A Genotype-guided Study of Irinotecan Administered in Combination With 5-fluorouracil/Leucovorin (FOLFIRI) and Bevacizumab in Advanced Colorectal Cancer Patients

NCT01183494 on ClinicalTrials.gov Phase 1 University of Chicago (academic or other) Started 2009-12-12 Completed

Riskier than 76% of active trials

Model scores of the 29,894 trials active now.

Model score 21% for any early termination, 9% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 23% of the time (1,629 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 2017-06-02, after 2009-12-12 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 2017-06-02. 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: bevacizumabgenotypecellcancerbowel
Phrases that lowered it: drugdrugsnormalupper20
Sponsor's past termination rate: 19.6% (raises risk) · Sponsor's track record
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 1 (lowers risk) · Design
Disease area, cancer: Yes (raises risk) · Disease area
Sponsor type: academic or other (raises risk) · Sponsor's track record
Design: parallel (raises risk) · Design
Drug's FAERS reports with a death: 17.6% (lowers risk) · Drug's FDA history
Trials the sponsor started in the prior 2 years: 49 (lowers risk) · Sponsor's track record
Has a data monitoring committee: Yes (raises risk) · Design
Minimum age: 18 (raises risk) · Who can join
Primary purpose: treatment (raises risk) · Design
Maximum age: not given (raises risk) · Who can join
Drug's FAERS reports marked serious: 91.4% (raises risk) · Drug's FDA history
Collaborators: 1 (raises risk) · Design
Drug's FAERS reports before start: 16900 (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: 1 (typical: 2)
Number of arms: 2
Allocation: non randomized (typical: randomized)
Design: parallel
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: Yes (typical: 56% yes)
Responsible party: sponsor
Collaborators: 1 (typical: 0)
Keywords listed: 0 (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: 112 (typical: 32)
Sponsor's past termination rate: 19.6% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 49 (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: 16900 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 4498 (typical: 412.5)
Drug's FAERS reports marked serious: 91.4% (typical: 85.6%)
Drug's FAERS reports with a death: 17.6% (typical: 15.9%)

Disease area and drugs

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

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

Genotype-Directed Study Of Irinotecan Dosing In FOLFIRI + BevacizumabTreated Metastatic Colorectal Cancer NCT02138617 · started 2014 · scored riskier than 97% of active trials completed
Erbitux Study of CPT11, Oxaliplatin, UFToral Targeted Therapy NCT01225744 · started 2009 · scored riskier than 89% of active trials completed
A Study of RGX-202-01 (Ompenaclid) as Combination Therapy in RAS Mutant Advanced Colorectal Cancer NCT03597581 · started 2018 · scored riskier than 51% of active trials completed
Individualization of Dosage of Irinotecan in the FOLFIRI According to the Genetic Polymorphism of UGT1A1 in the First Line Treatment of Metastatic Colorectal Cancer NCT01963182 · started 2013 · scored riskier than 68% of active trials completed
A Study of NUC-3373 in Combination With Other Agents in Patients With Colorectal Cancer NCT05678257 · started 2023 · scored riskier than 74% of active trials terminated

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.