A Phase 1 Dose Escalation Study of GC4419 in Combination With Chemoradiation for Squamous Cell Cancer of the Head & Neck

Model scores of the 29,894 trials active now.

Model score 20% for any early termination, 5% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 16% of the time (1,938 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.

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2016-08-31. 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.

• Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: chemotherapyradiationcancerand neckhead and
  Phrases that lowered it: allergiesblood pressuresafety tolerabilityevaluatewithin 30
• Accepts healthy volunteers: No (raises risk) · Who can join
• Phase: 1 (lowers risk) · Design
• Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
• Disease area, cancer: Yes (raises risk) · Disease area
• Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
• Drug's FAERS reports with a death: 8.8% (lowers risk) · Drug's FDA history
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Design: single group (raises risk) · Design
• Minimum age: 18 (raises risk) · Who can join
• Maximum age: not given (raises risk) · Who can join
• Primary purpose: supportive care (lowers risk) · Design
• Number of arms: 1 (raises risk) · Design
• Drug's FAERS reports in the prior 12 months: 13820 (lowers risk) · Drug's FDA history
• Sponsor's past trials: 0 (raises risk) · Sponsor's track record
• Has a data monitoring committee: No (lowers risk) · Design
• Drug's FAERS reports marked serious: 66.5% (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.

• A Study of the Effects of GC4419 on Radiation Induced Oral Mucositis in Patients With Head/Neck Cancer NCT02508389 · started 2015 · scored riskier than 82% of active trials completed
• Ph 2 Open Label Study of GC4419 to Reduce SOM Associated With Chemoradiotherapy for Head and Neck Cancer NCT04529850 · started 2020 · scored riskier than 87% of active trials completed
• A Dose Escalating Study of SGX942 for Oral Mucositis in Patients With Head and Neck Cancer NCT02013050 · started 2013 · scored riskier than 95% of active trials completed
• Safety and Efficacy of RRx-001 in the Attenuation of Oral Mucositis in Patients Receiving Chemoradiation for the Treatment of Oral Cancers NCT03515538 · started 2018 · scored riskier than 98% of active trials completed
• Safety and Efficacy of ALD518 for Reducing Oral Mucositis in Head and Neck Cancer Subjects NCT01403064 · started 2011 · scored riskier than 83% of active trials terminated

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.