Ribociclib + PDR001 in Breast Cancer and Ovarian Cancer
Model scores of the 29,894 trials active now.
Model score 20% 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 in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2020-10-14, after 2017-11-08 start.
Reason given by the sponsor: “safety”
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 2020-10-14. 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: breast cancercoronaryher2surgeryovarian
Phrases that lowered it: participantscombinationmultiplechildmmhg -
Sponsor's past termination rate: 17.4% (raises risk) · Sponsor's track record
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Phase: 1 (lowers risk) · Design
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Accepts healthy volunteers: No (raises risk) · Who can join
-
Disease area, cancer: Yes (raises risk) · Disease area
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Drug's FAERS reports marked serious: 66.9% (lowers risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 78 (lowers risk) · Sponsor's track record
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Has a data monitoring committee: Yes (raises risk) · Design
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Design: parallel (raises risk) · Design
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Drug's FAERS reports with a death: 11.7% (lowers risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Sponsor's past trials: 270 (lowers risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
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Disease area, dermatology: Yes (raises risk) · Disease area
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Collaborators: 1 (raises risk) · Design
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Responsible party: principal investigator (lowers risk) · Design
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Drug's FAERS reports before start: 7055 (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
- 2
- Allocation
- non randomized (typical: randomized)
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- principal investigator (typical: 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
- 270 (typical: 32)
- Sponsor's past termination rate
- 17.4% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 78 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 3 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 7055 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2632 (typical: 412.5)
- Drug's FAERS reports marked serious
- 66.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 11.7% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, dermatology, urogenital, endocrine
- Drugs matched to FDA substances
- fulvestrant, pdr001, ribociclib, spartalizumab
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
- Study of AGEN1571 in Participants With Advanced Solid Tumors NCT05377528 · started 2022 · scored riskier than 43% of active trials completed
- A Trial of Ribocilcib (LEE011) and Weekly Paclitaxel in Patients With Rb+ Advanced Breast Cancer NCT02599363 · started 2016 · scored riskier than 63% of active trials completed
- A Phase II Study of Nivolumab in Combination With Cabozantinib for Metastatic Triple-negative Breast Cancer NCT03316586 · started 2017 · scored riskier than 82% of active trials completed
- An Open-Label, Phase Ib/II Clinical Trial Of Cdk 4/6 Inhibitor, Ribociclib (Lee011), In Combination With Trastuzumab Or T-Dm1 For Advanced/Metastatic Her2-Positive Breast Cancer. NCT02657343 · started 2016 · scored riskier than 94% of active trials completed
- Pembrolizumab and Olaparib in Cervical Cancer Patients NCT04483544 · started 2020 · scored riskier than 81% 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.