Larotrectinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With NTRK Fusions (A Pediatric MATCH Treatment Trial)

NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 2 Subprotocol of LOXO-101 (Larotrectinib) in Patients With Tumors Harboring Actionable NTRK Fusions

Sponsors

Lead Sponsor: National Cancer Institute (NCI)

Source National Cancer Institute (NCI)
Brief Summary

This phase II Pediatric MATCH trial studies how well larotrectinib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with NTRK fusions that have spread to other places in the body and have come back or do not respond to treatment. Larotrectinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Detailed Description

PRIMARY OBJECTIVE: I. To determine the objective response rate (ORR; complete response + partial response) in pediatric patients treated with LOXO-101 (larotrectinib) with advanced solid tumors (including central nervous system [CNS] tumors), non-Hodgkin lymphomas or histiocytic disorders harboring NTRK 1/2/3 fusions. SECONDARY OBJECTIVES: I. To estimate the progression free survival in pediatric patients treated with LOXO-101 (larotrectinib) with advanced solid tumors (including CNS tumors), non-Hodgkin lymphomas or histiocytic disorders with NTRK 1/2/3 fusions. II. To obtain additional information about the tolerability of LOXO-101 (larotrectinib) in children with relapsed or refractory cancer. III. To provide preliminary estimates of the pharmacokinetics of LOXO-101 (larotrectinib) in children with relapsed or refractory cancer. EXPLORATORY OBJECTIVE: I. To explore approaches to profiling changes in tumor genomics over time through evaluation of circulating tumor deoxyribonucleic acid (DNA). OUTLINE: Patients receive larotrectinib sulfate orally (PO) or via nasogastric (NG)- or gastric (G)-tube twice per day (BID) on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days, then periodically thereafter.

Overall Status Recruiting
Start Date 2017-07-24
Completion Date 2024-09-30
Primary Completion Date 2024-09-30
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Objective response rate Up to 5 years
Secondary Outcome
Measure Time Frame
Progression free survival The 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, assessed up to 5 years
Enrollment 49
Condition
Intervention

Intervention Type: Drug

Intervention Name: Larotrectinib

Description: Given PO or via nasogastric- or gastric-tube

Arm Group Label: Treatment (larotrectinib sulfate)

Intervention Type: Drug

Intervention Name: Larotrectinib Sulfate

Description: Given PO or via nasogastric- or gastric-tube

Arm Group Label: Treatment (larotrectinib sulfate)

Eligibility

Criteria:

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 absolute neutrophil [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] 5.0) resulting from prior therapy must be =< grade 2, with the exception of decreased tendon reflect (DTR); any grade of DTR is eligible - 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 due to risks of fetal and teratogenic adverse events as seen in animal/human studies; 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

Gender:

All

Minimum Age:

12 Months

Maximum Age:

