Phase 2 Study of KHK2375 in Subjects With Advanced or Recurrent Breast Cancer
Model scores of the 29,894 trials active now.
Model score 20% for any early termination, 7% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 22% of the time (1,598 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2021-03-26, after 2017-09-22 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 2021-03-26. 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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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: enrollmentradiationrecurrentcancercarcinoma of
Phrases that lowered it: 20pharmacokineticsand safetyevaluate theto evaluate -
Phase: 2 (raises risk) · Design
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Minimum age: 20 (lowers risk) · Who can join
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Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past termination rate: 10.2% (raises risk) · Sponsor's track record
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Disease area, cancer: Yes (raises risk) · Disease area
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Blinding: quadruple (lowers risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Drug's FAERS reports with a death: 12.5% (lowers risk) · Drug's FDA history
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Design: parallel (raises risk) · Design
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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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Disease area, dermatology: Yes (raises risk) · Disease area
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Trials the sponsor started in the prior 2 years: 18 (lowers risk) · Sponsor's track record
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Maximum age: not given (raises risk) · Who can join
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Drug's FAERS reports marked serious: 76.4% (lowers risk) · Drug's FDA history
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Number of arms: 2 (raises risk) · Design
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Responsible party: sponsor (lowers risk) · Design
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Collaborators: 0 (raises risk) · Design
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
- 2
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 20 (typical: 18)
- Maximum age
- not given (typical: 71)
- Sex
- female (typical: all)
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 88 (typical: 32)
- Sponsor's past termination rate
- 10.2% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 18 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 10169 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1617 (typical: 412.5)
- Drug's FAERS reports marked serious
- 76.4% (typical: 85.6%)
- Drug's FAERS reports with a death
- 12.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, dermatology
- Drugs matched to FDA substances
- entinostat, exemestane
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 of KHK2375 in Subjects With Advanced or Recurrent Breast Cancer NCT02623751 · started 2015 · scored riskier than 16% of active trials completed
- Exemestane in Treating Postmenopausal Women With Stage IV Breast Cancer NCT00810797 · started 2008 · scored riskier than 52% of active trials completed
- BI 836845 in Estrogen Receptor Positive Metastatic Breast Cancer NCT02123823 · started 2014 · scored riskier than 19% of active trials completed
- ZK 230211 in Postmenopausal Woman With Metastatic Breast Cancer NCT00555919 · started 2008 · scored riskier than 73% of active trials completed
- Phase I Study of BEBT-209 in Women With Advanced Breast Cancer NCT06047184 · started 2019 · scored riskier than 28% 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.