A Clinical Study Evaluating the Safety of Peptide Receptor Radionuclide Therapy (PRRT) With 177Lu-DOTA0-Tyr3-Octreotate in Children With Refractory or Recurrent Neuroblastoma Expressing Somatostatin Receptors.
Model scores of the 29,894 trials active now.
Model score 20% for any early termination, 9% 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 in 2015 or later: the model never saw it during training.
How it ended
Completed on 2024-08-30, after 2023-04-17 start.
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
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 2024-08-30. 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: petbraintherapystemmri
Phrases that lowered it: startfunctionliveruln109 -
Sponsor's past termination rate: 23.8% (raises 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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Has a data monitoring committee: not given (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: 33.3% (raises risk) · Drug's FDA history
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 7 (raises risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Maximum age: 18 (raises risk) · Who can join
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Collaborators: 1 (raises risk) · Design
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Number of arms: 1 (raises risk) · Design
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Drug's FAERS reports in the prior 12 months: 0 (raises risk) · Drug's FDA history
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Minimum age: 1 (lowers risk) · Who can join
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
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 2 (typical: 1)
Who can join
- Minimum age
- 1 (typical: 18)
- Maximum age
- 18 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 42 (typical: 32)
- Sponsor's past termination rate
- 23.8% (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
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 6 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 0 (typical: 412.5)
- Drug's FAERS reports marked serious
- 83.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 33.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer
- Drugs matched to FDA substances
- lutetium
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
- Dosimetry-Guided, Peptide Receptor Radiotherapy (PRRT) With 90Y-DOTA- tyr3-Octreotide (90Y-DOTATOC) NCT03273712 · started 2017 · scored riskier than 96% of active trials completed
- 67Cu-SARTATE™ Peptide Receptor Radionuclide Therapy Administered to Pediatric Patients With High-Risk, Relapsed, Refractory Neuroblastoma NCT04023331 · started 2020 · scored riskier than 79% of active trials terminated
- Phase 1 Study of AlphaMedix™ in Adult Subjects With SSTR (+) NET NCT03466216 · started 2018 · scored riskier than 87% of active trials terminated
- Study to Evaluate the Safety and Preliminary Efficacy of 177Lu-OPS201 in NETs NCT02592707 · started 2017 · scored riskier than 85% of active trials terminated
- Study to Evaluate the Safety and Activity (Including Distribution) of 177Lu-3BP-227 in Subjects With Solid Tumours Expressing Neurotensin Receptor Type 1. NCT03525392 · started 2018 · scored riskier than 81% 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.