21 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Katherine A Janeway Principal Investigator Children's Oncology Group
Location
Facility: Status: Contact: Investigator:
Children's Hospital of Alabama | Birmingham, Alabama, 35233, United States Recruiting Site Public Contact 205-638-9285 [email protected] Elizabeth D. Alva Principal Investigator
Providence Alaska Medical Center | Anchorage, Alaska, 99508, United States Recruiting Site Public Contact 907-212-6871 [email protected] Brenda J. Wittman Principal Investigator
Banner Children's at Desert | Mesa, Arizona, 85202, United States Recruiting Site Public Contact 480-412-3100 Joseph C. Torkildson Principal Investigator
Banner University Medical Center - Tucson | Tucson, Arizona, 85719, United States Recruiting Site Public Contact [email protected] Holly E. Pariury Principal Investigator
Arkansas Children's Hospital | Little Rock, Arkansas, 72202-3591, United States Recruiting Site Public Contact 501-364-7373 David L. Becton Principal Investigator
Kaiser Permanente Downey Medical Center | Downey, California, 90242, United States Recruiting Site Public Contact 626-564-3455 Robert M. Cooper Principal Investigator
Loma Linda University Medical Center | Loma Linda, California, 92354, United States Recruiting Site Public Contact 909-558-4050 Albert Kheradpour Principal Investigator
Miller Children's and Women's Hospital Long Beach | Long Beach, California, 90806, United States Recruiting Site Public Contact 562-933-5600 Jacqueline N. Casillas Principal Investigator
Children's Hospital Los Angeles | Los Angeles, California, 90027, United States Recruiting Site Public Contact 323-361-4110 Fariba Navid Principal Investigator
Valley Children's Hospital | Madera, California, 93636, United States Recruiting Site Public Contact 559-353-3000 [email protected] Karen S. Fernandez Principal Investigator
UCSF Benioff Children's Hospital Oakland | Oakland, California, 94609, United States Recruiting Site Public Contact 510-428-3324 [email protected] Carla B. Golden Principal Investigator
Kaiser Permanente-Oakland | Oakland, California, 94611, United States Recruiting Site Public Contact 877-642-4691 [email protected] Laura A. Campbell Principal Investigator
UCSF Medical Center-Mission Bay | San Francisco, California, 94158, United States Recruiting Site Public Contact 877-827-3222 Arun A. Rangaswami Principal Investigator
Children's Hospital Colorado | Aurora, Colorado, 80045, United States Recruiting Site Public Contact 303-764-5056 [email protected] Margaret E. Macy Principal Investigator
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center | Denver, Colorado, 80218, United States Recruiting Site Public Contact 303-839-6000 Jennifer J. Clark Principal Investigator
Yale University | New Haven, Connecticut, 06520, United States Recruiting Site Public Contact 203-785-5702 [email protected] Farzana Pashankar Principal Investigator
Alfred I duPont Hospital for Children | Wilmington, Delaware, 19803, United States Recruiting Site Public Contact 302-651-6884 [email protected] Scott M. Bradfield Principal Investigator
Children's National Medical Center | Washington, District of Columbia, 20010, United States Recruiting Site Public Contact 202-884-2549 Jeffrey S. Dome Principal Investigator
University of Florida Health Science Center - Gainesville | Gainesville, Florida, 32610, United States Recruiting Site Public Contact 352-273-8010 [email protected] William B. Slayton Principal Investigator
Nemours Children's Clinic-Jacksonville | Jacksonville, Florida, 32207, United States Recruiting Site Public Contact 904-697-3529 Scott M. Bradfield Principal Investigator
University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami, Florida, 33136, United States Recruiting Site Public Contact 305-243-2647 Julio C. Barredo Principal Investigator
Nicklaus Children's Hospital | Miami, Florida, 33155, United States Recruiting Site Public Contact 888-624-2778 Enrique A. Escalon Principal Investigator
AdventHealth Orlando | Orlando, Florida, 32803, United States Recruiting Site Public Contact 407-303-2090 [email protected] Fouad M. Hajjar Principal Investigator
