Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK1/2/3, ROS1, or ALK Gene Rearrangements (Fusions) (STARTRK-2)

Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK1/2/3, ROS1, or ALK Gene Rearrangements (Fusions) (STARTRK-2)

Gastrointestinal Stromal Tumor

Active, not recruiting

2

Start Date 10/01/2015

Age of Trial (yrs) 8.5

All

TRK Inhibitor

Block related tumor signal paths

GIST not specified. GIST patient enrollment unknown.

RXDX-101-02 2015‐003385‐84 ( EudraCT Number ) GO40782 ( Other Identifier: Hoffman-La Roche )

Hoffmann-La Roche

Reference Study ID Number: GO40782 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

Oral

This trial is currently recruiting only in China.

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