Ensartinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With ALK or ROS1 Genomic Alterations (A Pediatric MATCH Treatment Trial)

May 3, 2024 updated by: National Cancer Institute (NCI)

NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice)- Phase 2 Subprotocol of Ensartinib in Patients With Tumors Harboring ALK or ROS1 Genomic Alterations

This phase II Pediatric MATCH trial studies how well ensartinib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with ALK or ROS1 genomic alterations that have come back (recurrent) or does not respond to treatment (refractory) and may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Ensartinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. To determine the objective response rate (ORR; complete response + partial response) in pediatric patients treated with ensartinib with advanced solid tumors (including central nervous system [CNS] tumors), non-Hodgkin lymphomas or histiocytic disorders that harbor ALK or ROS1 fusions or that harbor ALK missense mutations.

SECONDARY OBJECTIVES:

I. To estimate the progression free survival in pediatric patients treated with ensartinib with advanced solid tumors (including CNS tumors), non-Hodgkin lymphomas or histiocytic disorders that harbor ALK or ROS1 fusions or that harbor ALK missense mutations.

II. To obtain information about the tolerability of ensartinib in children with relapsed or refractory cancer.

III. To provide preliminary estimates of the pharmacokinetics of ensartinib in children with relapsed or refractory cancer.

EXPLORATORY OBJECTIVES:

I. To evaluate other biomarkers as predictors of response to ensartinib and specifically, whether tumors that harbor different missense mutations or fusions (including the crizotinib resistant F1174L ALK variant) will demonstrate differential response to ensartinib treatment.

II. To explore approaches to profiling changes in tumor genomics over time through evaluation of circulating tumor deoxyribonucleic acid (DNA).

OUTLINE:

Patients receive ensartinib orally (PO) once daily (QD) on days 1-28. Cycles repeat every 28 days for 2 years (up to 26 cycles) in the absence of disease progression or unacceptable toxicity. Patients undergo an x-ray, computed tomography (CT) scan, magnetic resonance imaging (MRI), positron emission tomography (PET) scan, radionuclide imaging, and/or bone scan, as well as a bone marrow aspiration and/or biopsy during screening and on study. Patients also undergo blood sample collection on study.

Study Type

Interventional

Enrollment (Estimated)

