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(E)-SUNITINIB

  • Prescription medicine
  • Prescription only
  • Identity checked
  • Sources last checked 2026-09-04

This page shows what was measured, who it was measured in, and what that does not settle.

What (E)-SUNITINIB does in the body

Gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate

From the FDA-approved label: Sunitinib is a small molecule that inhibits multiple receptor tyrosine kinases (RTKs), some of which are implicated in tumor growth, pathologic angiogenesis, and metastatic progression of cancer. Sunitinib was evaluated for its inhibitory activity against a variety of kinases (> 80 kinases) and was identified as an inhibitor of platelet-derived growth factor receptors (PDGFRα and PDGFRβ), vascular endothelial growth factor receptors (VEGFR1, VEGFR2, and VEGFR3), stem cell factor receptor (KIT), Fms-like tyrosine kinase-3 (FLT3), colony stimulating factor receptor Type 1 (CSF-1R), and the glial cell-line derived neurotrophic factor receptor (RET).

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

  • Its recorded molecular formula is C22H27FN4O2∙C4H6O5, weighing 532.6 Daltons.

    US prescribing information · 43a4d7f8-48ae-4a63-9108-2fa8e3ea9d9c · read 2026-08-30

Where each sentence above came from

The recorded explanation is written in label language rather than for a beginner. The page opens with what it is taken for instead, and the recorded explanation follows below.

Shown as the opening line on this page.

No statement of the main limit is recorded.

The four opening statements run to 119 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 peopleRead 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.

Objective response rate (ORR)

The study did not show it

Who was studied
NCT02465060
How many people
6452
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. 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

Objective Response Rate defined as % of participants in a cohort with complete or partial response or with stable disease according to standard response criteria

The study did not show it

Who was studied
NCT02693535
How many people
4200
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. 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
NCT00326898
How many people
1943
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

Percentage of patients that are treated based on their molecular tumor profile

The study did not show it

Who was studied
NCT02925234
How many people
1550
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. 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

Incidence of Adverse Events (AEs)

The study did not show it

Who was studied
NCT03899155
How many people
1500
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. 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

Progression-free Survival (PFS)

The study did not show it

Who was studied
NCT00720941
How many people
1110
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 unclearRead 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.

  • Sunitinib malate capsules are a kinase inhibitor indicated for: • treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. ( 1.1 ) • treatment of adult patients with advanced renal cell carcinoma (RCC). ( 1.2 ) • adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy.

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 SUTENT in pediatric patients have not been established.”

    US prescribing information · 43a4d7f8-48ae-4a63-9108-2fa8e3ea9d9c · read 2026-08-30

  • On older people, the label states: “Clinical studies of SUTENT did not include sufficient numbers of patients with pNET to determine if patients 65 years of age and older respond differently than younger patients.”

    US prescribing information · 43a4d7f8-48ae-4a63-9108-2fa8e3ea9d9c · read 2026-08-30

  • On people who are pregnant, the label states: “Sunitinib (0.3, 1, 3 mg/kg/day) was evaluated in a pre- and postnatal development study in pregnant rats.”

    US prescribing information · 43a4d7f8-48ae-4a63-9108-2fa8e3ea9d9c · read 2026-08-30

  • On people who are breastfeeding, the label states: “There is no information regarding the presence of sunitinib and its metabolites in human milk.”

    US prescribing information · 43a4d7f8-48ae-4a63-9108-2fa8e3ea9d9c · read 2026-08-30

  • On people with reduced liver function, the label states: “No dose adjustment is required in patients with mild or moderate (Child-Pugh Class A or B) hepatic impairment [see Clinical Pharmacology (12.3) ] .”

    US prescribing information · 43a4d7f8-48ae-4a63-9108-2fa8e3ea9d9c · read 2026-08-30

  • On people with reduced kidney function, the label states: “No dose adjustment is recommended in patients with mild (CLcr 50 to 80 mL/min), moderate (CLcr 30 to <50 mL/min), or severe (CLcr <30 mL/min) renal impairment who are not on dialysis [see Clinical Pharmacology (12.3) ] .”

