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Rationale and Design of the Targeted Agent and Profiling Utilization Registry (TAPUR) Study.

Publication ,  Journal Article
Mangat, PK; Halabi, S; Bruinooge, SS; Garrett-Mayer, E; Alva, A; Janeway, KA; Stella, PJ; Voest, E; Yost, KJ; Perlmutter, J; Pinto, N; Kim, ES ...
Published in: JCO Precis Oncol
2018

PURPOSE: Case reports and small prospective trials suggest that administering targeted therapies to patients with advanced cancer and an identified genomic target may be associated with clinical benefit. The TAPUR Study, a phase II, prospective, non-randomized, multi-basket, pragmatic clinical trial aims to identify signals of drug activity when Food and Drug Administration (FDA) approved drugs are matched to pre-specified genomic targets in patients with advanced cancer, outside of approved indications. METHODS: Patients eligible to participate in TAPUR are ages 12 years and older, with advanced, measurable or evaluable solid tumors, multiple myeloma or B cell non-Hodgkin lymphoma. Eligible participants are matched to any of the sixteen FDA approved study drugs based on protocol specified genomic inclusion and exclusion criteria. Genomic profiling from any Clinical Laboratory Improvement Amendments certified, College of American Pathologists accredited laboratory is acceptable. The treating physician selects the treatment from the available study therapies, or consults with the TAPUR Molecular Tumor Board. Participants are placed into multiple parallel cohorts defined by tumor type, genomic alteration and drug. The primary study endpoint within each cohort is objective response or stable disease of at least 16 weeks duration. Secondary endpoints include safety, progression-free survival and overall survival. RESULTS: More than 1000 participants have thus far been registered and more than 800 treated with a TAPUR study drug. Two study cohorts have permanently closed to enrollment due to lack of anti-tumor activity and 12 have expanded to the second stage of enrollment due to promising preliminary activity. CONCLUSION: The TAPUR Study will describe the efficacy and toxicity of the targeted drugs used outside of their approved indications when matched to a somatic genomic variant.

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Published In

JCO Precis Oncol

DOI

ISSN

2473-4284

Publication Date

2018

Volume

2018

Location

United States

Related Subject Headings

  • 3211 Oncology and carcinogenesis
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Mangat, P. K., Halabi, S., Bruinooge, S. S., Garrett-Mayer, E., Alva, A., Janeway, K. A., … Schilsky, R. L. (2018). Rationale and Design of the Targeted Agent and Profiling Utilization Registry (TAPUR) Study. JCO Precis Oncol, 2018. https://doi.org/10.1200/PO.18.00122
Mangat, Pam K., Susan Halabi, Suanna S. Bruinooge, Elizabeth Garrett-Mayer, Ajjai Alva, Katherine A. Janeway, Philip J. Stella, et al. “Rationale and Design of the Targeted Agent and Profiling Utilization Registry (TAPUR) Study.JCO Precis Oncol 2018 (2018). https://doi.org/10.1200/PO.18.00122.
Mangat PK, Halabi S, Bruinooge SS, Garrett-Mayer E, Alva A, Janeway KA, et al. Rationale and Design of the Targeted Agent and Profiling Utilization Registry (TAPUR) Study. JCO Precis Oncol. 2018;2018.
Mangat, Pam K., et al. “Rationale and Design of the Targeted Agent and Profiling Utilization Registry (TAPUR) Study.JCO Precis Oncol, vol. 2018, 2018. Pubmed, doi:10.1200/PO.18.00122.
Mangat PK, Halabi S, Bruinooge SS, Garrett-Mayer E, Alva A, Janeway KA, Stella PJ, Voest E, Yost KJ, Perlmutter J, Pinto N, Kim ES, Schilsky RL. Rationale and Design of the Targeted Agent and Profiling Utilization Registry (TAPUR) Study. JCO Precis Oncol. 2018;2018.

Published In

JCO Precis Oncol

DOI

ISSN

2473-4284

Publication Date

2018

Volume

2018

Location

United States

Related Subject Headings

  • 3211 Oncology and carcinogenesis