Trial NCT04163900

View at ClinicalTrials.gov 
Org. Study IDs: NuTide:121
Secondary IDs: 2019-001025-28

Last trial update was posted on 2023-05-24

MeSH Interventions

Gemcitabine

MeSH Conditions

Biliary Tract Neoplasms

Other Conditions

Biliary Tract Cancer

Stopping Reasons

A pre-planned futility analysis concluded that NUC-1031 plus cisplatin was unlikely to achieve its primary objective of improving overall survival. Based on the IDMC's recommendation, NuCana has closed the study.

Limitations And Caveats

At Interim Analysis 1, the futility boundary for OS was crossed and the study was closed on 02 Mar 2022. Following study closure, data from the 05 April 2022 final data cut-off (30 day follow-up post the last patient last visit) were analysed. In general, the analyses performed on this final database were those that were scheduled to take place at Interim Analysis 2. However, any p-values or CIs obtained are only viewed as descriptive as the study was stopped for futility.

Result Publications

N/A

Annotations

Category Annotations
No annotators decided on categories yet

Intervention Annotations
# Outdated Intervention Condition
Name Route DrugBank ID