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 on ClinicalTrials.gov Phase 1/2 Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (industry) Started 2022-08-25 Terminated

Riskier than 33% of active trials

Model scores of the 29,894 trials active now.

Model score 14% for any early termination, 2% 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

Terminated on 2023-07-19, after 2022-08-25 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 2023-07-19. 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

Phase: 1/2 (raises risk) · Design
Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: cancerradiationpaclitaxelchemotherapyprior
Phrases that lowered it: lesionspatients whoscreeninginhibitorsmale
Accepts healthy volunteers: No (raises risk) · Who can join
Has a data monitoring committee: not given (lowers risk) · Design
Trials the sponsor started in the prior 2 years: 70 (lowers risk) · Sponsor's track record
Drug's FAERS reports with a death: 10.9% (lowers risk) · Drug's FDA history
Design: single group (raises risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Disease area, cancer: No (lowers risk) · Disease area
Minimum age: 18 (raises risk) · Who can join
Drug's FAERS reports marked serious: 77.2% (lowers risk) · Drug's FDA history
Maximum age: 85 (lowers risk) · Who can join
Sponsor's past termination rate: 8.1% (raises risk) · Sponsor's track record
Primary purpose: treatment (raises risk) · Design
Drug's FAERS reports before start: 402122 (lowers risk) · Drug's FDA history
Responsible party: sponsor (lowers risk) · Design
Number of arms: 1 (raises risk) · Design
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: single group (typical: parallel)
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: not given (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 0 (typical: 1)

Who can join

Minimum age: 18
Maximum age: 85 (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: 37 (typical: 32)
Sponsor's past termination rate: 8.1% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 70 (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: 402122 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 44719 (typical: 412.5)
Drug's FAERS reports marked serious: 77.2% (typical: 85.6%)
Drug's FAERS reports with a death: 10.9% (typical: 15.9%)

Disease area and drugs

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

Cabazitaxel and Abiraterone Acetate in Patients With Metastatic Castrate-Resistant Prostate Cancer NCT01511536 · started 2012 · scored riskier than 34% of active trials completed
Comparative Study of Abiraterone Acetate Tablets (I) or ZYTIGA® in Patients With Metastatic Castration-resistant Prostate Cancer NCT04862091 · started 2021 · scored riskier than 47% of active trials completed
TAVT-45 (Abiraterone Acetate) Granules in Patients With Prostate Cancer NCT04887506 · started 2021 · scored riskier than 32% of active trials completed
Biomarker Analysis of Castration-resistant Prostate Cancer Undergoing Bipolar Androgen Therapy NCT04424654 · started 2020 · scored riskier than 74% of active trials completed
A Phase II Study of Increased-Dose Abiraterone Acetate in Patients With Castration Resistant Prostate Cancer NCT01637402 · started 2013 · scored riskier than 67% 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.