Estimation Of Effect Of Ketoconazole On Pharmacokinetics Of Crizotinib In Healthy Volunteers
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 5% of the time (4,470 trials).
Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Completed on 2010-09-30, after 2010-07-31 start.
The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
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 2010-09-30. 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: multipledosespfdaysevidence
Phrases that lowered it: healthysingle dosekgbodyvolunteers -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Design: crossover (lowers risk) · Design
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Sponsor's past termination rate: 14.9% (raises risk) · Sponsor's track record
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Primary purpose: not given (lowers risk) · Design
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Phase: 1 (lowers risk) · Design
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Trials the sponsor started in the prior 2 years: 388 (raises risk) · Sponsor's track record
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Sponsor's past trials: 760 (raises risk) · Sponsor's track record
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Has a data monitoring committee: No (lowers risk) · Design
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Blinding: none (lowers risk) · Design
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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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Drug's FAERS reports with a death: 13.5% (lowers risk) · Drug's FDA history
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Minimum age: 18 (raises risk) · Who can join
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Disease area, neurology: No (lowers risk) · Disease area
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Maximum age: 55 (lowers risk) · Who can join
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
- 1 (typical: 2)
- Allocation
- non randomized (typical: randomized)
- Design
- crossover (typical: parallel)
- Primary purpose
- not given (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- No (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
- 760 (typical: 32)
- Sponsor's past termination rate
- 14.9% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 388 (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
- 1012 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 208 (typical: 412.5)
- Drug's FAERS reports marked serious
- 90.4% (typical: 85.6%)
- Drug's FAERS reports with a death
- 13.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- crizotinib, ketoconazole
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
- Estimation Of Effect Of Rifampin On Pharmacokinetics Of Crizotinib In Healthy Volunteers NCT01147055 · started 2010 · scored riskier than 1% of active trials completed
- A Phase 1 Absolute Bioavailability Study For Oral Crizotinib In Healthy Volunteers NCT01168934 · started 2010 · scored riskier than 3% of active trials completed
- Study to Compare the Safety and Pharmacokinetics of PK101 With Coadministration of the Two Separate Drugs NCT03876210 · started 2019 · scored riskier than 0% of active trials completed
- A Study of The Effects of Multiple Doses of Ketoconazole on Single Dose Pharmacokinetics of RO4602522 in Healthy Male Volunteers NCT01625806 · started 2012 · scored riskier than 1% of active trials completed
- Relative Bioavailability Of A Crizotinib Oral Liquid Formulation To Crizotinib Formulated Capsule NCT01297595 · started 2011 · scored riskier than 3% 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.