A Phase I/II Study of Radiation Therapy, Paclitaxel Poliglumex and Cetuximab in Advanced Head and Neck Cancer
Model scores of the 29,894 trials active now.
Model score 40% for any early termination, 25% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 26% of the time (851 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 2017-04-30, after 2008-03-31 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 2017-04-30. 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: cancerstageand neckhead andpatients must
Phrases that lowered it: dosetypestudycomparedcells mm3 -
Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past termination rate: 14.3% (raises risk) · Sponsor's track record
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Phase: 1/2 (raises risk) · Design
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Disease area, cancer: Yes (raises risk) · Disease area
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Has a data monitoring committee: Yes (raises risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Design: single group (raises risk) · Design
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Maximum age: not given (raises risk) · Who can join
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Drug's FAERS reports with a death: 10.8% (lowers risk) · Drug's FDA history
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Minimum age: 18 (raises risk) · Who can join
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Number of arms: 1 (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 9 (raises risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 79.2% (lowers risk) · Drug's FDA history
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Responsible party: principal investigator (lowers risk) · Design
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Drug's FAERS reports before start: 4360 (raises risk) · Drug's FDA history
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Blinding: none (raises risk) · Design
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Collaborators: 1 (raises risk) · Design
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Drug's FAERS reports in the prior 12 months: 1129 (raises risk) · Drug's FDA history
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Keywords listed: 1 (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
- 1/2 (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
- Yes (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 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
- academic or other
- Sponsor's past trials
- 7 (typical: 32)
- Sponsor's past termination rate
- 14.3% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 9 (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
- 4360 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1129 (typical: 412.5)
- Drug's FAERS reports marked serious
- 79.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 10.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer
- Drugs matched to FDA substances
- cetuximab, paclitaxel poliglumex
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 Phase Ib/II Study of BYL719 and Cetuximab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma NCT01602315 · started 2012 · scored riskier than 84% of active trials terminated
- Patritumab With Cetuximab and a Platinum Agent for Squamous Cell Carcinoma (Cancer) of the Head and Neck (SCCHN ) NCT02633800 · started 2015 · scored riskier than 95% of active trials terminated
- Study of the Combination of Panitumumab With Paclitaxel as First-line Treatment of Subjects With Head and Neck Cancer NCT01264328 · started 2011 · scored riskier than 85% of active trials completed
- Cetuximab, Combination Chemotherapy, and Radiation Therapy in Treating Patients With Newly Diagnosed Stage III or Stage IV Head and Neck Cancer That Cannot Be Removed By Surgery NCT00646659 · started 2008 · scored riskier than 80% of active trials terminated
- Induction Chemotherapy With ACF Followed by Chemoradiation Therapy for Adv. Head & Neck Cancer NCT01566435 · started 2012 · scored riskier than 99% 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.