First in Human Study of M4344 in Participants With Advanced Solid Tumors
Model scores of the 29,894 trials active now.
Model score 12% 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 5% of the time (4,470 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2021-09-24, after 2015-01-26 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 2021-09-24. 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: 0% (lowers risk) · Sponsor's track record
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: tumorchemotherapypriorprotocol definedother protocol
Phrases that lowered it: participantsparticipantfirst dosesingledaily -
Phase: 1 (lowers risk) · Design
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Accepts healthy volunteers: No (raises risk) · Who can join
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Number of arms: 18 (lowers risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Design: parallel (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 3 (raises risk) · Sponsor's track record
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Drug's FAERS reports with a death: 21.9% (raises risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports marked serious: 94.3% (raises risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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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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Maximum age: not given (raises risk) · Who can join
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Collaborators: 1 (raises risk) · Design
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
- 18 (typical: 2)
- Allocation
- non randomized (typical: randomized)
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 6 (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
- 3 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 3 (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
- 22236 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 3003 (typical: 412.5)
- Drug's FAERS reports marked serious
- 94.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 21.9% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- carboplatin
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
- M6620 First in Human Study NCT02157792 · started 2012 · scored riskier than 30% of active trials completed
- A Study of Zalifrelimab and Balstilimab for Treatment of Participants With Metastatic or Locally Advanced Solid Tumors, and Expansion Into Select Solid Tumors (Cervical) NCT03495882 · started 2017 · scored riskier than 68% of active trials completed
- A Study of AGEN2034 in Advanced Tumors and Cervical Cancer NCT03104699 · started 2017 · scored riskier than 67% of active trials completed
- Dose Finding Study Of PF-05212384 With Paclitaxel And Carboplatin In Patients With Advanced Solid Tumor NCT02069158 · started 2014 · scored riskier than 86% of active trials completed
- A Phase 1/2 Study of CAN04 in Combination With Different Chemotherapy Regimens in Subjects With Advanced Solid Tumors NCT05116891 · started 2021 · scored riskier than 64% 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.