Arnold Palmer Hospital for Children | Orlando, Florida, 32806, United States Recruiting Site Public Contact 321-841-2008 [email protected] Amy A. Smith Principal Investigator
Nemours Children's Hospital | Orlando, Florida, 32827, United States Recruiting Site Public Contact 407-650-7715 Scott M. Bradfield Principal Investigator
Nemours Children's Clinic - Pensacola | Pensacola, Florida, 32504, United States Active, not recruiting
Johns Hopkins All Children's Hospital | Saint Petersburg, Florida, 33701, United States Suspended
Saint Joseph's Hospital/Children's Hospital-Tampa | Tampa, Florida, 33607, United States Recruiting Site Public Contact 813-357-0849 [email protected] Don E. Eslin Principal Investigator
Saint Mary's Hospital | West Palm Beach, Florida, 33407, United States Recruiting Site Public Contact 561-881-2815 Narayana Gowda Principal Investigator
Children's Healthcare of Atlanta - Egleston | Atlanta, Georgia, 30322, United States Recruiting Site Public Contact 404-785-2025 [email protected] William T. Cash Principal Investigator
Saint Luke's Cancer Institute - Boise | Boise, Idaho, 83712, United States Recruiting Site Public Contact 208-381-2774 [email protected] Eugenia Chang Principal Investigator
Lurie Children's Hospital-Chicago | Chicago, Illinois, 60611, United States Recruiting Site Public Contact 773-880-4562 David O. Walterhouse Principal Investigator
University of Chicago Comprehensive Cancer Center | Chicago, Illinois, 60637, United States Recruiting Site Public Contact 773-702-8222 [email protected] Susan L. Cohn Principal Investigator
Saint Jude Midwest Affiliate | Peoria, Illinois, 61637, United States Recruiting Site Public Contact 888-226-4343 Jaime M. Libes Principal Investigator
Southern Illinois University School of Medicine | Springfield, Illinois, 62702, United States Recruiting Site Public Contact 217-545-7929 Gregory P. Brandt Principal Investigator
Riley Hospital for Children | Indianapolis, Indiana, 46202, United States Recruiting Site Public Contact 800-248-1199 Sandeep Batra Principal Investigator
Saint Vincent Hospital and Health Care Center | Indianapolis, Indiana, 46260, United States Recruiting Site Public Contact 317-338-2194 [email protected] Bassem I. Razzouk Principal Investigator
Blank Children's Hospital | Des Moines, Iowa, 50309, United States Recruiting Site Public Contact 515-241-8912 [email protected] Samantha L. Mallory Principal Investigator
University of Iowa/Holden Comprehensive Cancer Center | Iowa City, Iowa, 52242, United States Recruiting Site Public Contact 800-237-1225 Mariko Sato Principal Investigator
Norton Children's Hospital | Louisville, Kentucky, 40202, United States Recruiting Site Public Contact 502-629-5500 [email protected] Ashok B. Raj Principal Investigator
Children's Hospital New Orleans | New Orleans, Louisiana, 70118, United States Recruiting Site Public Contact [email protected] Lolie C. Yu Principal Investigator
Ochsner Medical Center Jefferson | New Orleans, Louisiana, 70121, United States Recruiting Site Public Contact 504-703-8712 [email protected] Craig Lotterman Principal Investigator
Eastern Maine Medical Center | Bangor, Maine, 04401, United States Recruiting Site Public Contact 207-973-4274 Nadine P. SantaCruz Principal Investigator
Sinai Hospital of Baltimore | Baltimore, Maryland, 21215, United States Recruiting Site Public Contact 410-601-6120 [email protected] Jason M. Fixler Principal Investigator
Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore, Maryland, 21287, United States Recruiting Site Public Contact 410-955-8804 [email protected] Kenneth J. Cohen Principal Investigator
C S Mott Children's Hospital | Ann Arbor, Michigan, 48109, United States Recruiting Site Public Contact 800-865-1125 Rajen Mody Principal Investigator
Helen DeVos Children's Hospital at Spectrum Health | Grand Rapids, Michigan, 49503, United States Recruiting Site Public Contact 616-391-1230 [email protected] Kathleen J. Yost Principal Investigator
Bronson Methodist Hospital | Kalamazoo, Michigan, 49007, United States Recruiting Site Public Contact 616-391-1230 [email protected] Kathleen J. Yost Principal Investigator
Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis, Minnesota, 55404, United States Recruiting Site Public Contact 612-813-5193 Michael K. Richards Principal Investigator
University of Minnesota/Masonic Cancer Center | Minneapolis, Minnesota, 55455, United States Recruiting Site Public Contact 612-624-2620 Emily G. Greengard Principal Investigator
Mayo Clinic in Rochester | Rochester, Minnesota, 55905, United States Recruiting Site Public Contact 855-776-0015 Carola A. Arndt Principal Investigator
University of Mississippi Medical Center | Jackson, Mississippi, 39216, United States Recruiting Site Public Contact 601-815-6700 Anderson (Andy) B. Collier Principal Investigator
Children's Mercy Hospitals and Clinics | Kansas City, Missouri, 64108, United States Recruiting Site Public Contact 816-302-6808 [email protected] Kevin F. Ginn Principal Investigator
Cardinal Glennon Children's Medical Center | Saint Louis, Missouri, 63104, United States Recruiting Site Public Contact 314-268-4000 William S. Ferguson Principal Investigator
Washington University School of Medicine | Saint Louis, Missouri, 63110, United States Recruiting Site Public Contact 800-600-3606 [email protected] Robert J. Hayashi Principal Investigator
Mercy Hospital Saint Louis | Saint Louis, Missouri, 63141, United States Recruiting Site Public Contact 314-251-7066 Robin D. Hanson Principal Investigator
Children's Hospital and Medical Center of Omaha | Omaha, Nebraska, 68114, United States Recruiting Site Public Contact 402-955-3949 Minnie Abromowitch Principal Investigator
University of Nebraska Medical Center | Omaha, Nebraska, 68198, United States Recruiting Site Public Contact 402-559-6941 [email protected] Minnie Abromowitch Principal Investigator
University Medical Center of Southern Nevada | Las Vegas, Nevada, 89102, United States Suspended
Sunrise Hospital and Medical Center | Las Vegas, Nevada, 89109, United States Suspended
Alliance for Childhood Diseases/Cure 4 the Kids Foundation | Las Vegas, Nevada, 89135, United States Suspended
Summerlin Hospital Medical Center | Las Vegas, Nevada, 89144, United States Suspended
Hackensack University Medical Center | Hackensack, New Jersey, 07601, United States Recruiting Site Public Contact 201-996-2879 Katharine Offer Principal Investigator
Morristown Medical Center | Morristown, New Jersey, 07960, United States Recruiting Site Public Contact 973-971-5900 Kathryn L. Laurie Principal Investigator
Saint Peter's University Hospital | New Brunswick, New Jersey, 08901, United States Recruiting Site Public Contact 732-745-8600 6163 [email protected] Nibal A. Zaghloul Principal Investigator
Albany Medical Center | Albany, New York, 12208, United States Recruiting Site Public Contact 518-262-5513 Lauren R. Weintraub Principal Investigator
Roswell Park Cancer Institute | Buffalo, New York, 14263, United States Recruiting Site Public Contact 800-767-9355 [email protected] Clare J. Twist Principal Investigator
The Steven and Alexandra Cohen Children's Medical Center of New York | New Hyde Park, New York, 11040, United States Recruiting Site Public Contact 718-470-3460 Julie I. Krystal Principal Investigator
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | New York, New York, 10032, United States Recruiting Site Public Contact 212-305-6361 [email protected] Justine M. Kahn Principal Investigator
Memorial Sloan Kettering Cancer Center | New York, New York, 10065, United States Recruiting Site Public Contact 212-639-7592 Christopher J. Forlenza Principal Investigator
NYP/Weill Cornell Medical Center | New York, New York, 10065, United States Recruiting Site Public Contact 212-746-1848 Jennifer M. Levine Principal Investigator
University of Rochester | Rochester, New York, 14642, United States Recruiting Site Public Contact 585-275-5830 Angela R. Girvin Principal Investigator
Stony Brook University Medical Center | Stony Brook, New York, 11794, United States Recruiting Site Public Contact 800-862-2215 Laura E. Hogan Principal Investigator
