Study of Safety and Efficacy of Ribociclib and Trametinib in Patients With Metastatic or Advanced Solid Tumors
Model scores of the 29,894 trials active now.
Model score 13% for any early termination, 1% 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 in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2019-09-24, after 2016-06-29 start.
Reason given by the sponsor: “business”
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 2019-09-24. 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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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: patient hascancerpancreaticpriorpatient is
Phrases that lowered it: open labelefficacyother protocoladvanced soliddefined inclusion -
Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past termination rate: 14.3% (raises risk) · Sponsor's track record
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Disease area, cancer: Yes (raises risk) · Disease area
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Drug's FAERS reports with a death: 7.8% (lowers risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 196 (lowers risk) · Sponsor's track record
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Design: single group (raises risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports marked serious: 96.1% (raises risk) · Drug's FDA history
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Sponsor's past trials: 900 (raises risk) · Sponsor's track record
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Maximum age: not given (raises risk) · Who can join
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Responsible party: sponsor (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
- 1 (typical: 2)
- Allocation
- not applicable (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
- 10 (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
- 900 (typical: 32)
- Sponsor's past termination rate
- 14.3% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 196 (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
- 128 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 43 (typical: 412.5)
- Drug's FAERS reports marked serious
- 96.1% (typical: 85.6%)
- Drug's FAERS reports with a death
- 7.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, digestive, endocrine
- Drugs matched to FDA substances
- ribociclib, trametinib
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 Multi-Center, Open-Label Study of Fruquintinib in Solid Tumors and Colorectal, and Breast Cancers NCT03251378 · started 2017 · scored riskier than 31% of active trials completed
- A Study of Repotrectinib in Combination With Other Anticancer Therapies for the Treatment of Subjects With KRAS-Mutant Solid Tumors NCT05071183 · started 2021 · scored riskier than 70% of active trials terminated
- Trametinib and Trifluridine and Tipiracil Hydrochloride in Treating Patients With Colon or Rectal Cancer That is Advanced, Metastatic, or Cannot Be Removed by Surgery NCT03317119 · started 2018 · scored riskier than 66% of active trials completed
- A Phase 1 Study Evaluating CB-5083 in Subjects With Advanced Solid Tumors NCT02243917 · started 2014 · scored riskier than 42% of active trials terminated
- Clinical Study Of PI3K/mTOR Inhibitors In Combination With An Oral MEK Inhibitor Or Irinotecan In Patients With Advanced Cancer NCT01347866 · started 2011 · scored riskier than 87% of active trials terminated
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.