98

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Western Australia
      • Perth, Western Australia, Australia, 6009
  • Puerto Rico
      • San Juan, Puerto Rico, 00926
        • Recruiting
        • University Pediatric Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 787-474-0333
        • Principal Investigator:
          • Maria E. Echevarria
      • San Juan, Puerto Rico, 00912
        • Active, not recruiting
        • San Jorge Children's Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • Children's Hospital of Alabama
        • Contact:
        • Principal Investigator:
          • Elizabeth D. Alva
    • Alaska
      • Anchorage, Alaska, United States, 99508
    • Arizona
      • Mesa, Arizona, United States, 85202
        • Recruiting
        • Banner Children's at Desert
        • Contact:
          • Site Public Contact
          • Phone Number: 480-412-3100
        • Principal Investigator:
          • Joseph C. Torkildson
      • Tucson, Arizona, United States, 85719
        • Recruiting
        • Banner University Medical Center - Tucson
        • Principal Investigator:
          • Holly E. Pariury
        • Contact:
    • Arkansas
      • Little Rock, Arkansas, United States, 72202-3591
        • Recruiting
        • Arkansas Children's Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 501-364-7373
        • Principal Investigator:
          • David L. Becton
    • California
      • Downey, California, United States, 90242
        • Recruiting
        • Kaiser Permanente Downey Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 626-564-3455
        • Principal Investigator:
          • Robert M. Cooper
      • Loma Linda, California, United States, 92354
        • Recruiting
        • Loma Linda University Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 909-558-4050
        • Principal Investigator:
          • Albert Kheradpour
      • Long Beach, California, United States, 90806
        • Recruiting
        • Miller Children's and Women's Hospital Long Beach
        • Contact:
          • Site Public Contact
          • Phone Number: 562-933-5600
        • Principal Investigator:
          • Jacqueline N. Casillas
      • Los Angeles, California, United States, 90027
        • Recruiting
        • Children's Hospital Los Angeles
        • Contact:
          • Site Public Contact
          • Phone Number: 323-361-4110
        • Principal Investigator:
          • Fariba Navid
      • Madera, California, United States, 93636
        • Recruiting
        • Valley Children's Hospital
        • Contact:
        • Principal Investigator:
          • Karen S. Fernandez
      • Oakland, California, United States, 94611
        • Recruiting
        • Kaiser Permanente-Oakland
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Aarati V. Rao
      • Oakland, California, United States, 94609
        • Recruiting
        • UCSF Benioff Children's Hospital Oakland
        • Principal Investigator:
          • Jennifer G. Michlitsch
        • Contact:
      • Orange, California, United States, 92868
        • Recruiting
        • Children's Hospital of Orange County
        • Contact:
        • Principal Investigator:
          • Elyssa M. Rubin
      • Sacramento, California, United States, 95817
        • Recruiting
        • University of California Davis Comprehensive Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 916-734-3089
        • Principal Investigator:
          • Marcio H. Malogolowkin
      • San Francisco, California, United States, 94158
        • Suspended
        • UCSF Medical Center-Mission Bay
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • Children's Hospital Colorado
        • Contact:
        • Principal Investigator:
          • Margaret E. Macy
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 303-839-6000
        • Principal Investigator:
          • Jennifer J. Clark
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Suspended
        • Yale University
    • Delaware
      • Wilmington, Delaware, United States, 19803
        • Recruiting
        • Alfred I duPont Hospital for Children
        • Contact:
        • Principal Investigator:
          • Scott M. Bradfield
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Recruiting
        • Children's National Medical Center
        • Principal Investigator:
          • Jeffrey S. Dome
        • Contact:
    • Florida
      • Gainesville, Florida, United States, 32610
        • Recruiting
        • University of Florida Health Science Center - Gainesville
        • Contact:
        • Principal Investigator:
          • William B. Slayton
      • Jacksonville, Florida, United States, 32207
        • Recruiting
        • Nemours Children's Clinic-Jacksonville
        • Contact:
        • Principal Investigator:
          • Scott M. Bradfield
      • Miami, Florida, United States, 33155
        • Recruiting
        • Nicklaus Children's Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 888-624-2778
        • Principal Investigator:
          • Ziad A. Khatib
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami Miller School of Medicine-Sylvester Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 305-243-2647
        • Principal Investigator:
          • Julio C. Barredo
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Arnold Palmer Hospital for Children
        • Principal Investigator:
          • Jaime M. Libes-Bander
        • Contact:
      • Orlando, Florida, United States, 32827
        • Recruiting
        • Nemours Children's Hospital
        • Contact:
        • Principal Investigator:
          • Scott M. Bradfield
      • Orlando, Florida, United States, 32803
        • Recruiting
        • AdventHealth Orlando
        • Contact:
        • Principal Investigator:
          • Fouad M. Hajjar
      • Pensacola, Florida, United States, 32504
        • Active, not recruiting
        • Nemours Children's Clinic - Pensacola
      • Saint Petersburg, Florida, United States, 33701
        • Recruiting
        • Johns Hopkins All Children's Hospital
