Clinical Study on the Safety and Tolerability of Macitentan in Combination With Dose-dense Temozolomide in Patients With Recurrent Glioblastoma
Model scores of the 29,894 trials active now.
Model score 22% 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 16% of the time (1,938 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 2016-04-30, after 2012-01-31 start.
Reason given by the sponsor: “other”
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 2016-04-30. 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
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: tumorcancerconcurrentescalationrecurrent
Phrases that lowered it: open labelperiodseverescreeningimpairment -
Sponsor's past termination rate: 16.7% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 1 (lowers risk) · Design
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Disease area, cancer: Yes (raises risk) · Disease area
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Design: single group (raises risk) · Design
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Drug's FAERS reports with a death: 23.8% (raises risk) · Drug's FDA history
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Minimum age: 18 (raises risk) · Who can join
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Has a data monitoring committee: No (lowers risk) · Design
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Drug's FAERS reports marked serious: 94.6% (raises risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 17 (lowers risk) · Sponsor's track record
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Maximum age: not given (raises risk) · Who can join
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Blinding: none (raises risk) · Design
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Drug's FAERS reports before start: 3419 (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
- sponsor
- Collaborators
- 0
- Keywords listed
- 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
- 42 (typical: 32)
- Sponsor's past termination rate
- 16.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 17 (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
- 3419 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 465 (typical: 412.5)
- Drug's FAERS reports marked serious
- 94.6% (typical: 85.6%)
- Drug's FAERS reports with a death
- 23.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer
- Drugs matched to FDA substances
- macitentan, temozolomide
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
- Clinical Study on Macitentan, RT and TMZ Concurrent Therapy Followed by Maintenance Macitentan and TMZ in Newly Diagnosed Glioblastoma NCT02254954 · started 2015 · scored riskier than 70% of active trials terminated
- Dose-Intense Temozolomide in Recurrent Glioblastoma NCT00657267 · started 2008 · scored riskier than 99% of active trials completed
- Study to Evaluate Ibudilast and TMZ Combo Treatment in Newly Diagnosed and Recurrent Glioblastoma NCT03782415 · started 2018 · scored riskier than 94% of active trials completed
- 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
- ABT-888, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme NCT00770471 · started 2009 · scored riskier than 79% 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.