A Study of Irinotecan and Cetuximab With or Without IMC-A12 for Treatment of Participants With Colon or Rectum Cancer Who Got Worse After Their First Treatment With Oxaliplatin and Bevacizumab

NCT00845039 on ClinicalTrials.gov Phase 2 Eli Lilly and Company (industry) Started 2009-05-31 Terminated

Riskier than 39% of active trials

Model scores of the 29,894 trials active now.

Model score 15% 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 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

Terminated on 2011-02-28, after 2009-05-31 start.

Reason given by the sponsor: “business”

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 2011-02-28. 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: tumorbowelrandomizationimagingdefined
Phrases that lowered it: participantparticipantslinethe studyoxaliplatin
Sponsor's past termination rate: 3.4% (lowers risk) · Sponsor's track record
Accepts healthy volunteers: No (raises risk) · Who can join
Trials the sponsor started in the prior 2 years: 154 (lowers risk) · Sponsor's track record
Phase: 2 (raises risk) · Design
Sponsor's past trials: 387 (lowers risk) · Sponsor's track record
Disease area, cancer: Yes (raises risk) · Disease area
Design: parallel (raises risk) · Design
Drug's FAERS reports with a death: 13.9% (lowers risk) · Drug's FDA history
Primary purpose: treatment (raises risk) · Design
Maximum age: not given (raises risk) · Who can join
Number of arms: 2 (raises risk) · Design
Minimum age: 18 (raises risk) · Who can join
Sponsor type: industry (lowers risk) · Sponsor's track record
Disease area, dermatology: No (lowers 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.

The trial

Design

Phase: 2
Number of arms: 2
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 1 (typical: 0)
Keywords listed: 4 (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: 387 (typical: 32)
Sponsor's past termination rate: 3.4% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 154 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 2 (typical: 1)
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 10564 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 2284 (typical: 412.5)
Drug's FAERS reports marked serious: 82.6% (typical: 85.6%)
Drug's FAERS reports with a death: 13.9% (typical: 15.9%)

Disease area and drugs

Disease areas: cancer, digestive
Drugs matched to FDA substances: cetuximab, cixutumumab, irinotecan

Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.

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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.