Ribociclib&Belinostat In Patients w Metastatic Triple Neg Breast Cancer & Recurrent Ovarian Cancer w Response Prediction By Genomics

NCT04315233 on ClinicalTrials.gov Phase 1 University of Utah (academic or other) Started 2021-05-03 Terminated

Riskier than 80% of active trials

Model scores of the 29,894 trials active now.

Model score 22% for any early termination, 6% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 23% of the time (1,629 trials).

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

How it ended

Terminated on 2025-09-25, after 2021-05-03 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 2025-09-25. 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: patientcancerbowelmetastaticconcurrent
Phrases that lowered it: ovarianopenmalemonthsupper
Sponsor's past termination rate: 20.8% (raises risk) · Sponsor's track record
Phase: 1 (lowers risk) · Design
Accepts healthy volunteers: No (raises risk) · Who can join
Collaborators: 3 (lowers risk) · Design
Disease area, cancer: Yes (raises risk) · Disease area
Trials the sponsor started in the prior 2 years: 93 (lowers risk) · Sponsor's track record
Design: single group (raises risk) · Design
Sponsor type: academic or other (raises risk) · Sponsor's track record
Has a data monitoring committee: Yes (raises risk) · Design
Drug's FAERS reports with a death: 17.0% (lowers risk) · Drug's FDA history
Primary purpose: treatment (raises risk) · Design
Minimum age: 18 (raises risk) · Who can join
Sponsor's past trials: 331 (lowers risk) · Sponsor's track record
Drug's FAERS reports marked serious: 81.9% (lowers risk) · Drug's FDA history
Disease area, dermatology: Yes (raises risk) · Disease area
Maximum age: not given (raises risk) · Who can join
Responsible party: sponsor (lowers risk) · Design
Keywords listed: 0 (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: 2
Allocation: non randomized (typical: randomized)
Design: single group (typical: parallel)
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: Yes (typical: 56% yes)
Responsible party: sponsor
Collaborators: 3 (typical: 0)
Keywords listed: 0 (typical: 1)

Who can join

Minimum age: 18
Maximum age: not given (typical: 71)
Sex: all
Accepts healthy volunteers: No (typical: 9% yes)

Sponsor's track record

Sponsor type: academic or other
Sponsor's past trials: 331 (typical: 32)
Sponsor's past termination rate: 20.8% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 93 (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: 8587 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 3201 (typical: 412.5)
Drug's FAERS reports marked serious: 81.9% (typical: 85.6%)
Drug's FAERS reports with a death: 17.0% (typical: 15.9%)

Disease area and drugs

Disease areas: cancer, dermatology, urogenital, endocrine
Drugs matched to FDA substances: belinostat, ribociclib

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

A Trial of Ribocilcib (LEE011) and Weekly Paclitaxel in Patients With Rb+ Advanced Breast Cancer NCT02599363 · started 2016 · scored riskier than 63% of active trials completed
Open-Label Study Evaluating the Safety and Tolerability of LJM716, BYL719 and Trastuzumab in Patients With Metastatic HER2+ Breast Cancer NCT02167854 · started 2014 · scored riskier than 23% of active trials completed
Ribociclib and Aromatase Inhibitor in Treating Older Participants With Hormone Receptor Positive Metastatic Breast Cancer NCT03477396 · started 2018 · scored riskier than 98% of active trials completed
The BURAN Study of Buparlisib in Patients With Recurrent or Metastatic HNSCC NCT04338399 · started 2020 · scored riskier than 68% of active trials completed
BEZ235 in Patients With Advanced Renal Cell Carcinoma (RCC) NCT01453595 · started 2011 · scored riskier than 73% 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.