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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

Name

Phase

Title

EudraCT 2017-000076-28
NCT03178552

B-FAST: Blood-First Assay Screening Trial

2/3

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

NCT02568267
EudraCT 2015-003385-84

STARTRK-2

2

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)

NCT02587650

2

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

EudraCT 2012-000148-88

ALKA-372-001

1

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

EudraCT 2014-001326-15
NCT02097810

STARTRK-1

1

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

NCT02650401

STARTRK-NG

1

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

NCT03330990

1

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

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

References

  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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