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STARTRK-2: An Open-Label, Multicenter, Global Phase 2 Basket Study of Entrectinib for the Treatment of Patients with Locally Advanced or Metastatic Solid Tumors that Harbor NTRK1/2/3, ROS1, or ALK Gene Rearrangements
This study will evaluate the safety (side effects) and antitumor activity of entrectinib in men and women with advanced cancer, based on certain types of DNA defect or damage.
Primary Objective: To determine the objective response rate (ORR) of entrectinib, as assessed by BICR, in each patient population basket of solid tumors that harbor an NTRK1/2/3, ROS1, or ALK gene rearrangement. Secondary Objectives: To determine the duration of response (DOR), time to response (TTR), and clinical benefit rate (CBR) of entrectinib, as assessed by BICR, in each patient population basket of solid tumors that harbor an NTRK1/2/3, ROS1, or ALK gene rearrangement. To determine the intracranial tumor response of entrectinib and CNS progression-free survival (CNS-PFS) in patients presenting with measurable brain metastases at baseline, as assessed by BICR using RANO-BM. To estimate the progression-free survival (PFS) and overall survival (OS) of patients with solid tumors that harbor anNTRK1/2/3, ROS1, or ALK gene rearrangement treated with entrectinib. To evaluate the safety and tolerability of entrectinib when administered at the RP2D in patients with solid tumors that harbor an NTRK1/2/3, ROS1, or ALK gene rearrangement. To assess the population pharmacokinetics (PK) of entrectinib and to explore correlations between PK, response, and/or safety findings in patients with NTRK1/2/3, ROS1, or ALK gene rearrangements. To evaluate the effect of entrectinib on ventricular repolarization in a subset of patients from selected countries. To assess treatment-related symptoms and general health status using validated instruments of patient reported outcomes.