Dose-Escalation and Efficacy Study of LAE001/Prednisone Plus Afuresertib Patients With m-CRPC

NCT04060394 on ClinicalTrials.gov Phase 1/2 Laekna Limited (industry) Started 2019-09-13 Completed

Riskier than 41% of active trials

Model scores of the 29,894 trials active now.

Model score 15% for any early termination, 4% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 16% of the time (257 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

How it ended

Completed on 2024-03-30, after 2019-09-13 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 2024-03-30. 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

Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: enrollmentleftpatients mustcancercardiac
Phrases that lowered it: patients whodays beforemoderatemaletype diabetes
Phase: 1/2 (raises risk) · Design
Accepts healthy volunteers: No (raises risk) · Who can join
Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
Drug's FAERS reports with a death: 10.8% (lowers risk) · Drug's FDA history
Number of arms: 6 (lowers risk) · Design
Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
Has a data monitoring committee: Yes (raises risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Design: sequential (lowers risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Drug's FAERS reports marked serious: 74.1% (lowers risk) · Drug's FDA history
Minimum age: 18 (raises risk) · Who can join
Primary purpose: treatment (raises risk) · Design
Drug's FAERS reports before start: 237392 (lowers risk) · Drug's FDA history
Drug's FAERS reports in the prior 12 months: 39258 (lowers risk) · Drug's FDA history
Responsible party: sponsor (lowers risk) · Design
Sponsor's past trials: 0 (raises risk) · Sponsor's track record
Blinding: none (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: 6 (typical: 2)
Allocation: randomized
Design: sequential (typical: parallel)
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: Yes (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: 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: 0 (typical: 32)
Sponsor's past termination rate: no earlier finished trials (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 1 (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: 237392 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 39258 (typical: 412.5)
Drug's FAERS reports marked serious: 74.1% (typical: 85.6%)
Drug's FAERS reports with a death: 10.8% (typical: 15.9%)

Disease area and drugs

Disease areas: none of the 14 tracked areas
Drugs matched to FDA substances: afuresertib, prednisone

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

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Denosumab in Combination With Enzalutamide in Progressive Metastatic Castrate-resistant Prostate Cancer and Bone Metastases. NCT03869762 · started 2019 · scored riskier than 79% of active trials terminated
Onvansertib in Combination With Abiraterone and Prednisone in Adult Patients With Metastatic Castration-Resistant Prostate Cancer NCT03414034 · started 2018 · scored riskier than 55% 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.