        • Contact:
        • Principal Investigator:
          • Stacie L. Stapleton
      • Tampa, Florida, United States, 33607
        • Active, not recruiting
        • Saint Joseph's Hospital/Children's Hospital-Tampa
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Children's Healthcare of Atlanta - Egleston
        • Contact:
        • Principal Investigator:
          • William T. Cash
    • Idaho
      • Boise, Idaho, United States, 83712
        • Recruiting
        • Saint Luke's Cancer Institute - Boise
        • Principal Investigator:
          • Martha M. Pacheco
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Lurie Children's Hospital-Chicago
        • Contact:
          • Site Public Contact
          • Phone Number: 773-880-4562
        • Principal Investigator:
          • David O. Walterhouse
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Susan L. Cohn
      • Peoria, Illinois, United States, 61637
        • Recruiting
        • Saint Jude Midwest Affiliate
        • Contact:
          • Site Public Contact
          • Phone Number: 888-226-4343
        • Principal Investigator:
          • Prerna Kumar
      • Springfield, Illinois, United States, 62702
        • Recruiting
        • Southern Illinois University School of Medicine
        • Contact:
          • Site Public Contact
          • Phone Number: 217-545-7929
        • Principal Investigator:
          • Gregory P. Brandt
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Riley Hospital for Children
        • Contact:
          • Site Public Contact
          • Phone Number: 800-248-1199
        • Principal Investigator:
          • Sandeep Batra
    • Iowa
      • Des Moines, Iowa, United States, 50309
        • Recruiting
        • Blank Children's Hospital
        • Contact:
        • Principal Investigator:
          • Samantha L. Mallory
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa/Holden Comprehensive Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-237-1225
        • Principal Investigator:
          • David S. Dickens
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • Norton Children's Hospital
        • Contact:
        • Principal Investigator:
          • Ashok B. Raj
    • Louisiana
      • New Orleans, Louisiana, United States, 70118
        • Recruiting
        • Children's Hospital New Orleans
        • Contact:
        • Principal Investigator:
          • Lolie C. Yu
      • New Orleans, Louisiana, United States, 70121
        • Recruiting
        • Ochsner Medical Center Jefferson
        • Contact:
        • Principal Investigator:
          • Craig Lotterman
    • Maine
      • Bangor, Maine, United States, 04401
        • Recruiting
        • Eastern Maine Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 207-973-4274
        • Principal Investigator:
          • Daniel L. Callaway
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins University/Sidney Kimmel Cancer Center
        • Contact:
        • Principal Investigator:
          • Kenneth J. Cohen
      • Baltimore, Maryland, United States, 21201
        • Suspended
        • University of Maryland/Greenebaum Cancer Center
      • Baltimore, Maryland, United States, 21215
        • Recruiting
        • Sinai Hospital of Baltimore
        • Contact:
        • Principal Investigator:
          • Jason M. Fixler
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 877-726-5130
        • Principal Investigator:
          • Katherine A. Janeway
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana-Farber Cancer Institute
        • Contact:
          • Site Public Contact
          • Phone Number: 877-442-3324
        • Principal Investigator:
          • Katherine A. Janeway
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • C S Mott Children's Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 800-865-1125
        • Principal Investigator:
          • Rajen Mody
      • East Lansing, Michigan, United States, 48824
        • Recruiting
        • Michigan State University Clinical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 517-975-9547
        • Principal Investigator:
          • Laura E. Agresta
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Helen DeVos Children's Hospital at Spectrum Health
        • Principal Investigator:
          • Kathleen J. Yost
        • Contact:
      • Kalamazoo, Michigan, United States, 49007
        • Recruiting
        • Bronson Methodist Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Recruiting
        • Children's Hospitals and Clinics of Minnesota - Minneapolis
        • Principal Investigator:
          • Michael K. Richards
        • Contact:
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota/Masonic Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 612-624-2620
        • Principal Investigator:
          • Emily G. Greengard
      • Rochester, Minnesota, United States, 55905
        • Withdrawn
        • Mayo Clinic in Rochester
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Recruiting
        • University of Mississippi Medical Center
        • Principal Investigator:
          • Betty L. Herrington
        • Contact:
          • Site Public Contact
          • Phone Number: 601-815-6700
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Recruiting
        • Children's Mercy Hospitals and Clinics
        • Contact:
          • Site Public Contact
          • Phone Number: 816-302-6808
          • Email: rryan@cmh.edu
        • Principal Investigator:
          • Kevin F. Ginn
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Contact:
        • Principal Investigator:
          • Amy Armstrong
      • Saint Louis, Missouri, United States, 63104
        • Recruiting
        • Cardinal Glennon Children's Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 314-268-4000
        • Principal Investigator:
          • William S. Ferguson
      • Saint Louis, Missouri, United States, 63141
        • Recruiting
        • Mercy Hospital Saint Louis
        • Contact:
          • Site Public Contact
