Dose Finding Study of BKM 120 in Combination With LH-RH Agonists and Bicalutamide in Men With Non Castrate Metastatic Prostate Cancer

NCT02487823 on ClinicalTrials.gov Phase 1 Institut Paoli-Calmettes (academic or other) Started 2014-10-31 Terminated

Riskier than 64% of active trials

Model scores of the 29,894 trials active now.

Model score 19% for any early termination, 7% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 11% of the time (918 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 2017-11-30, after 2014-10-31 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 2017-11-30. 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: ventricularcarcinomasquamous cellcardiacconcurrent
Phrases that lowered it: moderatediseasesdays beforeas judgedjudged by
Phase: 1 (lowers risk) · Design
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
Accepts healthy volunteers: No (raises risk) · Who can join
Design: single group (raises risk) · Design
Sponsor type: academic or other (raises risk) · Sponsor's track record
Disease area, cancer: No (lowers risk) · Disease area
Drug's FAERS reports with a death: 22.5% (raises risk) · Drug's FDA history
Minimum age: 18 (raises risk) · Who can join
Number of arms: 3 (lowers risk) · Design
Responsible party: sponsor (lowers risk) · Design
Sponsor's past trials: 7 (raises risk) · Sponsor's track record
Has a data monitoring committee: No (lowers risk) · Design
Primary purpose: treatment (raises risk) · Design
Keywords listed: 0 (raises risk) · Design
Trials the sponsor started in the prior 2 years: 15 (raises risk) · Sponsor's track record
Collaborators: 1 (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 (typical: 2)
Number of arms: 3 (typical: 2)
Allocation: non randomized (typical: randomized)
Design: single group (typical: parallel)
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 1 (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: 7 (typical: 32)
Sponsor's past termination rate: 0% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 15 (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: 4562 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 628 (typical: 412.5)
Drug's FAERS reports marked serious: 88.2% (typical: 85.6%)
Drug's FAERS reports with a death: 22.5% (typical: 15.9%)

Disease area and drugs

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

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

Neoadjuvant BKM120 in High-risk Prostate Cancer NCT01695473 · started 2013 · scored riskier than 96% of active trials terminated
BKM120 and Fulvestrant for Treating Postmenopausal Patients With Estrogen Receptor-Positive Stage IV Breast Cancer NCT01339442 · started 2011 · scored riskier than 92% of active trials completed
STAR Cape+BKM120 MBC With Brain Met NCT02000882 · started 2014 · scored riskier than 97% of active trials completed
BKM120 + Carboplatin + Paclitaxel for Patients With Advanced Solid Tumors NCT01297452 · started 2011 · scored riskier than 41% of active trials completed
BKM120 + mFOLFOX6 in Advanced Solid Tumors With Expansion Cohort Pancreatic Cancer NCT01571024 · started 2012 · scored riskier than 54% 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.