Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT03213704 : Pediatric MATCH: Trk Inhibitor LOXO-101 in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With NTRK Fusions
PhasePhase 2
AgesMin: 12 Months Max: 21 Years
Eligibility
Inclusion Criteria:

- APEC1621SC: Patient must have enrolled onto APEC1621SC and must have been given a
treatment assignment to molecular analysis for therapy choice (MATCH) to APEC1621A
based on the presence of an actionable mutation

- 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)+ evaluable disease are eligible; measurable disease in patients with
CNS involvement is defined as tumor that is measurable in two perpendicular diameters
on magnetic resonance imaging (MRI) and visible on more than one slice; 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 time frame,
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;
for agents not listed, the duration of this interval must be discussed with the
study chair and the study-assigned research coordinator prior to enrollment

- >= 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 ANC counts): >= 7 days after the last dose of agent; for
agents not listed, the duration of this interval must be discussed with the study
chair and the study-assigned research coordinator prior to enrollment

- 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 leukocyte 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, 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 brain metastases (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 other NTRK inhibitors including
but not limited to LOXO-101 (larotrectinib), entrectinib (RXDX-101), DS6051,
PLX7486

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

- Peripheral absolute neutrophil count (ANC) >= 1000/mm^3

- Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving
platelet transfusions for at least 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 or

- A serum creatinine based on age/gender as follows:

- Age: 1 to < 2 years; maximum serum creatinine (mg/dL); male: 0.6 female: 0.6

- Age: 2 to < 6 years; maximum serum creatinine (mg/dL); male: 0.8 female: 0.8

- Age: 6 to < 10 years; maximum serum creatinine (mg/dL); male: 1 female: 1

- Age: 10 to < 13 years; maximum serum creatinine (mg/dL); male: 1.2 female: 1.2

- Age: 13 to < 16 years; maximum serum creatinine (mg/dL); male: 1.5 female: 1.4

- Age: >= 16 years; maximum serum creatinine (mg/dL); male: 1.7 female: 1.4

- Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for
age

- Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 135
U/L; (for the purpose of this study, the ULN for SGPT is 45 U/L)

- Serum albumin >= 2 g/dL

- Patients with seizure disorder may be enrolled if on anti-convulsants and well
controlled

- Nervous system disorders (Common Terminology Criteria for Adverse Events [CTCAE]
version [v] 4) resulting from prior therapy must be =< grade 2

- 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; 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

- 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

- Patients who are currently receiving another investigational drug are not eligible

- Patients who are currently receiving other anti-cancer agents are not eligible

- Patients who are receiving cyclosporine, tacrolimus or other agents to prevent
graft-versus-host disease (GVHD) post bone marrow transplant are not eligible for this
trial

- Patients who are currently receiving drugs that are strong inducers or 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 received prior therapy with a specific inhibitor of TRK (including
but not limited to entrectinib [RXDX-101], DS-6051b, and PLX7486) are not eligible

- 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
LinksPermanent Link to THIS page: http://virtualtrials.com/nct/display1trial.cfm?nct=NCT03213704      |      Link to official Clinicaltrials.gov listing
Locations
Birmingham, Alabama
Facility: Children's Hospital of Alabama
Investigator: Elizabeth D. Alva
Contact: Elizabeth D. Alva
Click HERE to send email to this center

Mesa, Arizona
Facility: Cardon Children's Medical Center
Investigator: Erlyn C. Smith
Contact: Erlyn C. Smith
Click HERE to send email to this center

Little Rock, Arkansas
Facility: Arkansas Children's Hospital
Investigator: David L. Becton
Contact: David L. Becton
Click HERE to send email to this center

Los Angeles, California
Facility: Children's Hospital Los Angeles
Investigator: Leo Mascarenhas
Contact: Leo Mascarenhas
Click HERE to send email to this center

Madera, California
Facility: Children's Hospital Central California
Investigator: Vonda L. Crouse
Contact: Vonda L. Crouse
Click HERE to send email to this center

Oakland, California
Facility: Children's Hospital and Research Center at Oakland
Investigator: Carla B. Golden
Contact: Carla B. Golden
Click HERE to send email to this center

Oakland, California
Facility: Kaiser Permanente-Oakland
Investigator: Steven K. Bergstrom
Contact: Steven K. Bergstrom Phone: 510-891-3400
Email not avaialable