          • Phone Number: 314-251-7066
        • Principal Investigator:
          • Robin D. Hanson
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Recruiting
        • Children's Hospital and Medical Center of Omaha
        • Contact:
          • Site Public Contact
          • Phone Number: 402-955-3949
        • Principal Investigator:
          • Jill C. Beck
      • Omaha, Nebraska, United States, 68198
        • Recruiting
        • University of Nebraska Medical Center
        • Contact:
        • Principal Investigator:
          • Jill C. Beck
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Suspended
        • University Medical Center of Southern Nevada
      • Las Vegas, Nevada, United States, 89135
        • Suspended
        • Alliance for Childhood Diseases/Cure 4 the Kids Foundation
      • Las Vegas, Nevada, United States, 89144
        • Suspended
        • Summerlin Hospital Medical Center
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • Hackensack University Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 201-996-2879
        • Principal Investigator:
          • Katharine Offer
      • Morristown, New Jersey, United States, 07960
        • Recruiting
        • Morristown Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 973-971-5900
        • Principal Investigator:
          • Kathryn L. Laurie
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • Saint Peter's University Hospital
        • Contact:
        • Principal Investigator:
          • Nibal A. Zaghloul
    • New York
      • Albany, New York, United States, 12208
        • Recruiting
        • Albany Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 518-262-5513
        • Principal Investigator:
          • Lauren R. Weintraub
      • Bronx, New York, United States, 10467
        • Recruiting
        • Montefiore Medical Center - Moses Campus
        • Contact:
        • Principal Investigator:
          • Alice Lee
      • Buffalo, New York, United States, 14263
        • Recruiting
        • Roswell Park Cancer Institute
        • Contact:
        • Principal Investigator:
          • Clare J. Twist
      • New Hyde Park, New York, United States, 11040
        • Recruiting
        • The Steven and Alexandra Cohen Children's Medical Center of New York
        • Contact:
          • Site Public Contact
          • Phone Number: 718-470-3460
        • Principal Investigator:
          • Julie I. Krystal
      • New York, New York, United States, 10032
        • Recruiting
        • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
        • Principal Investigator:
          • Luca Szalontay
        • Contact:
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Kavitha Ramaswamy
      • New York, New York, United States, 10065
        • Recruiting
        • NYP/Weill Cornell Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 212-746-1848
        • Principal Investigator:
          • Alexander J. Chou
      • Rochester, New York, United States, 14642
        • Recruiting
        • University of Rochester
        • Contact:
          • Site Public Contact
          • Phone Number: 585-275-5830
        • Principal Investigator:
          • Rafi R. Kazi
      • Syracuse, New York, United States, 13210
        • Recruiting
        • State University of New York Upstate Medical University
        • Contact:
          • Site Public Contact
          • Phone Number: 315-464-5476
        • Principal Investigator:
          • Melanie A. Comito
      • Valhalla, New York, United States, 10595
        • Recruiting
        • New York Medical College
        • Contact:
          • Site Public Contact
          • Phone Number: 914-594-3794
        • Principal Investigator:
          • Jessica C. Hochberg
    • North Carolina
      • Asheville, North Carolina, United States, 28801
      • Charlotte, North Carolina, United States, 28203
        • Recruiting
        • Carolinas Medical Center/Levine Cancer Institute
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-9376
        • Principal Investigator:
          • Joel A. Kaplan
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Novant Health Presbyterian Medical Center
        • Contact:
        • Principal Investigator:
          • Jessica A. Bell
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Medical Center
        • Principal Investigator:
          • Jessica M. Sun
        • Contact:
          • Site Public Contact
          • Phone Number: 888-275-3853
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest University Health Sciences
        • Contact:
          • Site Public Contact
          • Phone Number: 336-713-6771
        • Principal Investigator:
          • Thomas W. McLean
      • Winston-Salem, North Carolina, United States, 27157
        • Not yet recruiting
        • Wake Forest Baptist Medical Center
        • Contact:
        • Principal Investigator:
          • David E. Kram
    • North Dakota
      • Fargo, North Dakota, United States, 58122
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Children's Hospital Medical Center
        • Contact:
        • Principal Investigator:
          • Erin H. Breese
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • Rainbow Babies and Childrens Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 216-844-5437
        • Principal Investigator:
          • Duncan S. Stearns
      • Cleveland, Ohio, United States, 44195
        • Suspended
        • Cleveland Clinic Foundation
      • Columbus, Ohio, United States, 43205
      • Dayton, Ohio, United States, 45404
        • Recruiting
        • Dayton Children's Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 800-228-4055
        • Principal Investigator:
          • Mukund G. Dole
      • Toledo, Ohio, United States, 43606
        • Recruiting
        • ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
        • Contact:
        • Principal Investigator:
          • Jamie L. Dargart
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma Health Sciences Center
        • Contact:
        • Principal Investigator:
