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NCT02568267 · ClinicalTrials.gov record · last posted 2026-08-25

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)

Name: 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) — clinical trial record (NCT02568267)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Study acronym: STARTRK-2

StatusActive, Not Recruiting

PhasePhase 2

SponsorHoffmann-La Roche

Started2015-11-19

View on ClinicalTrials.gov ↗

from the ClinicalTrials.gov record

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.

Protocol amendment history 3 changes detected by DataLookout

2026-08-26

Trial sites reduced: 130 → 120 locations

2026-05-28

Primary completion pushed: 2026-05-14 → 2027-06-30

2026-05-28

Completion pushed: 2026-05-14 → 2027-06-30

Trial Details

NCT Number	NCT02568267
Lead Sponsor	Hoffmann-La Roche
Conditions	Breast Cancer, Cholangiocarcinoma, Colorectal Cancer, Head and Neck Neoplasms, Lymphoma, Large-Cell, Anaplastic, Melanoma, Neuroendocrine Tumors, Non-Small Cell Lung Cancer +8 more
Enrollment	534 participants
Start Date	2015-11-19
Primary Completion	2027-06-30 (estimated)
Study Completion	2027-06-30 (estimated)
Updated on ClinicalTrials.gov	2026-08-25