Nintedanib Alone or in Combination With Capecitabine in Refractory Metastatic Colorectal Cancer [LUME-Colon 2]

NCT02780700 on ClinicalTrials.gov Phase 2 Boehringer Ingelheim (industry) Started 2016-07-05 Terminated

Riskier than 44% of active trials

Model scores of the 29,894 trials active now.

Model score 15% 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 in 2015 or later: the model never saw it during training.

How it ended

Terminated on 2016-09-09, after 2016-07-05 start.

Reason given by the sponsor: “other”

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 2016-09-09. 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: cancerpatientmetastaticto assessassess the
Phrases that lowered it: and safetyefficacy andsafety ofthe efficacybleeding
Accepts healthy volunteers: No (raises risk) · Who can join
Sponsor's past termination rate: 5.6% (lowers risk) · Sponsor's track record
Trials the sponsor started in the prior 2 years: 105 (lowers risk) · Sponsor's track record
Phase: 2 (raises risk) · Design
Drug's FAERS reports with a death: 31.8% (raises risk) · Drug's FDA history
Has a data monitoring committee: not given (lowers risk) · Design
Disease area, cancer: Yes (raises risk) · Disease area
Design: parallel (raises risk) · Design
Sponsor's past trials: 392 (lowers risk) · Sponsor's track record
Minimum age: 18 (raises risk) · Who can join
Primary purpose: treatment (raises risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Responsible party: sponsor (lowers risk) · Design
Drug's FAERS reports before start: 35350 (raises risk) · Drug's FDA history
Maximum age: not given (raises risk) · Who can join

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: not given (typical: 56% yes)
Responsible party: sponsor
Collaborators: 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: industry (typical: academic or other)
Sponsor's past trials: 392 (typical: 32)
Sponsor's past termination rate: 5.6% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 105 (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: 35350 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 4988 (typical: 412.5)
Drug's FAERS reports marked serious: 91.1% (typical: 85.6%)
Drug's FAERS reports with a death: 31.8% (typical: 15.9%)

Disease area and drugs

Disease areas: cancer, digestive
Drugs matched to FDA substances: capecitabine, nintedanib

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

Nintedanib and Capecitabine in Treating Patients With Refractory Metastatic Colorectal Cancer NCT02393755 · started 2015 · scored riskier than 74% of active trials completed
Nintedanib (BIBF 1120) vs Placebo in Refractory Metastatic Colorectal Cancer (LUME-Colon 1) NCT02149108 · started 2014 · scored riskier than 17% of active trials completed
TRICC-C (AIO-KRK-0111): BIBF 1120 Versus Placebo in Patients Receiving Oxaliplatin Plus Fluorouracil and Leucovorin (mFOLFOX6) for Advanced, Chemorefractory Metastatic Colorectal Cancer (mCRC) NCT01362361 · started 2011 · scored riskier than 61% of active trials completed
Comparing Efficacy and Safety of Stivant (AryoGen Bevacizumab) Versus Avastin in Metastatic Colorectal Cancer NCT03288987 · started 2016 · scored riskier than 40% of active trials completed
A Study of Rivoceranib and Trifluridine/Tipiracil for Metastatic Colorectal Cancer (mCRC) NCT04073615 · started 2019 · scored riskier than 47% 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.