A Phase 1/2 Study of INCB001158 in Combination With Chemotherapy in Subjects With Solid Tumors
Model scores of the 29,894 trials active now.
Model score 23% for any early termination, 4% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 29% of the time (655 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2022-11-28, after 2017-11-21 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 2022-11-28. 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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Sponsor's past termination rate: 47.6% (raises risk) · Sponsor's track record
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: cancermetastatictherapychemotherapymalignancy
Phrases that lowered it: to evaluateparticipantsreceiptevaluate thecombination -
Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 1/2 (raises risk) · Design
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Disease area, cancer: Yes (raises risk) · Disease area
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Trials the sponsor started in the prior 2 years: 34 (lowers risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
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Keywords listed: 14 (raises risk) · Design
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Design: single group (raises risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Number of arms: 3 (lowers risk) · Design
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Blinding: none (raises risk) · Design
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Drug's FAERS reports marked serious: 94.4% (raises risk) · Drug's FDA history
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Maximum age: not given (raises risk) · Who can join
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Drug's FAERS reports before start: 175205 (lowers risk) · Drug's FDA history
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Drugs with FDA adverse-event history: 6 (lowers risk) · Drug's FDA history
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Drug's FAERS reports with a death: 21.3% (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
- 1/2 (typical: 2)
- Number of arms
- 3 (typical: 2)
- Allocation
- non randomized (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
- 14 (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
- 42 (typical: 32)
- Sponsor's past termination rate
- 47.6% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 34 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 6 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 175205 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 26480 (typical: 412.5)
- Drug's FAERS reports marked serious
- 94.4% (typical: 85.6%)
- Drug's FAERS reports with a death
- 21.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, digestive, urogenital, endocrine
- Drugs matched to FDA substances
- cisplatin, fluorouracil, gemcitabine, leucovorin, oxaliplatin, paclitaxel
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
- Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors NCT04242199 · started 2020 · scored riskier than 86% of active trials completed
- A Dose-escalation Study in Subjects With Advanced Malignancies NCT01072266 · started 2010 · scored riskier than 93% of active trials completed
- A Dose-escalation Study in Subjects With Advanced Malignancies NCT01195311 · started 2010 · scored riskier than 86% of active trials completed
- Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Advanced Solid Tumors NCT04272034 · started 2021 · scored riskier than 91% of active trials terminated
- A Study to Evaluate the Safety, Tolerability, and Antitumor Activity of INCB001158 Plus Epacadostat, With or Without Pembrolizumab, in Advanced Solid Tumors NCT03361228 · started 2018 · scored riskier than 84% 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.