Nal-IRI and 5-FU Compared to 5-FU in Patients With Cholangio- and Gallbladder Carcinoma Previously Treated With Gemcitabine-based Therapies
Model scores of the 29,894 trials active now.
Model score 24% for any early termination, 14% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 16% of the time (1,198 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2022-03-08, after 2017-10-24 start.
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
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 2022-03-08. 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: patientsubjectpriorbreastpatients
Phrases that lowered it: accordingdays before20diseasesclinical -
Sponsor's past termination rate: 30% (raises risk) · Sponsor's track record
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Phase: 2 (raises risk) · Design
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Accepts healthy volunteers: No (raises risk) · Who can join
-
Design: parallel (raises risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports with a death: 18.4% (lowers risk) · Drug's FDA history
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports in the prior 12 months: 8653 (lowers risk) · Drug's FDA history
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Drug's FAERS reports marked serious: 92.3% (raises risk) · Drug's FDA history
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Number of arms: 2 (raises risk) · Design
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Collaborators: 1 (raises risk) · Design
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Drugs with FDA adverse-event history: 3 (lowers risk) · Drug's FDA history
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Maximum age: not given (raises risk) · Who can join
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Sponsor's past trials: 10 (lowers risk) · Sponsor's track record
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
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 2 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 10 (typical: 32)
- Sponsor's past termination rate
- 30% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 14 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 3 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 59780 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 8653 (typical: 412.5)
- Drug's FAERS reports marked serious
- 92.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 18.4% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- fluorouracil, irinotecan sucrosofate, leucovorin
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
- Nal-IRI With 5-fluorouracil (5-FU) and Leucovorin or Gemcitabine Plus Cisplatin in Advanced Biliary-tract Cancer NCT03044587 · started 2018 · scored riskier than 82% of active trials completed
- 2nd-line Therapy With Nal-IRI After Gem/Nab-pac in Advanced Pancreatic Cancer - Predictive Role of 1st-line Therapy NCT03468335 · started 2018 · scored riskier than 82% of active trials completed
- Regorafenib Plus Gemcitabine in Metastatic Pancreatic Cancer NCT02383433 · started 2016 · scored riskier than 86% of active trials terminated
- A Study of Napabucasin (BBI-608) in Combination With FOLFIRI in Adult Patients With Previously Treated Metastatic Colorectal Cancer NCT02753127 · started 2016 · scored riskier than 27% of active trials completed
- Liposomal Irinotecan in Combination With Oxaliplatin, Leucovorin, and 5-fluorouracil for Patients With Locally Advanced Pancreatic Carcinoma: NCT03861702 · started 2020 · scored riskier than 99% 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.