Study of Lenvatinib (E7080) in Unresectable Biliary Tract Cancer (BTC) Who Failed Gemcitabine-based Combination Chemotherapy
Model scores of the 29,894 trials active now.
Model score 19% for any early termination, 4% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 22% of the time (1,598 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2019-02-27, after 2015-10-23 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 2019-02-27. 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: cancerdlbrainrequiringstage
Phrases that lowered it: participantparticipantsdrugopen labelcombination -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 1.7% (lowers risk) · Sponsor's track record
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Minimum age: 20 (lowers risk) · Who can join
-
Phase: 2 (raises risk) · Design
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Disease area, cancer: Yes (raises risk) · Disease area
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Drug's FAERS reports with a death: 27.0% (raises risk) · Drug's FDA history
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Design: single group (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 11 (raises risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Has a data monitoring committee: No (lowers risk) · Design
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Sponsor's past trials: 60 (lowers risk) · Sponsor's track record
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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: 1 (raises risk) · Design
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Maximum age: not given (raises risk) · Who can join
-
Sponsor type: industry (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
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 6 (typical: 1)
Who can join
- Minimum age
- 20 (typical: 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
- 60 (typical: 32)
- Sponsor's past termination rate
- 1.7% (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
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 248 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 241 (typical: 412.5)
- Drug's FAERS reports marked serious
- 92.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 27.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, digestive
- Drugs matched to FDA substances
- lenvatinib
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
- Lenvatinib in Patients With Previously Treated Advanced Biliary Tract Cancer NCT04656249 · started 2018 · scored riskier than 37% of active trials completed
- A Phase Ib/II Clinical Study of Camrelizumab and Apatinib Plus GP in the Treatment of Advanced Biliary Tract Cancer NCT05742750 · started 2023 · scored riskier than 99% of active trials completed
- Cabozantinib and Erlotinib for Patients With EGFR and c-Met Co-expressing Metastatic Pancreatic Adenocarcinoma NCT03213626 · started 2017 · scored riskier than 88% of active trials terminated
- Study of the Safety and Activity of Lenvatinib (E7080) in Subjects With KIF5B-RET-Positive Adenocarcinoma of the Lung NCT01877083 · started 2013 · scored riskier than 99% of active trials completed
- Trial of Ulixertinib in Combination With Hydroxychloroquine in Patients With Advanced Gastrointestinal (GI) Malignancies NCT05221320 · started 2022 · scored riskier than 96% of active trials terminated
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.