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 is an open-label, multicenter, global Phase 2 basket study of entrectinib (RXDX-101) for the treatment of patients with solid tumors that harbor an NTRK1/2/3, ROS1, or ALK gene rearrangement. Patients will be assigned to different baskets according to tumor type and gene rearrangement. NSCLC and mCRC will be the main patient populations of interest.

Inclusion Criteria:

* 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 (ALCL) harboring a gene rearrangement of interest may be eligible provided they meet all other inclusion/exclusion criteria

* For patients enrolled via local molecular testing, an archival or fresh tumor tissue (unless medically contraindicated) is required to be submitted for independent central molecular testing at Ignyta's CLIA laboratory post-enrollment

* Measurable or evaluable disease

* Patients with CNS involvement, including leptomeningeal carcinomatosis, which is either asymptomatic or previously-treated and controlled, are allowed

* Prior anticancer therapy is allowed (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 in ALK- or ROS1-rearranged NSCLC patients presenting with CNS-only progression

*At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed after prior chemotherapy or small molecule targeted therapy

* At least 4 weeks must have elapsed since completion of antibody-directed therapy
Prior radiotherapy is allowed if more than 14 days have elapsed since the end of treatment

* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Phase II
Cancer, All Other
Multiple Tumor Types
Rom Leidner, M.D.
Ignyta, Inc.
Melissa Pomeroy
  • Oncology and Hematology Care Eastside
  • Oncology and Hematology Care Westside