; "A new alternative treatment caused the decrease in the rhythm of recruitment."
NCT00148135
terminated; "recruitment goals met"
NCT00148720
terminated; "Slow accrual"
NCT00176787
terminated; "recruitment goals met"
NCT00177255
terminated; "Roche has withdrawn support"
NCT00201734
terminated; "Due to lack of funding provided for Phase II portion of trial"
NCT00216073
terminated; "Lack of patient accrual"
NCT00216086
terminated; "Funding withdrawn"
recorded 2026-09-01 · last checked 2026-09-04
Q5
Human studies of Capecitabine used Capecitabine 1000 mg/m^2 — over how long?
studies of Capecitabine used the recorded amount. ClinicalTrials.gov · 2026-09-01
18 recorded entries; human; orally; also "Capecitabine 1000 mg/m^2", "Capecitabine 825 mg/m2 bid (total daily dose 1650 mg/m2) will be administered orally for 14 days (days 1-14).", "Capecitabine 2500 mg/m2/d in two divided doses"
Show the evidence
human
NCT00069095
Capecitabine 1000 mg/m^2
NCT00177255
orally; Capecitabine 825 mg/m2 bid (total daily dose 1650 mg/m2) will be administered orally for 14 days (days 1-14).
0.75 hour; Elimination The elimination half-lives of capecitabine and fluorouracil were approximately 0.75 hour.
tmaxpharmacokinetics
1.5 hours; Absorption Following oral administration of capecitabine 1,255 mg/m 2 orally twice daily (the recommended dosage when used as single agent), the median T max of capecitabine and its metabolite fluorouracil was approximately 1.5 hours and 2 hours, respectively.
metabolismpharmacokinetics
Metabolism Capecitabine undergoes metabolism by carboxylesterase and is hydrolyzed to 5’-DFCR.
recorded 2026-07-21 · last checked 2026-09-04
Q7
Which running trial of Capecitabine could settle lifespan?
NCT06975917 measures Recurrence-free survival, reading out 2025-05-30.
172 open trials; n 600; "Adjuvant Chemotherapy Regimens in Resected Biliary Tract Cancers (TOG/GI-SAFRADJU-2501)"
Show the evidence
Trial
NCT06975917
"Adjuvant Chemotherapy Regimens in Resected Biliary Tract Cancers (TOG/GI-SAFRADJU-2501)"; n 600; "Recurrence-free survival"; 2025-05-30
NCT04295317
"PD-1 Antibody (SHR-1210) Plus Capecitabine in Patients with Intrahepatic Cholangiocarcinoma After Surgery"; n 65; "recurrence-free survival"; 2025-06-01
NCT02170090
"Adjuvant Chemotherapy With Gemcitabine and Cisplatin Compared to Standard of Care After Curative Intent Resection of Biliary Tract Cancer"; n 789; "Disease free survival (DFS)"; 2025-12
NCT02299999
"SAFIR02_Breast - Efficacy of Genome Analysis as a Therapeutic Decision Tool for Patients With Metastatic Breast Cancer"; n 1460; "Progression-free survival in the targeted drug arm compared to standard maintenance therapy arm"; 2025-12
NCT07156058
"MiniPDX-based Postoperative Adjuvant Therapy for Biliary Tract Cancer"; n 204; "Relapse-Free Survival (RFS)"; 2025-12-31
NCT06282445
"Efficacy and Safety of Chemotherapy With XELOX (Oxaliplatin + Capecitabine) and Bevacizumab in Combination With Adebrelimab in First-line Treatment of Microsatellite Stable (MSS) Initially Unresectable Metastatic Colorectal Cancer"; n 36; "Progression-free survival"; 2026-03-31
14 further recorded trials
NCT05063786
"Trastuzumab + Alpelisib +/- Fulvestrant vs Trastuzumab + CT in Patients With PIK3CA Mutated Previously Treated HER2+ Advanced BrEasT Cancer (ALPHABET)"; n 27; "Progression Free Survival (PFS)"; 2026-06
NCT04494425
"Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer"; n 866; "Progression-Free Survival (PFS) Assessed by Blinded Independent Central Review (BICR) in the Hormone Receptor-Positive (HR+), Human Epidermal Growth Factor Receptor 2 (HER2)-Low Population"; 2026-06-19
NCT06279364
"A Study of SKB264 Versus Investigator's Choice Chemotherapy in Patients With Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer"; n 524; "Overall Survival (OS)"; 2026-07
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
NCT05568095
"A Clinical Trial of a New Combination Treatment, Domvanalimab and Zimberelimab, Plus Chemotherapy, for People With an Upper Gastrointestinal Tract Cancer That Cannot be Removed With Surgery That Has Spread to Other Parts of the Body"; n 1040; "Overall survival"; 2026-08
NCT03734029
"Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]"; n 557; "Progression-free Survival (PFS) Based on Blinded Independent Central Review (BICR) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer"; 2026-08-01
NCT03653507
"A Study of Zolbetuximab (IMAB362) Plus CAPOX Compared With Placebo Plus CAPOX as First-line Treatment of Subjects With Claudin (CLDN) 18.2-positive, HER2-negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (GLOW)."; n 507; "Progression Free Survival (PFS)"; 2026-09-30
NCT06192680
"Liposomal Irinotecan and Capecitabine Plus Bevacizumab as Second-line Therapy in Metastatic Colorectal Cancer"; n 63; "Progression free Survival"; 2026-09-30
NCT05044117
"Single-agent Capecitabine as Metronomic Chemotherapy in LAHNSCC (CMHN)"; n 220; "Progression-free survival"; 2026-10
NCT06094868
"Clinical Study of Fruquintinib Combined With Sintilimab and XELOX Regimen in the Treatment of Advanced Cancer"; n 45; "Progression-free survival (PFS)"; 2026-10
NCT05387603
"Systemic Targeted Adaptive RadioTherapy of NeuroEndocrine Tumors."; n 300; "Median progression free survival (PFS) defined as time from randomization to radiological progression."; 2026-10-01
NCT01972919
"MR Guided Phase II Radiotherapy Dose Escalation in Unresectable Non-Metastatic Pancreatic Cancer"; n 23; "Overall Survival"; 2026-11
NCT02008656
"Trial Evaluating 3-year Disease Free Survival in Patients With Locally Advanced Rectal Cancer Treated With Chemoradiation Plus Induction or Consolidation Chemotherapy and Total Mesorectal Excision or Non-operative Management"; n 358; "disease-free survival (DFS)"; 2026-11
NCT01824875
"Temozolomide With or Without Capecitabine in Treating Patients With Advanced Pancreatic Neuroendocrine Tumors"; n 144; "Progression-free Survival"; 2026-12
Q8
Which 311 trials of Capecitabine posted no result?
