Combination of Trametinib (MEK Inhibitor) and Hydroxychloroquine (HCQ) (Autophagy Inhibitor) in Patients With KRAS Mutation Refractory Bile Tract Carcinoma (BTC).
Model scores of the 29,894 trials active now.
Model score 26% for any early termination, 17% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 22% of the time (376 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2022-12-31, after 2022-02-15 start.
Reason given by the sponsor: “enrollment”
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 2022-12-31. 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: or equalequal togreater thanheartpatients must
Phrases that lowered it: participantsparticipantaminotransferaseclinicalpatients who -
Sponsor's past termination rate: 19.3% (raises risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 2 (raises risk) · Design
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Sponsor's past trials: 1387 (raises risk) · Sponsor's track record
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Disease area, cancer: Yes (raises risk) · Disease area
-
Design: single group (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 148 (lowers risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 76.8% (lowers risk) · Drug's FDA history
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Minimum age: 18 (raises risk) · Who can join
-
Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports in the prior 12 months: 16270 (lowers risk) · Drug's FDA history
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Disease area, dermatology: No (lowers risk) · Disease area
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Sponsor type: government (raises risk) · Sponsor's track record
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Drug's FAERS reports with a death: 4.9% (lowers risk) · Drug's FDA history
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Collaborators: 0 (raises risk) · Design
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Maximum age: not given (raises risk) · Who can join
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
- 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
- principal investigator (typical: sponsor)
- Collaborators
- 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
- government (typical: academic or other)
- Sponsor's past trials
- 1387 (typical: 32)
- Sponsor's past termination rate
- 19.3% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 148 (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
- 113086 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 16270 (typical: 412.5)
- Drug's FAERS reports marked serious
- 76.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 4.9% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, digestive
- Drugs matched to FDA substances
- hydroxychloroquine, 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
- Binimetinib and Hydroxychloroquine in Treating Patients With KRAS Mutant Metastatic Pancreatic Cancer NCT04132505 · started 2019 · scored riskier than 84% of active trials completed
- Pembrolizumab and Lenvatinib in Patients With Advanced HCC Who Are Refractory to Atezolizumab and Bevacizumab/ IO-based Therapy NCT05101629 · started 2022 · scored riskier than 50% of active trials completed
- Trial of Ulixertinib in Combination With Hydroxychloroquine in Patients With Advanced Gastrointestinal (GI) Malignancies NCT05221320 · started 2022 · scored riskier than 96% of active trials terminated
- Lenvatinib Combined Pembrolizumab in Advanced Hepatobiliary Tumors NCT03895970 · started 2019 · scored riskier than 24% of active trials completed
- Pemigatinib After Curative Local Therapy in Advanced iCCA With FGFR2 Fusion/Rearrangements NCT05565794 · started 2022 · scored riskier than 94% 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.