PK Study to Assess Drug-drug Interaction and QTc Between Sitravatinib and a Cocktail of Substrates
Model scores of the 29,894 trials active now.
Model score 14% 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 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
Completed on 2022-12-22, after 2021-04-08 start.
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 2022-12-22. 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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Sponsor's past termination rate: 35% (raises risk) · Sponsor's track record
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Phase: 1 (lowers risk) · Design
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Accepts healthy volunteers: No (raises risk) · Who can join
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: advancedsolidtumormetastaticmarrow
Phrases that lowered it: interactiondrugeffect ofthe effectopen label -
Drug's FAERS reports with a death: 14.5% (lowers risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
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Design: sequential (lowers risk) · Design
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Drug's FAERS reports before start: 638698 (lowers risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports marked serious: 75.3% (lowers risk) · Drug's FDA history
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Number of arms: 3 (lowers risk) · Design
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Drug's FAERS reports in the prior 12 months: 69909 (lowers risk) · Drug's FDA history
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Maximum age: not given (raises risk) · Who can join
-
Trials the sponsor started in the prior 2 years: 7 (raises risk) · Sponsor's track record
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Has a data monitoring committee: No (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
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (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
- 20 (typical: 32)
- Sponsor's past termination rate
- 35% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 7 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 8 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 638698 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 69909 (typical: 412.5)
- Drug's FAERS reports marked serious
- 75.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 14.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- acetylcysteine, dextromethorphan, digoxin, midazolam, nivolumab, rosuvastatin, sitravatinib, warfarin
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
- Drug Interaction Study of SAR302503 in Patients With Solid Tumor NCT01585623 · started 2012 · scored riskier than 19% of active trials completed
- A Phase 1b Study to Assess Sitravatinib in Combination With Tislelizumab in Participants With Advanced Solid Tumors NCT03666143 · started 2018 · scored riskier than 21% of active trials completed
- Safety and Pharmacokinetics of SAR245408 Daily Oral in Patients With Solid Tumors NCT01392924 · started 2011 · scored riskier than 26% of active trials completed
- 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
- Study of Sitravatinib, Nivolumab and Ipilimumab in Advanced or Metastatic Clear-Cell Renal Cell Carcinoma or Other Solid Malignancies NCT04518046 · started 2020 · scored riskier than 78% 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.