A Safety Study of Oraxol (HM30181 + Oral Paclitaxel) in Cancer Patients

Model scores of the 29,894 trials active now.

Model score 17% for any early termination, 6% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 13% of the time (1,304 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 2021-06-15. 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: cancerulnpaclitaxeleligibleheart failure
  Phrases that lowered it: participantsbioavailabilityinvestigatorpktablet
• Design: factorial (lowers risk) · Design
• Phase: 2 (raises risk) · Design
• Accepts healthy volunteers: No (raises risk) · Who can join
• Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
• Disease area, cancer: No (lowers risk) · Disease area
• Trials the sponsor started in the prior 2 years: 4 (raises risk) · Sponsor's track record
• Collaborators: 2 (lowers risk) · Design
• Drug's FAERS reports with a death: 24.0% (raises risk) · Drug's FDA history
• Drug's FAERS reports marked serious: 96.1% (raises risk) · Drug's FDA history
• Minimum age: 18 (raises risk) · Who can join
• Has a data monitoring committee: No (lowers risk) · Design
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Primary purpose: treatment (raises risk) · Design
• Sponsor's past trials: 2 (raises risk) · Sponsor's track record
• Blinding: none (raises risk) · Design
• Maximum age: not given (raises risk) · Who can join
• Number of arms: 2 (raises risk) · Design
• Disease area, neurology: No (lowers risk) · Disease area
• Drug's FAERS reports in the prior 12 months: 5020 (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 to Determine the Bioequivalence of Oraxol in Cancer Patients Treated With Intravenous Paclitaxel NCT04035473 · started 2015 · scored riskier than 11% of active trials completed
• A PK Study of Oraxol in Breast Cancer Patients NCT04993040 · started 2019 · scored riskier than 46% of active trials completed
• A Study to Evaluate the Safety, Tolerability, MTD, PK, and Activity of Oraxol in Subjects w Adv. Malignancies NCT02730481 · started 2016 · scored riskier than 20% of active trials completed
• A Clinical Study to Determine the Pharmacokinetics of Oraxol in Breast Cancer Patients NCT03165955 · started 2017 · scored riskier than 43% of active trials completed
• Ph3 Study To Determine Safety,Tolerability&Tumor Response Of Oraxol Compared To Taxol In Metastatic Breast Cancer NCT02594371 · started 2015 · scored riskier than 73% 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.