    US prescribing information · 43a4d7f8-48ae-4a63-9108-2fa8e3ea9d9c · 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 takeRead 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 takeRead 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, S4.

No source is stored against this line.

What is in the pack

Sold as capsule, 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 takeNothing 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 unclearRead 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

  • SUTENT is oral at 3 DOSAGE FORMS AND STRENGTHS Capsules, hard gelatin: • 12.5 mg sunitinib: orange cap and orange body, printed with white ink “Pfizer” on the cap and “STN 12.5 mg” on the body. • 25 mg sunitinib: caramel cap and orange b…, recorded as fda label in effect 2026-02-20 in the United States.

    US prescribing information · 43a4d7f8-48ae-4a63-9108-2fa8e3ea9d9c · 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 takeRead 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 (E)-SUNITINIB 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 unclearRead 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 (E)-SUNITINIB 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 peopleNothing found in the sources checked

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.

Nothing found in the sources checked

No traced study record is stored for this substance.

The sources listed were searched and held nothing. That is not the same as nothing existing.

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, S4.

  • Passed

    Canonical metadata present

    slug and display name present

What is missing or unclearRead from sources, not yet reviewed

What to learn next

Ordered by what would most change how you read this page, starting with what is easiest to misunderstand.

This order is fixed in code and does not count clicks or time on the page.

What is not here

10 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.
  • How this medicine reached us — 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 (9)

On the (E)-SUNITINIB label: indicated for what?

"SUTENT is a kinase inhibitor indicated for: • treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. ( 1.1 ) • treatment of adult patients with advanced renal cell carcinoma (RCC).": indications and usage on (E)-SUNITINIB's label. DailyMed label · 43a4d7f8-48ae-4a63-9108-2fa8e3ea9d9c · 2026-02-20

390 registered trials of (E)-SUNITINIB — at which phases?

Registered studies posting no result
201 of 390

390 registered studies of (E)-SUNITINIB: 240 phase2, 80 phase1, 43 phase3, 29 na or unstated, 15 na, 8 phase4, 2 early phase1. CLINICALTRIALS_SNAPSHOT · 2026-09-01

687 with a PubMed record

Show the evidence
  • phase2
    240
  • phase1
    80
  • phase3
    43
  • na or unstated
    29
  • na
    15
  • phase4
    8
10 more recorded rows
  • early phase1
    2
  • completed
    238
  • terminated
    74
  • unknown
    32
  • active not recruiting
    17
  • recruiting
    15
  • withdrawn
    9
  • approved for marketing
    2
  • not yet recruiting
    2
  • available
    1

recorded 2026-09-01 · last checked 2026-09-04

72 of (E)-SUNITINIB's trials stopped: safety, futility/efficacy, accrual/recruitment, funding/business, sponsor decision unspecified, other?

safety (8), futility/efficacy (4), accrual/recruitment (27), funding/business (3), sponsor decision unspecified (3) and other (27): (E)-SUNITINIB's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"Slow accrual."; 72 of 390 registered studies

Show the evidence

Trial

  • NCT00330564
    terminated; "Slow accrual."
  • NCT00372567
    terminated; "See termination reason in detailed description."
  • NCT00373113
    terminated; "See termination reason in detailed description."
  • NCT00393796
    terminated; "Low accrual"
  • NCT00417885
    terminated; "See Detailed Description for Termination Reason"
  • NCT00428597
    terminated; "Refer to Detailed Description."
14 further recorded trials
  • NCT00434226
    terminated; "Based on data collected, the combination appeared to be poorly tolearated."
  • NCT00434356
    terminated; "Based on data collected, the combination appeared to be poorly tolearated."
  • NCT00480935
    terminated; "poor recruitment"
  • NCT00482911
    terminated; "Investigator left the institute."
  • NCT00491738
    terminated; "Based on the data collected, the combination of bevacizumab and sunitinib appeared to be poorly tolerated."
  • NCT00496223
    terminated; "toxicities required dose reduction compromising effectiveness and PI left Moffitt"
  • NCT00520533
    terminated; "Closed prematurely due to toxicity"
  • NCT00521092
    withdrawn; "No participants enrolled."
  • NCT00522249
    terminated; "PI decision"
  • NCT00524186
    terminated; "PI left institute"
  • NCT00524316
    terminated; "low accrual"
  • NCT00556205
    withdrawn; "Toxicity of combination from other trials"
  • NCT00570908
    terminated; "Due to poor accrual this study is being closed to accrual"
  • NCT00573404
    terminated; "slow accrual"

