PLX2853 in Combination With Abiraterone Acetate and Prednisone and in Combination With Olaparib in Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

NCT04556617 on ClinicalTrials.gov Phase 1/2 Opna Bio LLC (industry) Started 2020-09-21 Terminated

Riskier than 72% of active trials

Model scores of the 29,894 trials active now.

Model score 20% 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 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 2022-05-24, after 2020-09-21 start.

Reason given by the sponsor: “business”

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 2022-05-24. 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: cancermetastaticcellcarcinomasubject
Phrases that lowered it: pharmacokineticspharmacodynamicsprostateevaluatemale
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
Number of arms: 5 (lowers risk) · Design
Disease area, cancer: Yes (raises risk) · Disease area
Drug's FAERS reports with a death: 11.4% (lowers risk) · Drug's FDA history
Trials the sponsor started in the prior 2 years: 2 (raises risk) · Sponsor's track record
Sponsor type: industry (lowers risk) · Sponsor's track record
Minimum age: 18 (raises risk) · Who can join
Drug's FAERS reports marked serious: 75.0% (lowers risk) · Drug's FDA history
Primary purpose: treatment (raises risk) · Design
Drug's FAERS reports in the prior 12 months: 55136 (lowers risk) · Drug's FDA history
Has a data monitoring committee: No (lowers risk) · Design
Design: parallel (raises risk) · Design
Drug's FAERS reports before start: 316260 (lowers risk) · Drug's FDA history
Maximum age: not given (raises risk) · Who can join
Responsible party: sponsor (lowers risk) · Design
Disease area, urogenital: Yes (raises risk) · Disease area

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: 5 (typical: 2)
Allocation: non randomized (typical: randomized)
Design: parallel
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 6 (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: 2 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 3 (typical: 1)
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 316260 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 55136 (typical: 412.5)
Drug's FAERS reports marked serious: 75.0% (typical: 85.6%)
Drug's FAERS reports with a death: 11.4% (typical: 15.9%)

Disease area and drugs

Disease areas: cancer, urogenital
Drugs matched to FDA substances: abiraterone, olaparib, plx2853, 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

Pilot Study of PLX3397 in Patients With Advanced Castration-Resistant Prostate Cancer (CRPC) NCT01499043 · started 2012 · scored riskier than 88% of active trials terminated
Enzalutamide and Niraparib in the Treatment of Metastatic Castrate-Resistant Prostate Cancer (CRPC) NCT02500901 · started 2016 · scored riskier than 27% of active trials terminated
Study to Assess Safety and Efficacy of AsiDNA in Combination with Olaparib in Participants with Recurrent Solid Tumors NCT05700669 · started 2023 · scored riskier than 67% of active trials completed
Phase 1/2A Study of TRC253, an Androgen Receptor Antagonist, in Metastatic Castration-resistant Prostate Cancer Patients NCT02987829 · started 2017 · scored riskier than 66% of active trials completed
ProSTAR: A Study Evaluating CPI-1205 in Patients With Metastatic Castration Resistant Prostate Cancer NCT03480646 · started 2017 · scored riskier than 63% 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.