Phase 3 Study of Zandelisib (ME-401) in Combination With Rituximab in Patients With iNHL - (COASTAL)
Model scores of the 29,894 trials active now.
Model score 19% 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 (927 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2023-03-20, after 2021-08-13 start.
Reason given by the sponsor: “other”
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 2023-03-20. 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
-
Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: functionrituximabadequateleukemiacell
Phrases that lowered it: subjectsclinically significantmale20combination -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 3 (lowers risk) · Design
-
Sponsor's past termination rate: 14.3% (raises risk) · Sponsor's track record
-
Disease area, cancer: Yes (raises risk) · Disease area
-
Drug's FAERS reports with a death: 14.8% (lowers risk) · Drug's FDA history
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Design: parallel (raises risk) · Design
-
Minimum age: 18 (raises risk) · Who can join
-
Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
-
Drug's FAERS reports in the prior 12 months: 98547 (lowers risk) · Drug's FDA history
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Drug's FAERS reports before start: 673199 (lowers risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
-
Maximum age: not given (raises risk) · Who can join
-
Collaborators: 1 (raises risk) · Design
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Drug's FAERS reports marked serious: 85.5% (lowers 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
- 3 (typical: 2)
- Number of arms
- 2
- Allocation
- 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
- 0 (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
- 7 (typical: 32)
- Sponsor's past termination rate
- 14.3% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 0 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 7 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 673199 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 98547 (typical: 412.5)
- Drug's FAERS reports marked serious
- 85.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 14.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, immunology, hematology
- Drugs matched to FDA substances
- bendamustine, cyclophosphamide, hydroxydoxorubicin, prednisone, rituximab, vincristine, zandelisib
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
- IBI376 in Patients With Relapsed or Refractory Follicular Lymphoma/Marginal Zone Lymphoma NCT04298879 · started 2020 · scored riskier than 18% of active trials completed
- Study of GS-0189 (Formerly FSI-189) as Monotherapy and in Combination With Rituximab in Participants With Relapsed/Refractory Non-Hodgkin Lymphoma NCT04502706 · started 2020 · scored riskier than 33% of active trials terminated
- Zandelisib (ME-401) in Subjects With Follicular Lymphoma or Marginal Zone Lymphoma After Failure of Two or More Prior Therapies (TIDAL) NCT03768505 · started 2019 · scored riskier than 71% of active trials terminated
- Efficacy and Safety Study of Idelalisib in Participants With Indolent B-Cell Non-Hodgkin Lymphomas NCT01282424 · started 2011 · scored riskier than 95% of active trials completed
- Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas NCT01732926 · started 2013 · scored riskier than 92% 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.