State University of New York Upstate Medical University | Syracuse, New York, 13210, United States Recruiting Site Public Contact 315-464-5476 Philip M. Monteleone Principal Investigator
New York Medical College | Valhalla, New York, 10595, United States Recruiting Site Public Contact 914-594-3794 Jessica C. Hochberg Principal Investigator
Mission Hospital | Asheville, North Carolina, 28801, United States Recruiting Site Public Contact 828-213-7055 [email protected] Douglas J. Scothorn Principal Investigator
Carolinas Medical Center/Levine Cancer Institute | Charlotte, North Carolina, 28203, United States Recruiting Site Public Contact 800-804-9376 Joel A. Kaplan Principal Investigator
Novant Health Presbyterian Medical Center | Charlotte, North Carolina, 28204, United States Recruiting Site Public Contact 980-201-6360 [email protected] Jessica A. Bell Principal Investigator
Duke University Medical Center | Durham, North Carolina, 27710, United States Recruiting Site Public Contact 888-275-3853 Lars M. Wagner Principal Investigator
Sanford Broadway Medical Center | Fargo, North Dakota, 58122, United States Recruiting Site Public Contact 701-323-5760 [email protected] Samuel J. Milanovich Principal Investigator
Cincinnati Children's Hospital Medical Center | Cincinnati, Ohio, 45229, United States Recruiting Site Public Contact 513-636-2799 [email protected] Erin H. Breese Principal Investigator
Rainbow Babies and Childrens Hospital | Cleveland, Ohio, 44106, United States Recruiting Site Public Contact 216-844-5437 Duncan S. Stearns Principal Investigator
Cleveland Clinic Foundation | Cleveland, Ohio, 44195, United States Suspended
Nationwide Children's Hospital | Columbus, Ohio, 43205, United States Recruiting Site Public Contact 614-072-2657 [email protected] Mark A. Ranalli Principal Investigator
Dayton Children's Hospital | Dayton, Ohio, 45404, United States Recruiting Site Public Contact 800-228-4055 Mukund G. Dole Principal Investigator
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital | Toledo, Ohio, 43606, United States Recruiting Site Public Contact 419-824-1842 Jamie L. Dargart Principal Investigator
University of Oklahoma Health Sciences Center | Oklahoma City, Oklahoma, 73104, United States Recruiting Site Public Contact 405-271-8777 [email protected] Rene Y. McNall-Knapp Principal Investigator
Legacy Emanuel Children's Hospital | Portland, Oregon, 97227, United States Recruiting Site Public Contact 503-413-2560 Janice F. Olson Principal Investigator
Oregon Health and Science University | Portland, Oregon, 97239, United States Recruiting Site Public Contact 503-494-1080 [email protected] Katrina Winsnes Principal Investigator
Geisinger Medical Center | Danville, Pennsylvania, 17822, United States Recruiting Site Public Contact 570-271-5251 [email protected] Jagadeesh Ramdas Principal Investigator
Children's Hospital of Philadelphia | Philadelphia, Pennsylvania, 19104, United States Recruiting Site Public Contact 267-425-5544 [email protected] Frank M. Balis Principal Investigator
Children's Hospital of Pittsburgh of UPMC | Pittsburgh, Pennsylvania, 15224, United States Recruiting Site Public Contact 412-692-8570 [email protected] Jean M. Tersak Principal Investigator
BI-LO Charities Children's Cancer Center | Greenville, South Carolina, 29605, United States Recruiting Site Public Contact 864-522-2066 [email protected] Aniket Saha Principal Investigator
Sanford USD Medical Center - Sioux Falls | Sioux Falls, South Dakota, 57117-5134, United States Recruiting Site Public Contact 605-312-3320 [email protected] Kayelyn J. Wagner Principal Investigator
East Tennessee Childrens Hospital | Knoxville, Tennessee, 37916, United States Recruiting Site Public Contact 865-541-8266 Susan E. Spiller Principal Investigator
Saint Jude Children's Research Hospital | Memphis, Tennessee, 38105, United States Recruiting Site Public Contact 888-226-4343 [email protected] Alberto S. Pappo Principal Investigator
The Children's Hospital at TriStar Centennial | Nashville, Tennessee, 37203, United States Suspended
Vanderbilt University/Ingram Cancer Center | Nashville, Tennessee, 37232, United States Recruiting Site Public Contact 800-811-8480 Scott C. Borinstein Principal Investigator