recorded 2026-09-01 · last checked 2026-09-04

Human studies of (E)-SUNITINIB used Crixotinib 200 mg and Sunitinib Cohort 1 — over how long?

studies of (E)-SUNITINIB used the recorded amount. ClinicalTrials.gov · 2026-09-01

8 recorded entries; human; also "Crixotinib 200 mg and Sunitinib Cohort 1", "Sunitinib (Sutent) 25.0 mg once a day", "Crixotinib 250 mg and Sunitinib Cohort 2"

Show the evidence

human

  • NCT02074878
    Crixotinib 200 mg and Sunitinib Cohort 1
  • NCT02074878
    Sunitinib (Sutent) 25.0 mg once a day
  • NCT02074878
    Crixotinib 250 mg and Sunitinib Cohort 2
  • NCT02074878
    Crizotinib & Sunitinib 37.5 mg Cohort 3
  • NCT02074878
    Sunitinib (Sutent) 37.5 mg
  • NCT03275558
    Sunitinib 5 MG
2 more recorded rows
  • human NCT03277924
    Sunitinib 37.5 MG, Sunitinib 25 MG [Sutent]
  • human NCT03424876
    Sunitinib 37.5Mg Oral Capsule

recorded 2026-09-01 · last checked 2026-09-04

(E)-SUNITINIB's half-life is 40 to 60 hours — which schedules were studied?

40 to 60 hours, the half-life (E)-SUNITINIB's label states: "Elimination Following administration of a single oral dose in healthy subjects, the terminal half-lives of sunitinib and its primary active metabolite are approximately 40 to 60 hours and 80 to 110 hours, respectively." DailyMed label · 43a4d7f8-48ae-4a63-9108-2fa8e3ea9d9c · 2026-02-20

tmax 6 to 12 hours.

Show the evidence
  • half life pharmacokinetics
    40 to 60 hours; Elimination Following administration of a single oral dose in healthy subjects, the terminal half-lives of sunitinib and its primary active metabolite are approximately 40 to 60 hours and 80 to 110 hours, respectively.
  • tmax pharmacokinetics
    6 to 12 hours; Absorption Following oral administration of sunitinib, the time to maximum plasma concentration (T max ) ranged from 6 to 12 hours.
  • metabolism pharmacokinetics
    Metabolism Sunitinib is metabolized primarily by CYP3A4 to its primary active metabolite, which is further metabolized by CYP3A4.

recorded 2026-02-20 · last checked 2026-09-04

Which running trial of (E)-SUNITINIB could settle lifespan?

NCT04523272 measures Progression free survival (PFS) evaluated by Independent Review Committee(IRC), reading out 2025-12.

15 open trials; n 528; "A Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule Versus Sunitinib in Subjects With Advanced Renal Cancer"

