BKM120 Combined With Vemurafenib (PLX4032) in BRAFV600E/K Mutant Advanced Melanoma
Model scores of the 29,894 trials active now.
Model score 30% for any early termination, 13% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 26% of the time (851 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 2017-03-21, after 2012-06-09 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 2017-03-21. 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: carcinomamelanomastarting studyto startingcell
Phrases that lowered it: trialpatient hasthe investigatorpatient ispartner -
Phase: 1/2 (raises risk) · Design
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Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past termination rate: 14.1% (raises risk) · Sponsor's track record
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Disease area, cancer: Yes (raises risk) · Disease area
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Sponsor's past trials: 256 (lowers risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 117 (lowers risk) · Sponsor's track record
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Design: single group (raises risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Drug's FAERS reports marked serious: 98.1% (raises risk) · Drug's FDA history
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Minimum age: 18 (raises risk) · Who can join
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports with a death: 25.1% (raises risk) · Drug's FDA history
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Collaborators: 1 (raises risk) · Design
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Responsible party: principal investigator (lowers risk) · Design
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Disease area, dermatology: Yes (raises risk) · Disease area
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Maximum age: not given (raises risk) · Who can join
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Blinding: none (raises risk) · Design
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Number of arms: 1 (raises risk) · Design
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Drug's FAERS reports in the prior 12 months: 739 (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
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: 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
- 4 (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
- 256 (typical: 32)
- Sponsor's past termination rate
- 14.1% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 117 (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
- 740 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 739 (typical: 412.5)
- Drug's FAERS reports marked serious
- 98.1% (typical: 85.6%)
- Drug's FAERS reports with a death
- 25.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, dermatology
- Drugs matched to FDA substances
- vemurafenib
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
- STAR Cape+BKM120 MBC With Brain Met NCT02000882 · started 2014 · scored riskier than 97% of active trials completed
- Open-Label Study Evaluating the Safety and Tolerability of LJM716, BYL719 and Trastuzumab in Patients With Metastatic HER2+ Breast Cancer NCT02167854 · started 2014 · scored riskier than 23% of active trials completed
- Cabozantinib and Pembrolizumab for Advanced Metastatic Melanoma NCT03957551 · started 2019 · scored riskier than 82% of active trials terminated
- A Trial of Irinotecan and BKM120 in Previously Treated Advanced Colorectal Cancer NCT01304602 · started 2011 · scored riskier than 76% of active trials completed
- BKM120 + mFOLFOX6 in Advanced Solid Tumors With Expansion Cohort Pancreatic Cancer NCT01571024 · started 2012 · scored riskier than 54% 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.