CB-839 in Combination With Niraparib in Platinum Resistant BRCA -Wild-type Ovarian Cancer Patients

NCT03944902 on ClinicalTrials.gov Phase 1 University of Alabama at Birmingham (academic or other) Started 2021-09-01 Terminated

Riskier than 68% of active trials

Model scores of the 29,894 trials active now.

Model score 20% for any early termination, 10% 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 2022-01-05, after 2021-09-01 start.

Reason given by the sponsor: “business”

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 2022-01-05. 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: prostateto determinecancerradiationcell
Phrases that lowered it: aminotransferasecombinationthe efficacypatientsuln
Phase: 1 (lowers risk) · Design
Accepts healthy volunteers: No (raises risk) · Who can join
Sponsor's past termination rate: 12.9% (raises risk) · Sponsor's track record
Disease area, cancer: Yes (raises risk) · Disease area
Has a data monitoring committee: Yes (raises risk) · Design
Trials the sponsor started in the prior 2 years: 135 (lowers risk) · Sponsor's track record
Drug's FAERS reports with a death: 7.3% (lowers risk) · Drug's FDA history
Sponsor type: academic or other (raises risk) · Sponsor's track record
Drug's FAERS reports marked serious: 67.0% (lowers risk) · Drug's FDA history
Primary purpose: treatment (raises risk) · Design
Minimum age: 18 (raises risk) · Who can join
Sponsor's past trials: 464 (lowers risk) · Sponsor's track record
Responsible party: principal investigator (lowers risk) · Design
Number of arms: 3 (lowers risk) · Design
Maximum age: not given (raises risk) · Who can join
Design: sequential (lowers 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: sequential (typical: parallel)
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: Yes (typical: 56% yes)
Responsible party: principal investigator (typical: sponsor)
Collaborators: 0
Keywords listed: 3 (typical: 1)

Who can join

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

Sponsor's track record

Sponsor type: academic or other
Sponsor's past trials: 464 (typical: 32)
Sponsor's past termination rate: 12.9% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 135 (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: 11206 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 3259 (typical: 412.5)
Drug's FAERS reports marked serious: 67.0% (typical: 85.6%)
Drug's FAERS reports with a death: 7.3% (typical: 15.9%)

Disease area and drugs

Disease areas: cancer, urogenital, endocrine
Drugs matched to FDA substances: niraparib

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 Maintenance Study With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer NCT01847274 · started 2013 · scored riskier than 84% of active trials completed
A Single-Arm Study Evaluating Carboplatin/Gemcitabine in Combination With BSI-201 in Patients With Platinum-Resistant Recurrent Ovarian Cancer NCT01033292 · started 2009 · scored riskier than 82% of active trials completed
A Single-Arm Study Evaluating Carboplatin/Gemcitabine in Combination With BSI-201 in Patients With Platinum-Sensitive Recurrent Ovarian Cancer NCT01033123 · started 2009 · scored riskier than 86% of active trials completed
A Study of Niraparib in Patients With Ovarian Cancer Who Have Received Three or Four Previous Chemotherapy Regimens NCT02354586 · started 2015 · scored riskier than 93% of active trials completed
Single Arm Study of BSI-201 in Patients With BRCA-1 or BRCA-2 Associated Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer NCT00677079 · started 2008 · scored riskier than 86% 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.