🏛️ Verified NIH Record • Updated 2026-08-24

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) (NCT02568267)

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

🔵 Active, Not Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Hoffmann-La Roche

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (12 items) and avoid the listed exclusions (14 items).

Location: Dignity Health St Joseph's Hospital and Medical Center — Phoenix, Arizona

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Current participation in another therapeutic clinical trial
  • Prior treatment with approved or investigational Trk, ROS1, or ALK inhibitors in patients who have tumors that harbor those respective gene rearrangements \- Note: prior treatment with crizotinib is permitted only in ALK- or ROS1-rearranged NSCLC patients presenting with CNS-only progression. Other ALK inhibitors are prohibited.
  • History of other previous cancer that would interfere with the determination of safety or efficacy
  • Familial or personal history of congenital bone disorders, or bone metabolism alterations
  • Incomplete recovery from any surgery
  • History of recent (within the past 3 months) symptomatic congestive heart failure or ejection fraction ≤50% observed during screening for the study
  • History of non-pharmacologically induced prolonged QTc interval
  • History of additional risk factors for torsades de pointes
  • Peripheral neuropathy Grade ≥ 2
  • Known active infections
  • Active gastrointestinal disease or other malabsorption syndromes

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (120 Sites)

Showing the first 25 of 120 sites.

  • Dignity Health St Joseph's Hospital and Medical Center — Phoenix, Arizona
  • Mayo Clinic — Phoenix, Arizona
  • City of Hope Cancer Center — Duarte, California
  • City of Hope Duarte - Comprehensive Cancer Center, Investigational Drug Services — Duarte, California
  • Scripps Clinic — La Jolla, California
  • University of California San Diego Moores Cancer Center — La Jolla, California
  • Southern California Kaiser Permanente — Los Angeles, California
  • Univ Of California Irvine College Of Medicine — Orange, California
  • UCSF Mount Zion Medical Ctr — San Francisco, California
  • UCSF Mission Bay — San Francisco, California
  • Sarcoma Oncology Center — Santa Monica, California
  • Sarcoma Oncology Research Center LLC — Santa Monica, California
  • University of Colorado Cancer Center — Aurora, Colorado
  • Yale University — New Haven, Connecticut
  • Georgetown University Medical Center Lombardi Cancer Center — Washington D.C., District of Columbia
  • Florida Cancer Specialists - Sarasota — Sarasota, Florida
  • H. Lee Moffitt Cancer Center and Research Inst. — Tampa, Florida
  • Moffitt Cancer Center — Tampa, Florida
  • University Cancer & Blood Center, LLC — Athens, Georgia
  • Winship Cancer Institute — Atlanta, Georgia
  • Southeastern Regional Medical Center, Inc. — Newnan, Georgia
  • Northwestern University — Chicago, Illinois
  • Advocate Medical Group - Park Ridge, Luther Lane - Oncology — Park Ridge, Illinois
  • Midwestern Regional Medical Center — Zion, Illinois
  • Weinberg Cancer Institution at Franklin Square — Baltimore, Maryland

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