Wilmington, Delaware
Facility: Alfred I duPont Hospital for Children
Investigator: Scott M. Bradfield
Contact: Scott M. Bradfield Phone: 302-651-5755
Email not avaialable

Washington, District of Columbia
Facility: Children's National Medical Center
Investigator: Jeffrey S. Dome
Contact: Jeffrey S. Dome
Click HERE to send email to this center

Jacksonville, Florida
Facility: Nemours Children's Clinic-Jacksonville
Investigator: Scott M. Bradfield
Contact: Scott M. Bradfield
Click HERE to send email to this center

Miami, Florida
Facility: University of Miami Miller School of Medicine-Sylvester Cancer Center
Investigator: Julio C. Barredo
Contact: Julio C. Barredo Phone: 305-243-2647
Email not avaialable

Orlando, Florida
Facility: Arnold Palmer Hospital for Children
Investigator: Vincent F. Giusti
Contact: Vincent F. Giusti Phone: 321-843-2584
Email not avaialable

Orlando, Florida
Facility: Nemours Children's Hospital
Investigator: Scott M. Bradfield
Contact: Scott M. Bradfield
Click HERE to send email to this center

Pensacola, Florida
Facility: Nemours Children's Clinic - Pensacola
Investigator: Scott M. Bradfield
Contact: Scott M. Bradfield
Click HERE to send email to this center

Boise, Idaho
Facility: Saint Luke's Mountain States Tumor Institute
Investigator: Eugenia Chang
Contact: Eugenia Chang
Click HERE to send email to this center

Indianapolis, Indiana
Facility: Riley Hospital for Children
Investigator: Kamnesh R. Pradhan
Contact: Kamnesh R. Pradhan Phone: 800-248-1199
Email not avaialable

Des Moines, Iowa
Facility: Blank Children's Hospital
Investigator: Wendy L. Woods-Swafford
Contact: Wendy L. Woods-Swafford
Click HERE to send email to this center

New Orleans, Louisiana
Facility: Ochsner Medical Center Jefferson
Investigator: Craig Lotterman
Contact: Craig Lotterman Phone: 504-842-3708
Email not avaialable

Minneapolis, Minnesota
Facility: University of Minnesota/Masonic Cancer Center
Investigator: Emily G. Greengard
Contact: Emily G. Greengard
Click HERE to send email to this center

Jackson, Mississippi
Facility: University of Mississippi Medical Center
Investigator: Anderson (Andy) B. Collier
Contact: Anderson (Andy) B. Collier Phone: 601-815-6700
Email not avaialable

Saint Louis, Missouri
Facility: Washington University School of Medicine
Investigator: Robert J. Hayashi
Contact: Robert J. Hayashi Phone: 800-600-3606
Click HERE to send email to this center

Saint Louis, Missouri
Facility: Mercy Hospital Saint Louis
Investigator: Bethany G. Sleckman
Contact: Bethany G. Sleckman Phone: 314-251-6770
Email not avaialable

Las Vegas, Nevada
Facility: University Medical Center of Southern Nevada
Investigator: Alan K. Ikeda
Contact: Alan K. Ikeda Phone: 702-384-0013
Email not avaialable

Las Vegas, Nevada
Facility: Children's Specialty Center of Nevada II
Investigator: Alan K. Ikeda
Contact: Alan K. Ikeda
Click HERE to send email to this center

Las Vegas, Nevada
Facility: Sunrise Hospital and Medical Center
Investigator: Alan K. Ikeda
Contact: Alan K. Ikeda Phone: 702-384-0013
Email not avaialable

Las Vegas, Nevada
Facility: Summerlin Hospital Medical Center
Investigator: Alan K. Ikeda
Contact: Alan K. Ikeda Phone: 702-384-0013
Email not avaialable

Buffalo, New York
Facility: Roswell Park Cancer Institute
Investigator: Clare J. Twist
Contact: Clare J. Twist Phone: 877-275-7724
Email not avaialable

Rochester, New York
Facility: University of Rochester
Investigator: Jeffrey R. Andolina
Contact: Jeffrey R. Andolina Phone: 585-275-5830
Email not avaialable