          • Rene Y. McNall-Knapp
    • Oregon
      • Portland, Oregon, United States, 97227
        • Recruiting
        • Legacy Emanuel Children's Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 503-413-2560
        • Principal Investigator:
          • Jason M. Glover
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health and Science University
        • Contact:
        • Principal Investigator:
          • Katrina Winsnes
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Recruiting
        • Geisinger Medical Center
        • Contact:
        • Principal Investigator:
          • Jagadeesh Ramdas
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Children's Hospital of Philadelphia
        • Contact:
        • Principal Investigator:
          • Theodore W. Laetsch
      • Pittsburgh, Pennsylvania, United States, 15224
        • Recruiting
        • Children's Hospital of Pittsburgh of UPMC
        • Contact:
        • Principal Investigator:
          • Jean M. Tersak
    • South Carolina
      • Columbia, South Carolina, United States, 29203
        • Recruiting
        • Prisma Health Richland Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 864-241-6251
        • Principal Investigator:
          • Stuart L. Cramer
      • Greenville, South Carolina, United States, 29605
        • Recruiting
        • BI-LO Charities Children's Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 864-241-6251
        • Principal Investigator:
          • Aniket Saha
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57117-5134
    • Tennessee
      • Knoxville, Tennessee, United States, 37916
        • Suspended
        • East Tennessee Childrens Hospital
      • Memphis, Tennessee, United States, 38105
        • Recruiting
        • Saint Jude Children's Research Hospital
        • Contact:
        • Principal Investigator:
          • Alberto S. Pappo
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University/Ingram Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-811-8480
        • Principal Investigator:
          • Scott C. Borinstein
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • The Children's Hospital at TriStar Centennial
        • Contact:
          • Site Public Contact
          • Phone Number: 615-342-1919
        • Principal Investigator:
          • Jennifer A. Domm
    • Texas
      • Austin, Texas, United States, 78723
        • Recruiting
        • Dell Children's Medical Center of Central Texas
        • Contact:
        • Principal Investigator:
          • Shannon M. Cohn
      • Dallas, Texas, United States, 75390
        • Recruiting
        • UT Southwestern/Simmons Cancer Center-Dallas
        • Contact:
        • Principal Investigator:
          • Avanthi T. Shah
      • Dallas, Texas, United States, 75230
        • Recruiting
        • Medical City Dallas Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 972-566-5588
        • Principal Investigator:
          • Stanton C. Goldman
      • Fort Worth, Texas, United States, 76104
      • Houston, Texas, United States, 77030
        • Recruiting
        • M D Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Najat C. Daw
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 713-798-1354
          • Email: burton@bcm.edu
        • Principal Investigator:
          • Jennifer H. Foster
      • San Antonio, Texas, United States, 78207
        • Recruiting
        • Children's Hospital of San Antonio
        • Contact:
        • Principal Investigator:
          • Timothy C. Griffin
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • University of Texas Health Science Center at San Antonio
        • Contact:
        • Principal Investigator:
          • Anne-Marie R. Langevin
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Methodist Children's Hospital of South Texas
        • Contact:
        • Principal Investigator:
          • Jose M. Esquilin
    • Utah
      • Salt Lake City, Utah, United States, 84113
        • Recruiting
        • Primary Children's Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 801-585-5270
        • Principal Investigator:
          • Matthew Dietz
    • Vermont
      • Burlington, Vermont, United States, 05405
        • Recruiting
        • University of Vermont and State Agricultural College
        • Contact:
          • Site Public Contact
          • Phone Number: 802-656-8990
          • Email: rpo@uvm.edu
        • Principal Investigator:
          • Jessica L. Heath
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Recruiting
        • Children's Hospital of The King's Daughters
        • Contact:
        • Principal Investigator:
          • Eric J. Lowe
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • Virginia Commonwealth University/Massey Cancer Center
        • Contact:
        • Principal Investigator:
          • Gita V. Massey
    • Washington
      • Seattle, Washington, United States, 98105
        • Recruiting
        • Seattle Children's Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 866-987-2000
        • Principal Investigator:
          • Sarah E. Leary
      • Spokane, Washington, United States, 99204
        • Recruiting
        • Providence Sacred Heart Medical Center and Children's Hospital
        • Contact:
        • Principal Investigator:
          • Judy L. Felgenhauer
      • Tacoma, Washington, United States, 98431
        • Recruiting
        • Madigan Army Medical Center
        • Principal Investigator:
          • Melissa A. Forouhar
        • Contact:
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Active, not recruiting
        • West Virginia University Healthcare
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University of Wisconsin Carbone Cancer Center
        • Principal Investigator:
          • Kenneth B. De Santes
        • Contact:
      • Marshfield, Wisconsin, United States, 54449
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Children's Hospital of Wisconsin
        • Contact:
        • Principal Investigator:
          • Paul D. Harker-Murray

