This page shows what was measured, who it was measured in, and what that does not settle.
What Topotecan does in the body
Topotecan binds to the topoisomerase I-DNA complex and prevents re-ligation of these single-strand breaks.
From the FDA-approved label: Topoisomerase I relieves torsional strain in DNA by inducing reversible single-strand breaks. The cytotoxicity of topotecan is thought to be due to double-strand DNA damage produced during DNA synthesis, when replication enzymes interact with the ternary complex formed by topotecan, topoisomerase I, and DNA. Mammalian cells cannot efficiently repair these double-strand breaks.
Why people take it. Metastatic ovarian cancer after disease progression on or after initial or subsequent chemotherapy
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 C23H23N3O5•HCl, weighing 457.9 g/mol.
US prescribing information · b23b46f5-c276-47f5-8bbd-940680b3f579 · 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 94 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.
Overall Survival
✗ The study did not show it
Who was studied
NCT00011986
How many people
4312
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
Event Free Survival (R1: MAT therapy)
✗ The study did not show it
Who was studied
NCT01704716
How many people
3300
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
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator
✗ The study did not show it
Who was studied
NCT07213804
How many people
1630
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
Progression free Survival (PFS)
✗ The study did not show it
Who was studied
NCT07218809
How many people
1100
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
Survival
✗ The study did not show it
Who was studied
NCT00102375
How many people
900
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
Objective Response Rate (ORR) Based on Blinded Independent Central Review (BICR) Assessment (Part A)
✗ The study did not show it
Who was studied
NCT06161025
How many people
860
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
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.
Topotecan hydrochloride for injection is a topoisomerase inhibitor indicated for treatment of: • Patients with metastatic ovarian cancer after disease progression on or after initial or subsequent chemotherapy, as a single agent. ( 1.1 ) • Patients with small cell lung cancer (SCLC) platinum-sensitive disease who progressed at least 60 days after initiation of first-line chemotherapy, as a single agent.
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: “Safety and effectiveness in pediatric patients have not been established.”
US prescribing information · b23b46f5-c276-47f5-8bbd-940680b3f579 · read 2026-08-30
On older people, the label states: “Of the 682 patients with lung cancer who received HYCAMTIN capsules in the four clinical trials, 33% were aged 65 years and older, while 4.8% were aged 75 years and older.”
US prescribing information · b23b46f5-c276-47f5-8bbd-940680b3f579 · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary Based on animal data and its mechanism of action, HYCAMTIN can cause fetal harm when administered to a pregnant woman.”
US prescribing information · b23b46f5-c276-47f5-8bbd-940680b3f579 · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary There are no data on the presence of topotecan or its metabolites in human milk, or their effects on the breastfed infant or milk production.”
US prescribing information · b23b46f5-c276-47f5-8bbd-940680b3f579 · read 2026-08-30
On people with reduced kidney function, the label states: “No dosage adjustment is recommended for patients with creatinine clearance (CLcr) greater than or equal to 50 mL/min.”
US prescribing information · b23b46f5-c276-47f5-8bbd-940680b3f579 · 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, capsule, solution, injection, given by the injection, oral, 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
11 products list this as an active ingredient in the United States drug directory. 11 of them contain it and nothing else.
FDA National Drug Code directory · 61187-001 · read 2026-08-29
They are sold as capsule, injection, injection, powder, lyophilized, for solution, injection, solution, concentrate and powder, taken intravenous and oral.
FDA National Drug Code directory · 61187-001 · 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 · 61187-001 · read 2026-08-29
7 published labels name it as an active ingredient. 7 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · b23b46f5-c276-47f5-8bbd-940680b3f579 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · b23b46f5-c276-47f5-8bbd-940680b3f579 · read 2026-08-29
HYCAMTIN is oral at 3 DOSAGE FORMS AND STRENGTHS Capsules • 0.25 mg: opaque white to yellowish-white and imprinted with HYCAMTIN and 0.25 mg. • 1 mg: opaque pink and imprinted with HYCAMTIN and 1 mg., recorded as fda label in effect 2023-09-18 in the United States.
US prescribing information · b23b46f5-c276-47f5-8bbd-940680b3f579 · 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 Topotecan 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 Topotecan 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.
◇Read from sources, not yet reviewed
No traced study record is stored for this substance.
Built from stored sources by fixed rules. No reviewer has signed it off.
How many documents were read
7 documents were read for this substance.
RNAWiki source record
6 of them state the same proteinBinding, and they agree.
RNAWiki source record
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
18 approved applications cover products containing this substance. The earliest was NDA020671, approved 19960528 to SANDOZ.
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 Topotecan label: indicated for what?
"Topotecan Injection is indicated for the treatment of: small cell lung cancer sensitive disease after failure of first-line chemotherapy. In clinical studies submitted to support approval, sensitive disease was defined as disease responding to chemotherapy but subsequently progressing at least 60 days (in the Phase 3…": indications and usage on Topotecan's label. DailyMed label · 7636bc1e-77b6-46ad-9df0-c8bb1c5e503f · 2025-12-17
Q3
382 registered trials of Topotecan — at which phases?
