A Trial of Lenvatinib (E7080) in Subjects With Iodine-131 Refractory Differentiated Thyroid Cancer to Evaluate Whether an Oral Starting Dose of 18 Milligram (mg) Daily Will Provide Comparable Efficacy to a 24 mg Starting Dose, But Have a Better Safety Profile
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 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 2020-09-10, after 2017-06-08 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 2020-09-10. 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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Accepts healthy volunteers: No (raises risk) · Who can join
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: cancernodeheartlymphsurgery
Phrases that lowered it: participantsparticipantmgmeasurableweeks -
Phase: 2 (raises risk) · Design
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Sponsor's past termination rate: 10.0% (raises risk) · Sponsor's track record
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Design: parallel (raises risk) · Design
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Disease area, cancer: Yes (raises risk) · Disease area
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Trials the sponsor started in the prior 2 years: 25 (lowers risk) · Sponsor's track record
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Sponsor's past trials: 219 (lowers risk) · Sponsor's track record
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Drug's FAERS reports with a death: 23.2% (raises risk) · Drug's FDA history
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Blinding: double (raises risk) · Design
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Has a data monitoring committee: No (lowers risk) · Design
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Collaborators: 1 (raises risk) · Design
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Drug's FAERS reports marked serious: 86.3% (lowers risk) · Drug's FDA history
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
- double (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 6 (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
- 219 (typical: 32)
- Sponsor's past termination rate
- 10.0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 25 (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
- 1550 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 916 (typical: 412.5)
- Drug's FAERS reports marked serious
- 86.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 23.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, endocrine
- 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
- A Trial of Lenvatinib (E7080) in Radioiodine (131 I)-Refractory Differentiated Thyroid Cancer in China NCT02966093 · started 2017 · scored riskier than 32% of active trials completed
- A Phase 2 Trial of Lenvatinib for the Treatment of Anaplastic Thyroid Cancer (ATC) NCT02657369 · started 2016 · scored riskier than 64% of active trials terminated
- Lenvatinib in Locally Advanced Invasive Thyroid Cancer NCT04321954 · started 2021 · scored riskier than 87% of active trials completed
- Efficacy of MEK (Trametinib) and BRAFV600E (Dabrafenib) Inhibitors With Radioactive Iodine (RAI) for the Treatment of Refractory Metastatic Differentiated Thyroid Cancer NCT03244956 · started 2017 · scored riskier than 90% of active trials completed
- Adaptive Tyrosine Kinase Inhibitor (TKI) Therapy In Patients With Thyroid Cancer NCT03630120 · started 2018 · scored riskier than 57% 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.