A Randomised Trial With Irinotecan, Cetuximab and Everolimus (ICE)Compared to Capecitabine and Oxaliplatin (CapOx) for Patients With Gemcitabin Resistant Pancreatic Cancer

NCT01042028 on ClinicalTrials.gov Phase 1/2 Per Pfeiffer (academic or other) Started 2010-01-31 Terminated

Riskier than 23% of active trials

Model scores of the 29,894 trials active now.

Model score 12% 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 26% of the time (851 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

Terminated on 2014-01-31, after 2010-01-31 start.

Reason given by the sponsor: “enrollment”

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 2014-01-31. 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

Design: crossover (lowers risk) · Design
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 1/2 (raises risk) · Design
Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: patientcancerpatients mustchemotherapyprogressive
Phrases that lowered it: trialupperefficacynormalto investigate
Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
Disease area, cancer: Yes (raises risk) · Disease area
Has a data monitoring committee: Yes (raises risk) · Design
Sponsor type: academic or other (raises risk) · Sponsor's track record
Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
Minimum age: 18 (raises risk) · Who can join
Responsible party: sponsor investigator (raises risk) · Design
Maximum age: not given (raises risk) · Who can join
Collaborators: 2 (lowers risk) · Design
Drugs with FDA adverse-event history: 5 (lowers risk) · Drug's FDA history
Drug's FAERS reports before start: 27043 (lowers risk) · Drug's FDA history
Drug's FAERS reports in the prior 12 months: 6577 (lowers risk) · Drug's FDA history
Primary purpose: treatment (raises 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.

The trial

Design

Phase: 1/2 (typical: 2)
Number of arms: 2
Allocation: randomized
Design: crossover (typical: parallel)
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: Yes (typical: 56% yes)
Responsible party: sponsor investigator (typical: sponsor)
Collaborators: 2 (typical: 0)
Keywords listed: 7 (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: academic or other
Sponsor's past trials: 0 (typical: 32)
Sponsor's past termination rate: no earlier finished trials (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 1 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 5 (typical: 1)
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 27043 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 6577 (typical: 412.5)
Drug's FAERS reports marked serious: 89.4% (typical: 85.6%)
Drug's FAERS reports with a death: 21.3% (typical: 15.9%)

Disease area and drugs

Disease areas: cancer, digestive, endocrine
Drugs matched to FDA substances: capecitabine, cetuximab, everolimus, irinotecan, oxaliplatin

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

Combination of Irinotecan, Oxaliplatin and Cetuximab for Locally Advanced or Metastatic Pancreatic Cancer NCT00871169 · started 2008 · scored riskier than 54% of active trials completed
A Study of Gemcitabine, Nab-paclitaxel, Capecitabine, Cisplatin, and Irinotecan in Metastatic Pancreatic Cancer NCT03535727 · started 2018 · scored riskier than 97% of active trials completed
Second-Line Oxaliplatin and Irinotecan Versus Irinotecan Alone for Gemcitabine and S-1 Refractory Pancreatic Cancer NCT02558868 · started 2015 · scored riskier than 41% of active trials completed
Everolimus, Cetuximab and Capecitabine in Patients With Metastatic Pancreatic Cancer NCT01077986 · started 2009 · scored riskier than 71% of active trials completed
ATX Study:A Study of Avastin (Bevacizumab), Tarceva (Erlotinib) and Xeloda (Capecitabine) in Patients With Locally Advanced and/or Metastatic Pancreatic Cancer NCT00925769 · started 2009 · scored riskier than 24% 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.