E7080 in Combination With Carboplatin + Gemcitabine Versus Carboplatin + Gemcitabine Alone as Second Line Therapy in Patients With Platinum-Sensitive Recurrent Ovarian Cancer by CA125

NCT01133756 on ClinicalTrials.gov Phase 1/2 Eisai Inc. (industry) Started 2010-03-31 Terminated

Riskier than 60% of active trials

Model scores of the 29,894 trials active now.

Model score 18% for any early termination, 4% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 29% of the time (655 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

Terminated on 2012-09-30, after 2010-03-31 start.

Reason given by the sponsor: “enrollment”

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 2012-09-30. 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: stagecancerulnserumto determine
Phrases that lowered it: ovarianopenparticipantsevaluate theto evaluate
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 1/2 (raises risk) · Design
Sponsor's past termination rate: 10.4% (raises risk) · Sponsor's track record
Drug's FAERS reports with a death: 19.6% (lowers risk) · Drug's FDA history
Disease area, cancer: Yes (raises risk) · Disease area
Design: parallel (raises risk) · Design
Trials the sponsor started in the prior 2 years: 40 (lowers risk) · Sponsor's track record
Sponsor type: industry (lowers risk) · Sponsor's track record
Minimum age: 18 (raises risk) · Who can join
Primary purpose: treatment (raises risk) · Design
Maximum age: not given (raises risk) · Who can join
Has a data monitoring committee: No (lowers risk) · Design
Disease area, dermatology: No (lowers risk) · Disease area

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: 2
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 1 (typical: 0)
Keywords listed: 0 (typical: 1)

Who can join

Minimum age: 18
Maximum age: not given (typical: 71)
Sex: female (typical: all)
Accepts healthy volunteers: No (typical: 9% yes)

Sponsor's track record

Sponsor type: industry (typical: academic or other)
Sponsor's past trials: 106 (typical: 32)
Sponsor's past termination rate: 10.4% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 40 (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: 12810 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 2536 (typical: 412.5)
Drug's FAERS reports marked serious: 92.8% (typical: 85.6%)
Drug's FAERS reports with a death: 19.6% (typical: 15.9%)

Disease area and drugs

Disease areas: cancer, urogenital, endocrine
Drugs matched to FDA substances: carboplatin, gemcitabine, lenvatinib

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 Study Comparing the Combination of the Best Supportive Care Plus E7080 Versus Best Supportive Care Alone, in Patients With Advanced Lung Cancer or Lung Cancer That Has Spread, Who Have Been Previously Treated, Unsuccessfully, With at Least 2 Different Treatments NCT01529112 · started 2011 · scored riskier than 92% of active trials completed
An Open-Label, Multicenter, Phase 1/2 Study of Poly(ADP-Ribose) Polymerase (PARP) Inhibitor E7449 as Single Agent in Subjects With Advanced Solid Tumors or With B-cell Malignancies and in Combination With Temozolomide (TMZ) or With Carboplatin and Paclitaxel in Subjects With Advanced Solid Tumors NCT01618136 · started 2012 · scored riskier than 90% of active trials completed
Study of Lenvatinib (E7080) in Unresectable Biliary Tract Cancer (BTC) Who Failed Gemcitabine-based Combination Chemotherapy NCT02579616 · started 2015 · scored riskier than 62% of active trials completed
Platine, Avastin and OLAparib in 1st Line NCT02477644 · started 2015 · scored riskier than 59% of active trials completed
A Study of AGEN2034 in Advanced Tumors and Cervical Cancer NCT03104699 · started 2017 · scored riskier than 67% 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.