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Trial

  • NCT04523272
    "A Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule Versus Sunitinib in Subjects With Advanced Renal Cancer"; n 528; "Progression free survival (PFS) evaluated by Independent Review Committee(IRC)"; 2025-12
  • NCT03673501
    "A Study of Ripretinib vs Sunitinib in Advanced GIST Patients After Treatment With Imatinib"; n 453; "Progression Free Survival (PFS) in the KIT Exon 11 Intent to Treat (ITT) Population"; 2026-12
  • NCT02068586
    "Sunitinib Malate or Valproic Acid in Preventing Metastasis in Patients With High-Risk Uveal Melanoma"; n 210; "Overall survival (Cohort 1)"; 2026-12-31
  • NCT03091192
    "Savolitinib vs. Sunitinib in MET-driven PRCC."; n 60; "Progression Free Survival (PFS) by Blinded Independent Central Review (BICR)"; 2026-12-31
  • NCT05043090
    "Savolitinib Plus Durvalumab Versus Sunitinib and Durvalumab Monotherapy in MET-Driven, Unresectable and Locally Advanced or Metastatic PRCC"; n 148; "Progression-Free Survival (PFS) /savolitinib plus durvalumab relative to sunitinib"; 2027-02-01
  • NCT02811861
    "Lenvatinib/Everolimus or Lenvatinib/Pembrolizumab Versus Sunitinib Alone as Treatment of Advanced Renal Cell Carcinoma"; n 1069; "Progression-free Survival (PFS) by Independent Imaging Review (IIR)"; 2027-03-31
9 further recorded trials
  • NCT03541902
    "Cabozantinib or Sunitinib Malate in Treating Participants With Metastatic Variant Histology Renal Cell Carcinoma"; n 32; "Progression-Free Survival (PFS) Evaluated Using RECIST 1.1 Criteria"; 2027-07-31
  • NCT07477457
    "A Study of Gefitinib, Trametinib, Disulfiram, and Sunitinib in Addition to Standard Chemotherapy in People With Osteosarcoma"; n 45; "12-month progression free survival (PFS) (cohort 1)"; 2028-03-11
  • NCT05678673
    "Study of XL092 + Nivolumab vs Sunitinib in Subjects With Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma"; n 317; "Duration of Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), by Blinded Independent Radiology Committee (BIRC)"; 2028-06-30
  • NCT05734105
    "A Study of Ripretinib vs Sunitinib in Patients With Advanced GIST With Specific KIT Exon Mutations Who Were Previously Treated With Imatinib"; n 54; "Progression-free Survival (PFS)"; 2028-12
  • NCT06326190
    "177Lu-DOTATATE for Recurrent Meningioma"; n 136; "Progression Free Survival (PFS)"; 2028-12-22
  • NCT05773274
    "Comparing Retreatment of 177Lu-DOTATATE PRRT Versus the Usual Treatment in Patients With Metastatic Unresectable Gastroenteropancreatic Neuroendocrine Tumors, NET RETREAT Trial"; n 100; "Progression-free survival (PFS)"; 2029-04-30
  • NCT07165418
    "A Comparison of Vorolanib Tablets Combined With Everolimus Versus Sunitinib in Patients With Advanced Renal Cell Carcinoma Who Have Progressed After Treatment With Immunotherapy Monotherapy or in Combination With TKI"; n 116; "Progression Free Survival（PFS）"; 2029-12-30
  • NCT07218926
    "A Study of IDRX-42 (GSK6042981) Versus (vs) Sunitinib in Participants With Gastrointestinal Stromal Tumors After Imatinib Therapy"; n 450; "Progression-Free Survival (PFS)"; 2030-11-29
  • NCT06032728
    "Multimodal Recurrence Scoring System for Stratifying Stage III Clear Cell Renal Cell Carcinoma of Receiving Adjuvant Treatment"; n 488; "Disease free survival"; 2033-10-01

Which 89 trials of (E)-SUNITINIB posted no result?

Posted no result
89 of 89 completed trials
Registrations
NCT00056693, NCT00092001, NCT00712504, NCT00583063, NCT00617253 and NCT00514228, and 83 more
Completion dates
oldest 2006-09; newest 2024-06-30
Show the evidence

Trial

  • NCT00056693
    2006-09
  • NCT00092001
    2007-03
  • NCT00712504
    2007-11
  • NCT00583063
    2008-04
  • NCT00617253
    2008-06-30
  • NCT00514228
    2009-02
14 further recorded trials
  • NCT00270413
    2009-03
  • NCT00361309
    2009-03
  • NCT00904657
    2009-04
  • NCT00399152
    2009-10
  • NCT00444314
    2009-10
  • NCT00378911
    2010-01
  • NCT00663559
    2010-02
  • NCT00720148
    2010-07
  • NCT00430261
    2010-10
  • NCT00437372
    2010-12
  • NCT01743300
    2010-12
  • NCT00891475
    2011-01
  • NCT00482755
    2011-01-18
  • NCT01168440
    2011-02

At the median, (E)-SUNITINIB's trials enrolled 45 people — anything larger?

