Safety, Tolerability and Pharmacokinetics of Oral Tablet of Irinotecan in Adult Patients With Solid Tumors

Model scores of the 29,894 trials active now.

Model score 17% for any early termination, 7% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 23% of the time (1,629 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 2018-10-30. 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.

• Sponsor's past termination rate: 100% (raises risk) · Sponsor's track record
• Primary purpose: other (lowers risk) · Design
• Phase: 1 (lowers risk) · Design
• Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: priorpatientsbowelulndisease
  Phrases that lowered it: pharmacokineticsirinotecancombinationadultoral
• Accepts healthy volunteers: No (raises risk) · Who can join
• Disease area, cancer: Yes (raises risk) · Disease area
• Drug's FAERS reports with a death: 31.7% (raises risk) · Drug's FDA history
• Design: parallel (raises risk) · Design
• Has a data monitoring committee: Yes (raises risk) · Design
• Sponsor type: academic or other (raises risk) · Sponsor's track record
• Minimum age: 18 (raises risk) · Who can join
• Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
• Responsible party: sponsor investigator (raises risk) · Design
• Drug's FAERS reports in the prior 12 months: 5086 (raises risk) · Drug's FDA history
• Drug's FAERS reports marked serious: 93.8% (raises risk) · Drug's FDA history
• Maximum age: not given (raises risk) · Who can join
• Drug's FAERS reports before start: 43338 (raises 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 Trial Assessing Several Schedules of Oral S-1 in Combination With a Fixed Dose of Oxaliplatin and Irinotecan NCT02387138 · started 2014 · scored riskier than 59% of active trials completed
• Study of NK012 and 5-FU/LV in Solid Tumors Followed by Dose Expansion in Colorectal Cancer NCT01238939 · started 2010 · scored riskier than 25% of active trials completed
• Safety, Tolerability and Pharmacokinetics of Injectable PEG-Irinotecan (JK-1201I) in Patients with Malignant Solid Tumor NCT04366648 · started 2018 · scored riskier than 17% of active trials completed
• Safety Study of ON 01910.Na in Combination With Irinotecan or Oxaliplatin NCT00861328 · started 2008 · scored riskier than 41% of active trials completed
• AZD2281 and Irinotecan in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer NCT00535353 · started 2008 · scored riskier than 49% 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.