Phase II Randomized Trial of the Combination of Cetuximab and Sorafenib or Single Agent Cetuximab
Model scores of the 29,894 trials active now.
Model score 21% for any early termination, 6% 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 (376 trials).
Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Completed on 2014-01-31, after 2009-07-31 start.
The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
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 2014-01-31. 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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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: celltumorand neckhead andheart
Phrases that lowered it: refractoryor suspectedtrialcombinationknown or -
Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 2 (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 211 (lowers risk) · Sponsor's track record
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Sponsor's past trials: 308 (lowers risk) · Sponsor's track record
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Sponsor's past termination rate: 5.5% (lowers risk) · Sponsor's track record
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Disease area, cancer: Yes (raises risk) · Disease area
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Has a data monitoring committee: not given (lowers risk) · Design
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Design: parallel (raises risk) · Design
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Drug's FAERS reports with a death: 12.4% (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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Drug's FAERS reports marked serious: 76.7% (lowers risk) · Drug's FDA history
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Number of arms: 2 (raises risk) · Design
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Disease area, dermatology: No (lowers risk) · Disease area
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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
- 2
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- not given (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
- government (typical: academic or other)
- Sponsor's past trials
- 308 (typical: 32)
- Sponsor's past termination rate
- 5.5% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 211 (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
- 9611 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2397 (typical: 412.5)
- Drug's FAERS reports marked serious
- 76.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 12.4% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer
- Drugs matched to FDA substances
- cetuximab, sorafenib
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
- Sorafenib Tosylate, Cisplatin, and Docetaxel in Treating Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck NCT02035527 · started 2014 · scored riskier than 52% of active trials completed
- Study of Sorafenib/Cetuximab in Head and Neck Cancer NCT00815295 · started 2008 · scored riskier than 82% of active trials completed
- Sorafenib for Patients With Metastatic or Recurrent Esophageal and Gastroesophageal Junction Cancer NCT00917462 · started 2009 · scored riskier than 51% of active trials completed
- Sorafenib in Treating Patients With Advanced Malignant Solid Tumors NCT00810394 · started 2008 · scored riskier than 88% of active trials completed
- Phase I Study of Vorinostat and Sorafenib in Advanced Cancer NCT00635791 · started 2008 · scored riskier than 24% 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.