A Study of ASTX660 as a Single Agent and in Combination With ASTX727 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (AML)
Model scores of the 29,894 trials active now.
Model score 22% for any early termination, 2% 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 (1,938 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2022-01-14, after 2020-06-12 start.
Reason given by the sponsor: “other”
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 2022-01-14. 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
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: leukemiaamlmyeloidchemotherapytherapy
Phrases that lowered it: pharmacokineticsparticipantparticipantssafetyprostate -
Sponsor's past termination rate: 16.7% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 1 (lowers risk) · Design
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Has a data monitoring committee: not given (lowers risk) · Design
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Drug's FAERS reports with a death: 31.0% (raises risk) · Drug's FDA history
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Disease area, cancer: Yes (raises risk) · Disease area
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Minimum age: 18 (raises risk) · Who can join
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Primary purpose: treatment (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 3 (raises risk) · Sponsor's track record
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Design: sequential (raises risk) · Design
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Number of arms: 3 (lowers risk) · Design
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Drug's FAERS reports marked serious: 94.6% (raises risk) · Drug's FDA history
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Maximum age: not given (raises risk) · Who can join
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Keywords listed: 16 (raises risk) · Design
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Responsible party: sponsor (lowers risk) · Design
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
- 3 (typical: 2)
- Allocation
- non randomized (typical: randomized)
- Design
- sequential (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 16 (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
- industry (typical: academic or other)
- Sponsor's past trials
- 24 (typical: 32)
- Sponsor's past termination rate
- 16.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 3 (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
- 2263 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 479 (typical: 412.5)
- Drug's FAERS reports marked serious
- 94.6% (typical: 85.6%)
- Drug's FAERS reports with a death
- 31.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, hematology
- Drugs matched to FDA substances
- cedazuridine, cedazuridine decitabine, decitabine
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 Astarabine in Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia NCT02544438 · started 2015 · scored riskier than 90% of active trials completed
- Study of ASTX727 vs IV Decitabine in Participants With MDS, CMML, and AML NCT03306264 · started 2018 · scored riskier than 33% of active trials completed
- Effect of Food on Blood Levels of ASTX727 NCT03813186 · started 2018 · scored riskier than 33% of active trials completed
- A Dose Optimisation Study of ASLAN003 in Acute Myeloid Leukemia NCT03451084 · started 2018 · scored riskier than 39% of active trials completed
- Efficacy Study for AC220 to Treat Acute Myeloid Leukemia (AML) NCT00989261 · started 2009 · scored riskier than 67% 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.