BIBW 2992 as add-on to Gem/Cis in Advanced Biliary Tract Cancer

NCT01679405 on ClinicalTrials.gov Phase 1 Johannes Gutenberg University Mainz (academic or other) Started 2012-08-31 Terminated

Riskier than 62% of active trials

Model scores of the 29,894 trials active now.

Model score 18% 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 23% of the time (1,629 trials).

Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.

How it ended

Terminated on 2016-04-30, after 2012-08-31 start.

Reason given by the sponsor: “other”

The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.

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 2016-04-30. 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: lymphomathe patientgemcitabineadenocarcinomadisease
Phrases that lowered it: to investigateefficacytractsafety ofopen label
Sponsor's past termination rate: 16.7% (raises risk) · Sponsor's track record
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 1 (lowers risk) · Design
Disease area, cancer: Yes (raises risk) · Disease area
Design: parallel (raises risk) · Design
Drug's FAERS reports marked serious: 95.7% (raises risk) · Drug's FDA history
Minimum age: 18 (raises risk) · Who can join
Primary purpose: treatment (raises risk) · Design
Sponsor type: academic or other (raises risk) · Sponsor's track record
Drug's FAERS reports with a death: 22.6% (raises risk) · Drug's FDA history
Drugs with FDA adverse-event history: 3 (lowers risk) · Drug's FDA history
Has a data monitoring committee: No (lowers risk) · Design
Maximum age: not given (raises risk) · Who can join
Sponsor's past trials: 12 (lowers risk) · Sponsor's track record
Responsible party: principal investigator (lowers risk) · Design
Drug's FAERS reports in the prior 12 months: 4511 (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: 1 (typical: 2)
Number of arms: 2
Allocation: non randomized (typical: randomized)
Design: parallel
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: principal investigator (typical: 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: academic or other
Sponsor's past trials: 12 (typical: 32)
Sponsor's past termination rate: 16.7% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 9 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 3 (typical: 1)
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 23818 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 4511 (typical: 412.5)
Drug's FAERS reports marked serious: 95.7% (typical: 85.6%)
Drug's FAERS reports with a death: 22.6% (typical: 15.9%)

Disease area and drugs

Disease areas: cancer, digestive
Drugs matched to FDA substances: afatinib, cisplatin, 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

Phase II Randomized Trial of SLOG vs GC in Locally Advanced or Metastatic Biliary Tract Cancer NCT03406299 · started 2018 · scored riskier than 88% of active trials completed
Active Symptom Control Alone or With mFOLFOX Chemotherapy for Locally Advanced/ Metastatic Biliary Tract Cancers NCT01926236 · started 2014 · scored riskier than 81% of active trials completed
A Study of Atezolizumab With or Without Bevacizumab in Combination With Cisplatin Plus Gemcitabine in Patients With Untreated, Advanced Biliary Tract Cancer NCT04677504 · started 2021 · scored riskier than 54% of active trials completed
Study of CX-4945 in Combination With Gemcitabine and Cisplatin for Frontline Treatment of Cholangiocarcinoma NCT02128282 · started 2014 · scored riskier than 95% of active trials completed
NGS as the First-line Treatment in Advanced Biliary Tract Cancer NCT04172402 · started 2019 · 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.