Dell Children's Medical Center of Central Texas | Austin, Texas, 78723, United States Recruiting Site Public Contact 512-628-1902 [email protected] Shannon M. Cohn Principal Investigator
Driscoll Children's Hospital | Corpus Christi, Texas, 78411, United States Recruiting Site Public Contact 361-694-5311 [email protected] Nkechi I. Mba Principal Investigator
Medical City Dallas Hospital | Dallas, Texas, 75230, United States Recruiting Site Public Contact 972-566-5588 Stanton C. Goldman Principal Investigator
UT Southwestern/Simmons Cancer Center-Dallas | Dallas, Texas, 75390, United States Recruiting Site Public Contact 214-648-7097 [email protected] Avanthi T. Shah Principal Investigator
Cook Children's Medical Center | Fort Worth, Texas, 76104, United States Recruiting Site Public Contact 682-885-2103 [email protected] Kelly L. Vallance Principal Investigator
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center | Houston, Texas, 77030, United States Recruiting Site Public Contact 713-798-1354 [email protected] Jennifer H. Foster Principal Investigator
M D Anderson Cancer Center | Houston, Texas, 77030, United States Recruiting Site Public Contact 877-632-6789 [email protected] Pooja Hingorani Principal Investigator
Children's Hospital of San Antonio | San Antonio, Texas, 78207, United States Recruiting Site Public Contact [email protected] Timothy C. Griffin Principal Investigator
Methodist Children's Hospital of South Texas | San Antonio, Texas, 78229, United States Recruiting Site Public Contact 210-575-6240 [email protected] Vinod K. Gidvani-Diaz Principal Investigator
University of Texas Health Science Center at San Antonio | San Antonio, Texas, 78229, United States Recruiting Site Public Contact 210-450-3800 [email protected] Anne-Marie R. Langevin Principal Investigator
Scott and White Memorial Hospital | Temple, Texas, 76508, United States Recruiting Site Public Contact 254-724-5407 Nicholas W. McGregor Principal Investigator
Primary Children's Hospital | Salt Lake City, Utah, 84113, United States Recruiting Site Public Contact 801-585-5270 Matthew Dietz Principal Investigator
Children's Hospital of The King's Daughters | Norfolk, Virginia, 23507, United States Recruiting Site Public Contact 757-668-7243 [email protected] Eric J. Lowe Principal Investigator
Virginia Commonwealth University/Massey Cancer Center | Richmond, Virginia, 23298, United States Recruiting Site Public Contact [email protected] Gita V. Massey Principal Investigator
Seattle Children's Hospital | Seattle, Washington, 98105, United States Recruiting Site Public Contact 866-987-2000 Sarah E. Leary Principal Investigator
Providence Sacred Heart Medical Center and Children's Hospital | Spokane, Washington, 99204, United States Recruiting Site Public Contact 800-228-6618 [email protected] Judy L. Felgenhauer Principal Investigator
Madigan Army Medical Center | Tacoma, Washington, 98431, United States Recruiting Site Public Contact 253-968-0129 [email protected] Melissa A. Forouhar Principal Investigator
West Virginia University Healthcare | Morgantown, West Virginia, 26506, United States Active, not recruiting
University of Wisconsin Hospital and Clinics | Madison, Wisconsin, 53792, United States Recruiting Site Public Contact 800-622-8922 Kenneth B. De Santes Principal Investigator
Children's Hospital of Wisconsin | Milwaukee, Wisconsin, 53226, United States Recruiting Site Public Contact 414-955-4727 [email protected] Paul D. Harker-Murray Principal Investigator
San Jorge Children's Hospital | San Juan, 00912, Puerto Rico Suspended
University Pediatric Hospital | San Juan, 00926, Puerto Rico Recruiting Site Public Contact 787-474-0333 Maria E. Echevarria Principal Investigator
Location Countries

Puerto Rico

United States

Verification Date

2021-06-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Treatment (larotrectinib sulfate)

Type: Experimental

Description: Patients receive larotrectinib sulfate PO or via NG- or G-tube twice per day (BID) on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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