A Study of LY3499446 in Participants With Advanced Solid Tumors With KRAS G12C Mutation
Model scores of the 29,894 trials active now.
Model score 19% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 29% of the time (655 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2020-10-30, after 2019-11-28 start.
Reason given by the sponsor: “safety”
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 2020-10-30. 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: tumorstudy drugeffectivebe willingtumors
Phrases that lowered it: participantshealthcriteriapregnantcontrol -
Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 1/2 (raises risk) · Design
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Sponsor's past termination rate: 6.4% (lowers risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 146 (lowers risk) · Sponsor's track record
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Disease area, cancer: Yes (raises risk) · Disease area
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Drug's FAERS reports with a death: 18.3% (lowers risk) · Drug's FDA history
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Sponsor's past trials: 1288 (raises risk) · Sponsor's track record
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Design: parallel (raises risk) · Design
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Number of arms: 6 (lowers risk) · Design
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Drug's FAERS reports before start: 105459 (lowers risk) · Drug's FDA history
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Minimum age: 18 (raises risk) · Who can join
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Primary purpose: treatment (raises risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 75.9% (lowers risk) · Drug's FDA history
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Drugs with FDA adverse-event history: 4 (lowers risk) · Drug's FDA history
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Has a data monitoring committee: No (lowers risk) · Design
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Blinding: none (raises risk) · Design
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Drug's FAERS reports in the prior 12 months: 18368 (lowers 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
- 1/2 (typical: 2)
- Number of arms
- 6 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- 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
- 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
- 1288 (typical: 32)
- Sponsor's past termination rate
- 6.4% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 146 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 4 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 105459 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 18368 (typical: 412.5)
- Drug's FAERS reports marked serious
- 75.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 18.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, respiratory, digestive
- Drugs matched to FDA substances
- abemaciclib, cetuximab, docetaxel, erlotinib
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 of LY3435151 in Participants With Solid Tumors NCT04099277 · started 2019 · scored riskier than 76% of active trials terminated
- Tarlox and Sotorasib in Patients With KRAS G12C Mutations NCT05313009 · started 2022 · scored riskier than 92% of active trials terminated
- A Phase I/IIa Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of AZD0022 as Monotherapy and in Combination With Anti-cancer Agents in Adult Participants With Tumours Harbouring a KRASG12D Mutation NCT06599502 · started 2024 · scored riskier than 37% of active trials terminated
- A Study of LY2801653 in Advanced Cancer NCT01285037 · started 2009 · scored riskier than 26% of active trials completed
- First-in-Human Study of JNJ-74699157 in Participants With Tumors Harboring the KRAS G12C Mutation NCT04006301 · 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.