Study of Cabozantinib (XL184) Versus Mitoxantrone Plus Prednisone in Men With Previously Treated Symptomatic Castration-resistant Prostate Cancer

NCT01522443 on ClinicalTrials.gov Phase 3 Exelixis (industry) Started 2012-03-31 Terminated

Riskier than 60% of active trials

Model scores of the 29,894 trials active now.

Model score 18% for any early termination, 8% 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 (927 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

Terminated on 2015-01-13, after 2012-03-31 start.

Reason given by the sponsor: “other”

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 2015-01-13. 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: 71.4% (raises risk) · Sponsor's track record
Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: boneradiationpainscancancer
Phrases that lowered it: evaluate thethe effecteffect ofwill evaluateformulations
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 3 (lowers risk) · Design
Disease area, cancer: Yes (raises risk) · Disease area
Has a data monitoring committee: Yes (raises risk) · Design
Drug's FAERS reports marked serious: 76.6% (lowers risk) · Drug's FDA history
Drug's FAERS reports with a death: 14.6% (lowers risk) · Drug's FDA history
Blinding: quadruple (lowers risk) · Design
Design: parallel (raises risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Drug's FAERS reports in the prior 12 months: 9870 (lowers risk) · Drug's FDA history
Minimum age: 18 (raises risk) · Who can join
Primary purpose: treatment (raises risk) · Design
Responsible party: sponsor (lowers risk) · Design
Drugs with FDA adverse-event history: 3 (lowers risk) · Drug's FDA history
Maximum age: not given (raises risk) · Who can join

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: 3 (typical: 2)
Number of arms: 2
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: quadruple (typical: none)
Has a data monitoring committee: Yes (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 4 (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: 7 (typical: 32)
Sponsor's past termination rate: 71.4% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 4 (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: 46258 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 9870 (typical: 412.5)
Drug's FAERS reports marked serious: 76.6% (typical: 85.6%)
Drug's FAERS reports with a death: 14.6% (typical: 15.9%)

Disease area and drugs

Disease areas: cancer, urogenital
Drugs matched to FDA substances: cabozantinib, mitoxantrone, 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

Study of Cabozantinib (XL184) Versus Prednisone in Men With Metastatic Castration-resistant Prostate Cancer Previously Treated With Docetaxel and Abiraterone or MDV3100 NCT01605227 · started 2012 · scored riskier than 41% of active trials completed
Docetaxel Versus Cabazitaxel Post Abiraterone or Enzalutamide NCT03764540 · started 2019 · scored riskier than 56% of active trials terminated
Phase I Cabazitaxel, Mitoxantrone, and Prednisone Metastatic Castration-Resistant Prostate Cancer NCT01594918 · started 2012 · scored riskier than 40% 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
Trial of Cabozantinib (XL184) in Castrate-Resistant Prostate Cancer Metastatic to Bone NCT01428219 · started 2012 · scored riskier than 98% 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.