Posted no result
311 of 311 completed trials
Registrations
NCT00004012, NCT00006023, NCT00006108, NCT00005649, NCT00037609 and NCT00003867, and 305 more
Completion dates
oldest 2000-12; newest 2024-06-30
Show the evidence
Trial
NCT00004012
2000-12
NCT00006023
2001-06
NCT00006108
2002-07
NCT00005649
2002-07-04
NCT00037609
2003-02
NCT00003867
2003-03
14 further recorded trials
NCT00003704
2003-07
NCT00004187
2004-04
NCT00212589
2004-04
NCT00005839
2004-06
NCT00021047
2004-06
NCT00031876
2004-09
NCT00146588
2004-12
NCT00006465
2005-04
NCT00003902
2005-09
NCT00052273
2005-10
NCT00165217
2005-12
NCT00207129
2005-12
NCT00004183
2006-01
NCT00077077
2006-01
Q9
At the median, Capecitabine's trials enrolled 63 people — anything larger?
Median enrolment
63
Largest enrolment
6088
Registered trials counted
1479
Q10
What do 22459 spontaneous reports say about Capecitabine — 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.
Capecitabine appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 22459 reaction mentions were counted: diarrhoea 5243; nausea 3117; palmar-plantar erythrodysaesthesia syndrome 2928; vomiting 2658. FAERS via Open Targets · CHEMBL1773 · 2026-06-24
Show the evidence
diarrhoea
5243
nausea
3117
palmar-plantar erythrodysaesthesia syndrome
2928
vomiting
2658
disease progression
2243
neutropenia
1664
4 more recorded rows
thrombocytopenia
1234
malignant neoplasm progression
1201
decreased appetite
1106
dehydration
1065
recorded 2026-06-24 · last checked 2026-09-04
Q11
Which 10 reactions does Capecitabine's label not list?
( 7.1 ) • CYP2C9 substrates : Closely monitor for adverse reactions when CYP2C9 substrates are coadministered with capecitabine.
drug_interactions
7.2 Effect of Capecitabine on Other Drugs CYP2C9 Substrates Capecitabine increased exposure of CYP2C9 substrates [see Clinical Pharmacology (12.3) ], which may increase the risk of adverse reactions related to these substrates.
drug_interactions
Closely monitor for adverse reactions of CYP2C9 substrates where minimal concentration changes may lead to serious adverse reactions when used concomitantly with capecitabine (e.g., anticoagulants, antidiabetic drugs).
pharmacokinetics
Effect of Capecitabine on Celecoxib: Concomitant administration of multiple doses of capecitabine (capecitabine 1,000 mg/m 2 twice daily for 14 days) increased celecoxib (sensitive CYP2C9 substrate) AUC by 28%, C max by 24% and C trough by 30%.
pharmacokinetics
In Vitro Studies Cytochrome P450 (CYP) Enzymes: Capecitabine and its metabolites (5’-DFUR, 5’-DFCR, fluorouracil, and FBAL) did not inhibit CYP1A2, CYP2A6, CYP3A4, CYP2C19, CYP2D6, or CYP2E1 in vitro .
clinical_pharmacology
Effect of Capecitabine on Celecoxib: Concomitant administration of multiple doses of capecitabine (capecitabine 1,000 mg/m 2 twice daily for 14 days) increased celecoxib (sensitive CYP2C9 substrate) AUC by 28%, C max by 24% and C trough by 30%.
1 more recorded row
Interaction statementclinical_pharmacology
In Vitro Studies Cytochrome P450 (CYP) Enzymes: Capecitabine and its metabolites (5’-DFUR, 5’-DFCR, fluorouracil, and FBAL) did not inhibit CYP1A2, CYP2A6, CYP3A4, CYP2C19, CYP2D6, or CYP2E1 in vitro .
ChEMBL 37 — CC BY-SA 3.0 Unported · ChEMBL ATC CC BY-SA · 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
✗ required summary fields resolved: 4 required field(s) not terminal: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
✓ public claims reviewed: 0 reviewed claim(s); drafts are never rendered
✓ source coverage passed: 6 source rows
✓ no critical contamination: no quarantine open
✓ canonical metadata passed: slug and display name present
✓ no raw internal fields: enforced by the copy-contract test over the rendered page
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