Clinical trialPhase 2Active not recruiting
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)
An Open-Label, Multicenter, Global Phase 2 Basket Study of Entrectinib for the Treatment of Patients With Locally Advanced or Metastatic Solid Tumors That Harbor NTRK1/2/3, ROS1, or ALK Gene Rearrangements
- Outcome
- Ongoing
- Phase
- Phase 2
- Status
- Active not recruiting
- Study type
- Interventional
- Start
- 19 November 2015
- Expected end
- 30 June 2027
- Enrollment
- 534 participants
- Sites
- 120
- Primary outcomes
- Objective Response Rate
- Sponsor
- Industry
- Results posted
- No
- Last update
- 25 August 2026
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Brief summary public domain (ClinicalTrials.gov)
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.
Papers 11
- Builds on itGastric Cancer, Version 2.2025, NCCN Clinical Practice Guidelines In Oncology. DOI 10.6004/jnccn.2025.0022↗
- Builds on itEfficacy and safety of entrectinib in children with extracranial solid or central nervous system (CNS) tumours harbouri… DOI 10.1016/j.ejca.2025.115308↗
- Builds on itEntrectinib versus crizotinib in Asian patients with ROS1-positive non-small cell lung cancer: A matching-adjusted indi… DOI 10.1016/j.lungcan.2024.108018↗
- Builds on itSerial Cell-Free DNA Sequencing in ROS1 Fusion-Positive Lung Cancers During Treatment With Entrectinib. DOI 10.1200/po.23.00721↗
- Builds on itReal-world experience of tropomyosin receptor kinase inhibition with entrectinib in ETV6-NTRK3 positive metastatic sali… DOI 10.1002/hed.27346↗
- Builds on itLetter re: 'Intrapatient comparisons of efficacy in a single-arm trial of entrectinib in tumour-agnostic indications'. DOI 10.1016/j.esmoop.2021.100282↗
- Builds on itComparative effectiveness analysis between entrectinib clinical trial and crizotinib real-world data in ROS1+ NSCLC. DOI 10.2217/cer-2021-0131↗
- Builds on itUpdated Integrated Analysis of the Efficacy and Safety of Entrectinib in Locally Advanced or Metastatic ROS1 Fusion-Pos… DOI 10.1200/jco.20.03025↗
- Builds on itEntrectinib in ROS1 fusion-positive non-small-cell lung cancer: integrated analysis of three phase 1-2 trials. DOI 10.1016/s1470-2045(19)30690-4↗
- Builds on itEntrectinib in patients with advanced or metastatic NTRK fusion-positive solid tumours: integrated analysis of three ph… DOI 10.1016/s1470-2045(19)30691-6↗
- Builds on itActivity of Entrectinib in a Patient With the First Reported NTRK Fusion in Neuroendocrine Cancer. DOI 10.6004/jnccn.2017.7029↗