Study of Oral RXDX-101 in Adult Patients With Locally Advanced or Metastatic Cancer Targeting NTRK1, NTRK2, NTRK3, ROS1, or ALK Molecular Alterations.
Completed · Phase 1
Conditions studied: Locally Advanced Solid Tumors, Metastatic Solid Tumors
In brief
Entrectinib (RXDX-101) is an orally available inhibitor of the tyrosine kinases TrkA (coded by the gene NTRK1), TrkB (coded by the gene NTRK2), TrkC (coded by the gene NTRK3), ROS1 (coded by the gene ROS1), and ALK (coded by the gene ALK). Molecular alterations to one or more of these targets are present in several different tumor types, including non-small cell lung cancer (NSCLC), colorectal cancer (CRC), prostate cancer, papillary thyroid cancer, pancreatic cancer, and neuroblastoma. Patients with locally advanced or metastatic cancer with a detectable molecular alteration in targets of interest may be eligible for enrollment. Phase 1 will assess safety and tolerability of entrectinib via standard dose escalation scheme and determine the recommended Phase 2 dose. Safety and efficacy will be assessed in the dose expansion portion of the study.
Key facts
- Study ID
- NCT02097810
- Run by
- Hoffmann-La Roche
- People needed
- 84
- Starts
- 2014-07-28
- Expected to finish
- 2020-06-02
- Last updated by the study team
- 2021-06-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- UC Irvine Medical Center — Orange, California, United States
- University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States
- University Of Colorado — Aurora, Colorado, United States
- Georgetown University Medical Center — Washington D.C., District of Columbia, United States
- Florida Cancer Specialists - Sarasota — Sarasota, Florida, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
- Tennessee Oncology — Nashville, Tennessee, United States
- University of Texas M.D. Anderson Cancer Center — Houston, Texas, United States
- Samsung Medical Center — Seoul, South Korea
Full record on ClinicalTrials.gov
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