A Parallel Arm Phase 1b/2a Study of DKN-01 as Monotherapy or in Combination With Docetaxel for the Treatment of Advanced Prostate Cancer With Elevated DKK1

NCT03837353 on ClinicalTrials.gov Phase 1/2 NYU Langone Health (academic or other) Started 2019-04-01 Terminated

Riskier than 53% of active trials

Model scores of the 29,894 trials active now.

Model score 17% 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 26% of the time (851 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

How it ended

Terminated on 2022-09-20, after 2019-04-01 start.

Reason given by the sponsor: “enrollment”

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 2022-09-20. 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: 21.3% (raises risk) · Sponsor's track record
Accepts healthy volunteers: No (raises risk) · Who can join
Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: carcinomaheartcancer2ainterval
Phrases that lowered it: patientsinvestigatorhormonegroupaminotransferase
Phase: 1/2 (raises risk) · Design
Maximum age: 100 (lowers risk) · Who can join
Trials the sponsor started in the prior 2 years: 144 (lowers risk) · Sponsor's track record
Disease area, cancer: Yes (raises risk) · Disease area
Has a data monitoring committee: Yes (raises risk) · Design
Drug's FAERS reports marked serious: 78.5% (lowers risk) · Drug's FDA history
Sponsor's past trials: 315 (lowers risk) · Sponsor's track record
Sponsor type: academic or other (raises risk) · Sponsor's track record
Design: parallel (raises risk) · Design
Drug's FAERS reports with a death: 11.3% (lowers risk) · Drug's FDA history
Primary purpose: treatment (raises risk) · Design
Number of arms: 4 (lowers risk) · Design
Minimum age: 18 (raises risk) · Who can join
Drug's FAERS reports in the prior 12 months: 16601 (lowers risk) · Drug's FDA history
Responsible party: sponsor (lowers risk) · Design
Drug's FAERS reports before start: 47888 (lowers risk) · Drug's FDA history

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: 4 (typical: 2)
Allocation: non randomized (typical: randomized)
Design: parallel
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: Yes (typical: 56% yes)
Responsible party: sponsor
Collaborators: 1 (typical: 0)
Keywords listed: 0 (typical: 1)

Who can join

Minimum age: 18
Maximum age: 100 (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: 315 (typical: 32)
Sponsor's past termination rate: 21.3% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 144 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 1
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 47888 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 16601 (typical: 412.5)
Drug's FAERS reports marked serious: 78.5% (typical: 85.6%)
Drug's FAERS reports with a death: 11.3% (typical: 15.9%)

Disease area and drugs

Disease areas: cancer, urogenital
Drugs matched to FDA substances: dkn01, docetaxel

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

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Clinical Study of Atezolizumab (Anti-PD-L1) and Sipuleucel-T in Patients With Asymptomatic or Minimally Symptomatic Metastatic Castrate Resistant Prostate Cancer NCT03024216 · started 2017 · scored riskier than 35% of active trials completed
Dose-Escalation and Efficacy Study of LAE001/Prednisone Plus Afuresertib Patients With m-CRPC NCT04060394 · started 2019 · scored riskier than 41% 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
Genetic and Molecular Mechanisms in Assessing Response in Patients With Prostate Cancer Receiving Enzalutamide Therapy NCT02099864 · started 2014 · scored riskier than 97% 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.