On August 5, 2020 TargetCancer Foundation (TCF) proudly reported the initiation of the TCF-001 TRACK (Target Rare Cancer Knowledge) Study, an innovative trial that brings advances in precision medicine to people living with rare cancers and their treating physicians, right in their own communities (Press release, TargetCancer Foundation, AUG 5, 2020, View Source [SID1234562956]). TRACK aims to provide the treatment care team with individualized treatment recommendations, informed by genomic analysis and in consultation with field-leading rare cancer clinicians and researchers. TRACK challenges the traditional paradigm of clinical trial participation by incorporating remote consent, enabling patients to access genomic information and tailored treatment recommendations without the typical requirement to travel to an academic medical center.
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TargetCancer Foundation, a patient-founded not-for-profit organization, serves as the study sponsor, and is collaborating with renowned experts in the field of rare cancer, and Foundation Medicine, Inc., a molecular information company. The research team includes Principal Investigator Razelle Kurzrock, MD (University of California San Diego), as well as co-Principal Investigators Vivek Subbiah, MD (University of Texas MD Anderson Cancer Center), James Cleary, MD, PhD (Dana-Farber Cancer Institute), and Roman Groisberg, MD (Rutgers Cancer Institute of New Jersey).
"The establishment of TRACK is a significant milestone for TargetCancer Foundation as we seek to help patients with often-overlooked rare cancers identify an effective treatment path," said Jim Palma, Executive Director, TargetCancer Foundation. "In partnership with the study’s investigators and Foundation Medicine, we will drive scientific understanding of traditionally understudied rare cancers while directly enabling patients and their physicians to make better-informed, individualized targeted therapy choices."
"With the introduction of the TRACK study, we can now offer rare cancer patients as well as oncology investigators a detailed analysis of critical genomic information that holds the promise of a targeted treatment protocol for each patient," said Dr. Kurzrock, Principal Investigator. "While unprecedented advances throughout the field continue, lack of data and insights sometimes stymie progress for treating rare cancers. With TRACK we have the opportunity to advance rare cancer research and treatment through this exciting new partnership with TargetCancer Foundation and Foundation Medicine."
About the TRACK Study Design
TRACK aims to recruit 400 people in the United States diagnosed with any rare cancer, defined as incidence of six per 100,000 people per year in the United States. Given the relevance and promise of precision medicine in cholangiocarcinoma and cancer of unknown primary, TRACK will seek to enrich study enrollment for these two subsets. Once patients are enrolled, Foundation Medicine will perform comprehensive genomic profiling (CGP) using both its FoundationOneCDx test for solid tissue samples and FoundationOneLiquid test for blood samples at baseline, as well as at multiple timepoints over a one to two year period. Both the University of California San Diego and University of Texas MD Anderson Cancer Center will serve as enrolling sites for the study. In addition, patients will have the option to enroll in the study remotely with TargetCancer Foundation, without a requirement to travel to an enrolling site, allowing full participation from geographic areas that are often not served by clinical studies. A virtual molecular tumor board (VMTB) comprised of field leading oncologists, pathologists, surgeons and other experts will recommend treatment options, directed by the genomic information of each individual patient on study.
"Foundation Medicine is dedicated to advancing the field of precision medicine through innovative collaborations," says Brian Alexander, MD, MPH, Chief Medical Officer, Foundation Medicine. "We are proud to partner with TargetCancer Foundation and Drs. Kurzrock, Subbiah, Cleary, and Groisberg to create an innovative research framework that not only provides doctors and patients with more accessible options, but also supports decision-making and learns from their journey."
The resultant treatments and participant responses will be prospectively tracked for at least one year, linking molecularly-informed treatments to specific participant outcomes. Beyond potentially informing patient treatments, the data produced through TRACK will also contribute to the field’s understanding of genomics in rare cancers, meeting a critical need where such knowledge is otherwise lacking.
TargetCancer Foundation looks forward to collaborating with companies across the pharmaceutical, biotechnology and patient-centered technology industry who share a passion for rare cancers, and is grateful to Bayer for its perspective on patients with rare cancers, and commitment as a founding supporter of the TRACK Study.
To learn more about the TRACK study and how to enroll, visit www.targetcancerfoundation.org/track.