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Clinical Development Programme

To date, four clinical trials form the basis of the entrectinib clinical development programme (ALKA-372-001, STARTRK-1, STARTRK-2, STARTRK-NG) [1-3]. Entrectinib is also being investigated in other settings, including a phase 2/3 clinical trial investigating entrectinib versus other targeted therapies for patients with NSCLC [2, 3].

Table 12: Summary of Ongoing Clinical Trials for Entrectinib

Registry Number




EudraCT 2017-000076-28

B-FAST: Blood-First Assay Screening Trial


A study to evaluate efficacy and safety of multiple targeted Therapies as treatments for participants with non-small cell lung cancer (NSCLC)

EudraCT 2015-003385-84



Basket study of entrectinib (RXDX-101) for the treatment of patients with solid tumours harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK gene rearrangements (fusions)



Capmatinib, ceritinib, regorafenib, or entrectinib in treating patients with BRAF/NRAS wild-type stage III-IV melanoma

EudraCT 2012-000148-88



A phase I, first-in-human study of entrectinib

EudraCT 2014-001326-15



Study of oral RXDX-101 in adult patients with locally advanced or metastatic cancer targeting NTRK1, NTRK2, NTRK3, ROS1, or ALK molecular alterations




Study of entrectinib (Rxdx-101) in children and adolescents with no curative first-line treatment option, recurrent or refractory solid tumors and primary CNS tumors, with or without Trk, Ros1, or Alk Fusions



Evaluate the Effect of Entrectinib on the Pharmacokinetics of Midazolam in Cancer Patients

These data are current as of 6 June 2019 ( clinicaltrials.gov)


  1. Drilon A, Siena S, Ou SI et al. Safety and Antitumor Activity of the Multitargeted Pan-TRK, ROS1, and ALK Inhibitor Entrectinib: Combined Results from Two Phase I Trials (ALKA-372-001 and STARTRK-1). Cancer Discov 2017; 7: 400-409.
  2. Lassen UN, Albert CM, Kummar S et al. Larotrectinib efficacy and safety in TRK fusion cancer: An expanded clinical dataset showing consistency in an age and tumor agnostic approach. Annals of Oncology 2018; 29: mdy279.397-mdy279.397, https://doi.org/210.1093/annonc/mdy1279.1397.
  3. Sartore-Bianchi A, Ardini E, Bosotti R et al. Sensitivity to Entrectinib Associated With a Novel LMNA-NTRK1 Gene Fusion in Metastatic Colorectal Cancer. J Natl Cancer Inst 2016; 108.

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