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TAPUR Study Analysis Plan and Current Status

The TAPUR Study is a phase II, non-randomized, open label clinical trial that aims to define signals of drug activity. Participants are enrolled in cohorts defined by tumor type, genomic alteration, and study drug. Initially up to 10 participants are enrolled in a cohort and assessed for treatment response or lack of tumor growth for at least 16 weeks. If fewer than 2 participants have a successful outcome, then the cohort is permanently closed to further enrollment. If two or more participants have successful outcomes, the cohort is expanded to enroll an additional 18 participants. Once complete data from a cohort become available, the TAPUR Study Data Safety and Monitoring Board (DSMB) will review the cohort results. A signal of drug activity will be declared if at least 7 of the 28 participants experience a treatment response 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.

Summary of Cohort Activity in the TAPUR Study

The tables below display cohorts that have been expanded to stage II or closed after stage I as of April 26, 2018.

Expanded Cohorts

Treatment Cancer Variant
Cetuximab Ovarian KRAS, NRAS, BRAF wild type
Olaparib Breast Somatic or germline inactivating mutations in BRCA1 or BRCA2
Colorectal ATM mutation or deletion
Prostate Somatic or germline inactivating mutations in BRCA1 or BRCA2
Palbociclib Malignant neoplasm of bronchus and lung  CDKN2A loss or mutation
Soft tissue sarcoma CDK4 amplification
Head and neck CDKN2A loss or mutation
Ovarian CDKN2A loss or mutation
Pembrolizumab Breast High tumor mutational burden
Colorectal High tumor mutational burden 
Uterine High tumor mutational burden
Pertuzumab + Trastuzumab Colorectal ERBB2 amplification, mutation or overexpression
Uterine  ERBB2 amplification, mutation or overexpression
Sunitinib Breast FGFR1 mutation or amplification
Vemurafenib + Cobimetinib Colorectal BRAF_V600E mutation

Permanently Closed Cohorts

Treatment Cancer Variant
Palbociclib Pancreatic CDKN2A loss or mutation
Gallbladder and Bile Ducts CDKN2A loss or mutation