A Study Evaluating Regorafenib Following Completion of Standard Chemotherapy for Patients With Colon Cancer
Model scores of the 29,894 trials active now.
Model score 33% for any early termination, 16% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 20% of the time (607 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2019-10-31, after 2016-06-30 start.
Reason given by the sponsor: “enrollment”
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 2019-10-31. 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: randomizationequal toor equalimagingprior to
Phrases that lowered it: openoxaliplatinproteincarcinomainfection -
Sponsor's past termination rate: 20% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 3 (lowers risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Design: parallel (raises risk) · Design
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Disease area, cancer: Yes (raises risk) · Disease area
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 2 (raises risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
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Drug's FAERS reports with a death: 22.4% (raises risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports before start: 3000 (raises risk) · Drug's FDA history
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Drug's FAERS reports in the prior 12 months: 797 (raises risk) · Drug's FDA history
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Maximum age: not given (raises risk) · Who can join
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Keywords listed: 5 (lowers risk) · Design
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Blinding: quadruple (lowers risk) · Design
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Collaborators: 1 (raises risk) · Design
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Number of arms: 2 (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
- 3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 5 (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
- academic or other
- Sponsor's past trials
- 30 (typical: 32)
- Sponsor's past termination rate
- 20% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 2 (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
- 3000 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 797 (typical: 412.5)
- Drug's FAERS reports marked serious
- 88.0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 22.4% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, digestive
- Drugs matched to FDA substances
- regorafenib
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
- Study of Colorectal Cancer Patients (Stage IIIC) With Either Regorafenib or Standard of Care (No Treatment) After Adjuvant FOLFOX NCT02425683 · started 2015 · scored riskier than 92% of active trials terminated
- Lower or Standard Dose Regorafenib in Treating Patients With Refractory Metastatic Colorectal Cancer NCT02368886 · started 2015 · scored riskier than 88% of active trials completed
- Colorectal Cancer Treated With Adjuvant Regorafenib Versus Placebo After Curative Treatment of Liver Metastases in a Randomized, Double-blind, Placebo-Controlled Phase-III STudy NCT01939223 · started 2013 · scored riskier than 56% of active trials terminated
- Regorafenib Plus 5-Fluorouracil/Leucovorin Beyond Progression in mCRC NCT03099486 · started 2017 · scored riskier than 75% of active trials terminated
- Regorafenib in Good Performance Status Patients With Newly Diagnosed Metastatic Colorectal Adenocarcinoma NCT02023333 · started 2013 · scored riskier than 61% 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.