GCC 0845:Vorinostat and Lapatinib in Advanced Solid Tumors and Advanced Breast Cancer to Evaluate Response and Biomarkers
Model scores of the 29,894 trials active now.
Model score 33% for any early termination, 15% 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 (851 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
Terminated on 2012-10-31, after 2010-03-31 start.
Reason given by the sponsor: “business”
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 2012-10-31. 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: patients mustor equalequal togreatercardiac
Phrases that lowered it: to evaluatehumaninvestigatorwomen withacid -
Phase: 1/2 (raises risk) · Design
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Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past termination rate: 10.5% (raises risk) · Sponsor's track record
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Design: single group (raises risk) · Design
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Disease area, cancer: Yes (raises risk) · Disease area
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Drug's FAERS reports with a death: 9.7% (lowers risk) · Drug's FDA history
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Drug's FAERS reports marked serious: 59.2% (lowers risk) · Drug's FDA history
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Disease area, dermatology: Yes (raises risk) · Disease area
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Has a data monitoring committee: Yes (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Trials the sponsor started in the prior 2 years: 36 (lowers risk) · Sponsor's track record
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Maximum age: not given (raises risk) · Who can join
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Primary purpose: treatment (raises risk) · Design
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Blinding: none (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
- 1/2 (typical: 2)
- Number of arms
- 2
- Allocation
- non randomized (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 3 (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
- 57 (typical: 32)
- Sponsor's past termination rate
- 10.5% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 36 (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
- 3202 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1244 (typical: 412.5)
- Drug's FAERS reports marked serious
- 59.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 9.7% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, dermatology
- Drugs matched to FDA substances
- lapatinib, vorinostat
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
- HDAC Inhibitor Vorinostat (SAHA) With Capecitabine (Xeloda) Using a New Weekly Dose Regimen for Advanced Breast Cancer NCT00719875 · started 2008 · scored riskier than 63% of active trials completed
- Ixabepilone and Vorinostat in Treating Patients With Metastatic Breast Cancer NCT01084057 · started 2010 · scored riskier than 48% of active trials completed
- Lapatinib and Bortezomib in Patients With Advanced Malignancies NCT01497626 · started 2011 · scored riskier than 77% of active trials terminated
- Capecitabine and Vorinostat in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer NCT01267240 · started 2010 · scored riskier than 82% of active trials terminated
- Tucatinib, Palbociclib and Letrozole in Metastatic Hormone Receptor Positive and HER2-positive Breast Cancer NCT03054363 · started 2017 · scored riskier than 48% 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.