Special Combination of BBI608 and Pembrolizumab

NCT02851004 on ClinicalTrials.gov Phase 1/2 Takayuki Yoshino (academic or other) Started 2016-10-31 Terminated

Riskier than 42% of active trials

Model scores of the 29,894 trials active now.

Model score 15% for any early termination, 6% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 26% of the time (851 trials).

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

How it ended

Terminated on 2021-08-23, after 2016-10-31 start.

Reason given by the sponsor: “enrollment”

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 2021-08-23. 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

Accepts healthy volunteers: No (raises risk) · Who can join
Minimum age: 20 (lowers risk) · Who can join
Phase: 1/2 (raises risk) · Design
Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
Responsible party: sponsor investigator (raises risk) · Design
Drug's FAERS reports with a death: 33.9% (raises risk) · Drug's FDA history
Disease area, cancer: Yes (raises risk) · Disease area
Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
Design: single group (raises risk) · Design
Has a data monitoring committee: Yes (raises risk) · Design
Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: cancerenrollmentchemotherapystatuswomen
Phrases that lowered it: patients whogastrointestinaland safetyefficacy andpatients with
Sponsor type: academic or other (raises risk) · Sponsor's track record
Number of arms: 1 (raises risk) · Design
Primary purpose: treatment (raises risk) · Design
Maximum age: not given (raises risk) · Who can join
Collaborators: 1 (raises risk) · Design
Drug's FAERS reports marked serious: 78.1% (lowers risk) · Drug's FDA history
Blinding: none (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: 1/2 (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 investigator (typical: sponsor)
Collaborators: 1 (typical: 0)
Keywords listed: 0 (typical: 1)

Who can join

Minimum age: 20 (typical: 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: 0 (typical: 32)
Sponsor's past termination rate: no earlier finished trials (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 0 (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: 3432 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 2014 (typical: 412.5)
Drug's FAERS reports marked serious: 78.1% (typical: 85.6%)
Drug's FAERS reports with a death: 33.9% (typical: 15.9%)

Disease area and drugs

Disease areas: cancer, digestive
Drugs matched to FDA substances: napabucasin, pembrolizumab

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 BBI608 in Adult Patients With Advanced Colorectal Cancer NCT01776307 · started 2012 · scored riskier than 60% of active trials completed
A Study of BBI608 Administered in Combination With Immune Checkpoint Inhibitors in Adult Patients With Advanced Cancers NCT02467361 · started 2015 · scored riskier than 25% of active trials completed
A Study of BBI608 Administrated With FOLFIRI + Bevacizumab in Adult Patients With Metastatic Colorectal Cancer NCT02641873 · started 2015 · scored riskier than 18% of active trials completed
A Study of BBI608 and BBI503 Administered in Combination to Adult Patients With Advanced Solid Tumors NCT02432326 · started 2015 · scored riskier than 21% of active trials completed
A Study of BBI608 Administered With Paclitaxel in Adult Patients With Advanced Malignancies NCT01325441 · started 2011 · scored riskier than 54% 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.