A Home-Based Approach Study to Evaluate the Efficacy and Safety of Alectinib in Locally-Advanced or Metastatic ALK-Positive Solid Tumors
Model scores of the 29,894 trials active now.
Model score 17% for any early termination, 3% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 22% of the time (1,598 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2022-05-16, after 2021-05-24 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 2022-05-16. 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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Phase: 2 (raises risk) · Design
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Accepts healthy volunteers: No (raises risk) · Who can join
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: lung cancerbrainbreast cancersolidtumors
Phrases that lowered it: participantsevaluate theparticipantand safetyefficacy and -
Has a data monitoring committee: not given (lowers risk) · Design
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Sponsor's past termination rate: 9.9% (raises risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 128 (lowers risk) · Sponsor's track record
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Disease area, cancer: Yes (raises risk) · Disease area
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Drug's FAERS reports with a death: 16.0% (lowers risk) · Drug's FDA history
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Keywords listed: 30 (raises risk) · Design
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Disease area, dermatology: Yes (raises risk) · Disease area
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Design: single group (raises risk) · Design
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Disease area, neurology: Yes (raises risk) · Disease area
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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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Sponsor's past trials: 1187 (raises risk) · Sponsor's track record
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Maximum age: not given (raises risk) · Who can join
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Disease area, respiratory: Yes (raises risk) · Disease area
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Collaborators: 0 (raises risk) · Design
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Drug's FAERS reports marked serious: 74.0% (lowers risk) · Drug's FDA history
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Number of arms: 1 (raises risk) · Design
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Blinding: none (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
- 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
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 30 (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
- 1187 (typical: 32)
- Sponsor's past termination rate
- 9.9%
- Trials the sponsor started in the prior 2 years
- 128 (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
- 3294 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 906 (typical: 412.5)
- Drug's FAERS reports marked serious
- 74.0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 16.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, neurology, respiratory, digestive, immunology, dermatology, urogenital, hematology, endocrine
- Drugs matched to FDA substances
- alectinib
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
- A Study of the Efficacy and Safety of Alectinib in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer NCT03155009 · started 2017 · scored riskier than 38% of active trials completed
- A Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Participants NCT02075840 · started 2014 · scored riskier than 20% of active trials completed
- A Study of Alectinib (RO5424802) in Participants With Non-Small Cell Lung Cancer Who Have Anaplastic Lymphoma Kinase (ALK) Mutation and Failed Crizotinib Treatment NCT01801111 · started 2013 · scored riskier than 48% of active trials completed
- A Study to Evaluate and Compare the Efficacy and Safety of Alectinib Versus Crizotinib and to Evaluate the Pharmacokinetics of Alectinib in Asian Participants With Treatment-Naive Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-Small Cell Lung Cancer (NSCLC) NCT02838420 · started 2016 · scored riskier than 17% of active trials completed
- A Study of Alectinib (CH5424802/RO5424802) in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC) NCT01871805 · started 2013 · 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.