A Phase 2 Study to Evaluate the Safety and Efficacy of TAK-385, Together With a Leuprorelin Observational Cohort, in Participants With Prostate Cancer
Model scores of the 29,894 trials active now.
Model score 16% for any early termination, 3% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 22% of the time (1,598 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 2017-02-23, after 2014-03-26 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 2017-02-23. 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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Phase: 2 (raises risk) · Design
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Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past termination rate: 11.5% (raises risk) · Sponsor's track record
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Disease area, cancer: Yes (raises risk) · Disease area
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Drug's FAERS reports with a death: 24.9% (raises risk) · Drug's FDA history
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Design: parallel (raises risk) · Design
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Has a data monitoring committee: No (lowers risk) · Design
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Number of arms: 3 (lowers risk) · Design
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Trials the sponsor started in the prior 2 years: 23 (lowers risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
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Responsible party: sponsor (lowers risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Blinding: none (raises risk) · Design
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Keywords listed: 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
- 2
- Number of arms
- 3 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 1
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- male (typical: all)
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 52 (typical: 32)
- Sponsor's past termination rate
- 11.5% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 23 (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
- 2506 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 361 (typical: 412.5)
- Drug's FAERS reports marked serious
- 90.0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 24.9% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, urogenital
- Drugs matched to FDA substances
- leuprolide, relugolix
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
- Safety and Efficacy of TAK-385 for Patients With Localized Prostate Cancer NCT02135445 · started 2014 · scored riskier than 75% of active trials completed
- A Study of TAK-385 in Hormone Treatment-naïve Participants With Prostate Cancer NCT02141659 · started 2014 · scored riskier than 19% of active trials completed
- Study in Men With Prostate Cancer to Assess the Safety, Pharmacokinetics and Testosterone-Lowering Efficacy of TAK-448 NCT01132404 · started 2010 · scored riskier than 74% of active trials terminated
- Orteronel in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer NCT01866423 · started 2013 · scored riskier than 87% of active trials terminated
- A Study of Neoadjuvant TAK-700 and Leuprorelin Acetate Followed by Surgery Versus Surgery Alone NCT03211052 · started 2013 · scored riskier than 83% 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.