Trial of AZD5363 Plus Paclitaxel /AZD2014 Plus Paclitaxel in Biomarker Negative (PIK3CA/MEK/RAS/TP53/MET) Gastric Adenocarcinoma Patients as Second-line Chemotherapy

NCT02449655 on ClinicalTrials.gov Phase 2 Samsung Medical Center (academic or other) Started 2015-02-12 Terminated

Riskier than 41% of active trials

Model scores of the 29,894 trials active now.

Model score 15% for any early termination, 12% 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 (1,198 trials).

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

How it ended

Terminated on 2018-07-16, after 2015-02-12 start.

Reason given by the sponsor: “efficacy”

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 2018-07-16. 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: braincancerpriormetastasesher2
Phrases that lowered it: patientsgastricplatinumcycleefficacy
Sponsor's past termination rate: 3.9% (lowers risk) · Sponsor's track record
Minimum age: 20 (lowers risk) · Who can join
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 2 (raises risk) · Design
Trials the sponsor started in the prior 2 years: 76 (lowers risk) · Sponsor's track record
Design: parallel (raises risk) · Design
Sponsor's past trials: 129 (lowers risk) · Sponsor's track record
Drug's FAERS reports marked serious: 96.4% (raises risk) · Drug's FDA history
Sponsor type: academic or other (raises risk) · Sponsor's track record
Disease area, cancer: No (lowers risk) · Disease area
Primary purpose: treatment (raises risk) · Design
Responsible party: principal investigator (lowers risk) · Design
Has a data monitoring committee: No (lowers risk) · Design
Number of arms: 2 (raises risk) · Design
Maximum age: not given (raises risk) · Who can join

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: 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: 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: 129 (typical: 32)
Sponsor's past termination rate: 3.9% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 76 (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: 17867 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 3627 (typical: 412.5)
Drug's FAERS reports marked serious: 96.4% (typical: 85.6%)
Drug's FAERS reports with a death: 23.5% (typical: 15.9%)

Disease area and drugs

Disease areas: none of the 14 tracked areas
Drugs matched to FDA substances: capivasertib, paclitaxel, vistusertib

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

Study of AZD5363 in Combination With Paclitaxel, in Advanced Gastric Adenocarcinoma Patients Harboring PIK3CA Mutation and/or PIK3CA Amplification as a Second-line Chemotherapy NCT02451956 · started 2015 · scored riskier than 47% of active trials completed
Study of AZD1775 in Combination With Paclitaxel, in Advanced Gastric Adenocarcinoma Patients Harboring TP53 Mutation as a Second-line Chemotherapy NCT02448329 · started 2015 · scored riskier than 68% of active trials completed
Phase Ib, Single-arm Study of AZD6094 (Volitinib) in Combination With Docetaxel, in Any Solid Cancer and Sequential Phase II, Single-arm Study of AZD6094 (Volitinib) in Combination With Docetaxel in Advanced Gastric Adenocarcinoma Patients With MET Amplification as a Second Line Treatment NCT02447406 · started 2015 · scored riskier than 55% of active trials completed
Phase II Trial of AZD2014 in TSC1/2 Mutated or TSC1/2 Null GC Patients as Second-line Chemotherapy NCT03082833 · started 2017 · scored riskier than 86% of active trials terminated
Phase I, Dose Study to Look at the Safety and Pharmacokinetics of AZD8835 in Patients With Advanced Solid Tumours NCT02260661 · started 2014 · scored riskier than 18% 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.