Phase I/II Study of LDE225 With Gemcitabine and Nab-paclitaxel in Patients With Pancreatic Cancer
Model scores of the 29,894 trials active now.
Model score 16% for any early termination, 6% 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 (851 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2019-01-31, after 2015-09-30 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 2019-01-31. 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: cancerchronicsmallpaclitaxelprior
Phrases that lowered it: patients whopatients withfemaledrugshypertension -
Sponsor's past termination rate: 3.3% (lowers risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 1/2 (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 37 (lowers risk) · Sponsor's track record
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Disease area, cancer: Yes (raises risk) · Disease area
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Drug's FAERS reports with a death: 26.1% (raises risk) · Drug's FDA history
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Design: single group (raises risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Collaborators: 2 (lowers risk) · Design
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Responsible party: principal investigator (lowers risk) · Design
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Drug's FAERS reports marked serious: 96.3% (raises risk) · Drug's FDA history
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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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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Maximum age: not given (raises risk) · Who can join
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Number of arms: 1 (raises risk) · Design
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Sponsor's past trials: 30 (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
- 1/2 (typical: 2)
- Number of arms
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 2 (typical: 0)
- Keywords listed
- 4 (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
- 30 (typical: 32)
- Sponsor's past termination rate
- 3.3% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 37 (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
- 35100 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 8489 (typical: 412.5)
- Drug's FAERS reports marked serious
- 96.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 26.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, digestive, endocrine
- Drugs matched to FDA substances
- gemcitabine, 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
- VEGFR/PDGFR Dual Kinase Inhibitor X-82 and Everolimus for Treating Patients With Pancreatic Neuroendocrine Tumors NCT01784861 · started 2013 · scored riskier than 95% of active trials terminated
- Chemotherapy and Pembrolizumab, Followed by Pembrolizumab and Olaparib As Firstline Therapy in Her-2 Negative Gastric/GEJ Adenocarcinoma NCT05268510 · started 2022 · scored riskier than 67% of active trials completed
- Trametinib and Hydroxychloroquine in Treating Patients With Pancreatic Cancer NCT03825289 · started 2019 · scored riskier than 69% of active trials terminated
- LEE011 Plus Everolimus in Patients With Metastatic Pancreatic Adenocarcinoma Refractory to Chemotherapy NCT02985125 · started 2017 · scored riskier than 93% of active trials completed
- LDE225 and Paclitaxel in Solid Tumors NCT01954355 · started 2013 · scored riskier than 22% 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.