A Study Of PF-05212384 Plus Irinotecan Vs Cetuximab Plus Irinotecan In Patients With KRAS And NRAS Wild Type Metastatic Colorectal Cancer

NCT01925274 on ClinicalTrials.gov Phase 2 Pfizer (industry) Started 2013-11-15 Terminated

Riskier than 99% of active trials

Model scores of the 29,894 trials active now.

Model score 33% for any early termination, 5% 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 2016-04-06, after 2013-11-15 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 2016-04-06. 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: metastaticcancercolorectalirinotecanprogression
Phrases that lowered it: safety ofjapaneseinvestigatepatients wholung
Sponsor's past termination rate: 15.9% (raises risk) · Sponsor's track record
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 2 (raises risk) · Design
Disease area, cancer: Yes (raises risk) · Disease area
Sponsor's past trials: 1307 (raises risk) · Sponsor's track record
Minimum age: 18 (raises risk) · Who can join
Design: parallel (raises risk) · Design
Primary purpose: treatment (raises risk) · Design
Drug's FAERS reports with a death: 18.6% (lowers risk) · Drug's FDA history
Keywords listed: 11 (raises risk) · Design
Maximum age: not given (raises risk) · Who can join
Trials the sponsor started in the prior 2 years: 227 (raises risk) · Sponsor's track record
Sponsor type: industry (lowers risk) · Sponsor's track record
Number of arms: 2 (raises risk) · Design
Blinding: none (raises risk) · Design
Drug's FAERS reports before start: 23753 (lowers 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: 2
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 11 (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: 1307 (typical: 32)
Sponsor's past termination rate: 15.9% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 227 (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: 23753 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 3407 (typical: 412.5)
Drug's FAERS reports marked serious: 84.0% (typical: 85.6%)
Drug's FAERS reports with a death: 18.6% (typical: 15.9%)

Disease area and drugs

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

PEAK: Panitumumab Plus mFOLFOX6 vs. Bevacizumab Plus mFOLFOX6 for First Line Treatment of Metastatic Colorectal Cancer (mCRC) Patients With Wild-Type Kirsten Rat Sarcoma-2 Virus (KRAS) Tumors NCT00819780 · started 2009 · scored riskier than 57% of active trials completed
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
ASPECCT: A Study of Panitumumab Efficacy and Safety Compared to Cetuximab in Patients With KRAS Wild-Type Metastatic Colorectal Cancer NCT01001377 · started 2010 · scored riskier than 46% of active trials completed
Study to Evaluate the Effects of Panitumumab if Combined With Chemotherapy for 2nd Treatment of Colorectal Cancer NCT00950820 · started 2009 · scored riskier than 87% of active trials terminated
Irinotecan and Panitumumab as 3rd Line Treatment for mCRC Without KRAS Mutations NCT00792363 · started 2008 · scored riskier than 87% 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.