Registered studies posting no result
292 of 382
382 registered studies of Topotecan: 181 phase2, 142 phase1, 81 phase3, 7 na, 6 early phase1, 5 na or unstated, 2 phase4. CLINICALTRIALS_SNAPSHOT · 2026-09-01
"Study enrollment did not meet expected goals"; 52 of 382 registered studies
Show the evidence
Trial
NCT00003194
terminated; "Study enrollment did not meet expected goals"
NCT00005612
terminated; "Low accrual"
NCT00006032
terminated; "low accrual"
NCT00006374
withdrawn; "Slow accrual"
NCT00014443
terminated; "Poor enrollment"
NCT00084565
withdrawn; "Study was never activated at Fox Chase Cancer Center."
14 further recorded trials
NCT00087048
terminated; "Slow accrual"
NCT00107471
terminated; "The unpromising experience of the French group with topotecan given at a dosage of 0.4 mg/m2/day over 30 mins w/in 1 hr of radiation (Cancer 2005; 104: 2792)."
NCT00109798
withdrawn; "Sub-Investigator reloacted to another institution"
NCT00112619
terminated; "Slow accrual and company withdrawing support to supply the drug"
NCT00287859
terminated; "Withdrawn due to low accrual"
NCT00315211
terminated; "Slow Accrual"
NCT00322920
terminated; "Low accrual"
NCT00334867
withdrawn; "withdrawn"
NCT00389766
withdrawn; "Withdrawn because protocol has been discontinued. It was never opened."
NCT00437073
terminated; "Lapatinib-topotecan arm enrollment closed early per protocol amendment 2. Then enrollment into remaining arm terminated due to operational issues."
NCT00526799
terminated; "Study closed to accrual due unfavorable interim analysis"
NCT00720096
terminated; "Funds for this project have been spent, and it is thereby terminated."
NCT00808899
terminated; "Voluntarily closed and terminated by the PI due to lack of feasibility"
NCT00888810
terminated; "lack of efficacy (intermediate analysis)"
recorded 2026-09-01 · last checked 2026-09-04
Q5
Human studies of Topotecan used B1: AMG 386 10 mg/kg + Topotecan — over how long?
studies of Topotecan used the recorded amount. ClinicalTrials.gov · 2026-09-01
2 recorded entries; human; also "B1: AMG 386 10 mg/kg + Topotecan", "B3: AMG 386 15mg/kg + Topotecan"
Show the evidence
human
NCT00770536
B1: AMG 386 10 mg/kg + Topotecan
NCT00770536
B3: AMG 386 15mg/kg + Topotecan
recorded 2026-09-01 · last checked 2026-09-04
Q6
Topotecan's half-life is 2 to 3 hours — which schedules were studied?
2 to 3 hours; Topotecan exhibits multiexponential pharmacokinetics with a terminal half-life of 2 to 3 hours.
metabolismpharmacokinetics
Metabolism: Topotecan undergoes a reversible pH dependent hydrolysis of its lactone moiety; it is the lactone form that is pharmacologically active.
recorded 2025-12-17 · last checked 2026-09-04
Q7
Which running trial of Topotecan could settle lifespan?
NCT03709680 measures Phase 2 open-label, randomized: Event-free survival (EFS) based on Investigator assessment., reading out 2025-10-18.
36 open trials; n 128; "Study Of Palbociclib Combined With Chemotherapy In Pediatric Patients With Recurrent/Refractory Solid Tumors"
Show the evidence
Trial
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
NCT06500026
"A Study Comparing BL-B01D1 With Topotecan in Patients With Recurrent Small Cell Lung Cancer(PANKU-Lung03)"; n 722; "Overall survival (OS)"; 2026-12
NCT06394492
"SHR-A1921 for Injection in Patients With Platinum-Resistant Recurrent Epithelial Ovarian Cancer"; n 440; "Progression-free Survival (PFS) assessed by Blinded Independ Review Committee (BIRC) as per RECIST 1.1"; 2026-12-31
NCT02502266
"Testing the Combination of Cediranib and Olaparib in Comparison to Each Drug Alone or Other Chemotherapy in Recurrent Platinum-Resistant Ovarian Cancer"; n 582; "Progression-free Survival (PFS) (Phase II Only)"; 2027-03-04
NCT03896503
"Randomized Trial of Topotecan With M6620, an ATR Kinase Inhibitor, in Small Cell Lung Cancers and Small Cell Cancers Outside of the Lungs"; n 104; "Progression-free Survival (PFS) Reported With 80% Confidence Interval"; 2027-05-13
NCT06498479
"ARTEMIS-008：HS-20093 Compared With Topotecan in Subjects With Relapsed Small Cell Lung Cancer"; n 460; "Overall survival"; 2027-05-31
14 further recorded trials
NCT04739800
"Comparison of Standard of Care Treatment With a Triplet Combination of Targeted Immunotherapeutic Agents"; n 120; "Progression Free Survival"; 2027-06-25
NCT04322318
