RO4929097 and Whole-Brain Radiation Therapy or Stereotactic Radiosurgery in Treating Patients With Brain Metastases From Breast Cancer

NCT01217411 on ClinicalTrials.gov Phase 1/2 National Cancer Institute (NCI) (government) Started 2010-10-01 Terminated

Riskier than 91% of active trials

Model scores of the 29,894 trials active now.

Model score 26% for any early termination, 4% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 30% of the time (96 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 2011-11-30, after 2010-10-01 start.

Reason given by the sponsor: “other”

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 2011-11-30. 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: breast cancerpatientbrainher2lung cancer
Phrases that lowered it: patients whometastaticthe efficacycardiovascularpregnant
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 1/2 (raises risk) · Design
Has a data monitoring committee: not given (lowers risk) · Design
Disease area, cancer: Yes (raises risk) · Disease area
Disease area, dermatology: Yes (raises risk) · Disease area
Sponsor's past trials: 435 (lowers risk) · Sponsor's track record
Design: parallel (raises risk) · Design
Trials the sponsor started in the prior 2 years: 236 (lowers risk) · Sponsor's track record
Disease area, neurology: Yes (raises risk) · Disease area
Minimum age: 18 (raises risk) · Who can join
Drug's FAERS reports marked serious: 100% (raises risk) · Drug's FDA history
Sponsor type: government (lowers risk) · Sponsor's track record
Primary purpose: treatment (raises risk) · Design
Maximum age: not given (raises risk) · Who can join
Drug's FAERS reports with a death: 0% (lowers risk) · Drug's FDA history
Sponsor's past termination rate: 8.5% (raises risk) · Sponsor's track record

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: 2
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: not given (typical: 56% yes)
Responsible party: sponsor
Collaborators: 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: government (typical: academic or other)
Sponsor's past trials: 435 (typical: 32)
Sponsor's past termination rate: 8.5% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 236 (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: 2 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 1 (typical: 412.5)
Drug's FAERS reports marked serious: 100% (typical: 85.6%)
Drug's FAERS reports with a death: 0% (typical: 15.9%)

Disease area and drugs

Disease areas: cancer, neurology, respiratory, dermatology
Drugs matched to FDA substances: dimethyl

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

Gamma-secretase/Notch Signalling Pathway Inhibitor RO4929097 in Treating Patients With Advanced, Metastatic, or Recurrent Triple Negative Invasive Breast Cancer NCT01151449 · started 2010 · scored riskier than 95% of active trials terminated
RO4929097 in Treating Patients With Advanced Non-Small Cell Lung Cancer Who Have Recently Completed Treatment With Front-Line Chemotherapy NCT01193868 · started 2010 · scored riskier than 69% of active trials terminated
Gamma-Secretase/Notch Signalling Pathway Inhibitor RO4929097 in Treating Patients With Recurrent or Progressive Glioblastoma NCT01122901 · started 2010 · scored riskier than 97% of active trials terminated
RO4929097, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Malignant Glioma NCT01119599 · started 2010 · scored riskier than 55% of active trials completed
Gamma-Secretase/Notch Signalling Pathway Inhibitor RO4929097, Paclitaxel, and Carboplatin Before Surgery in Treating Patients With Stage II or Stage III Triple-Negative Breast Cancer NCT01238133 · started 2010 · scored riskier than 51% 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.