Temsirolimus to Reverse Androgen Insensitivity for Castration-resistant Prostate Cancer

NCT01020305 on ClinicalTrials.gov Phase 1/2 Sandy Srinivas (academic or other) Started 2009-10-31 Terminated

Riskier than 86% of active trials

Model scores of the 29,894 trials active now.

Model score 24% for any early termination, 12% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 26% of the time (851 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 2012-04-30, after 2009-10-31 start.

Reason given by the sponsor: “enrollment”

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 2012-04-30. 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: cancercellheartcarcinomaprior
Phrases that lowered it: castrationresistant prostateprostate cancergroupdays before
Phase: 1/2 (raises risk) · Design
Accepts healthy volunteers: No (raises risk) · Who can join
Collaborators: 3 (lowers risk) · Design
Disease area, cancer: Yes (raises risk) · Disease area
Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
Responsible party: sponsor investigator (raises risk) · Design
Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
Sponsor type: academic or other (raises risk) · Sponsor's track record
Number of arms: 1 (raises risk) · Design
Has a data monitoring committee: Yes (raises risk) · Design
Sponsor's past trials: 0 (raises risk) · Sponsor's track record
Maximum age: not given (raises risk) · Who can join
Drug's FAERS reports with a death: 25.1% (raises risk) · Drug's FDA history
Minimum age: 18 (raises risk) · Who can join
Design: single group (raises risk) · Design
Primary purpose: treatment (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: Yes (typical: 56% yes)
Responsible party: sponsor investigator (typical: sponsor)
Collaborators: 3 (typical: 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: 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: 1 (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: 2202 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 768 (typical: 412.5)
Drug's FAERS reports marked serious: 89.6% (typical: 85.6%)
Drug's FAERS reports with a death: 25.1% (typical: 15.9%)

Disease area and drugs

Disease areas: cancer, urogenital
Drugs matched to FDA substances: bicalutamide, temsirolimus

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

Impact of Temsirolimus Therapy on Circulating Tumor Cell Biology In Men With Castration Resistant Metastatic Prostate Cancer NCT00887640 · started 2009 · scored riskier than 99% of active trials terminated
Single Agent Temsirolimus (Torisel®) in Chemotherapy-naïve Castration-Resistant Prostate Cancer Patients NCT00919035 · started 2009 · scored riskier than 46% of active trials completed
A Phase 2 Study to Evaluate Safety and Efficacy of Abiraterone in Participants With Prostate Cancer NCT01756638 · started 2012 · scored riskier than 23% of active trials completed
Safety and Efficacy of Therapies for Metastatic Castration-resistant Prostate Cancer (mCRPC) NCT04631601 · started 2021 · scored riskier than 48% of active trials terminated
ESK981 and Nivolumab for the Treatment of Metastatic Castration Resistant Prostate Cancer NCT04159896 · started 2019 · scored riskier than 79% 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.