Efficacy/Safety of CPI-613 in Combination With HD Cyt. and Mito. vs HD Cyt. and Mito. in Older Patients With R/R AML
Model scores of the 29,894 trials active now.
Model score 24% 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 16% of the time (927 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2022-01-19, after 2018-11-12 start.
Reason given by the sponsor: “efficacy”
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 2022-01-19. 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: amlcancercytarabineleukemiaheart
Phrases that lowered it: patients whocombinationdoseweeks beforecontaining -
Sponsor's past termination rate: 66.7% (raises risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 3 (lowers risk) · Design
-
Drug's FAERS reports with a death: 28.1% (raises risk) · Drug's FDA history
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Has a data monitoring committee: Yes (raises risk) · Design
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Disease area, cancer: Yes (raises risk) · Disease area
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Minimum age: 50 (lowers risk) · Who can join
-
Design: parallel (raises risk) · Design
-
Drug's FAERS reports marked serious: 94.8% (raises risk) · Drug's FDA history
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Drug's FAERS reports in the prior 12 months: 18125 (lowers risk) · Drug's FDA history
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
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Drug's FAERS reports before start: 96215 (lowers risk) · Drug's FDA history
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Responsible party: sponsor (lowers risk) · Design
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Drugs with FDA adverse-event history: 5 (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
- 3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 50 (typical: 18)
- Maximum age
- not given (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
- 3 (typical: 32)
- Sponsor's past termination rate
- 66.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 1 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 5 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 96215 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 18125 (typical: 412.5)
- Drug's FAERS reports marked serious
- 94.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 28.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, hematology
- Drugs matched to FDA substances
- cytarabine, etoposide, filgrastim, fludarabine, mitoxantrone
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
- Quizartinib With Azacitidine or Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome NCT01892371 · started 2013 · scored riskier than 98% of active trials completed
- Midostaurin and Azacitidine in Treating Elderly Patients With Acute Myelogenous Leukemia NCT01093573 · started 2009 · scored riskier than 88% of active trials completed
- PKC412 and 5-Azacytidine NCT01202877 · started 2011 · scored riskier than 99% of active trials completed
- Pevonedistat and Decitabine in Treating Patients With High Risk Acute Myeloid Leukemia NCT03009240 · started 2017 · scored riskier than 82% of active trials completed
- DS-1594b With or Without Azacitidine, Venetoclax, or Mini-HCVD for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia NCT04752163 · started 2021 · scored riskier than 94% 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.