RAD001 in Combination With Capecitabine and Oxaliplatin (XELOX) in Patients With Advanced Gastric Cancer: RAD001+XELOX

NCT01049620 on ClinicalTrials.gov Phase 1 Asan Medical Center (academic or other) Started 2010-02-28 Completed

Riskier than 32% of active trials

Model scores of the 29,894 trials active now.

Model score 14% for any early termination, 9% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 11% of the time (918 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 2013-09-30, after 2010-02-28 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 2013-09-30. 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: cancerchemotherapycombinationcelladenocarcinoma
Phrases that lowered it: bleedingeffectopengastricinteraction
Sponsor's past termination rate: 4% (lowers risk) · Sponsor's track record
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 1 (lowers risk) · Design
Drug's FAERS reports with a death: 26.3% (raises risk) · Drug's FDA history
Design: single group (raises risk) · Design
Trials the sponsor started in the prior 2 years: 42 (lowers risk) · Sponsor's track record
Sponsor type: academic or other (raises risk) · Sponsor's track record
Disease area, cancer: No (lowers risk) · Disease area
Minimum age: 18 (raises risk) · Who can join
Responsible party: principal investigator (lowers risk) · Design
Primary purpose: treatment (raises risk) · Design
Maximum age: 70 (lowers risk) · Who can join
Drug's FAERS reports marked serious: 93.1% (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: 1 (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: No (typical: 56% yes)
Responsible party: principal investigator (typical: sponsor)
Collaborators: 0
Keywords listed: 3 (typical: 1)

Who can join

Minimum age: 18
Maximum age: 70 (typical: 71)
Sex: all
Accepts healthy volunteers: No (typical: 9% yes)

Sponsor's track record

Sponsor type: academic or other
Sponsor's past trials: 25 (typical: 32)
Sponsor's past termination rate: 4% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 42 (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: 15574 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 4224 (typical: 412.5)
Drug's FAERS reports marked serious: 93.1% (typical: 85.6%)
Drug's FAERS reports with a death: 26.3% (typical: 15.9%)

Disease area and drugs

Disease areas: none of the 14 tracked areas
Drugs matched to FDA substances: capecitabine, capecitabine oxaliplatin, everolimus, oxaliplatin

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

A Trial of RAD001/Capecitabine in Refractory Gastric Cancer NCT01099527 · started 2009 · scored riskier than 62% of active trials completed
RAD001 (Everolimus) Salvage Monotherapy in Advanced Gastric Cancer (AGC) Who Failed Standard First-line Treatment NCT00729482 · started 2008 · scored riskier than 36% of active trials completed
Low-dose RAD001(Everolimus) Plus Cisplatin-HDFL Chemotherapy for the First-line Treatment of Advanced Gastric Cancer NCT00632268 · started 2008 · scored riskier than 38% of active trials completed
A Randomized, Double Blind Study Evaluating Paclitaxel With and Without RAD001 in Patients With Gastric Carcinoma After Prior Chemotherapy NCT01248403 · started 2011 · scored riskier than 69% of active trials completed
Gastric Cancer RAD001 Study NCT01514110 · started 2008 · scored riskier than 93% 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.