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient must have enrolled onto APEC1621SC and must have been given a treatment assignment to Molecular Analysis for Therapy Choice (MATCH) to APEC1621F based on the presence of an actionable mutation
  • Patients must be >= than 12 months and =< 21 years of age at the time of study enrollment.
  • Patients must have a body surface area >= 0.5 m^2 at enrollment

  • Patients must have radiographically measurable disease at the time of study enrollment. Patients with neuroblastoma who do not have measurable disease but have iobenguane (MIBG) positive (+) evaluable disease are eligible; measurable disease in patients with CNS involvement is defined as any lesion that is at minimum 10 mm in one dimension on a standard MRI or CT

    • Note: The following do not qualify as measurable disease:

      • Malignant fluid collections (e.g., ascites, pleural effusions)
      • Bone marrow infiltration except that detected by MIBG scan for neuroblastoma
      • Lesions only detected by nuclear medicine studies (e.g., bone, gallium or positron emission tomography [PET] scans) except as noted for neuroblastoma
      • Elevated tumor markers in plasma or cerebrospinal fluid (CSF)
      • Previously radiated lesions that have not demonstrated clear progression post radiation
      • Leptomeningeal lesions that do not meet the measurement requirements for Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

  • Karnofsky >= 50% for patients > 16 years of age and Lansky >= 50 for patients =< 16 years of age

    • Note: Neurologic deficits in patients with CNS tumors must have been relatively stable for at least 7 days prior to study enrollment; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score

  • Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required timeframe, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately

    • Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive: >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)
    • Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil counts [ANC] counts): >= 7 days after the last dose of agent
    • Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1
    • Corticosteroids: if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid
    • Hematopoietic growth factors: >= 14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor; for growth factors that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator
    • Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)

    • Stem cell Infusions (with or without total body irradiation [TBI]):

      • Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days after infusion and no evidence of graft versus host disease (GVHD)
      • Autologous stem cell infusion including boost infusion: >= 42 days
    • Cellular therapy: >= 42 days after the completion of any type of cellular therapy (e.g. modified T cells, natural killer [NK] cells, dendritic cells, etc.)

