Effect of a Proton Pump Inhibitor on the PK of Tepotinib
Model scores of the 29,894 trials active now.
Model score 2% for any early termination, 0% 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 (1,938 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2018-07-02, after 2018-05-14 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 2018-07-02. 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) (lowers risk) · Wording
Phrases that raised it: cancercellpriorsmallii
Phrases that lowered it: healthysingle dosecrossoveradministrationpharmacokinetics -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Design: crossover (lowers risk) · Design
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Sponsor's past termination rate: 12.5% (raises risk) · Sponsor's track record
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Primary purpose: other (lowers risk) · Design
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Phase: 1 (lowers risk) · Design
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Has a data monitoring committee: not given (lowers 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: 9.2% (lowers risk) · Drug's FDA history
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Drug's FAERS reports in the prior 12 months: 41403 (raises risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 16 (lowers risk) · Sponsor's track record
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Maximum age: 55 (lowers risk) · Who can join
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Drug's FAERS reports marked serious: 71.0% (lowers risk) · Drug's FDA history
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Blinding: none (lowers risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Disease area, respiratory: Yes (raises risk) · Disease area
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Number of arms: 6 (lowers risk) · Design
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Disease area, psychiatry: No (lowers risk) · Disease area
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Disease area, neurology: No (lowers risk) · Disease area
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 (typical: 2)
- Number of arms
- 6 (typical: 2)
- Allocation
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- other (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 5 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 55 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 144 (typical: 32)
- Sponsor's past termination rate
- 12.5% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 16 (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
- 233931 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 41403 (typical: 412.5)
- Drug's FAERS reports marked serious
- 71.0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 9.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, respiratory
- Drugs matched to FDA substances
- omeprazole, tepotinib
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
- Bioequivalence of 5 Tablets of 100 mg Versus 2 Tablets of 250 mg TF3 of Tepotinib NCT04204902 · started 2019 · scored riskier than 0% of active trials completed
- Bioequivalence of TF3 and TF2 and Effect of Food on the PK of Tepotinib NCT03629223 · started 2018 · scored riskier than 0% of active trials completed
- Effect of Tepotinib on PK of CYP3A Substrate Midazolam NCT03628339 · started 2018 · scored riskier than 1% of active trials completed
- A Trial to Evaluate the Effect of the Proton Pump Inhibitor Esomeprazole on the Single-dose Pharmacokinetics (PK) of Oral TAK-906 in Healthy Adult Participants NCT03849690 · started 2019 · scored riskier than 2% of active trials completed
- Effect of Tepotinib on the PK of the P-gp Substrate Dabigatran Etexilate NCT03492437 · started 2018 · scored riskier than 1% 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.