Phase Ib Study of SUnitinib Alternating With REgorafenib in Patients With Metastatic and/or Unresectable GIST
Model scores of the 29,894 trials active now.
Model score 19% for any early termination, 5% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 23% of the time (1,629 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 2021-05-31, after 2014-07-31 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 2021-05-31. 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: cellpatients mustmalignancysymptomssquamous
Phrases that lowered it: participantsopen labelstudy drugcombinationknown or -
Phase: 1 (lowers risk) · Design
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Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past termination rate: 14.4% (raises risk) · Sponsor's track record
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Has a data monitoring committee: Yes (raises risk) · Design
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Drug's FAERS reports with a death: 31.2% (raises risk) · Drug's FDA history
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Disease area, cancer: Yes (raises risk) · Disease area
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Design: single group (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 50 (lowers risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
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Sponsor's past trials: 195 (lowers risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 84.8% (lowers risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Responsible party: principal investigator (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
- 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
- principal investigator (typical: sponsor)
- Collaborators
- 2 (typical: 0)
- Keywords listed
- 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
- academic or other
- Sponsor's past trials
- 195 (typical: 32)
- Sponsor's past termination rate
- 14.4% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 50 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 19267 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 3707 (typical: 412.5)
- Drug's FAERS reports marked serious
- 84.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 31.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, digestive
- Drugs matched to FDA substances
- regorafenib, sunitinib
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
- Regorafenib in Patients With Metastatic and/or Unresectable Gastrointestinal Stromal Tumor NCT01068769 · started 2010 · scored riskier than 84% of active trials completed
- Study of Regorafenib as a 3rd-line or Beyond Treatment for Gastrointestinal Stromal Tumors (GIST) NCT01271712 · started 2011 · scored riskier than 29% of active trials completed
- Phase II Study of Regorafenib Continuous Dosing of Regorafenib in Patients With GISTs NCT02889328 · started 2016 · scored riskier than 66% of active trials completed
- A Study to Assess DCC-2618 and Sunitinib in Patients With Advanced GIST After Treatment With Imatinib NCT04633122 · started 2020 · scored riskier than 91% of active trials completed
- Single Agent Regorafenib in First-line for Metastatic/Unresectable KIT/PDGFR Wild Type GIST NCT02638766 · started 2015 · scored riskier than 75% 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.