A Study to Find the Best Dose of BI 905711 in Combination With Chemotherapy and to Test Whether This Dose Helps People With Advanced Gastrointestinal Cancers
Model scores of the 29,894 trials active now.
Model score 14% 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
Completed on 2023-11-14, after 2021-11-24 start.
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 2023-11-14. 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: cancerbevacizumabchemotherapybiopsyhepatitis virus
Phrases that lowered it: patients whocolorectalparticipantsopensafety of -
Phase: 1 (lowers risk) · Design
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Accepts healthy volunteers: No (raises risk) · Who can join
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Trials the sponsor started in the prior 2 years: 92 (lowers 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: 24.4% (raises risk) · Drug's FDA history
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Sponsor's past termination rate: 7.7% (raises risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Has a data monitoring committee: No (lowers risk) · Design
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Maximum age: not given (raises risk) · Who can join
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Drug's FAERS reports before start: 85190 (lowers risk) · Drug's FDA history
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Number of arms: 3 (lowers risk) · Design
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Responsible party: sponsor (lowers risk) · Design
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Drug's FAERS reports in the prior 12 months: 8416 (lowers risk) · Drug's FDA history
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Sponsor's past trials: 672 (raises risk) · Sponsor's track record
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
- randomized
- Design
- sequential (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 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
- industry (typical: academic or other)
- Sponsor's past trials
- 672 (typical: 32)
- Sponsor's past termination rate
- 7.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 92 (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
- 85190 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 8416 (typical: 412.5)
- Drug's FAERS reports marked serious
- 90.4% (typical: 85.6%)
- Drug's FAERS reports with a death
- 24.4% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, digestive
- Drugs matched to FDA substances
- bevacizumab
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 Study to Find a Safe and Effective Dose of BI 905711 in Patients With Advanced Gastrointestinal Cancer NCT04137289 · started 2020 · scored riskier than 29% of active trials completed
- Pembrolizumab In Combination With Debio 1143 In Pancreatic and Colorectal Advanced/Metastatic Adenocarcinoma NCT03871959 · started 2019 · scored riskier than 80% of active trials completed
- A Study to Test Different Doses of BI 1701963 in Combination With Irinotecan in People With Advanced Bowel Cancer With Kirsten Rat Sarcoma Viral Oncogene Homologue (KRAS) Mutation NCT04627142 · started 2020 · scored riskier than 31% of active trials terminated
- Liposomal Irinotecan in Combination With Oxaliplatin, Leucovorin, and 5-fluorouracil for Patients With Locally Advanced Pancreatic Carcinoma: NCT03861702 · started 2020 · scored riskier than 99% of active trials completed
- SI-B001 as a Single Agent or in Combination With Chemotherapy in the Treatment of Digestive System Malignancies NCT05039944 · started 2021 · scored riskier than 52% 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.