A Study of Tazemetostat With Enzalutamide or Abiraterone/Prednisone in Participants With Advanced Prostate Cancer

NCT04179864 on ClinicalTrials.gov Phase 1/2 Epizyme, Inc. (industry) Started 2019-11-18 Terminated

Riskier than 31% of active trials

Model scores of the 29,894 trials active now.

Model score 13% 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 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 2024-11-04, after 2019-11-18 start.

Reason given by the sponsor: “efficacy”

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 2024-11-04. 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

Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
Phase: 1/2 (raises risk) · Design
Accepts healthy volunteers: No (raises risk) · Who can join
Disease area, cancer: Yes (raises risk) · Disease area
Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: cancerpriorsubjectbonetreatment with
Phrases that lowered it: prostateabirateronecastrationresistantandrogen
Drug's FAERS reports with a death: 12.9% (lowers risk) · Drug's FDA history
Number of arms: 4 (lowers risk) · Design
Drug's FAERS reports marked serious: 71.3% (lowers risk) · Drug's FDA history
Sponsor type: industry (lowers risk) · Sponsor's track record
Minimum age: 18 (raises risk) · Who can join
Primary purpose: treatment (raises risk) · Design
Sponsor's past trials: 4 (raises risk) · Sponsor's track record
Maximum age: not given (raises risk) · Who can join
Responsible party: sponsor (lowers risk) · Design
Has a data monitoring committee: No (lowers risk) · Design
Keywords listed: 9 (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: 4 (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: 9 (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: 4 (typical: 32)
Sponsor's past termination rate: 0% (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: 4 (typical: 1)
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 308047 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 49276 (typical: 412.5)
Drug's FAERS reports marked serious: 71.3% (typical: 85.6%)
Drug's FAERS reports with a death: 12.9% (typical: 15.9%)

Disease area and drugs

Disease areas: cancer, urogenital
Drugs matched to FDA substances: abiraterone, enzalutamide, prednisone, tazemetostat

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

A Study of ZEN003694 in Combination With Enzalutamide in Patients With Metastatic Castration-Resistant Prostate Cancer NCT02711956 · started 2016 · scored riskier than 55% of active trials completed
A Study of ZEN003694 in Patients With Metastatic Castration-Resistant Prostate Cancer NCT02705469 · started 2016 · scored riskier than 17% of active trials completed
Mitoxantrone ± Cetuximab 2nd Line Androgen Independent Prostate Cancer (AIPC) NCT00661492 · started 2008 · scored riskier than 99% of active trials completed
Study Comparing Orteronel Plus Prednisone in Participants With Metastatic Castration-Resistant Prostate Cancer. NCT01193257 · started 2010 · scored riskier than 42% of active trials completed
To Evaluate the Efficacy of TQB3823 Combined With Abiraterone and Prednisone in Metastatic Castration-resistant Prostate Cancer Patientsprednisone Acetate Tablets in Patients With Metastatic Castration-resistant Prostate Cancer NCT05405439 · started 2022 · scored riskier than 33% 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.