SF1126 in Recurrent or Progressive SCCHN and Mutations in PIK3CA Gene and/or PI-3 Kinase Pathway Genes
Model scores of the 29,894 trials active now.
Model score 36% for any early termination, 12% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 26% of the time (3,728 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2016-12-31, after 2016-11-30 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 2016-12-31. 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: metastaticheartradiationbraincardiac
Phrases that lowered it: platinumgoodgrowthpatientsupper -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 2 (raises risk) · Design
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Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
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Disease area, cancer: Yes (raises risk) · Disease area
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Responsible party: sponsor investigator (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
-
Design: single group (raises risk) · Design
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Primary purpose: treatment (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
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Disease area, neurology: Yes (raises risk) · Disease area
-
Number of arms: 1 (raises risk) · Design
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Maximum age: not given (raises risk) · Who can join
-
Sponsor's past trials: 0 (raises risk) · Sponsor's track record
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Collaborators: 1 (raises risk) · Design
-
Blinding: none (raises risk) · Design
-
Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
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Drug's FAERS reports marked serious: no FAERS history (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
- 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
- sponsor investigator (typical: sponsor)
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 11 (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
- 0 (typical: 32)
- Sponsor's past termination rate
- no earlier finished trials (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 0 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 0 (typical: 1)
- Drug has FAERS history
- No (typical: 64% yes)
- Drug's FAERS reports before start
- 0 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 0 (typical: 412.5)
- Drug's FAERS reports marked serious
- no FAERS history (typical: 85.6%)
- Drug's FAERS reports with a death
- no FAERS history (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, neurology
- Drugs matched to FDA substances
- none matched
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
- PI3K Inhibitor BKM120 and Cetuximab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer NCT01816984 · started 2013 · scored riskier than 78% of active trials completed
- GDC-0941 and Cisplatin in Treating Patients With Androgen Receptor-Negative Triple Negative Metastatic Breast Cancer NCT01918306 · started 2013 · scored riskier than 99% of active trials terminated
- Phosphatidylinositol 3-kinase (PI3K) Alpha iNhibition In Advanced Breast Cancer NCT02506556 · started 2015 · scored riskier than 99% of active trials completed
- Study of FCN-437c in Patients With Advanced Solid Tumors NCT03951116 · started 2019 · scored riskier than 35% of active trials completed
- PIPA: Combination of PI3 Kinase Inhibitors and PAlbociclib NCT02389842 · started 2015 · scored riskier than 55% 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.