A Study to Assess the Effects of Itraconazole, Rifampicin, and Omeprazole on Pharmacokinetics of Adavosertib
Model scores of the 29,894 trials active now.
Model score 8% 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 5% of the time (4,470 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2022-06-01, after 2021-06-28 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 2022-06-01. 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: advancedtransplantbrainmetastaticheart failure
Phrases that lowered it: pharmacokineticsopen labelthe effecteffect ofdiseases -
Phase: 1 (lowers risk) · Design
-
Design: crossover (lowers risk) · Design
-
Primary purpose: other (lowers risk) · Design
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Maximum age: 130 (lowers risk) · Who can join
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Sponsor's past termination rate: 8.1% (lowers risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 171 (lowers risk) · Sponsor's track record
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Sponsor's past trials: 1674 (raises risk) · Sponsor's track record
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: 9.6% (lowers risk) · Drug's FDA history
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Drug's FAERS reports in the prior 12 months: 35188 (raises risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Has a data monitoring committee: No (lowers risk) · Design
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Number of arms: 3 (lowers risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Drug's FAERS reports marked serious: 74.7% (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
- 3 (typical: 2)
- Allocation
- non randomized (typical: randomized)
- Design
- crossover (typical: parallel)
- Primary purpose
- other (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 4 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 130 (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
- 1674 (typical: 32)
- Sponsor's past termination rate
- 8.1% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 171 (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
- 381813 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 35188 (typical: 412.5)
- Drug's FAERS reports marked serious
- 74.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 9.6% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- adavosertib, itraconazole, omeprazole, rifampin
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
- Human Absorption, Distribution, Metabolism, and Excretion Study of [14C]Adavosertib NCT05008913 · started 2021 · scored riskier than 13% of active trials terminated
- A Study to Assess the Safety and Tolerability of Adavosertib for Patients With Advanced Solid Tumours NCT04949425 · started 2021 · scored riskier than 42% of active trials terminated
- Drug-drug Interaction Study With AZD5305 and Itraconazole in Patients With Advanced Solid Malignancies NCT05573724 · started 2022 · scored riskier than 22% of active trials completed
- Efficacy, Safety and Pharmacokinetics Study of Antroquinonol to Treat NSCLC NCT02047344 · started 2013 · scored riskier than 77% of active trials completed
- A Study of the Drug-Drug Interaction of RO5503781 and Posaconazole, the Relative Bioavailability of New Formulations of RO5503781 and the Food-Effect on the Pharmacokinetics of RO5503781 in Patients With Solid Tumors NCT01901172 · started 2013 · scored riskier than 11% 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.