A Study of Avastin (Bevacizumab) And Fotemustine in Patients With Recurrent Glioblastoma

NCT01474239 on ClinicalTrials.gov Phase 2 Hoffmann-La Roche (industry) Started 2011-11-30 Completed

Riskier than 33% of active trials

Model scores of the 29,894 trials active now.

Model score 14% for any early termination, 2% 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 2013-12-31, after 2011-11-30 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 2013-12-31. 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

Accepts healthy volunteers: No (raises risk) · Who can join
Has a data monitoring committee: not given (lowers risk) · Design
Phase: 2 (raises risk) · Design
Sponsor's past termination rate: 10.2% (raises risk) · Sponsor's track record
Disease area, cancer: Yes (raises risk) · Disease area
Design: parallel (raises risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Drug's FAERS reports with a death: 19.8% (lowers risk) · Drug's FDA history
Trials the sponsor started in the prior 2 years: 203 (lowers risk) · Sponsor's track record
Primary purpose: treatment (raises risk) · Design
Drug's FAERS reports marked serious: 94.2% (raises risk) · Drug's FDA history
Minimum age: 18 (raises risk) · Who can join
Sponsor's past trials: 463 (lowers risk) · Sponsor's track record
Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: chemotherapycarcinomacellradiotherapyrecurrent
Phrases that lowered it: efficacykgand safetym2relevant
Maximum age: not given (raises risk) · Who can join
Number of arms: 2 (raises risk) · Design
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: non randomized (typical: 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: 0 (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: 463 (typical: 32)
Sponsor's past termination rate: 10.2% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 203 (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: 18525 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 3446 (typical: 412.5)
Drug's FAERS reports marked serious: 94.2% (typical: 85.6%)
Drug's FAERS reports with a death: 19.8% (typical: 15.9%)

Disease area and drugs

Disease areas: cancer
Drugs matched to FDA substances: bevacizumab, fotemustine

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 of Bevacizumab and Extended Treatment of Temozolomide in Patients With Recurrent Glioblastoma Multiforme NCT01115491 · started 2010 · scored riskier than 52% of active trials completed
A Phase 3, Pivotal Trial of VB-111 Plus Bevacizumab vs. Bevacizumab in Patients With Recurrent Glioblastoma (GLOBE) NCT02511405 · started 2015 · scored riskier than 79% of active trials completed
A Study of Avastin (Bevacizumab) and Irinotecan Versus Temozolomide Radiochemistry in Patients With Glioblastoma NCT00967330 · started 2010 · scored riskier than 31% of active trials completed
A Study of Bevacizumab (Avastin®) in Combination With Temozolomide and Radiotherapy in Participants With Newly Diagnosed Glioblastoma NCT00943826 · started 2009 · scored riskier than 48% of active trials completed
A Study of Onartuzumab (MetMAb) in Combination With Bevacizumab Compared to Bevacizumab Alone or Onartuzumab Monotherapy in Participants With Recurrent Glioblastoma NCT01632228 · started 2012 · scored riskier than 53% 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.