An Open Label Phase I Study to Eval the Safety and Tolerability of a Vaccine (GI-6207) Consisting of Whole, Heat-killed Recombinant Saccharomyces Cerevisiae (Yeast) Genetically Modified to Express CEA Protein in Adults With Metastatic CEA-expressing ...
Model scores of the 29,894 trials active now.
Model score 21% for any early termination, 7% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 24% of the time (231 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 2012-08-02, after 2009-03-13 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 2012-08-02. 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: equal toor equalgreatereffectsmetastatic
Phrases that lowered it: breast cancerextensionpatients wholabelopen -
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: 5.7% (lowers risk) · Sponsor's track record
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Maximum age: 120 (lowers risk) · Who can join
-
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: 213 (lowers risk) · Sponsor's track record
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Has a data monitoring committee: not given (lowers risk) · Design
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Sponsor's past trials: 283 (lowers risk) · Sponsor's track record
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Responsible party: not given (raises risk) · Design
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Disease area, dermatology: Yes (raises risk) · Disease area
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Minimum age: 18 (raises risk) · Who can join
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Drug's FAERS reports with a death: 12.5% (lowers risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Sponsor type: government (raises risk) · Sponsor's track record
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Number of arms: not given (lowers risk) · Design
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Disease area, respiratory: Yes (raises risk) · Disease area
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Drug's FAERS reports marked serious: 87.5% (raises 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
- not given (typical: 2)
- Allocation
- non randomized (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- not given (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 6 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 120 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- government (typical: academic or other)
- Sponsor's past trials
- 283 (typical: 32)
- Sponsor's past termination rate
- 5.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 213 (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
- 16 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 12 (typical: 412.5)
- Drug's FAERS reports marked serious
- 87.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 12.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, respiratory, digestive, dermatology, urogenital
- Drugs matched to FDA substances
- yeast
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
- Cancer Vaccine Targeting Brachyury Protein in Tumors NCT01519817 · started 2012 · scored riskier than 56% of active trials completed
- QUILT-3.006 for Recurrent Medullary Thyroid Cancer NCT01856920 · started 2013 · scored riskier than 99% of active trials completed
- QUILT-2.025 NANT Neoepitope Yeast Vaccine (YE-NEO-001): Adjuvant Immunotherapy Using a Personalized Neoepitope Yeast-Based Vaccine To Induce T-Cell Responses In Subjects W/ Previously Treated Cancers. NCT03552718 · started 2018 · scored riskier than 99% of active trials completed
- Phase II Trial of Combination Immunotherapy in Subjects With Advanced Small Bowel and Colorectal Cancers NCT04491955 · started 2020 · scored riskier than 77% of active trials completed
- Evaluation of a Multi-phosphopeptide Vaccine Plus PolyICLC in Participants With High Risk and Advanced Malignancies NCT01846143 · started 2013 · scored riskier than 97% 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.