409TiP - A phase II basket study of the oral TRK inhibitor LOXO–101 in adult subjects with NTRK fusion-positive tumors

Date 10 October 2016
Event ESMO 2016 Congress
Session Poster display
Topics Clinical Research
Basic Scientific Principles
Presenter Alexander Drilon
Citation Annals of Oncology (2016) 27 (6): 114-135. 10.1093/annonc/mdw368
Authors A. Drilon1, D. Hong2, J. Deeken3, S. Smith4, M. Reynolds4, S. Cruickshank4, M. Deegan4, N. Ku4, D. Hyman5
  • 1Thoracic Oncology Service, Memorial Sloan Kettering Cancer Center, 10065 - New York/US
  • 2Investigational Cancer Therapeutics, MD Anderson Cancer Center, 77030 - Houston/US
  • 3Medical Oncology, Inova Cancer Center, 22031 - Fairfax/US
  • 4Clinical Research, Loxo Oncology, Inc, 06901 - Stamford/US
  • 5Investigational Therapeutics, Memorial Sloan Kettering Cancer Center, 10065 - New York/US



The TRK family of neurotrophin receptors (TRKA, TRKB, and TRKC encoded by NTRK1, NTRK2, and NTRK3 genes, respectively) and their ligands regulate growth, differentiation and survival of neurons. Fusions of NTRK genes which involve the kinase domain are oncogenic and have been identified across common tumor types. Fusions occur at a frequency of

Trial design

The phase II global study of LOXO-101 (NCT02576431) is an open-label, multi-center trial for patients with any type of advanced solid tumor or primary CNS malignancy harboring an NTRK fusion. Patients age 12 and older with NTRK1, 2, or 3 fusion-positive solid tumors who have progressed following standard therapy are eligible. Prior progression with an investigational or approved agent targeting TRK is an exclusion; intolerance to a prior inhibitor is allowed. The primary endpoint of the study is overall response rate by RECIST 1.1 or RANO. Key secondary endpoints include duration of response, percent tumor regression as best response, PFS and duration of OS. Patients undergo radiographic evaluation for their disease at regular intervals. LOXO-101 is administered orally BID in capsule form starting at 100mg for continuous 28-day cycles. Archival tissue and/ or fresh tissue are required for future molecular assessment

Clinical trial identification

NCT 02576431 release date: 12 October 2015 EudraCT 2015-003582-28 release date: 14 April 2016

Legal entity responsible for the study

Loxo Oncology, Inc


Loxo Oncology, Inc


D. Hong: Travel support from Loxo Oncology, Inc. S. Smith, M. Reynolds, S. Cruickshank: Paid consultant for Loxo Oncology, Inc. M. Deegan, N. Ku: Employee and stockholder of Loxo Oncology, Inc. All other authors have declared no conflicts of interest.