A Phase I Comparative Study of Pharmacokinetics, Safety, and Efficacy of RPH-002 and Erbitux® in Unresectable Metastatic or Recurrent Head and Neck Squamous Cell Carcinoma

Model scores of the 29,894 trials active now.

Model score 15% for any early termination, 3% 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 in 2015 or later: the model never saw it during training.

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2024-07-17. 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: uncontrolledheartulnmyocardialmri
  Phrases that lowered it: investigatormonths beforedrugspharmacokineticscombination
• Accepts healthy volunteers: No (raises risk) · Who can join
• Phase: 1 (lowers risk) · Design
• Sponsor's past termination rate: 12.5% (raises risk) · Sponsor's track record
• Disease area, cancer: Yes (raises risk) · Disease area
• Drug's FAERS reports with a death: 15.0% (lowers risk) · Drug's FDA history
• Design: parallel (raises risk) · Design
• Trials the sponsor started in the prior 2 years: 3 (raises risk) · Sponsor's track record
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Drug's FAERS reports before start: 130917 (lowers risk) · Drug's FDA history
• Drug's FAERS reports in the prior 12 months: 17199 (lowers risk) · Drug's FDA history
• Primary purpose: treatment (raises risk) · Design
• Minimum age: 18 (raises risk) · Who can join
• Drug's FAERS reports marked serious: 85.1% (lowers risk) · Drug's FDA history
• Drugs with FDA adverse-event history: 3 (lowers risk) · Drug's FDA history
• Has a data monitoring committee: No (lowers 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.

• A Comparative Study of Efficacy and Safety of RPH-002 and Erbitux® in Unresectable Metastatic or Recurrent Head and Neck Squamous Cell Carcinoma NCT07435324 · started 2024 · scored riskier than 41% of active trials completed
• A Study to Evaluate NT219 Alone and in Combination with ERBITUX® (Cetuximab) in Adults with Advanced Solid Tumors and Head and Neck Cancer NCT04474470 · started 2020 · scored riskier than 82% of active trials completed
• Afatinib and Pembrolizumab for Head and Neck Squamous Cell Carcinoma (ALPHA Study) NCT03695510 · started 2019 · scored riskier than 74% of active trials completed
• Nivolumab in Recurrent and/or Metastatic SCCHN NCT03226756 · started 2017 · scored riskier than 78% of active trials completed
• Trial of Ibrutinib Combined With Nivolumab or Cetuximab to Treat Recurrent/Metastatic HNSCC NCT03646461 · started 2018 · scored riskier than 87% 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.