Trastuzumab in Combination With Capecitabine and Oxaliplatin(XELOX) in Patients With Advanced Gastric Cancer(AGC): Her+XELOX

NCT01396707 on ClinicalTrials.gov Phase 2 Asan Medical Center (academic or other) Started 2011-06-30 Completed

Riskier than 40% of active trials

Model scores of the 29,894 trials active now.

Model score 15% for any early termination, 7% 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 (3,728 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 2019-03-31, after 2011-06-30 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 2019-03-31. 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: her2trastuzumabcancermetastaticheart
Phrases that lowered it: accordingsolidpatients20male
Sponsor's past termination rate: 2.6% (lowers risk) · Sponsor's track record
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 2 (raises risk) · Design
Minimum age: 20 (lowers risk) · Who can join
Trials the sponsor started in the prior 2 years: 47 (lowers risk) · Sponsor's track record
Disease area, cancer: Yes (raises risk) · Disease area
Design: single group (raises risk) · Design
Sponsor type: academic or other (raises risk) · Sponsor's track record
Primary purpose: treatment (raises risk) · Design
Sponsor's past trials: 38 (lowers risk) · Sponsor's track record
Number of arms: 1 (raises risk) · Design
Responsible party: principal investigator (lowers risk) · Design
Collaborators: 1 (raises risk) · Design
Drug's FAERS reports with a death: 24.3% (raises 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: 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: No (typical: 56% yes)
Responsible party: principal investigator (typical: sponsor)
Collaborators: 1 (typical: 0)
Keywords listed: 4 (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: 38 (typical: 32)
Sponsor's past termination rate: 2.6% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 47 (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: 25879 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 5334 (typical: 412.5)
Drug's FAERS reports marked serious: 93.6% (typical: 85.6%)
Drug's FAERS reports with a death: 24.3% (typical: 15.9%)

Disease area and drugs

Disease areas: cancer
Drugs matched to FDA substances: capecitabine, oxaliplatin, trastuzumab

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

Trastuzumab Plus Docetaxel and Capecitabine For First Line Treatment of Her2-Positive Advanced Gastric Cancer NCT02004769 · started 2013 · scored riskier than 46% of active trials completed
A Study to Evaluate the Efficacy and Safety of Trastuzumab in Combination With Capecitabine and Oxaliplatin as First-line Chemotherapy for Inoperable, Locally Advanced or Recurrent and/or Metastatic Gastric Cancer NCT01364493 · started 2011 · scored riskier than 57% of active trials completed
Efficacy and Safety of Trastuzumab, Capecitabine y Oxaliplatine as Treatment Gastric Cancer Metastatic (HER2)Positive NCT01503983 · started 2011 · scored riskier than 69% of active trials completed
A Study of Trastuzumab in Combination With Capecitabine and Cisplatin in Patients With Tissue HER2- But Serum HER2+ AGC NCT04309578 · started 2020 · scored riskier than 90% of active trials completed
Phase II of AUY922 in Second-line Gastric Cancer in Combination With Trastuzumab in HER2 Positive Patients NCT01402401 · started 2011 · scored riskier than 72% 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.