ASCO’S TARGETED Agent and Profiling Utilization Registry (TAPUR) Study now provides a full list of patient cohort expansions and closures on its website. Based on treatment responses in stage I, patient cohorts are either expanded to stage II for further study and identification of a signal or permanently closed. ASCO’s TAPUR Study offers a clinical trial opportunity for patients with advanced cancer who have not responded or are no longer responding to standard treatment and who have genomic alterations in their tumors that can be targeted with a TAPUR Study drug.
About the TAPUR Study Design
TAPUR STUDY participants are enrolled in cohorts based on their tumor type (advanced solid tumors, multiple myeloma, or B-cell non-Hodgkin lymphoma), the genomic defects of their tumor, and the targeted drug that corresponds to those defects. Stage I enrolls up to 10 participants in a cohort and monitors for treatment responses or a lack of tumor growth for at least 16 weeks. If two or more participants have successful outcomes, the cohort is expanded to stage II.
Although cohort expansion from stage I to stage II indicates that a signal of drug activity has been observed in a small number of patients—warranting further study of the drug in that cohort—no conclusions should be drawn as to whether the drug will ultimately be shown to be effective. Final results will be disseminated after the cohort has reached stage II.
During stage II, an additional 18 participants are enrolled in the cohort and monitored. Once complete data from stage II become available, the data safety and monitoring board will review the trial results.
For the results to be considered positive, at least 7 of the 28 participants must experience treatment responses or a lack of tumor growth for at least 16 weeks. ASCO will then publish these study findings in peer-reviewed journals to inform clinical practice and future research.
Closure of a cohort after stage I is an indication that drug activity was insufficient to warrant further study. If fewer than two participants in a cohort have successful outcomes, the cohort is then closed.
To see the full list of patient cohort updates, go to TAPUR.org/news. ■
© 2018. American Society of Clinical Oncology. All rights reserved.