Phase 1 Study of SF1126 in Combination With Nivolumab in Patients With Advanced Hepatocellular Carcinoma
Model scores of the 29,894 trials active now.
Model score 18% for any early termination, 4% 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
Terminated on 2020-06-29, after 2017-03-27 start.
Reason given by the sponsor: “enrollment”
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 2020-06-29. 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
-
Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: sorafenibhccsubjectunresectablesubjects
Phrases that lowered it: pharmacokineticspatientsdosethe effecttrial -
Phase: 1 (lowers risk) · Design
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Drug's FAERS reports with a death: 35.2% (raises risk) · Drug's FDA history
-
Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
-
Design: single group (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
-
Primary purpose: treatment (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Disease area, cancer: No (lowers risk) · Disease area
-
Number of arms: 1 (raises risk) · Design
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Drug's FAERS reports marked serious: 87.8% (raises risk) · Drug's FDA history
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Has a data monitoring committee: No (lowers risk) · Design
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Maximum age: not given (raises risk) · Who can join
-
Collaborators: 1 (raises risk) · Design
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Drug's FAERS reports in the prior 12 months: 8456 (lowers risk) · Drug's FDA history
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
- 1 (typical: 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
- 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
- 12152 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 8456 (typical: 412.5)
- Drug's FAERS reports marked serious
- 87.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 35.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- nivolumab
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
- Hepatic Arterial Infusion of Oxaliplatin, Fluorouracil/Leucovorin Versus Sorafenib in Advanced Hepatocellular Carcinoma NCT03164382 · started 2017 · scored riskier than 27% of active trials completed
- A Multicenter, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib (E7080) Versus Sorafenib in First-line Treatment of Participants With Unresectable Hepatocellular Carcinoma NCT01761266 · started 2013 · scored riskier than 59% of active trials completed
- PK Trial of Sorafenib & Erlotinib in Patients With Refractory Solid Tumors NCT00759928 · started 2008 · scored riskier than 20% of active trials completed
- Pembrolizumab (Keytruda) in Advanced Hepatocellular Carcinoma NCT02658019 · started 2016 · scored riskier than 82% of active trials completed
- Immunotherapy With Nivolumab in Combination With Lenvatinib for Advanced Stage Hepatocellular Carcinoma NCT03841201 · started 2019 · scored riskier than 91% 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.