Prexasertib in Combination With MEC in Relapsed/Refractory AML and High Risk MDS - a Phase I Trial
Model scores of the 29,894 trials active now.
Model score 30% for any early termination, 12% 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 2019-03-29, after 2019-01-18 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 2019-03-29. 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: leukemiainstitutionaltransplantmdsacute
Phrases that lowered it: patients whorefractoryparticipantulnscreening -
Sponsor's past termination rate: 17.5% (raises risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 1 (lowers risk) · Design
-
Disease area, cancer: Yes (raises risk) · Disease area
-
Drug's FAERS reports with a death: 27.0% (raises risk) · Drug's FDA history
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Trials the sponsor started in the prior 2 years: 100 (lowers risk) · Sponsor's track record
-
Drug's FAERS reports marked serious: 96.9% (raises risk) · Drug's FDA history
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Design: single group (raises risk) · Design
-
Sponsor's past trials: 292 (lowers risk) · Sponsor's track record
-
Minimum age: 18 (raises risk) · Who can join
-
Primary purpose: treatment (raises risk) · Design
-
Collaborators: 1 (raises risk) · Design
-
Keywords listed: 7 (lowers risk) · Design
-
Drug's FAERS reports in the prior 12 months: 12390 (lowers risk) · Drug's FDA history
-
Drugs with FDA adverse-event history: 4 (lowers 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 (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
- Yes (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 7 (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
- 292 (typical: 32)
- Sponsor's past termination rate
- 17.5% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 100 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 4 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 63013 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 12390 (typical: 412.5)
- Drug's FAERS reports marked serious
- 96.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 27.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, hematology
- Drugs matched to FDA substances
- cytarabine, etoposide, mitoxantrone, prexasertib
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
- Bortezomib and Vorinostat in Treating Patients With High-Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia NCT00818649 · started 2009 · scored riskier than 97% of active trials terminated
- Phase II Study of the Combination of Mitoxantrone, Etoposide and Gemtuzumab Ozogamicin (MEGO) for Patients With Acute Myeloid Leukemia Refractory to Initial Standard Induction Therapy NCT03839446 · started 2019 · scored riskier than 79% of active trials completed
- Magrolimab, Azacitidine, and Venetoclax for the Treatment of Acute Myeloid Leukemia NCT04435691 · started 2020 · scored riskier than 88% of active trials terminated
- Prexasertib (LY2606368), Cytarabine, and Fludarabine in Patients With Relapsed or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome NCT02649764 · started 2016 · scored riskier than 98% of active trials completed
- Study of Plerixafor Combined With Cytarabine and Daunorubicin in Patients With Newly Diagnosed Acute Myeloid Leukemia NCT00990054 · started 2009 · scored riskier than 89% 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.