A Trial of mFOLFIRI With MEK162 in Patients With Advanced RAS (HRAS, NRAS, or KRAS) Positive Metastatic Colorectal Cancers

NCT02613650 on ClinicalTrials.gov Phase 1 University of Utah (academic or other) Started 2016-08-19 Completed

Riskier than 61% of active trials

Model scores of the 29,894 trials active now.

Model score 18% 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 11% of the time (918 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

How it ended

Completed on 2022-12-21, after 2016-08-19 start.

The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.

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 2022-12-21. 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: coronarymetastaticdefinedtherapyevidence
Phrases that lowered it: patients whodrugwilling toinvestigatoropen label
Sponsor's past termination rate: 16.2% (raises risk) · Sponsor's track record
Phase: 1 (lowers risk) · Design
Accepts healthy volunteers: No (raises risk) · Who can join
Trials the sponsor started in the prior 2 years: 47 (lowers risk) · Sponsor's track record
Drug's FAERS reports marked serious: 100% (raises risk) · Drug's FDA history
Has a data monitoring committee: Yes (raises risk) · Design
Sponsor type: academic or other (raises risk) · Sponsor's track record
Drug's FAERS reports with a death: 14.3% (lowers risk) · Drug's FDA history
Design: single group (raises risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Minimum age: 18 (raises risk) · Who can join
Primary purpose: treatment (raises risk) · Design
Sponsor's past trials: 179 (lowers risk) · Sponsor's track record
Responsible party: sponsor (lowers risk) · Design
Collaborators: 1 (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 (typical: 2)
Number of arms: 1 (typical: 2)
Allocation: not applicable (typical: randomized)
Design: single group (typical: 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: 179 (typical: 32)
Sponsor's past termination rate: 16.2% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 47 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 1
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 7 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 0 (typical: 412.5)
Drug's FAERS reports marked serious: 100% (typical: 85.6%)
Drug's FAERS reports with a death: 14.3% (typical: 15.9%)

Disease area and drugs

Disease areas: none of the 14 tracked areas
Drugs matched to FDA substances: binimetinib

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

MEK Inhibitor MEK162 in Combination With Leucovorin Calcium, Fluorouracil, and Oxaliplatin in Treating Patients With Advanced Metastatic Colorectal Cancer NCT02041481 · started 2014 · scored riskier than 60% of active trials completed
Trial of Ulixertinib in Combination With Hydroxychloroquine in Patients With Advanced Gastrointestinal (GI) Malignancies NCT05221320 · started 2022 · scored riskier than 96% of active trials terminated
BRAF/MEK Inhibition in Relapsed/Refractory Multiple Myeloma (BIRMA) NCT02834364 · started 2016 · scored riskier than 62% of active trials completed
Trametinib and Trifluridine and Tipiracil Hydrochloride in Treating Patients With Colon or Rectal Cancer That is Advanced, Metastatic, or Cannot Be Removed by Surgery NCT03317119 · started 2018 · scored riskier than 66% of active trials completed
A Study of Efficacy and Safety of Fruquintinib (HMPL-013) in Participants With Metastatic Colorectal Cancer NCT04322539 · started 2020 · scored riskier than 48% 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.