Mekinist trametinib: Phase II started

NIH's National Cancer Institute (NCI) began the single-blind Phase II M-PACT trial to evaluate whether treatment based on specific gene mutations improves the rate and duration of response in patients with advanced, refractory solid tumors. NCI said trials conducted by other companies randomly assign patients to treatment options, while M-PACT will test an approach of using predefined detection of mutations to assign patients. The trial is slated to enroll 180 patients with mutations or amplifications in DNA repair pathways, the phosphoinositide 3-kinase (PI3K) pathway or the RAS, RAF or MEK pathway. To screen patients, NCI will genetically sequence tumor samples to look for 391 mutations in 20 genes that are known to affect the efficacy of targeted therapies. Patients will be grouped by their tumor gene variation and then further split into two arms: patients in one arm will receive a treatment prospectively identified to target their specific mutation or pathway, while patients in the other arm will receive a treatment not designed to target their mutation or pathway. NCI said the trial will evaluate 1 arm vs. the other and treatment will be administered at the same doses and schedules for both arms. M-PACT is not powered to compare individual treatments between arms.

The trial will be conducted initially at NCI and subsequently be expanded to other sites in the NCI-supported Early Therapeutics Clinical Trials Network. NCI also said it hopes to report data from the trial by 2017. ...