Roll-over Study to Continue Treatment With the Investigational Drug Rogaratinib and to Further Test Its Safety
Model scores of the 29,894 trials active now.
Model score 23% for any early termination, 6% 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
Completed on 2021-02-16, after 2019-10-30 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 2021-02-16. 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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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: cancercellneckcarcinomahead
Phrases that lowered it: participantsclinicaldrugfactorare currently -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Drug's FAERS reports with a death: 60% (raises risk) · Drug's FDA history
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Phase: 2 (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 92 (lowers risk) · Sponsor's track record
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Design: single group (raises risk) · Design
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Disease area, cancer: Yes (raises risk) · Disease area
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Minimum age: 18 (raises risk) · Who can join
-
Primary purpose: treatment (raises risk) · Design
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Maximum age: not given (raises risk) · Who can join
-
Disease area, dermatology: Yes (raises risk) · Disease area
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Sponsor's past termination rate: 7.4% (lowers risk) · Sponsor's track record
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Number of arms: 1 (raises risk) · Design
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Has a data monitoring committee: No (lowers risk) · Design
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Collaborators: 0 (raises risk) · Design
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Drug's FAERS reports marked serious: 100% (raises risk) · Drug's FDA history
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Blinding: none (raises risk) · Design
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Keywords listed: 9 (raises risk) · Design
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Disease area, respiratory: Yes (raises risk) · Disease area
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Responsible party: sponsor (lowers risk) · Design
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Drug's FAERS reports before start: 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
- 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
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 9 (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
- 868 (typical: 32)
- Sponsor's past termination rate
- 7.4% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 92 (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
- 5 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 4 (typical: 412.5)
- Drug's FAERS reports marked serious
- 100% (typical: 85.6%)
- Drug's FAERS reports with a death
- 60% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, respiratory, dermatology, musculoskeletal
- Drugs matched to FDA substances
- rogaratinib
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
- Rogaratinib (BAY1163877) in Chinese Patients NCT03788603 · started 2019 · scored riskier than 53% of active trials completed
- A Clinical Study of Regorafenib in Participants Who Have Been Treated in Previous Bayer-sponsored Regorafenib Studies That Have Been Completed NCT03890731 · started 2019 · scored riskier than 52% of active trials completed
- Phase 1 Study of the Combination of Rogaratinib With Copanlisib in Patients With Fibroblast Growth Factor Receptor (FGFR)-Positive, Locally Advanced or Metastatic Solid Tumors NCT03517956 · started 2018 · scored riskier than 36% of active trials completed
- A Rollover Study of Alectinib in Patients With Anaplastic Lymphoma Kinase (ALK)-Positive or Rearranged During Transfection (RET)-Positive Cancer NCT03194893 · started 2017 · scored riskier than 38% of active trials completed
- Rogaratinib in Patients With Advanced Pretreated Squamous-cell Non-small Cell Lung Cancer (SQCLC) NCT03762122 · started 2019 · scored riskier than 53% 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.