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)
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)
Objective Response Rate — Approximately 24 months Assessed by blinded independent central review (BICR) using RECIST v1.1
Trial sites (120)
Facility
City
Region
Status
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.
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.
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