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STARTRK-2: An open-label, multicenter, global phase II 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

Description

This is an open-label, multicenter, global phase II basket study of entrectinib (RXDX-101) for the treatment of participants with solid tumors that harbor an NTRK1/2/3, ROS1 or ALK gene fusion. Participants will be assigned to different baskets according to tumor type and gene fusion.

This study will evaluate the safety (side effects) and antitumor activity of study drug in men and women with advanced cancer, based on certain types of DNA defect or damage.

Status

Accepting new patients

Primary Study Objective(s)

The primary objective is to determine the objective response rate of entrectinib, as assessed by BICR, in each population basket of solid tumors that harbor an NTRK1/2/3, ROS1 or ALK gene rearrangement.

Core eligibility

Note: This is only a partial list of eligibility criteria.

Including patients:

  • With a histologically- or cytologically-confirmed diagnosis of locally advanced or metastatic solid tumor that harbors an NTRK1/2/3, ROS1, or ALK gene rearrangement
    • Note: Patients diagnosed with anaplastic large cell lymphoma harboring a gene rearrangement of interest may be eligible provided they meet all other inclusion/exclusion criteria
  • Enrolled via local molecular testing, an archival or fresh tumor tissue (unless medically contraindicated), but they are required to be submitted for independent central molecular testing at Ignyta's laboratory post-enrollment
  • Who have measurable or evaluable disease
  • With central nervous system involvement, including leptomeningeal carcinomatosis, which is either asymptomatic or previously treated and controlled
  • Who have had prior anticancer therapy (excluding approved or investigational TRK, ROS1 or ALK inhibitors in patients who have tumors that harbor those respective gene rearrangements)
    • Note: Prior treatment with crizotinib is permitted only in ALK- or ROS1-rearranged non-small cell lung cancer (NSCLC) patients presenting with central nervous system-only progression. Other ALK inhibitors are prohibited.

Excluding patients who:

  • Are currently participating in another therapeutic clinical trial
  • Have had prior treatment with approved or investigational TRK, ROS1 or ALK inhibitors in patients who have tumors that harbor those respective gene rearrangements
    • Note: Prior treatment with crizotinib is permitted only in ALK- or ROS1-rearranged NSCLC patients presenting with central nervous system-only progression. Other ALK inhibitors are prohibited.
  • Have a history of other previous cancer that would interfere with the determination of safety or efficacy