A Phase I Study of RXDX-101 in Patients with Locally Advanced or Metastatic Cancers Containing Alternations in the TRKA, TRKB, TRKC, ROS1, or ALK Proteins

Full Title

A Phase 1/2A, Multicenter, Open-Label Study of Oral Entrectinib (RXDX-101) in Adult Patients with Locally Advanced or Metastatic Cancer Confirmed to be Positive for NTRK1, NTRK2, NTRK3, ROS1, or ALK Molecular Alterations


RXDX-101 is an investigational drug that inhibits altered versions of the proteins TRKA, TRKB, TRKC, ROS1, or ALK. When these proteins are altered, they can cause normal cells to become abnormal and form tumors. Laboratory studies have shown that RXDX-101 can shrink tumors with molecular changes in these proteins.

The purpose of this study is to find the highest dose of RXDX-101 that can be given safely in patients with locally advanced or metastatic cancers containing alterations in the TRKA, TRKB, TRKC, ROS1, or ALK proteins. RXDX-101 is taken orally (by mouth).


To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have a locally advanced or metastatic solid tumor that contains molecular changes in the TRKA, TRKB, TRKC, ROS1, or ALK proteins.
  • At least 2 to 4 weeks must pass between the completion of prior therapies and entry into the study.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Alexander Drilon at 646-888-4206.