Observational studyBMC cancer2025
Patient characteristics related to screening failure in Phase I trials.
Observational study in BMC cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundScreening failure, loss of eligibility after trial consent and before the initial administration of an investigational new drug (IND), can delay the development of anticancer agents in Phase I trials. However, the previous literature on characteristics of these patients has been limited. Consequently, this study aimed to identify the factors associated with screening failure in this modern era of early drug development.
methodsThis retrospective, observational study included data from all patients referred to a Phase I trial centre at the Japanese Foundation for Cancer Research, Tokyo, Japan, from August 2020 to May 2023. Referral patient data were collected from electronic medical records and analysed.
resultsOf the 331 patients referred, 73 were excluded primarily due to slot unavailability and 84 did not meet the inclusion criteria. The remaining 174 patients gave a trial consent: 31 failed screening; 3 dropped out after the initial administration of an IND; 4 were during the first cycle of an IND; and 136 completed the first cycle or discontinued due to dose-limiting toxicities (DLTs). Screening failure was primarily attributable to disease progression during the screening period (45.2%), followed by infectious diseases, transaminitis, and incompatible gene polymorphisms (9.7% each). Age, sex, and cancer type were similar between the patients who failed screening compared with those who completed the first cycle or discontinued due to DLTs. Between these patient groups, statistically significant differences were observed in baseline brain metastasis (p = 0.0044) and ascites (p = 0.015) on Fisher's exact test, in performance status (PS) (p = 0.036) on Mann–Whitney U test, and in albumin levels (p = 0.013) and the number of days from referral to trial consent (p = 0.027) on Student's t-test. Additionally, brain metastasis, ascites and PS ≥ 1 were associated with disease progression during the screening period.
conclusionPhase I trial candidates presenting with brain metastases, ascites, decreased albumin levels, and PS ≥ 1 at baseline should be carefully evaluated, as these factors are associated with an increased risk of screening failure primarily due to disease progression during the screening period.
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