Phase I Clinical Study of the Safety of Photodynamic Therapy (PDT) Using LS11 in Children With Plexiform Neurofibromas
Model scores of the 29,894 trials active now.
Model score 28% for any early termination, 17% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 23% of the time (1,629 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 2012-07-31, after 2008-07-31 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 2012-07-31. 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
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: patients musttumorchildrencminstitutional
Phrases that lowered it: lightintendedmedicalsignificantsafety of -
Phase: 1 (lowers risk) · Design
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Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past termination rate: 13.0% (raises risk) · Sponsor's track record
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Disease area, cancer: Yes (raises risk) · Disease area
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Has a data monitoring committee: Yes (raises risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Design: single group (raises risk) · Design
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Minimum age: 3 (lowers risk) · Who can join
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Maximum age: 21 (raises risk) · Who can join
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Trials the sponsor started in the prior 2 years: 20 (lowers risk) · Sponsor's track record
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Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
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Drug's FAERS reports before start: 0 (lowers risk) · Drug's FDA history
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Number of arms: 1 (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
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 4 (typical: 1)
Who can join
- Minimum age
- 3 (typical: 18)
- Maximum age
- 21 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 23 (typical: 32)
- Sponsor's past termination rate
- 13.0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 20 (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
- talaporfin
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
- Phase I Photodynamic Therapy (PDT) for Benign Dermal Neurofibromas (NF1) NCT01682811 · started 2012 · scored riskier than 57% of active trials completed
- Photodynamic Therapy for Benign Dermal Neurofibromas- Phase II NCT02728388 · started 2016 · scored riskier than 87% of active trials terminated
- Photodynamic Therapy (PDT) for Recurrent Pediatric Brain Tumors NCT01682746 · started 2013 · scored riskier than 92% of active trials completed
- Tolerability of Device Based Therapies for Neurofibromatosis Type 1 Cutaneous Neurofibromas NCT04730583 · started 2021 · scored riskier than 54% of active trials completed
- Efficacy of Skin Cooling in Reducing Pain Associated With Non-invasive Treatments of Neurofibromatosis Type 1 Cutaneous Neurofibromas NCT06132165 · started 2024 · scored riskier than 31% 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.