    • Radiation therapy (XRT)/external beam irradiation including protons: >= 14 days after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial none marrow (BM) radiation

      • Note: Radiation may not be delivered to "measurable disease" tumor site(s) being used to follow response to subprotocol treatment
    • Radiopharmaceutical therapy (e.g., radiolabeled antibody, 131I-MIBG): >= 42 days after systemically administered radiopharmaceutical therapy
    • Patients must not have received prior exposure to ensartinib; prior treatment with other ALK inhibitors is permitted given that at least 5 half-lives or 21 days have elapsed since therapy discontinuation, whichever is greater

  • For patients with solid tumors without known bone marrow involvement:

    • Peripheral absolute neutrophil count (ANC) >= 1000/mm^3 (within 7 days prior to enrollment)
    • Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment) (within 7 days prior to enrollment)
  • Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions); these patients will not be evaluable for hematologic toxicity

  • Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 ml/min/1.73 m^2 (within 7 days prior to enrollment) or a serum creatinine based on age/gender as follows (within 7 days prior to enrollment):

    • Age 1 to < 2 years: maximum serum creatinine 0.6 mg/dL for male and 0.6 mg/dL for female
    • Age 2 to < 6 years: maximum serum creatinine 0.8 mg/dL for male and 0.8 mg/dL for female
    • Age 6 to < 10 years: maximum serum creatinine 1 mg/dL for male and 1 mg/dL for female
    • Age 10 to < 13 years: maximum serum creatinine 1.2 mg/dL for male and 1.2 mg/dL for female
    • Age 13 to < 16 years: maximum serum creatinine 1.5 mg/dL for male and 1.4 mg/dL for female
    • Age >= 16 years: maximum serum creatinine 1.7 mg/dL for male and 1.4 mg/dL for female
  • Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment)
  • Serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) =< 135 U/L (within 7 days prior to enrollment) (for the purpose of this study, the ULN for SGPT is 45 U/L)
  • Serum albumin >= 2 g/dL (within 7 days prior to enrollment)
  • Patients must be able to swallow intact capsules
  • All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines

Exclusion Criteria:

  • Pregnant or breast-feeding women will not be entered on this study because there is currently no available information regarding human fetal or teratogenic toxicities; pregnancy tests must be obtained in girls who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method for the duration of study treatment and for one week after the last dose of ensartinib

  • Concomitant medications

    • Corticosteroids: patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid
    • Investigational drugs: patients who are currently receiving another investigational drug are not eligible
    • Anti-cancer agents: patients who are currently receiving other anti-cancer agents are not eligible
    • Anti-GVHD agents post-transplant: patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial

    • CYP3A4 agents: patients who are currently receiving drugs that are strong inducers or strong inhibitors of CYP3A4 are not eligible; strong inducers or inhibitors of CYP3A4 should be avoided from 14 days prior to enrollment to the end of the study

