A Study To Taste Three New Types Of Crizotinib Formulation In Comparison Of An Oral Solution And To Measure The Amount Of Crizotinib In The Body After These Formulations Are Orally Given, Relative To Capsule Formulation
Model scores of the 29,894 trials active now.
Model score 3% 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 2014-03-31, after 2013-12-31 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 2014-03-31. 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) (lowers risk) · Wording
Phrases that raised it: childbearing potentialdefineddiseaselimitedpotential must
Phrases that lowered it: healthyallergiesbioavailabilityblood pressurevolunteers -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Sponsor's past termination rate: 15.9% (raises risk) · Sponsor's track record
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Design: crossover (lowers risk) · Design
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Phase: 1 (lowers risk) · Design
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Drug's FAERS reports with a death: 32.8% (raises risk) · Drug's FDA history
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Sponsor's past trials: 1320 (raises risk) · Sponsor's track record
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Primary purpose: basic science (raises 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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Has a data monitoring committee: No (lowers risk) · Design
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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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Maximum age: 55 (lowers risk) · Who can join
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Disease area, neurology: No (lowers risk) · Disease area
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Drug's FAERS reports before start: 1909 (raises risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 221 (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 (typical: 2)
- Number of arms
- 2
- Allocation
- not given (typical: randomized)
- Design
- crossover (typical: parallel)
- Primary purpose
- basic science (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 3 (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
- 1320 (typical: 32)
- Sponsor's past termination rate
- 15.9% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 221 (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
- 1909 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1076 (typical: 412.5)
- Drug's FAERS reports marked serious
- 64.6% (typical: 85.6%)
- Drug's FAERS reports with a death
- 32.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- crizotinib
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 Study To Investigate The Taste Of Crizotinib Liquid In Trained Healthy Adult Volunteers NCT01125904 · started 2010 · scored riskier than 4% 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
- Relative Bioavailability Of A Crizotinib Oral Liquid Formulation To Crizotinib Formulated Capsule NCT01297595 · started 2011 · scored riskier than 3% of active trials completed
- Bioequivalence And Food Effect Study Comparing The Commercial Formulation Of Crizotinib To Its Clinical Study Formulations And Commercial Formulation With Or Without Food In Healthy Volunteers NCT01154218 · started 2010 · scored riskier than 0% of active trials completed
- Assessment of Relative Bioavailability of NKTR-118 in Three Formulations in Healthy Subjects NCT01365000 · started 2011 · scored riskier than 2% 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.