Home 5 Clinical Diagnostic Insider 5 NCI Launches Sequencing-Based, Personalized Medicine Trial

NCI Launches Sequencing-Based, Personalized Medicine Trial

by | Feb 19, 2015 | Clinical Diagnostic Insider, Diagnostic Testing and Emerging Technologies, Inside the Diagnostics Industry-dtet

The National Cancer Institute recently launched a pilot trial that has the potential to advance both personalized medicine and the use of next-generation sequencing (NGS) as a pretreatment screening tool for cancer patients with solid tumors. The prospective, randomized clinical trial, Molecular Profiling based Assignment of Cancer Therapeutics (M-PACT), will assign treatment based on sequencing-based prescreening with a custom panel. Tumor samples from an estimated 700 patients with advanced tumors resistant to standard therapy will be analyzed to identify patients with at least one of 391 mutations in 20 genes that are known to affect the effectiveness of targeted therapies. Based on detection of mutations of interest, 180 patients will be enrolled in the trial and divided into groups based on mutations to a genetic pathway (DNA repair, PI3K, or RAS/RAF). These lesser-studied mutations were deliberately chosen, as were the therapies, including candidate drugs. Within these groups patients will be randomly assigned to receive a treatment regimen prospectively identified to target their specific mutation or to receive a treatment regimen not specific to the genetic pathway. These patients will have the option to cross over to the targeted treatment arm if their disease progresses on their initial study treatment. Given […]

The National Cancer Institute recently launched a pilot trial that has the potential to advance both personalized medicine and the use of next-generation sequencing (NGS) as a pretreatment screening tool for cancer patients with solid tumors. The prospective, randomized clinical trial, Molecular Profiling based Assignment of Cancer Therapeutics (M-PACT), will assign treatment based on sequencing-based prescreening with a custom panel. Tumor samples from an estimated 700 patients with advanced tumors resistant to standard therapy will be analyzed to identify patients with at least one of 391 mutations in 20 genes that are known to affect the effectiveness of targeted therapies. Based on detection of mutations of interest, 180 patients will be enrolled in the trial and divided into groups based on mutations to a genetic pathway (DNA repair, PI3K, or RAS/RAF). These lesser-studied mutations were deliberately chosen, as were the therapies, including candidate drugs. Within these groups patients will be randomly assigned to receive a treatment regimen prospectively identified to target their specific mutation or to receive a treatment regimen not specific to the genetic pathway. These patients will have the option to cross over to the targeted treatment arm if their disease progresses on their initial study treatment. Given the heterogeneity of tumors, it is not always known which mutation to target. Patients with well-established genetic markers such as BRAF mutations (in melanoma), BRCA (in breast or ovarian cancer), or EGFR (in non-small cell lung cancer) can only enroll if their cancer progressed on targeted therapy and other mutations are present. For more information on how NGS is being adopted in clinical practice, please see Inside the Diagnostics Industry on page 5.

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