Study of RAD001 + AMG479 for Patients With Advanced Solid Tumors
Model scores of the 29,894 trials active now.
Model score 18% for any early termination, 6% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 23% of the time (1,629 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 2015-01-19, after 2010-05-14 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 2015-01-19. 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: moderatediseasecancerbrainbiopsy
Phrases that lowered it: bleedingsafety ofcombinationhepatitishiv -
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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Drug's FAERS reports with a death: 25.3% (raises risk) · Drug's FDA history
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Design: single group (raises risk) · Design
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Responsible party: sponsor investigator (raises risk) · Design
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Disease area, cancer: Yes (raises risk) · Disease area
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Has a data monitoring committee: Yes (raises risk) · Design
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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: 0 (raises risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
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Collaborators: 2 (lowers risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports marked serious: 98.1% (raises risk) · Drug's FDA history
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Maximum age: not given (raises risk) · Who can join
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Sponsor's past trials: 0 (raises risk) · Sponsor's track record
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Number of arms: 1 (raises risk) · Design
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Drug's FAERS reports before start: 482 (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
- 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
- 2 (typical: 0)
- Keywords listed
- 0 (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
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 482 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 400 (typical: 412.5)
- Drug's FAERS reports marked serious
- 98.1% (typical: 85.6%)
- Drug's FAERS reports with a death
- 25.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer
- Drugs matched to FDA substances
- everolimus, ganitumab
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 Multiple Ascending Dose Study of the mTOR Inhibitor (RAD001) in Combination With R1507 in Patients With Advanced Solid Tumors NCT00985374 · started 2009 · scored riskier than 23% of active trials terminated
- Dose Finding Study of RAD001 (Everolimus, Afinitor®) in Combination With BEZ235 in Patients With Advanced Solid Tumors NCT01482156 · started 2012 · scored riskier than 44% of active trials completed
- Everolimus in Treating Patients With Previously Treated Unresectable or Metastatic Esophageal Cancer or Stomach Cancer NCT00985192 · started 2009 · scored riskier than 98% of active trials completed
- RAD001, FOLFOX and Bevacizumab in Treatment of Colorectal Carcinoma NCT01047293 · started 2010 · scored riskier than 90% of active trials completed
- Phase I Study of Daily RAD001 in Combination With Mitomycin C in Patients With Advanced Gastric Cancer or Cancer of the Esophagogastric Junction NCT01042782 · started 2008 · scored riskier than 74% 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.