Phase Ib/II Trials of RAD001 in Triple Negative Metastatic Breast Cancer

NCT01939418 on ClinicalTrials.gov Phase 1/2 National Cancer Center, Korea (government) Started 2013-08-31 Terminated

Riskier than 55% 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 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 2017-07-30, after 2013-08-31 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 2017-07-30. 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

Sponsor's past termination rate: 15.6% (raises risk) · Sponsor's track record
Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: metastaticgemcitabineuncontrolledpriorpulmonary
Phrases that lowered it: breast cancerthe efficacytrial20compare
Minimum age: 20 (lowers risk) · Who can join
Phase: 1/2 (raises risk) · Design
Accepts healthy volunteers: No (raises risk) · Who can join
Disease area, cancer: Yes (raises risk) · Disease area
Design: single group (raises risk) · Design
Trials the sponsor started in the prior 2 years: 24 (lowers risk) · Sponsor's track record
Drug's FAERS reports with a death: 25.2% (raises risk) · Drug's FDA history
Drug's FAERS reports in the prior 12 months: 6885 (lowers risk) · Drug's FDA history
Primary purpose: treatment (raises risk) · Design
Responsible party: principal investigator (lowers risk) · Design
Number of arms: 1 (raises risk) · Design
Drug's FAERS reports before start: 34933 (lowers risk) · Drug's FDA history
Maximum age: not given (raises risk) · Who can join
Drug's FAERS reports marked serious: 95.1% (raises 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: 1 (typical: 2)
Allocation: not applicable (typical: randomized)
Design: single group (typical: parallel)
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: principal investigator (typical: sponsor)
Collaborators: 0
Keywords listed: 4 (typical: 1)

Who can join

Minimum age: 20 (typical: 18)
Maximum age: not given (typical: 71)
Sex: female (typical: all)
Accepts healthy volunteers: No (typical: 9% yes)

Sponsor's track record

Sponsor type: government (typical: academic or other)
Sponsor's past trials: 32
Sponsor's past termination rate: 15.6% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 24 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 3 (typical: 1)
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 34933 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 6885 (typical: 412.5)
Drug's FAERS reports marked serious: 95.1% (typical: 85.6%)
Drug's FAERS reports with a death: 25.2% (typical: 15.9%)

Disease area and drugs

Disease areas: cancer, dermatology
Drugs matched to FDA substances: cisplatin, everolimus, gemcitabine

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 Phase 3, Multi-Center Study of Gemcitabine/Carboplatin, With or Without BSI-201, in Patients With ER-, PR-, and Her2-Negative Metastatic Breast Cancer NCT00938652 · started 2009 · scored riskier than 31% of active trials completed
A Double-blind Study of Paclitaxel in Combination With Reparixin or Placebo for Metastatic Triple-Negative Breast Cancer NCT02370238 · started 2015 · scored riskier than 97% of active trials completed
Study of Eryaspase in Combination With Chemotherapy Versus Chemotherapy Alone for the Treatment of TNBC (TRYbeCA-2) NCT03674242 · started 2019 · scored riskier than 69% of active trials terminated
RAD001 Plus Carboplatin in Breast Cancer Patients NCT01127763 · started 2010 · scored riskier than 96% of active trials completed
Study of SAR240550 (BSI-201) in Combination With Gemcitabine/Carboplatin, in Patients With Metastatic Triple Negative Breast Cancer NCT01045304 · started 2010 · scored riskier than 75% 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.