- View the latest TAPUR Study news press releases with information about study progress, growth, and collaborations.
- See the TAPUR Study abstract and poster presented at the 2018 ASCO Annual Meeting for information about the Stage 1 analysis of patients with pancreatic cancer and CDKN2A alterations treated with palbociclib.
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.
|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
|Palbociclib||Pancreatic||CDKN2A loss or mutation|
|Gallbladder and Bile Ducts||CDKN2A loss or mutation|