SI-B001 as a Single Agent or in Combination With Chemotherapy in the Treatment of Digestive System Malignancies

NCT05039944 on ClinicalTrials.gov Phase 2 Sichuan Baili Pharmaceutical Co., Ltd. (industry) Started 2021-11-30 Terminated

Riskier than 52% of active trials

Model scores of the 29,894 trials active now.

Model score 17% 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 2022-06-06, after 2021-11-30 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 2022-06-06. 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: her2heartcancerventricularfailure
Phrases that lowered it: colorectal cancermetastatic colorectallinediseasesgastric
Sponsor's past termination rate: 0% (lowers 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
Has a data monitoring committee: not given (lowers risk) · Design
Number of arms: 6 (lowers risk) · Design
Design: parallel (raises risk) · Design
Trials the sponsor started in the prior 2 years: 8 (raises risk) · Sponsor's track record
Drug's FAERS reports marked serious: 94.8% (raises risk) · Drug's FDA history
Minimum age: 18 (raises risk) · Who can join
Sponsor type: industry (lowers risk) · Sponsor's track record
Primary purpose: treatment (raises risk) · Design
Maximum age: not given (raises risk) · Who can join
Drug's FAERS reports with a death: 20.5% (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: 6 (typical: 2)
Allocation: non randomized (typical: 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: 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: 1 (typical: 32)
Sponsor's past termination rate: 0% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 8 (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: 32715 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 2645 (typical: 412.5)
Drug's FAERS reports marked serious: 94.8% (typical: 85.6%)
Drug's FAERS reports with a death: 20.5% (typical: 15.9%)

Disease area and drugs

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

Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.

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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.