"A Study of Combination Chemotherapy for Patients With Newly Diagnosed DAWT and Relapsed FHWT"; n 256; "Event-free survival (EFS) for stratum 1-3"; 2027-07-01
NCT05303727
"Allogeneic Hematopoietic Stem Cell Transplantation for 4/M Neuroblastoma"; n 64; "overall survival(OS) at 3 year"; 2027-08
NCT05874401
"Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan"; n 302; "Overall survival (OS)"; 2027-10-30
NCT06751485
"JSKN003 in Platinum-Resistant, Relapsed Epithelial Ovarian Cancer"; n 430; "Progression-free Survival (PFS) assessed by Blinded Independent Review Committee (BIRC) as per RECIST 1.1"; 2027-12-30
NCT05740566
"Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer"; n 509; "Overall Survival (OS)"; 2028-03-26
NCT06954246
"A Study of MHB088C Injection Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer"; n 450; "Overall Survival"; 2028-04
NCT06581380
"JK-1201I Compared with Topotecan in Patients with Relapsed Extensive Stage Small Cell Lung Cancer"; n 394; "Overall survival (OS)"; 2028-04-16
NCT06619236
"Study to Assess the Efficacy of Rina-S Compared to Treatment of Investigator's Choice in Participants With Platinum Resistant Ovarian Cancer"; n 530; "Progression-Free Survival (PFS)"; 2028-05-23
NCT06496048
"Lurbinectedin or in Combination with Irinotecan Versus Topotecan in Patients with Relapsed SCLC"; n 180; "Overall survival (OS)"; 2028-06-30
NCT06128837
"Study of LY01610 in Patients With Recurrent Small Cell Lung Cancer"; n 686; "Overall survival (OS)"; 2028-10
NCT07106528
"Organoid-guided vs Topotecan Therapy in Relapsed Extensive-Stage Small Cell Lung Cancer"; n 128; "Progression-Free Survival (PFS)"; 2028-12
NCT07189455
"Study Comparing ZG006 With Investigator-Selected Chemotherapy in Participants With Relapsed Small Cell Lung Cancer"; n 420; "Overall Survival (OS)"; 2028-12
NCT07545460
"A Study Comparing BL-M07D1 With Physician's Choice of Chemotherapy in Patients With HER2-Expressing Platinum-Resistant Recurrent Epithelial Ovarian Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer"; n 404; "Progression-free survival (PFS)"; 2028-12
Q8
Which 133 trials of Topotecan posted no result?
Posted no result
133 of 133 completed trials
Registrations
NCT00003340, NCT00003198, NCT00002625, NCT00004979, NCT00001333 and NCT00002587, and 127 more
Completion dates
oldest 2000-02; newest 2023-12-30
Show the evidence
Trial
NCT00003340
2000-02
NCT00003198
2000-05
NCT00002625
2000-09
NCT00004979
2000-09
NCT00001333
2000-12
NCT00002587
2000-12
14 further recorded trials
NCT00002588
2001-01
NCT00003297
2001-01
NCT00100477
2001-06
NCT00003917
2001-11
NCT00002814
2001-12
NCT00001335
2002-01
NCT00002950
2002-02-10
NCT00003415
2002-11
NCT00041015
2002-11
NCT00003943
2003-02
NCT00003944
2003-02
NCT00005593
2003-03
NCT00005021
2003-05
NCT00003065
2004-02
Q9
At the median, Topotecan's trials enrolled 41 people — anything larger?
Median enrolment
41
Largest enrolment
4312
Registered trials counted
357
Q10
What do 1936 spontaneous reports say about Topotecan — 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.
Topotecan appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 1936 reaction mentions were counted: anaemia 305; febrile neutropenia 216; nausea 207; neutropenia 207. FAERS via Open Targets · CHEMBL1607 · 2026-06-24
Show the evidence
anaemia
305
febrile neutropenia
216
nausea
207
neutropenia
207
thrombocytopenia
195
white blood cell count decreased
176
4 more recorded rows
pyrexia
164
platelet count decreased
162
vomiting
161
neutrophil count decreased
143
recorded 2026-06-24 · last checked 2026-09-04
Q11
Which 10 reactions does Topotecan's label not list?
In vitro inhibition studies using marker substrates known to be metabolized by human P450 CYP1A2, CYP2A6, CYP2C8/9, CYP2C19, CYP2D6, CYP2E, CYP3A, or CYP4A or dihydropyrimidine dehydrogenase indicate that the activities of these enzymes were not altered by topotecan.
clinical_pharmacology
In vitro inhibition studies using marker substrates known to be metabolized by human P450 CYP1A2, CYP2A6, CYP2C8/9, CYP2C19, CYP2D6, CYP2E, CYP3A, or CYP4A or dihydropyrimidine dehydrogenase indicate that the activities of these enzymes were not altered by topotecan.
ChEMBL 37 — CC BY-SA 3.0 Unported · 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
✓ 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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