Trial to Assess the Efficacy of Midostaurin (PKC412) in Patients With c-KIT or FLT3-ITD Mutated t(8;21) AML
Model scores of the 29,894 trials active now.
Model score 25% 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 26% of the time (3,728 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
Completed on 2019-10-30, after 2013-03-13 start.
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 2019-10-30. 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
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: chemotherapymarrowboneamlleukemia
Phrases that lowered it: the efficacyefficacy oftrial tosinglecombination -
Drug's FAERS reports with a death: 56.2% (raises risk) · Drug's FDA history
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Accepts healthy volunteers: No (raises risk) · Who can join
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Disease area, cancer: Yes (raises risk) · Disease area
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Phase: 2 (raises risk) · Design
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Design: single group (raises risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Sponsor's past termination rate: 7.1% (raises risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Number of arms: 1 (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 11 (raises risk) · Sponsor's track record
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Collaborators: 1 (raises risk) · Design
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Maximum age: 65 (lowers risk) · Who can join
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Drug's FAERS reports marked serious: 100% (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
- 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
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 7 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 65 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 42 (typical: 32)
- Sponsor's past termination rate
- 7.1% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 11 (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
- 16 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 9 (typical: 412.5)
- Drug's FAERS reports marked serious
- 100% (typical: 85.6%)
- Drug's FAERS reports with a death
- 56.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, hematology
- Drugs matched to FDA substances
- midostaurin
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 Global Study of the Efficacy and Safety of Midostaurin + Chemotherapy in Newly Diagnosed Patients With FLT3 Mutation Negative (FLT3-MN) Acute Myeloid Leukemia (AML) NCT03512197 · started 2018 · scored riskier than 71% of active trials completed
- Protocol in Acute Myeloid Leukemia With FLT3-ITD NCT01477606 · started 2012 · scored riskier than 57% of active trials completed
- A Study of Midostaurin Efficacy and Safety in Newly Diagnosed Patients With FLT3-mutated AML NCT03280030 · started 2018 · scored riskier than 64% of active trials completed
- Standard of Care +/- Midostaurin to Prevent Relapse Post Stem Cell Transplant in Patients With FLT3-ITD Mutated AML NCT01883362 · started 2014 · scored riskier than 70% of active trials completed
- Imatinib Mesylate in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia Who Have Received Chemotherapy NCT00509093 · started 2008 · scored riskier than 94% 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.