OPAL Study: A Study of Avastin (Bevacizumab) in Combination With FOLFOXIRI in Patients With Previously Untreated Metastatic Colorectal Cancer

NCT00940303 on ClinicalTrials.gov Phase 2 Hoffmann-La Roche (industry) Started 2009-06-30 Completed

Riskier than 58% of active trials

Model scores of the 29,894 trials active now.

Model score 18% for any early termination, 3% 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 2014-02-28, after 2009-06-30 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 2014-02-28. 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: metastaticcancerchemotherapycolorectalcombination
Phrases that lowered it: singlekgand safetyefficacy andthe efficacy
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 2 (raises risk) · Design
Sponsor's past termination rate: 11.8% (raises risk) · Sponsor's track record
Has a data monitoring committee: not given (lowers risk) · Design
Disease area, cancer: Yes (raises risk) · Disease area
Sponsor type: industry (lowers risk) · Sponsor's track record
Trials the sponsor started in the prior 2 years: 193 (lowers risk) · Sponsor's track record
Design: single group (raises risk) · Design
Maximum age: 70 (lowers risk) · Who can join
Drug's FAERS reports with a death: 18.1% (lowers risk) · Drug's FDA history
Primary purpose: treatment (raises risk) · Design
Sponsor's past trials: 221 (lowers risk) · Sponsor's track record
Minimum age: 18 (raises risk) · Who can join
Number of arms: 1 (raises risk) · Design
Keywords listed: 0 (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: 1 (typical: 2)
Allocation: non randomized (typical: randomized)
Design: single group (typical: parallel)
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: not given (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 0 (typical: 1)

Who can join

Minimum age: 18
Maximum age: 70 (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: 221 (typical: 32)
Sponsor's past termination rate: 11.8% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 193 (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: 34407 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 8180 (typical: 412.5)
Drug's FAERS reports marked serious: 90.0% (typical: 85.6%)
Drug's FAERS reports with a death: 18.1% (typical: 15.9%)

Disease area and drugs

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

A Study of Avastin (Bevacizumab) With XELOX or FOLFOX in Patients With Metastatic Colorectal Cancer and Disease Progression Under First-line FOLFIRI and Avastin NCT01077739 · started 2009 · scored riskier than 32% of active trials completed
Sequential and Concurrent FOLFOXIRI/Bevacizumab Regimens Versus FOLFOX/Bevacizumab in First-Line Metastatic Colorectal Cancer NCT01765582 · started 2013 · scored riskier than 42% of active trials terminated
A Study Of PF-05212384 Plus FOLFIRI Versus Bevacizumab Plus FOLFIRI In Metastatic Colorectal Cancer NCT01937715 · started 2014 · scored riskier than 87% of active trials terminated
A Study of Avastin (Bevacizumab) and Xeloda (Capecitabine) as Maintenance Treatment in Patients With Metastatic Colorectal Cancer NCT00623805 · started 2008 · scored riskier than 17% of active trials completed
Phase 2 Study of ABT-869 in Combination With mFOLFOX6 Versus Bevacizumab in Combination With mFOLFOX6 to Treat Advanced Colorectal Cancer NCT00707889 · started 2008 · scored riskier than 67% 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.