Study to Assess Safety and Preliminary Activity of Eribulin Mesylate in Pediatric Participants With Relapsed/Refractory Rhabdomyosarcoma (RMS), Non-rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS) and Ewing Sarcoma (EWS)
Model scores of the 29,894 trials active now.
Model score 18% 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 22% of the time (1,598 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2022-01-21, after 2018-04-17 start.
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 2022-01-21. 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: infusionpostsurgerytherapylong
Phrases that lowered it: participantsparticipantstudy periodscreeninghiv infected -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 2 (raises risk) · Design
-
Sponsor's past termination rate: 9.8% (raises risk) · Sponsor's track record
-
Disease area, cancer: Yes (raises risk) · Disease area
-
Design: parallel (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 37 (lowers risk) · Sponsor's track record
-
Sponsor's past trials: 235 (lowers risk) · Sponsor's track record
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Has a data monitoring committee: No (lowers risk) · Design
-
Primary purpose: treatment (raises risk) · Design
-
Maximum age: 18 (raises risk) · Who can join
-
Number of arms: 3 (lowers risk) · Design
-
Drug's FAERS reports with a death: 20.9% (lowers risk) · Drug's FDA history
-
Drug's FAERS reports before start: 2622 (raises risk) · Drug's FDA history
-
Responsible party: sponsor (lowers risk) · Design
-
Drug's FAERS reports marked serious: 91.9% (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
- 2
- Number of arms
- 3 (typical: 2)
- Allocation
- non randomized (typical: randomized)
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 2 (typical: 1)
Who can join
- Minimum age
- 1 (typical: 18)
- Maximum age
- 18 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 235 (typical: 32)
- Sponsor's past termination rate
- 9.8% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 37 (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
- 2622 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 512 (typical: 412.5)
- Drug's FAERS reports marked serious
- 91.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 20.9% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer
- Drugs matched to FDA substances
- eribulin
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
- Study Evaluating the Safety and Efficacy of Eribulin Mesilate in Combination With Irinotecan Hydrochloride in Children With Refractory or Recurrent Solid Tumors NCT03245450 · started 2018 · scored riskier than 48% of active trials completed
- This is a Phase 1 Study of Eribulin Mesylate in Pediatric Participants With Recurrent or Refractory Solid Tumors (Excluding [Central Nervous System] CNS), Including Lymphomas NCT02171260 · started 2014 · scored riskier than 20% of active trials completed
- Study of Azacitidine in Combination With Pembrolizumab in R/R AML Patients and in Newly Diagnosed Older Patients NCT02845297 · started 2016 · scored riskier than 85% of active trials completed
- A Study of Eribulin in Combination With Oral Irinotecan for Adolescent and Young Adult Patients With Relapsed or Refractory Solid Tumors NCT02596503 · started 2015 · scored riskier than 33% of active trials completed
- PAZIT Study for Children and Young Adults With Relapsed or Refractory Sarcoma NCT03139331 · started 2017 · scored riskier than 14% 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.