BEZ235 Phase II Trial in Patients With Advanced Pancreatic Neuroendocrine Tumors (pNET) After Failure of mTOR Inhibitor Therapy.
Model scores of the 29,894 trials active now.
Model score 24% for any early termination, 8% 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.
How it ended
Completed on 2015-07-31, after 2012-11-30 start.
The score above never used this outcome: 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.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2015-07-31. 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.
What moved the score
-
Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: stagecarcinomacelltherapystudy treatment
Phrases that lowered it: the efficacyopen labelsinglemulticenterdesign -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 13.1% (raises risk) · Sponsor's track record
-
Phase: 2 (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 302 (raises risk) · Sponsor's track record
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Sponsor's past trials: 452 (lowers risk) · Sponsor's track record
-
Design: single group (raises risk) · Design
-
Drug's FAERS reports marked serious: 100% (raises risk) · Drug's FDA history
-
Disease area, cancer: Yes (raises risk) · Disease area
-
Drug's FAERS reports with a death: 0% (lowers risk) · Drug's FDA history
-
Minimum age: 18 (raises risk) · Who can join
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Primary purpose: treatment (raises risk) · Design
-
Collaborators: 0 (raises risk) · Design
-
Maximum age: not given (raises risk) · Who can join
-
Number of arms: 1 (raises risk) · Design
-
Drug's FAERS reports in the prior 12 months: 1 (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.
The trial
Design
- Phase
- 2
- Number of arms
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 3 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 452 (typical: 32)
- Sponsor's past termination rate
- 13.1% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 302 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 1 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1 (typical: 412.5)
- Drug's FAERS reports marked serious
- 100% (typical: 85.6%)
- Drug's FAERS reports with a death
- 0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer
- Drugs matched to FDA substances
- dactolisib
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- Efficacy and Safety of BEZ235 Compared to Everolimus in Patients With Advanced Pancreatic Neuroendocrine Tumors NCT01628913 · started 2012 · scored riskier than 94% of active trials terminated
- Efficacy of Everolimus Alone or in Combination With Pasireotide LAR in Advanced PNET NCT01374451 · started 2011 · scored riskier than 93% of active trials terminated
- Sequentiality of Everolimus and STZ-5FU in Advanced Pancreatic Neuroendocrine Tumor NCT02246127 · started 2014 · scored riskier than 18% of active trials completed
- Efficacy And Safety Of Sunitinib In Patients With Advanced Well-Differentiated Pancreatic Neuroendocrine Tumors NCT01121562 · started 2010 · scored riskier than 80% of active trials completed
- Everolimus Plus Best Supportive Care vs Placebo Plus Best Supportive Care in the Treatment of Patients With Advanced Neuroendocrine Tumors (GI or Lung Origin) NCT01524783 · started 2012 · scored riskier than 79% 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.