Phase II Trial of AUY922 vs. Comparators in Advanced Gastric Cancer

NCT01084330 on ClinicalTrials.gov Phase 2 Novartis Pharmaceuticals (industry) Started 2010-04-30 Completed

Riskier than 69% of active trials

Model scores of the 29,894 trials active now.

Model score 20% 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 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 2012-05-31, after 2010-04-30 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 2012-05-31. 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: cancerchemotherapykidney diseaseto determinemetastatic
Phrases that lowered it: and safetysafety ofadultcompareopen label
Phase: 2 (raises risk) · Design
Accepts healthy volunteers: No (raises risk) · Who can join
Has a data monitoring committee: not given (lowers risk) · Design
Sponsor's past termination rate: 10.1% (raises risk) · Sponsor's track record
Design: parallel (raises risk) · Design
Disease area, cancer: Yes (raises risk) · Disease area
Minimum age: 18 (raises risk) · Who can join
Sponsor type: industry (lowers risk) · Sponsor's track record
Sponsor's past trials: 218 (lowers risk) · Sponsor's track record
Trials the sponsor started in the prior 2 years: 241 (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% (raises risk) · Drug's FDA history
Drug's FAERS reports marked serious: 93.3% (raises risk) · Drug's FDA history
Disease area, dermatology: No (lowers risk) · Disease area
Collaborators: 0 (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: 2
Number of arms: 2
Allocation: 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: 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: industry (typical: academic or other)
Sponsor's past trials: 218 (typical: 32)
Sponsor's past termination rate: 10.1% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 241 (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: 8625 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 1919 (typical: 412.5)
Drug's FAERS reports marked serious: 93.3% (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: auy922, docetaxel, irinotecan

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

XELOX Versus FOLFOX for Advanced Gastric Cancer (AGC) NCT01748851 · started 2012 · scored riskier than 29% of active trials terminated
Andecaliximab With mFOLFOX6 as First Line Treatment for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma NCT02545504 · started 2015 · scored riskier than 38% of active trials completed
Neoadjuvant Chemoradiotherapy vs. Chemotherapy Followed by Radical Gastrectomy and Adjuvant Chemotherapy for Advanced Gastric Cancer NCT01815853 · started 2013 · scored riskier than 17% of active trials completed
Low-Tox Vs Eox In Patients With Locally Advanced Unresectable Or Metastatic Gastric Cancer NCT02076594 · started 2013 · scored riskier than 43% of active trials terminated
PI3K Inhibitor BYL719 in Combination With the HSP90 Inhibitor AUY922 in Patients With Advanced or Metastatic Gastric Cancer NCT01613950 · started 2012 · scored riskier than 38% 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.