Volasertib + Decitabine in Patients With Acute Myeloid Leukemia (AML)
Model scores of the 29,894 trials active now.
Model score 12% for any early termination, 1% 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 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Terminated on 2016-05-15, after 2014-01-29 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 2016-05-15. 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: amlleukemiamdspriordecitabine
Phrases that lowered it: pharmacokineticsinvestigatorpatientsinvestigateaccording -
Phase: 1 (lowers risk) · Design
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 4.8% (lowers risk) · Sponsor's track record
-
Has a data monitoring committee: not given (lowers risk) · Design
-
Drug's FAERS reports with a death: 29.2% (raises risk) · Drug's FDA history
-
Design: sequential (lowers risk) · Design
-
Disease area, cancer: Yes (raises risk) · Disease area
-
Trials the sponsor started in the prior 2 years: 139 (lowers risk) · Sponsor's track record
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Sponsor's past trials: 228 (lowers risk) · Sponsor's track record
-
Drug's FAERS reports marked serious: 98.9% (raises risk) · Drug's FDA history
-
Responsible party: sponsor (lowers risk) · Design
-
Primary purpose: treatment (raises risk) · Design
-
Keywords listed: 0 (raises risk) · Design
-
Number of arms: 1 (raises risk) · Design
-
Minimum age: 65 (raises risk) · Who can join
-
Blinding: none (raises 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
- 1 (typical: 2)
- Allocation
- not given (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
- 0 (typical: 1)
Who can join
- Minimum age
- 65 (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
- 228 (typical: 32)
- Sponsor's past termination rate
- 4.8% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 139 (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
- 455 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 88 (typical: 412.5)
- Drug's FAERS reports marked serious
- 98.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 29.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, hematology
- Drugs matched to FDA substances
- decitabine, volasertib
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
- Phase I Dose Escalation Trial of Volasertib in Combination With Azacitidine in Patients With MDS or CMML NCT01957644 · started 2013 · scored riskier than 39% of active trials terminated
- Volasertib in Combination With Low-dose Cytarabine in Patients Aged 65 Years and Above With Previously Untreated Acute Myeloid Leukaemia, Who Are Ineligible for Intensive Remission Induction Therapy (POLO-AML-2) NCT01721876 · started 2013 · scored riskier than 41% of active trials completed
- A Study of Venetoclax in Combination With Low Dose Cytarabine Versus Low Dose Cytarabine Alone in Treatment Naive Patients With Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy NCT03069352 · started 2017 · scored riskier than 76% of active trials completed
- GLAD-AML - Glasdegib (Pf-04449913) With Two Standard Decitabine Regimens for Older Patients With Poor-risk Acute Myeloid Leukemia NCT04051996 · started 2019 · scored riskier than 80% of active trials terminated
- Study of ASTX727 vs IV Decitabine in Participants With MDS, CMML, and AML NCT03306264 · started 2018 · scored riskier than 33% 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.