Safety, Tolerability & Potential Anti-cancer Activity of Increasing Doses of AZD5363 in Different Treatment Schedules

Model scores of the 29,894 trials active now.

Model score 16% for any early termination, 2% 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 2024-12-03. 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: advancedcancermetastaticexpectancylife
  Phrases that lowered it: investigateopen labelpharmacokineticsdrugpositive
• Phase: 1 (lowers risk) · Design
• Maximum age: 130 (lowers risk) · Who can join
• Accepts healthy volunteers: No (raises risk) · Who can join
• Trials the sponsor started in the prior 2 years: 345 (raises risk) · Sponsor's track record
• Design: parallel (raises risk) · Design
• Sponsor's past trials: 907 (raises risk) · Sponsor's track record
• Disease area, neurology: Yes (raises risk) · Disease area
• Sponsor's past termination rate: 7.7% (lowers risk) · Sponsor's track record
• Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
• Disease area, cancer: Yes (raises risk) · Disease area
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Minimum age: 18 (raises risk) · Who can join
• Primary purpose: treatment (raises risk) · Design
• Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
• Number of arms: 4 (lowers risk) · Design
• Disease area, dermatology: Yes (raises risk) · Disease area
• 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.

• Phase I, Dose Study to Look at the Safety and Pharmacokinetics of AZD8835 in Patients With Advanced Solid Tumours NCT02260661 · started 2014 · scored riskier than 18% of active trials completed
• Comparison of Two Formulations of AZD5363 and the Effect of Food on Pharmacokinetic Exposure, Safety and Tolerability NCT01895946 · started 2013 · scored riskier than 42% of active trials completed
• Study is Designed to Assess the Safety and Tolerability of AZD4547 at Increasing Doses in Patients With Advanced Tumours NCT00979134 · started 2009 · scored riskier than 18% of active trials terminated
• Study to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Preliminary Efficacy of AZD2014 NCT01026402 · started 2009 · scored riskier than 32% of active trials completed
• AKT Inhibitor in Oestrogen Positive Breast Cancer NCT02077569 · started 2014 · scored riskier than 63% 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.