A Study of LY3039478 in Participants With Advanced or Metastatic Solid Tumors

NCT02784795 on ClinicalTrials.gov Phase 1 Eli Lilly and Company (industry) Started 2016-11-04 Terminated

Riskier than 35% of active trials

Model scores of the 29,894 trials active now.

Model score 14% for any early termination, 1% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 16% of the time (1,938 trials).

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

How it ended

Terminated on 2020-02-13, after 2016-11-04 start.

Reason given by the sponsor: “business”

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 2020-02-13. 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: metastaticadvancedbreast cancersolidbowel
Phrases that lowered it: participantsparticipantsafety ofevaluate theto evaluate
Phase: 1 (lowers risk) · Design
Accepts healthy volunteers: No (raises risk) · Who can join
Sponsor's past termination rate: 6.3% (lowers risk) · Sponsor's track record
Trials the sponsor started in the prior 2 years: 145 (lowers risk) · Sponsor's track record
Disease area, cancer: Yes (raises risk) · Disease area
Design: parallel (raises risk) · Design
Drug's FAERS reports with a death: 23.2% (raises risk) · Drug's FDA history
Sponsor's past trials: 1049 (raises risk) · Sponsor's track record
Minimum age: 18 (raises risk) · Who can join
Primary purpose: treatment (raises risk) · Design
Number of arms: 12 (lowers risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Drug's FAERS reports marked serious: 95.4% (raises risk) · Drug's FDA history
Drug's FAERS reports in the prior 12 months: 12613 (lowers risk) · Drug's FDA history
Maximum age: not given (raises risk) · Who can join
Drug's FAERS reports before start: 79208 (lowers risk) · Drug's FDA history
Responsible party: sponsor (lowers risk) · Design
Disease area, dermatology: Yes (raises risk) · Disease area
Drugs with FDA adverse-event history: 4 (lowers risk) · Drug's FDA history
Has a data monitoring committee: No (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: 1 (typical: 2)
Number of arms: 12 (typical: 2)
Allocation: non randomized (typical: randomized)
Design: parallel
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 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: 1049 (typical: 32)
Sponsor's past termination rate: 6.3% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 145 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 4 (typical: 1)
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 79208 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 12613 (typical: 412.5)
Drug's FAERS reports marked serious: 95.4% (typical: 85.6%)
Drug's FAERS reports with a death: 23.2% (typical: 15.9%)

Disease area and drugs

Disease areas: cancer, digestive, dermatology
Drugs matched to FDA substances: abemaciclib, carboplatin, cisplatin, crenigacestat, gemcitabine

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 LY3039478 in Participants With Advanced Cancer NCT01695005 · started 2012 · scored riskier than 36% of active trials completed
A Study of LY3405105 in Participants With Advanced Cancer NCT03770494 · started 2019 · scored riskier than 44% of active trials terminated
A Study of LY3023414 in Participants With Advanced Cancer NCT01655225 · started 2012 · scored riskier than 43% of active trials completed
A Study of LY2880070 in Participants With Advanced or Metastatic Cancer NCT02632448 · started 2016 · scored riskier than 96% of active trials completed
A Study of LY2584702 in Participants With Advanced Cancer NCT01394003 · started 2008 · scored riskier than 14% 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.