Study to Evaluate the Safety and Preliminary Efficacy of 177Lu-OPS201 in NETs
Model scores of the 29,894 trials active now.
Model score 24% 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 29% of the time (655 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2022-02-22, after 2017-03-06 start.
Reason given by the sponsor: “other”
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 2022-02-22. 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: tumorcancerpatienttherapyreceptor
Phrases that lowered it: efficacythe studysafetyinvestigatorevaluate -
Sponsor's past termination rate: 21.4% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 1/2 (raises risk) · Design
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Disease area, cancer: Yes (raises risk) · Disease area
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Minimum age: 18 (raises risk) · Who can join
-
Design: sequential (lowers risk) · Design
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Drug's FAERS reports with a death: 19.6% (lowers risk) · Drug's FDA history
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Drug's FAERS reports in the prior 12 months: 33733 (lowers risk) · Drug's FDA history
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Number of arms: 1 (raises risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports marked serious: 85.5% (lowers risk) · Drug's FDA history
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Drug's FAERS reports before start: 135337 (lowers risk) · Drug's FDA history
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Blinding: none (raises risk) · Design
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Has a data monitoring committee: No (lowers risk) · Design
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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
- 1/2 (typical: 2)
- Number of arms
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- sequential (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 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
- 98 (typical: 32)
- Sponsor's past termination rate
- 21.4% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 14 (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
- 135337 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 33733 (typical: 412.5)
- Drug's FAERS reports marked serious
- 85.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 19.6% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer
- Drugs matched to FDA substances
- dexamethasone, ondansetron
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
- 177Lutetium-DOTA-Octreotate Therapy in Somatostatin Receptor-Expressing Neuroendocrine Neoplasms NCT01237457 · started 2010 · scored riskier than 99% of active trials completed
- Antitumor Efficacy of Peptide Receptor Radionuclide Therapy With 177Lutetium -Octreotate Randomized vs Sunitinib in Unresectable Progressive Well-differentiated Neuroendocrine Pancreatic Tumor: First Randomized Phase II NCT02230176 · started 2015 · scored riskier than 85% of active trials completed
- Peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-DOTATATE in Advanced Gastro-entero Pancreatic Neuroendocrine Tumors NCT02489604 · started 2013 · scored riskier than 96% of active trials terminated
- 68Ga-OPS202 Study for Diagnostic Imaging of GEP NET NCT02162446 · started 2014 · scored riskier than 75% of active trials completed
- Evaluate the Safety, Tolerability, Biodistribution and Anti Tumour Activity of 177LU-OPS201 With Companion Imaging 68Ga-OPS202 PET/CT in Previously Treated Subjects With Locally Advanced or Metastatic Cancers Expressing Somatostatin Receptor 2 (SSTR2) NCT03773133 · started 2019 · scored riskier than 80% 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.