An Open Label Dose Escalation Safety Study of Convection-Enhanced Delivery of IL13-PE38QQR in Patients With Progressive Pediatric Diffuse Infiltrating Brainstem Glioma and Supratentorial High-grade Glioma
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 24% of the time (231 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 2015-06-05, after 2009-04-07 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 2015-06-05. 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: pediatricgreater thanbraintoxineffects
Phrases that lowered it: patientsdoseinvestigatorhealthyopen label -
Sponsor's past termination rate: 3.4% (lowers risk) · Sponsor's track record
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Phase: 1 (lowers risk) · Design
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Accepts healthy volunteers: No (raises risk) · Who can join
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Disease area, cancer: Yes (raises risk) · Disease area
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Has a data monitoring committee: not given (lowers risk) · Design
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Trials the sponsor started in the prior 2 years: 7 (raises risk) · Sponsor's track record
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Design: single group (raises risk) · Design
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Maximum age: 17 (raises risk) · Who can join
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Disease area, neurology: Yes (raises risk) · Disease area
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Primary purpose: treatment (raises risk) · Design
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Number of arms: not given (lowers risk) · Design
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Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
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Minimum age: not given (raises risk) · Who can join
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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
- 1 (typical: 2)
- Number of arms
- not given (typical: 2)
- Allocation
- non randomized (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 6 (typical: 1)
Who can join
- Minimum age
- not given (typical: 18)
- Maximum age
- 17 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- government (typical: academic or other)
- Sponsor's past trials
- 88 (typical: 32)
- Sponsor's past termination rate
- 3.4% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 7 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 0 (typical: 1)
- Drug has FAERS history
- No (typical: 64% yes)
- Drug's FAERS reports before start
- 0 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 0 (typical: 412.5)
- Drug's FAERS reports marked serious
- no FAERS history (typical: 85.6%)
- Drug's FAERS reports with a death
- no FAERS history (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, neurology
- Drugs matched to FDA substances
- none matched
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
- D2C7 for Adult Patients With Recurrent Malignant Glioma NCT02303678 · started 2015 · scored riskier than 90% of active trials completed
- PDGFR Inhibitor Crenolanib in Children/Young Adults With Diffuse Intrinsic Pontine Glioma or Recurrent High-Grade Glioma NCT01393912 · started 2011 · scored riskier than 89% of active trials completed
- Phase I Study of Cellular Immunotherapy for Recurrent/Refractory Malignant Glioma Using Intratumoral Infusions of GRm13Z40-2, An Allogeneic CD8+ Cytolitic T-Cell Line Genetically Modified to Express the IL 13-Zetakine and HyTK and to be Resistant to Glucocorticoids, in Combination With Interleukin-2 NCT01082926 · started 2010 · scored riskier than 44% of active trials completed
- Molecularly Determined Treatment of Diffuse Intrinsic Pontine Gliomas (DIPG) NCT01182350 · started 2011 · scored riskier than 67% of active trials terminated
- Convection-enhanced Delivery of OS2966 for Patients With High-grade Glioma Undergoing a Surgical Resection NCT04608812 · started 2021 · scored riskier than 64% 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.