Irinotecan, Gemcitabine, Chemotherapy for Biliary Tract Cancer
Model scores of the 29,894 trials active now.
Model score 17% for any early termination, 5% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 26% of the time (3,728 trials).
Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Completed on 2010-03-31, after 2008-06-30 start.
The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2010-03-31. The rest of the way to 100% is still running.
From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.
What moved the score
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: cancerchemotherapylimitgemcitabinebiliary
Phrases that lowered it: the studyoldin patientscriteriaupper normal -
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 2 (raises risk) · Design
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Disease area, cancer: Yes (raises risk) · Disease area
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Has a data monitoring committee: not given (lowers risk) · Design
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Trials the sponsor started in the prior 2 years: 26 (lowers risk) · Sponsor's track record
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Maximum age: 75 (lowers risk) · Who can join
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Primary purpose: treatment (raises risk) · Design
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Responsible party: not given (raises risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Blinding: not given (lowers risk) · Design
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Number of arms: 1 (raises risk) · Design
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Design: not given (raises risk) · Design
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Drug's FAERS reports with a death: 19.9% (lowers risk) · Drug's FDA history
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Sponsor's past trials: 4 (raises risk) · Sponsor's track record
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Minimum age: 17 (raises risk) · Who can join
Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.
The trial
Design
- Phase
- 2
- Number of arms
- 1 (typical: 2)
- Allocation
- not given (typical: randomized)
- Design
- not given (typical: parallel)
- Primary purpose
- treatment
- Blinding
- not given (typical: none)
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- not given (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 1
Who can join
- Minimum age
- 17 (typical: 18)
- Maximum age
- 75 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 4 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 26 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 6097 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1377 (typical: 412.5)
- Drug's FAERS reports marked serious
- 90.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 19.9% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, digestive
- Drugs matched to FDA substances
- gemcitabine, irinotecan
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- Second-line Irinotecan and Capecitabine Versus Irinotecan for Gemcitabine and Cisplatin Refractory Biliary Tract Cancer NCT02558959 · started 2015 · scored riskier than 29% of active trials completed
- Phase II Study of Gemcitabine and TS-1 in Biliary Trat Cancer NCT01171755 · started 2008 · scored riskier than 64% of active trials terminated
- Study of Gemcitabine, Irinotecan and Panitumumab in Patients With Advanced and Metastatic Biliary Tract Adenocarcinoma NCT00948935 · started 2009 · scored riskier than 85% of active trials completed
- A Study of S-1 in Combination With Gemcitabine as First-Line Treatment in Patients With Advanced Biliary Tract Cancer NCT02425137 · started 2015 · scored riskier than 50% of active trials completed
- GEM/Cisplatin/S-1 vs GEM/Cisplatin for Biliary Tract Cancer NCT02182778 · started 2014 · scored riskier than 21% of active trials completed
Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.