A Phase I Study of LJM716 in Japanese Patients With Advanced Solid Tumors
Model scores of the 29,894 trials active now.
Model score 20% for any early termination, 2% 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 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Completed on 2015-03-31, after 2013-09-30 start.
The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
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 2015-03-31. 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: breast cancerher2tumorspriormetastatic
Phrases that lowered it: japanesegastricevaluatedosesafety -
Phase: 1 (lowers risk) · Design
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Sponsor's past termination rate: 12.7% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Disease area, cancer: Yes (raises risk) · Disease area
-
Minimum age: 18 (raises risk) · Who can join
-
Sponsor's past trials: 553 (raises risk) · Sponsor's track record
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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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Trials the sponsor started in the prior 2 years: 308 (raises risk) · Sponsor's track record
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Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
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Collaborators: 0 (raises risk) · Design
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Number of arms: 1 (raises risk) · Design
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Drug's FAERS reports with a death: no FAERS history (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
- 1 (typical: 2)
- Allocation
- non randomized (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- 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
- industry (typical: academic or other)
- Sponsor's past trials
- 553 (typical: 32)
- Sponsor's past termination rate
- 12.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 308 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 0 (typical: 1)
- Drug has FAERS history
- No (typical: 64% yes)
- Drug's FAERS reports before start
- 0 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 0 (typical: 412.5)
- Drug's FAERS reports marked serious
- no FAERS history (typical: 85.6%)
- Drug's FAERS reports with a death
- no FAERS history (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer
- Drugs matched to FDA substances
- none matched
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
- Phase I Study LJM716 Combined With Trastuzumab in Patients With HER2 Overexpressing Metastatic Breast or Gastric Cancer NCT01602406 · started 2012 · scored riskier than 25% of active trials completed
- Safety and Tolerability of Oral LCL161 in Japanese Adult Patients With Advanced Solid Tumors NCT01968915 · started 2013 · scored riskier than 38% of active trials completed
- A Phase I Study of LJM716 in Squamous Cell Carcinoma of Head and Neck, or HER2+ Breast Cancer or Gastric Cancer NCT01598077 · started 2012 · scored riskier than 80% of active trials completed
- Phase I Study of MK-1496 in Patients With Advanced Solid Tumor (MK-1496-002 AM 4)(COMPLETED) NCT00880568 · started 2009 · scored riskier than 88% of active trials completed
- A Phase Ib/II Study Of JS015 Combination Therapy in Advanced Solid Tumors NCT06139211 · started 2023 · scored riskier than 66% of active trials completed
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.