Phase I Dose Escalation Study of Intravenous VCN-01 With or Without Gemcitabine and Abraxane® in Patients With Advanced Solid Tumors
Model scores of the 29,894 trials active now.
Model score 10% 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 16% of the time (1,938 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 2020-01-31, after 2014-01-31 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 2020-01-31. 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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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: no earlier finished trials (lowers risk) · Sponsor's track record
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: 25.2% (raises risk) · Drug's FDA history
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: to determinepatients mustiicancertherapy
Phrases that lowered it: solidadministrationmalevaccinesweeks before -
Disease area, cancer: Yes (raises risk) · Disease area
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Design: single group (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Drug's FAERS reports marked serious: 96.7% (raises risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Number of arms: 3 (lowers risk) · Design
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Blinding: none (raises risk) · Design
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Keywords listed: 6 (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
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 6 (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
- 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
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 23605 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 4217 (typical: 412.5)
- Drug's FAERS reports marked serious
- 96.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 25.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, digestive, endocrine
- Drugs matched to FDA substances
- gemcitabine, paclitaxel
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
- A Phase I Dose Escalation Study of Intratumoral VCN-01 Injections With Gemcitabine and Abraxane® in Patients With Advanced Pancreatic Cancer NCT02045589 · started 2014 · scored riskier than 25% of active trials completed
- Ph 1 Study of VS-4718, a FAK Inhibitor, in Combination With Nab-paclitaxel and Gemcitabine in Advanced Cancer Subjects NCT02651727 · started 2015 · scored riskier than 70% of active trials terminated
- Nab-paclitaxel, Gemcitabine, and Bevacizumab in Advanced Malignancies NCT01113476 · started 2010 · scored riskier than 54% of active trials completed
- Study of Nab-Paclitaxel and Gemcitabine and Plus/Minus VCN-01 in Patients With Metastatic Pancreatic Cancer NCT05673811 · started 2023 · scored riskier than 72% of active trials completed
- A Feasibility Trial of Avastin (Bevacizumab) in Combination With Concomitant Chemoradiation (Cisplatin and Vinorelbine) in Patients With Locally Advanced Non-Squamous Non-Small Cell Lung Cancer. NCT00773188 · started 2008 · scored riskier than 18% 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.