      • Note: CYP3A4 inducing anti-epileptic drugs and dexamethasone for CNS tumors or metastases, on a stable dose, are allowed
  • Patients who have an uncontrolled infection are not eligible
  • Patients who have received a prior solid organ transplantation are not eligible
  • Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment (ensartinib)
Patients receive ensartinib PO QD on days 1-28. Cycles repeat every 28 days for 2 years (up to 26 cycles) in the absence of disease progression or unacceptable toxicity. Patients undergo an x-ray, CT scan, MRI, PET scan, radionuclide imaging, and/or bone scan, as well as a bone marrow aspiration and/or biopsy during screening and on study. Patients also undergo blood sample collection on study.
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Pharmacological Study
Correlative studies
Procedure: Magnetic Resonance Imaging
Undergo MRI
Other Names:
  • MRI
  • Magnetic Resonance
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR
  • MR Imaging
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging
  • Magnetic Resonance Imaging (MRI)
  • sMRI
  • Magnetic resonance imaging (procedure)
  • MRIs
  • Structural MRI
Procedure: Biospecimen Collection
Undergo blood sample collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Procedure: Computed Tomography
Undergo a CT scan
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT Scan
  • tomography
  • Computerized axial tomography (procedure)
  • Computerized Tomography (CT) scan
Procedure: Bone Scan
Undergo a bone scan
Other Names:
  • Bone Scintigraphy
Procedure: Radionuclide Imaging
Undergo radionuclide imaging
Other Names:
  • NM
  • Nuclear Medicine
  • nuclear medicine scan
  • radioimaging
  • Radionuclide Scanning
  • Scan
  • Scintigraphy
Procedure: X-Ray Imaging
Undergo an x-ray
Other Names:
  • Conventional X-Ray
  • Diagnostic Radiology
  • Medical Imaging, X-Ray
  • Radiographic Imaging
  • Radiography
  • RG
  • Static X-Ray
  • X-Ray
  • Plain film radiographs
  • Radiographic imaging procedure (procedure)
Drug: Ensartinib
Given PO
Other Names:
  • X-396
Procedure: Positron Emission Tomography
Undergo a PET scan
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging
  • PT
  • Positron emission tomography (procedure)
Procedure: Bone Marrow Aspiration and Biopsy
Undergo a bone marrow aspiration and/or biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate
Time Frame: From enrollment to the end of treatment, up to 2 years
A responder is defined as a patient who achieves a best response of partial response or complete response on the study. Response rates will be calculated as the percent of evaluable patients who are responders, and confidence intervals will be constructed using the Wilson score interval method.
From enrollment to the end of treatment, up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients experiencing grade 3 or higher adverse events
Time Frame: From enrollment to the end of treatment, up to 2 years
Percentage of patients experiencing grade 3 or higher adverse events will be evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. All patients who receive at least one dose of protocol therapy will be considered in the evaluation of toxicity.
From enrollment to the end of treatment, up to 2 years
Progression free survival (PFS)
Time Frame: From the initiation of protocol treatment to the occurrence of disease progression or disease recurrence or death from any cause, assessed up to 5 years
Progression free survival will be defined as time from the initiation of protocol treatment to the occurrence of any of the following events: disease progression or disease recurrence or death from any cause. PFS along with the confidence intervals will be estimated using the Kaplan-Meier method.
From the initiation of protocol treatment to the occurrence of disease progression or disease recurrence or death from any cause, assessed up to 5 years
Pharmacokinetic (PK) parameters
Time Frame: Pre-dose, 1, 2, 4, 6-8, and 20-24 hours post day 1 dose and pre-dose, 1, 2, 4, and 6-8 hours post day 28 dose of cycle 1
A descriptive analysis of PK parameters will be performed to define systemic exposure, drug clearance, and other pharmacokinetic parameters. The PK parameters will be summarized with simple summary statistics, including means, medians, ranges, and standard deviations (if numbers and distribution permit).
Pre-dose, 1, 2, 4, 6-8, and 20-24 hours post day 1 dose and pre-dose, 1, 2, 4, and 6-8 hours post day 28 dose of cycle 1

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biomarkers as predictors of response to ensartinib
Time Frame: Up to 4 years
Descriptive analysis will be performed and will be summarized with simple summary statistics.
Up to 4 years
Changes in tumor genomic profile
Time Frame: Up to 4 years
Approaches to profiling changes in tumor genomics over time through evaluation of circulating tumor deoxyribonucleic acid will be explored. Descriptive analysis will be performed and will be summarized with simple summary statistics.
Up to 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Collaborators

Children's Oncology Group

Investigators

  • Principal Investigator: Meredith S Irwin, Children's Oncology Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2018

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

July 10, 2017

First Submitted That Met QC Criteria

July 10, 2017

First Posted (Actual)

July 11, 2017

Study Record Updates

Last Update Posted (Actual)

May 6, 2024

Last Update Submitted That Met QC Criteria

May 3, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2017-01243 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • U10CA180886 (U.S. NIH Grant/Contract)
  • APEC1621F (Other Identifier: CTEP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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