A Phase I Study of Vorinostat and Bortezomib in Children With Refractory of Recurrent Solid Tumors, Including CNS Tumors and Lymphomas
Model scores of the 29,894 trials active now.
Model score 19% for any early termination, 5% 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
Completed on 2011-04-13, after 2010-05-10 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 2011-04-13. 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: tumoreffectscellssafetumors
Phrases that lowered it: participantspharmacokineticspatientsdrugscycle -
Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 1 (lowers risk) · Design
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Has a data monitoring committee: not given (lowers risk) · Design
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Drug's FAERS reports with a death: 27.7% (raises risk) · Drug's FDA history
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Sponsor's past trials: 393 (lowers risk) · Sponsor's track record
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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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Trials the sponsor started in the prior 2 years: 220 (lowers risk) · Sponsor's track record
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Responsible party: not given (raises risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Maximum age: 21 (raises risk) · Who can join
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Drug's FAERS reports marked serious: 90.0% (raises risk) · Drug's FDA history
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Number of arms: not given (raises risk) · Design
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Sponsor's past termination rate: 8.4% (lowers risk) · Sponsor's track record
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
- not given (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 10 (typical: 1)
Who can join
- Minimum age
- 1 (typical: 18)
- Maximum age
- 21 (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
- 393 (typical: 32)
- Sponsor's past termination rate
- 8.4% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 220 (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
- 6631 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1493 (typical: 412.5)
- Drug's FAERS reports marked serious
- 90.0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 27.7% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, immunology, urogenital, hematology
- Drugs matched to FDA substances
- bortezomib, vorinostat
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
- Vorinostat and Bortezomib in Treating Young Patients With Refractory or Recurrent Solid Tumors, Including Central Nervous System Tumors and Lymphoma NCT00994500 · started 2009 · scored riskier than 37% of active trials completed
- Vorinostat in Children NCT01422499 · started 2012 · scored riskier than 96% of active trials completed
- Clinical Study of Vorinostat in Combination With Etoposide in Pediatric Patients < 21 Years at Diagnosis With Refractory Solid Tumors NCT01294670 · started 2011 · scored riskier than 42% of active trials completed
- Vorinostat and Temozolomide in Treating Young Patients With Relapsed or Refractory Primary Brain Tumors or Spinal Cord Tumors NCT01076530 · started 2010 · scored riskier than 54% of active trials completed
- Vorinostat Combined With Isotretinoin and Chemotherapy in Treating Younger Patients With Embryonal Tumors of the Central Nervous System NCT00867178 · started 2009 · scored riskier than 27% 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.