Early Switch From First-Line Docetaxel/Prednisone to Cabazitaxel/Prednisone and the Opposite Sequence, Exploring Molecular Markers in Men With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

NCT01718353 on ClinicalTrials.gov Phase 2 Sanofi (industry) Started 2013-03-31 Completed

Riskier than 29% of active trials

Model scores of the 29,894 trials active now.

Model score 13% 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 13% of the time (1,304 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 2015-08-31, after 2013-03-31 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 2015-08-31. 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

Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 2 (raises risk) · Design
Sponsor's past termination rate: 12.0% (raises risk) · Sponsor's track record
Trials the sponsor started in the prior 2 years: 106 (lowers risk) · Sponsor's track record
Sponsor's past trials: 698 (raises risk) · Sponsor's track record
Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: cellcancerbonemetastaticcells
Phrases that lowered it: participantparticipantspulmonaryprostateclinical trial
Sponsor type: industry (lowers risk) · Sponsor's track record
Minimum age: 18 (raises risk) · Who can join
Drug's FAERS reports before start: 66279 (lowers risk) · Drug's FDA history
Drug's FAERS reports with a death: 15.1% (lowers risk) · Drug's FDA history
Disease area, cancer: No (lowers risk) · Disease area
Primary purpose: treatment (raises risk) · Design
Drug's FAERS reports in the prior 12 months: 15420 (lowers risk) · Drug's FDA history
Design: parallel (raises risk) · Design
Has a data monitoring committee: No (lowers risk) · Design
Drug's FAERS reports marked serious: 77.5% (lowers risk) · Drug's FDA history
Number of arms: 2 (raises risk) · Design
Keywords listed: 0 (lowers 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: 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: 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: 698 (typical: 32)
Sponsor's past termination rate: 12.0% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 106 (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: 66279 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 15420 (typical: 412.5)
Drug's FAERS reports marked serious: 77.5% (typical: 85.6%)
Drug's FAERS reports with a death: 15.1% (typical: 15.9%)

Disease area and drugs

Disease areas: none of the 14 tracked areas
Drugs matched to FDA substances: cabazitaxel, docetaxel, 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 at 20 mg/m² Compared to 25 mg/m² With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer NCT01308580 · started 2011 · scored riskier than 18% of active trials completed
Cabazitaxel Versus Docetaxel Both With Prednisone in Patients With Metastatic Castration Resistant Prostate Cancer NCT01308567 · started 2011 · scored riskier than 20% of active trials completed
Docetaxel Versus Cabazitaxel Post Abiraterone or Enzalutamide NCT03764540 · started 2019 · scored riskier than 56% of active trials terminated
Cabazitaxel Versus the Switch to Alternative AR Targeted Therapy Enzalutamide or Abiraterone in Metastatic Castration-Resistant Prostate Cancer (mCRPC) Primary Resistant Patients to Abiraterone or Enzalutamide NCT02379390 · started 2015 · scored riskier than 21% of active trials terminated
Cabazitaxel and Abiraterone Acetate in Patients With Metastatic Castrate-Resistant Prostate Cancer NCT01511536 · started 2012 · scored riskier than 34% 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.