A Trial to Evaluate the Safety, Local Tolerability, Pharmacokinetics and Pharmacodynamics of LDE225 on Skin Basal Cell Carcinomas in Gorlin Syndrome Patients

Model scores of the 29,894 trials active now.

Model score 15% 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 22% of the time (1,598 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. 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.

• Accepts healthy volunteers: No (raises risk) · Who can join
• Sponsor's past termination rate: 8.5% (raises risk) · Sponsor's track record
• Disease area, cancer: Yes (raises risk) · Disease area
• Phase: 2 (raises risk) · Design
• Has a data monitoring committee: not given (lowers risk) · Design
• Design: parallel (raises risk) · Design
• Number of arms: 4 (lowers risk) · Design
• Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
• Blinding: double (raises risk) · Design
• Minimum age: 18 (raises risk) · Who can join
• Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
• Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: double blindcellother protocolmay applyprotocol defined
  Phrases that lowered it: vehicletopicalpharmacokineticsevaluate theto evaluate
• Primary purpose: treatment (raises risk) · Design
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Maximum age: 75 (lowers risk) · Who can join
• Disease area, musculoskeletal: Yes (raises risk) · Disease area
• Sponsor's past trials: 176 (lowers risk) · Sponsor's track record
• Trials the sponsor started in the prior 2 years: 194 (lowers risk) · Sponsor's track record

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.

• Efficacy, Safety and Pharmacokinetics of Oral LDE225 in Treatment of Patients With Nevoid Basal Cell Carcinoma Syndrome (NBCCS) NCT01350115 · started 2011 · scored riskier than 92% of active trials completed
• To Evaluate the Safety, Local Tolerability, PK and PD of LDE225 on Sporadic Superficial and Nodular Skin Basal Cell Carcinomas (sBCC) NCT01033019 · started 2009 · scored riskier than 43% of active trials terminated
• A Study of Patidegib Topical Gel, 2%, for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas in Patients With Non-Gorlin High Frequency BCC NCT04155190 · started 2019 · scored riskier than 90% of active trials terminated
• Efficacy and Safety of Patidegib Gel 2% for Preventing Basal Cell Carcinomas on the Face of Adults With Gorlin Syndrome NCT06050122 · started 2024 · scored riskier than 45% of active trials completed
• A Phase II Study of Efficacy and Safety in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma NCT01327053 · started 2011 · scored riskier than 76% 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.