Median enrolment
45
Largest enrolment
6452
Registered trials counted
387

(E)-SUNITINIB and CYP3A4: shared by which compounds?

CYP3A4 appear in (E)-SUNITINIB's recorded interaction sentences, 8 in all. DailyMed label · 43a4d7f8-48ae-4a63-9108-2fa8e3ea9d9c · 2026-02-20

CYP3A4, CYP3A4, CYP3A4; 3 shared nodes; drug_interactions, pharmacokinetics

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Interaction statement

  • drug_interactions
    • CYP3A4 Inhibitors : Consider dose reduction of SUTENT when administered with strong CYP3A4 inhibitors.
  • drug_interactions
    ( 7.1 ) • CYP3A4 Inducers : Consider dose increase of SUTENT when administered with strong CYP3A4 inducers.
  • drug_interactions
    ( 7.1 ) 7.1 Effect of Other Drugs on SUTENT Strong CYP3A4 Inhibitors Co-administration with strong CYP3A4 inhibitors may increase sunitinib plasma concentrations [see Clinical Pharmacology (12.3) ] .
  • drug_interactions
    Consider a dose reduction for SUTENT when it is co-administered with strong CYP3A4 inhibitors [see Dosage and Administration (2.5) ] .
  • drug_interactions
    Strong CYP3A4 Inducers Co-administration with strong CYP3A4 inducers may decrease sunitinib plasma concentrations [see Clinical Pharmacology (12.3) ] .
  • drug_interactions
    Consider a dose increase for SUTENT when it must be co-administered with CYP3A4 inducers [see Dosage and Administration (2.5) ] .
2 more recorded rows
  • Interaction statement pharmacokinetics
    Metabolism Sunitinib is metabolized primarily by CYP3A4 to its primary active metabolite, which is further metabolized by CYP3A4.
  • Interaction statement pharmacokinetics
    Drug Interaction Studies Clinical Studies Effect of strong CYP3A4 inhibitors on sunitinib : Co-administration of a single SUTENT dose with ketoconazole (strong CYP3A4 inhibitor) increased the combined sunitinib and its active metabolite C max and AUC 0–inf by 49% and 51%, respectively, in healthy subjects.

CYP3A4

  • FINGOLIMOD LAURYL SULFATE, ERYTHROMYCIN LACTOBIONATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Beclometasone, Rasagiline, Sofpironium
  • FINGOLIMOD LAURYL SULFATE, ERYTHROMYCIN LACTOBIONATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Beclometasone, Rasagiline, Sofpironium
  • FINGOLIMOD LAURYL SULFATE, ERYTHROMYCIN LACTOBIONATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Beclometasone, Rasagiline, Sofpironium

recorded 2026-02-20 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

PubChem CID
6456016
CAS number
1691223-83-2
InChIKey
WINHZLLDWRZWRT-SFQUDFHCSA-N
Also called
Sunitinib
Salt form
Sunitinib Malate
Trade name
Sutent, Sunitinib Accord
Component
Sunitinib
Sources (5)

Sources

  • CLINICALTRIALS_SNAPSHOT K1:AVT2TW6522 ·
  • ClinicalTrials.gov clinicaltrials.gov ·
  • drugsfda+ema drugsfda+ema ·
  • DailyMed label 43a4d7f8-48ae-4a63-9108-2fa8e3ea9d9c ·
  • Drugs@FDA K1:AVT2TW6522 ·

ClinicalTrials.gov — US Government work · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work

How these records are assembled · Which registers were checked

Index-quality checks
  • identity passed: no open identity hold
  • 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: 5 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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