BGJ398 in Combination With Imatinib Mesylate in Patients With Untreated Advanced Gastrointestinal Stromal Tumor (GIST)

NCT02257541 on ClinicalTrials.gov Phase 1/2 Memorial Sloan Kettering Cancer Center (academic or other) Started 2014-10-02 Completed

Riskier than 78% of active trials

Model scores of the 29,894 trials active now.

Model score 22% for any early termination, 8% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 18% of the time (283 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

Completed on 2019-03-25, after 2014-10-02 start.

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 2019-03-25. 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: coronaryheartpatients mustocular hypertensionuncontrolled
Phrases that lowered it: and safetysafety ofdrugdays14
Sponsor's past termination rate: 4.1% (lowers risk) · Sponsor's track record
Collaborators: 3 (lowers risk) · Design
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 1/2 (raises risk) · Design
Sponsor's past trials: 386 (lowers risk) · Sponsor's track record
Has a data monitoring committee: not given (lowers risk) · Design
Trials the sponsor started in the prior 2 years: 105 (lowers risk) · Sponsor's track record
Design: single group (raises risk) · Design
Drug's FAERS reports with a death: 37.3% (raises risk) · Drug's FDA history
Minimum age: 18 (raises risk) · Who can join
Disease area, cancer: No (lowers risk) · Disease area
Sponsor type: academic or other (raises risk) · Sponsor's track record
Primary purpose: treatment (raises risk) · Design
Drug's FAERS reports marked serious: 96.9% (raises 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: not given (typical: 56% yes)
Responsible party: sponsor
Collaborators: 3 (typical: 0)
Keywords listed: 3 (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: academic or other
Sponsor's past trials: 386 (typical: 32)
Sponsor's past termination rate: 4.1% (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: 1
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 16974 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 2374 (typical: 412.5)
Drug's FAERS reports marked serious: 96.9% (typical: 85.6%)
Drug's FAERS reports with a death: 37.3% (typical: 15.9%)

Disease area and drugs

Disease areas: none of the 14 tracked areas
Drugs matched to FDA substances: imatinib, infigratinib

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

Nilotinib 800 Mg And Imatinib 800 Mg For The Treatment Of Patients With Gastrointestinal Stromal Tumors (Gist) Refractory To Imatinib 400 Mg NCT00751036 · started 2009 · scored riskier than 57% of active trials terminated
Single Agent Regorafenib in First-line for Metastatic/Unresectable KIT/PDGFR Wild Type GIST NCT02638766 · started 2015 · scored riskier than 75% of active trials completed
A Study of THE-630 in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) NCT05160168 · started 2022 · scored riskier than 65% of active trials terminated
(VOYAGER) Study of Avapritinib vs Regorafenib in Patients With Locally Advanced Unresectable or Metastatic GIST NCT03465722 · started 2018 · scored riskier than 23% of active trials completed
Trial of Tasigna (Nilotinib) 400 mg Twice Daily Alone or With Gleevec (Imatinib Mesylate) 400 mg Daily for Patients With Advanced Gastrointestinal Stromal Tumor (GIST) NCT01089595 · started 2009 · scored riskier than 84% 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.