Syracuse, New York
Facility: State University of New York Upstate Medical University
Investigator: Philip M. Monteleone
Contact: Philip M. Monteleone Phone: 315-464-5476
Email not avaialable

Asheville, North Carolina
Facility: Mission Hospital-Memorial Campus
Investigator: Douglas J. Scothorn
Contact: Douglas J. Scothorn Phone: 828-213-4150
Email not avaialable

Cleveland, Ohio
Facility: Cleveland Clinic Foundation
Investigator: Aron Flagg
Contact: Aron Flagg Phone: 866-223-8100
Email not avaialable

Toledo, Ohio
Facility: The Toledo Hospital/Toledo Children's Hospital
Investigator: Jamie L. Dargart
Contact: Jamie L. Dargart Phone: 419-824-1842
Email not avaialable

Oklahoma City, Oklahoma
Facility: University of Oklahoma Health Sciences Center
Investigator: Rene Y. McNall-Knapp
Contact: Rene Y. McNall-Knapp Phone: 405-271-8777
Click HERE to send email to this center

Portland, Oregon
Facility: Legacy Emanuel Children's Hospital
Investigator: Janice F. Olson
Contact: Janice F. Olson
Click HERE to send email to this center

Portland, Oregon
Facility: Oregon Health and Science University
Investigator: Suman Malempati
Contact: Suman Malempati Phone: 503-494-1080
Click HERE to send email to this center

Philadelphia, Pennsylvania
Facility: Children's Hospital of Philadelphia
Investigator: Elizabeth Fox
Contact: Elizabeth Fox
Click HERE to send email to this center

Philadelphia, Pennsylvania
Facility: Childrens Oncology Group
Investigator: Katherine A. Janeway
Contact: Katherine A. Janeway Phone: 877-442-3324
Click HERE to send email to this center

Pittsburgh, Pennsylvania
Facility: Children's Hospital of Pittsburgh of UPMC
Investigator: Jean M. Tersak
Contact: Jean M. Tersak
Click HERE to send email to this center

Greenville, South Carolina
Facility: BI-LO Charities Children's Cancer Center
Investigator: Nichole L. Bryant
Contact: Nichole L. Bryant
Click HERE to send email to this center

Sioux Falls, South Dakota
Facility: Sanford USD Medical Center - Sioux Falls
Investigator: Kayelyn J. Wagner
Contact: Kayelyn J. Wagner Phone: 605-328-1367
Email not avaialable

Memphis, Tennessee
Facility: St. Jude Children's Research Hospital
Investigator: Alberto S. Pappo
Contact: Alberto S. Pappo
Click HERE to send email to this center

Austin, Texas
Facility: Dell Children's Medical Center of Central Texas
Investigator: Amy C. Fowler
Contact: Amy C. Fowler
Click HERE to send email to this center

Dallas, Texas
Facility: Medical City Dallas Hospital
Investigator: Stanton C. Goldman
Contact: Stanton C. Goldman Phone: 972-566-5588
Email not avaialable

Dallas, Texas
Facility: UT Southwestern/Simmons Cancer Center-Dallas
Investigator: Theodore W. Laetsch
Contact: Theodore W. Laetsch Phone: 214-648-7097
Email not avaialable

Houston, Texas
Facility: Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Investigator: Jodi Muscal
Contact: Jodi Muscal Phone: 713-798-1354
Click HERE to send email to this center

Norfolk, Virginia
Facility: Childrens Hospital-King's Daughters
Investigator: Eric J. Lowe
Contact: Eric J. Lowe
Click HERE to send email to this center

Seattle, Washington
Facility: Seattle Children's Hospital
Investigator: Douglas S. Hawkins
Contact: Douglas S. Hawkins
Click HERE to send email to this center

Spokane, Washington
Facility: Providence Sacred Heart Medical Center and Children's Hospital
Investigator: Judy L. Felgenhauer
Contact: Judy L. Felgenhauer
Click HERE to send email to this center

Morgantown, West Virginia
Facility: West Virginia University Healthcare
Investigator: Stephan R. Paul
Contact: Stephan R. Paul Phone: 304-293-7374
Click HERE to send email to this center

Milwaukee, Wisconsin
Facility: Children's Hospital of Wisconsin
Investigator: Paul D. Harker-Murray
Contact: Paul D. Harker-Murray Phone: 414-955-4727
Click HERE to send email to this center




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