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)

Running, not enrolling · Phase 2

Conditions studied: Breast Cancer, Cholangiocarcinoma, Colorectal Cancer, Head and Neck Neoplasms, Lymphoma, Large-Cell, Anaplastic, Melanoma, Neuroendocrine Tumors, Non-Small Cell Lung Cancer, Ovarian Cancer, Pancreatic Cancer, Papillary Thyroid Cancer, Primary Brain Tumors, Renal Cell Carcinoma, Sarcomas, Salivary Gland Cancers, Adult Solid Tumor

In brief

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.

Key facts

Study ID

NCT02568267

Run by

Hoffmann-La Roche

People needed

534

Starts

2015-11-19

Expected to finish

2027-06-30

Last updated by the study team

2026-05-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically- or cytologically-confirmed diagnosis of locally advanced or metastatic solid tumor that harbors an NTRK1/2/3, ROS1, or ALK gene rearrangement
• For patients enrolled via local molecular testing, an archival or fresh tumor tissue (unless medically contraindicated) is required to be submitted for independent central molecular testing at Ignyta's CLIA laboratory post-enrollment
• Measurable or evaluable disease
• Patients with CNS involvement, including leptomeningeal carcinomatosis, which is either asymptomatic or previously-treated and controlled, are allowed
• Prior anticancer therapy is allowed (excluding 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.
• At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed after prior chemotherapy or small molecule targeted therapy
• At least 4 weeks must have elapsed since completion of antibody-directed therapy
• Prior radiotherapy is allowed if more than 14 days have elapsed since the end of treatment
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 and minimum life expectancy of 4 weeks
• Adequate organ function as defined per protocol
• Ability to swallow entrectinib intact
• Other protocol specified criteria

You may not qualify if…

• 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
• Known interstitial lung disease, interstitial fibrosis, or history of tyrosine kinase inhibitor-induced pneumonitis
• Other protocol specified criteria

Where it is running

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

Full record on ClinicalTrials.gov

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