A Study to Assess the Pharmacokinetics of Enasidenib (CC-90007) in Subjects With Moderate and Severe Hepatic Impairment.
Model scores of the 29,894 trials active now.
Model score 11% for any early termination, 1% 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 in 2015 or later: the model never saw it during training.
How it ended
Completed on 2018-10-26, after 2017-09-21 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 2018-10-26. 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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Sponsor's past termination rate: 16.3% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: subjects withimpairmentin subjectskeyimaging
Phrases that lowered it: has historyhealthypharmacokineticsfemaleat screening -
Phase: 1 (lowers risk) · Design
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Design: single group (raises risk) · Design
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Minimum age: 40 (lowers risk) · Who can join
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Trials the sponsor started in the prior 2 years: 43 (lowers risk) · Sponsor's track record
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Has a data monitoring committee: No (lowers risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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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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Sponsor's past trials: 141 (lowers risk) · Sponsor's track record
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Blinding: none (lowers risk) · Design
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Drug's FAERS reports before start: 10 (lowers risk) · Drug's FDA history
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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
- 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
- 5 (typical: 1)
Who can join
- Minimum age
- 40 (typical: 18)
- Maximum age
- 65 (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
- 141 (typical: 32)
- Sponsor's past termination rate
- 16.3% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 43 (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
- 10 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 10 (typical: 412.5)
- Drug's FAERS reports marked serious
- 90% (typical: 85.6%)
- Drug's FAERS reports with a death
- 20% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- enasidenib
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
- Pharmacokinetics of Enasidenib (CC-90007) in Participants With Mild, Moderate and Severe Hepatic Impairment NCT04573582 · started 2020 · scored riskier than 14% of active trials completed
- Evaluate the Pharmacokinetics of CC-220 in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared With Healthy Subjects NCT03824678 · started 2019 · scored riskier than 4% of active trials completed
- A Pharmacokinetics and Tolerability Study of Fedratinib in Subjects With Moderate and Severe Hepatic Impairment NCT03983161 · started 2019 · scored riskier than 6% of active trials completed
- Study to Evaluate Pharmacokinetics of Pomalidomide in Hepatically Impaired Males NCT01835561 · started 2013 · scored riskier than 3% of active trials completed
- Study to Evaluate the Pharmacokinetics and Safety of GSK2336805 in Subjects With Hepatic Impairment and Healthy Matched Control Subjects NCT01827657 · started 2013 · scored riskier than 12% 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.