A Study to Assess the Effectiveness and Safety of Irinotecan Liposome Injection, 5-fluorouracil/Leucovorin Plus Oxaliplatin in Patients Not Previously Treated for Metastatic Pancreatic Cancer, Compared to Nab-paclitaxel+Gemcitabine Treatment
Model scores of the 29,894 trials active now.
Model score 22% 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 10% of the time (1,463 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2025-02-18, after 2020-02-11 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 2025-02-18. 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: metastaticchemotherapypriorcancerct
Phrases that lowered it: efficacy andand safetyopen labelsafety ofthe efficacy -
Sponsor's past termination rate: 22.0% (raises risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 3 (lowers risk) · Design
-
Design: parallel (raises risk) · Design
-
Drug's FAERS reports with a death: 19.3% (lowers risk) · Drug's FDA history
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Drug's FAERS reports marked serious: 94.5% (raises risk) · Drug's FDA history
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Minimum age: 18 (raises risk) · Who can join
-
Drug's FAERS reports before start: 239953 (lowers risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 11 (raises risk) · Sponsor's track record
-
Drug's FAERS reports in the prior 12 months: 36537 (lowers risk) · Drug's FDA history
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Has a data monitoring committee: No (lowers risk) · Design
-
Maximum age: not given (raises risk) · Who can join
-
Collaborators: 0 (raises risk) · Design
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
- 3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (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
- industry (typical: academic or other)
- Sponsor's past trials
- 123 (typical: 32)
- Sponsor's past termination rate
- 22.0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 11 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 7 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 239953 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 36537 (typical: 412.5)
- Drug's FAERS reports marked serious
- 94.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 19.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- fluorouracil, gemcitabine, irinotecan, irinotecan sucrosofate, leucovorin, oxaliplatin, paclitaxel
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
- Phase 2 Study of Irinotecan Liposome Injection, Oxaliplatin, 5-fluorouracil/Levoleucovorin in Japanese Participants Not Previously Treated for Metastatic Adenocarcinoma of the Pancreas NCT06225999 · started 2024 · scored riskier than 90% of active trials completed
- Study of Nanoliposomal Irinotecan (Nal-IRI)-Containing Regimens Versus Nab-paclitaxel Plus Gemcitabine in Patients With Previously Untreated, Metastatic Pancreatic Adenocarcinoma NCT02551991 · started 2015 · scored riskier than 95% of active trials completed
- A Study of Irinotecan Liposome in Advanced Pancreatic Cancer NCT04796948 · started 2021 · scored riskier than 28% of active trials completed
- Irinotecan Liposome in Combination With 5-FU/LV Versus 5-FU/LV in Second-line Therapy for Gemcitabine-Refractory Pancreatic Cancer NCT05074589 · started 2018 · scored riskier than 47% of active trials completed
- Oxaliplatin Combined With Irinotecan Liposome Injection II Through Hepatic Artery Infusion (HAIC) Followed by 5-FU/LV (HAIC) or Tegorgor Oral Combination Therapy for Hepatic Metastasis of Pancreatic Cancer NCT06538623 · started 2024 · scored riskier than 80% 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.