by Dr. C.H. Weaver M.D. 6/2019
The American Society of Clinical Oncology’s (ASCO) Targeted Agent and Profiling Utilization Registry (TAPUR) clinical study has added the enrollment of additional patient groups and continues to grow with more than 500 participants and 16 therapies now available. The purpose of TAPUR is to help cancer patients who have exhausted standard options access targeted study drugs matched to the genomic profiles of their cancers and provide physicians assistance in interpreting genomic results and identifying potential treatment options. (1)
The TAPUR Study is designed to identify signals of activity of commercially available, targeted anticancer drugs in advanced cancer patients whose tumor harbors one or more genomic variants known to be a drug target. The TAPUR Study Data Safety and Monitoring Board (DSMB) has expanded enrollment of additional participants for the colorectal cancer patients with a BRAF_V600E mutation treated with Zelboraf (vemurafenib) plus Cotellic (cobimetinib).
The BRAF V600 kinase is a pathway in cells that is active in cellular replication and spread. BRAF V600 mutations (either V600K or V600E) result in unchecked cellular replication and spread, resulting in the growth of cancer cells.
Both Cotellic and Zelboraf block different cellular mechanisms to disrupt the over activity of BRAF V600 mutations. Zelboraf and Cotellic are already FDA approved for the treatment of advanced or unresectable (not able to be surgically removed) melanoma that has a BRAF V600 mutation.
TAPUR Study participants are enrolled into treatment groups based on tumor type (advanced solid tumors, multiple myeloma, or B cell non-Hodgkin lymphoma), genomic variant and study drug. Stage I enrolls up to 10 patients in a group and monitors their response to treatment for 16 weeks. If two or more patients have a successful response to treatment the group is expanded, and an additional 18 patients are enrolled.
Currently, 510 participants are enrolled in the TAPUR Study, which is available at 83 clinical sites in 20 states. Patients can also find study information such as general eligibility criteria, participating clinical sites, and contact information for the site study teams at www.TAPUR.org.