Phase I Dose Escalation and Expansion of Oral BAY 1143269 in Combination With Intravenous Docetaxel
Model scores of the 29,894 trials active now.
Model score 12% 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 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
Terminated on 2017-04-24, after 2015-06-15 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 2017-04-24. 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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Phase: 1 (lowers risk) · Design
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Accepts healthy volunteers: No (raises risk) · Who can join
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: subjectsfirst dosecancerdose ofof study
Phrases that lowered it: cell lungnon smallsmall celllung cancerhave history -
Sponsor's past termination rate: 5.8% (lowers risk) · Sponsor's track record
-
Trials the sponsor started in the prior 2 years: 122 (lowers risk) · Sponsor's track record
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Has a data monitoring committee: Yes (raises risk) · Design
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Disease area, cancer: Yes (raises risk) · Disease area
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
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Number of arms: 4 (lowers risk) · Design
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Design: sequential (lowers risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
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Maximum age: not given (raises 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
- non randomized (typical: randomized)
- Design
- sequential (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 5 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (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
- 566 (typical: 32)
- Sponsor's past termination rate
- 5.8% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 122 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 0 (typical: 1)
- Drug has FAERS history
- No (typical: 64% yes)
- Drug's FAERS reports before start
- 0 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 0 (typical: 412.5)
- Drug's FAERS reports marked serious
- no FAERS history (typical: 85.6%)
- Drug's FAERS reports with a death
- no FAERS history (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, respiratory
- Drugs matched to FDA substances
- none matched
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
- Phase I Dose Escalation Study With an Allosteric AKT 1/2 Inhibitor in Patients NCT01915576 · started 2013 · scored riskier than 47% of active trials completed
- Clinical Study to Evaluate Safety and Maximum Tolerated Dose of BAY1000394 Given in a 4 Week on / 2 Week Off Schedule in Subjects With Advanced Malignancies NCT01335256 · started 2010 · scored riskier than 59% of active trials completed
- Open Label Phase I Dose Escalation Study With BAY1143572 in Patients With Advanced Cancer NCT01938638 · started 2013 · scored riskier than 32% of active trials completed
- Clinical Study to Evaluate the Maximum Tolerated Dose of BAY1000394 Given in a 3 Days on / 4 Days Off Schedule in Subjects With Advanced Malignancies NCT01188252 · started 2010 · scored riskier than 47% of active trials completed
- Phase I Dose Escalation of Oral BAY1161909 in Combination With Intravenous Paclitaxel NCT02138812 · started 2014 · scored riskier than 14% of active trials terminated
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.