Dose Escalation Study of ALX-009 in Healthy Men and Cystic Fibrosis (CF) and Non-CF Bronchiectasis Patients
Model scores of the 29,894 trials active now.
Model score 5% 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 6% of the time (355 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2021-12-31, after 2015-11-30 start.
Reason given by the sponsor: “business”
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 2021-12-31. 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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Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: ascendingsubjectsafety tolerabilitypatienttolerability and
Phrases that lowered it: healthydrugfev1evaluate thevolunteers -
Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
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Phase: 1 (lowers risk) · Design
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Design: parallel (raises risk) · Design
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Number of arms: 4 (lowers risk) · Design
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Drug's FAERS reports with a death: 0% (lowers risk) · Drug's FDA history
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Blinding: double (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Has a data monitoring committee: No (lowers risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Sponsor's past trials: 0 (lowers risk) · Sponsor's track record
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Maximum age: 50 (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
- 4 (typical: 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
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 50 (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
- 0 (typical: 32)
- Sponsor's past termination rate
- no earlier finished trials (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 0 (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
- 13 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 6 (typical: 412.5)
- Drug's FAERS reports marked serious
- 84.6% (typical: 85.6%)
- Drug's FAERS reports with a death
- 0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- respiratory, digestive
- Drugs matched to FDA substances
- lactoferrin
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
- Study to Assess CSL787 in Non-cystic Fibrosis Bronchiectasis (NCFB) NCT04643587 · started 2020 · scored riskier than 11% of active trials completed
- A Study in Patients With Non-cystic Fibrosis Bronchiectasis to Test How Well Different Doses of BI 1323495 Are Tolerated and How BI 1323495 Affects Biomarkers of Inflammation NCT04656275 · started 2021 · scored riskier than 14% of active trials terminated
- A Phase IIb Study of OligoG in Subjects With Cystic Fibrosis NCT02157922 · started 2014 · scored riskier than 10% of active trials completed
- 28 Day Repeat Dose in Cystic Fibrosis Patients NCT00903201 · started 2009 · scored riskier than 27% of active trials completed
- A Study of OligoG in Cystic Fibrosis Subjects With Burkholderia Spp. Infection NCT02453789 · started 2015 · scored riskier than 7% 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.