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Clinical Trials in the UK / NCT02568267
Active, not recruiting Phase 2

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 · tracked via the Priya Life Science UK tracker
Sponsor
Hoffmann-La Roche
Phase
Phase 2
Started
2015-11-19
Last updated
2026-08-25

Condition(s) studied

Breast CancerCholangiocarcinomaColorectal CancerHead and Neck NeoplasmsLymphoma, Large-Cell, AnaplasticMelanomaNeuroendocrine TumorsNon-Small Cell Lung CancerOvarian CancerPancreatic CancerPapillary Thyroid CancerPrimary Brain TumorsRenal Cell CarcinomaSarcomasSalivary Gland CancersAdult Solid Tumor

Investigational drug(s) / intervention(s)

Entrectinib

Entrectinib: TrkA/B/C, ROS1, and ALK inhibitor

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * 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 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 * Known interstitial lung disease, interstitial fibrosis, or history of tyrosine kinase inhibitor-induced pneumonitis * Other protocol specified criteria

Primary outcome measure(s)

Trial sites (120)

FacilityCityRegionStatus
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
Massachusetts General Hosp CAR Boston Massachusetts
Massachusetts General Hospital Boston Massachusetts
Beth Israel Deaconess Medical Center Boston Massachusetts
Dana Farber Cancer Institute Boston Massachusetts
Karmanos Cancer Center Detroit Michigan
Henry Ford Hospital Detroit Michigan
Regents of the University of Minnesota Minneapolis Minnesota
Washington University St Louis Missouri
Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley Las Vegas Nevada
North Shore Hem Onc Associates East Setauket New York
Memorial Sloan Kettering Cancer Center New York New York
Atrium Health Levine Cancer Institute Charlotte North Carolina
Levine Cancer Institute Charlotte North Carolina
Duke Cancer Institute Durham North Carolina
Ohio State University Columbus Ohio

+ 80 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02568267 on ClinicalTrials.gov ↗ ← All trials in the UK