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Last Updated: January 27, 2023

CLINICAL TRIALS PROFILE FOR ENTRECTINIB


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All Clinical Trials for Entrectinib

Trial ID Title Status Sponsor Phase Start Date Summary
NCT02097810 ↗ Study of Oral RXDX-101 in Adult Patients With Locally Advanced or Metastatic Cancer Targeting NTRK1, NTRK2, NTRK3, ROS1, or ALK Molecular Alterations. Completed Hoffmann-La Roche Phase 1 2014-07-28 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.
NCT02097810 ↗ Study of Oral RXDX-101 in Adult Patients With Locally Advanced or Metastatic Cancer Targeting NTRK1, NTRK2, NTRK3, ROS1, or ALK Molecular Alterations. Completed Ignyta, Inc. Phase 1 2014-07-28 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.
NCT02568267 ↗ Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions) Recruiting Hoffmann-La Roche Phase 2 2015-11-19 This is an open-label, multicenter, global Phase 2 basket study of entrectinib (RXDX-101) for the treatment of patients with solid tumors that harbor an NTRK1/2/3, ROS1, or ALK gene fusion. Patients will be assigned to different baskets according to tumor type and gene fusion.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Entrectinib

Condition Name

Condition Name for Entrectinib
Intervention Trials
Non-Small Cell Lung Cancer 4
Metastatic Malignant Solid Neoplasm 3
Breast Cancer 3
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Condition MeSH

Condition MeSH for Entrectinib
Intervention Trials
Neoplasms 8
Carcinoma, Non-Small-Cell Lung 6
Lung Neoplasms 4
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Clinical Trial Locations for Entrectinib

Trials by Country

Trials by Country for Entrectinib
Location Trials
United States 240
Italy 39
Spain 22
Australia 19
Brazil 15
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Trials by US State

Trials by US State for Entrectinib
Location Trials
Oregon 12
California 11
Texas 11
Florida 10
Tennessee 9
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Clinical Trial Progress for Entrectinib

Clinical Trial Phase

Clinical Trial Phase for Entrectinib
Clinical Trial Phase Trials
Phase 3 2
Phase 2/Phase 3 1
Phase 2 15
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Clinical Trial Status

Clinical Trial Status for Entrectinib
Clinical Trial Phase Trials
Recruiting 17
Completed 6
Not yet recruiting 4
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Clinical Trial Sponsors for Entrectinib

Sponsor Name

Sponsor Name for Entrectinib
Sponsor Trials
Hoffmann-La Roche 11
Genentech, Inc. 10
Oregon Health and Science University 4
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Sponsor Type

Sponsor Type for Entrectinib
Sponsor Trials
Industry 50
Other 43
NIH 1
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