Selpercatinib for the Treatment of Advanced Solid Tumors, Lymphomas, or Histiocytic Disorders With Activating RET Gene Alterations, a Pediatric MATCH Treatment Trial

NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 2 Subprotocol of LOXO-292 in Patients With Tumors Harboring RET Gene Alterations

Sponsors

Lead Sponsor: National Cancer Institute (NCI)

Collaborator: Children's Oncology Group

Source National Cancer Institute (NCI)
Brief Summary

This phase II pediatric MATCH trial studies how well selpercatinib works in treating patients with solid tumors that have spread to other places in the body (advanced), lymphomas, or histiocytic disorders that have activating RET gene alterations. Selpercatinib may block the growth of cancer cells that have specific genetic changes in an important signaling pathway (called the RET pathway) and may reduce tumor size.

Detailed Description

PRIMARY OBJECTIVE: I. To determine the objective response rate (ORR; complete response + partial response) in pediatric patients treated with selpercatinib (LOXO-292) with advanced solid tumors (including central nervous system [CNS] tumors), lymphomas or histiocytic disorders that harbor activating genetic alterations in the RET pathway. SECONDARY OBJECTIVES: I. To estimate the progression free survival in pediatric patients treated with LOXO-292 with advanced solid tumors (including CNS tumors), lymphomas or histiocytic disorders that harbor activating genetic alterations in the RET pathway. II. To obtain information about the tolerability of LOXO-292 in children and adolescents 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 selpercatinib orally (PO) twice daily (BID) on days 1-28. Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed for 30 days, then periodically thereafter.

Overall Status Recruiting
Start Date 2020-09-14
Completion Date 2027-09-30
Primary Completion Date 2027-09-30
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Objective response rate (complete response + partial response) in pediatric patients treated with selpercatinib (LOXO-292) Up to 2 years
Secondary Outcome
Measure Time Frame
Progression-free survival (PFS) From the initiation of subprotocol (APEC1621N) treatment to the occurrence of any of the following events: disease progression or disease recurrence or death from any cause, assessed up to 2 years
Percentage of patients experiencing grade 3 or 4 adverse events Up to 2 years
Enrollment 49
Condition
Intervention

Intervention Type: Drug

Intervention Name: Selpercatinib

Description: Given PO

Arm Group Label: Treatment (selpercatinib)

Eligibility

Criteria:

Inclusion Criteria: - Patient must have enrolled onto APEC1621SC and must have been given a treatment assignment to MATCH to APEC1621N 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 metaiodobenzylguanidine (MIBG) positive (+) 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 cerebral spinal 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 [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 bone 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 LOXO-292 or other specific RET inhibitors - For patients with solid tumors without known bone marrow involvement (within 7 days prior to enrollment): - Peripheral absolute neutrophil count (ANC) >= 1000/mm^3 - For patients with solid tumors without known bone marrow involvement (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) - 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: Maximum serum creatinine (mg/dL) - 1 to < 2 years: male (0.6), female (0.6) - 2 to < 6 years: male (0.8), female (0.8) - 6 to < 10 years: male (1), female (1) - 10 to < 13 years: male (1.2), female (1.2) - 13 to < 16 years: male (1.5), female (1.4) - >= 16 years: male (1.7), female (1.4) - Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment) - Serum glutamate pyruvate 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) - Corrected QT (QTc) interval =< 480 milliseconds (within 7 days prior to enrollment) - 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 two (2) highly effective contraceptive method for the duration of study treatment and for at least 3 months after the last dose of LOXO-292. Male study participants are to refrain from sperm donation during treatment and for 6 months after the last dose of LOXO-292 - 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 post bone marrow transplant are not eligible for this trial - Patients who are currently receiving drugs that are moderate or 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 - Concomitant use of proton pump inhibitors (PPI)s during LOXO-292 therapy is prohibited. PPIs are to be discontinued at least 1 week prior to the start of protocol therapy - Patients who have major surgery within 14 days prior to cycle 1 day 1 (C1D1) are not eligible. (Central line placement or subcutaneous port placement is not considered major surgery) - Patients with known clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of LOXO-292 are excluded - Patients with known hypersensitivity to any of the components of the investigational agent, LOXO 292 are excluded - Patients with uncontrolled hypertension are excluded - Patients with uncontrolled symptomatic hyperthyroidism and hypothyroidism (i.e. the patient required a modification to current thyroid medication in 7 days prior to enrollment) are excluded - Patients with uncontrolled symptomatic hypercalcemia and hypocalcemia are excluded - 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
Andrea T Franson 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
Phoenix Childrens Hospital | Phoenix, Arizona, 85016, United States Recruiting Site Public Contact 602-546-0920 Jessica Boklan 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
City of Hope Comprehensive Cancer Center | Duarte, California, 91010, United States Recruiting Site Public Contact 800-826-4673 [email protected] Anna B. Pawlowska 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
Cedars Sinai Medical Center | Los Angeles, California, 90048, United States Recruiting Site Public Contact 310-423-8965 Fataneh (Fae) Majlessipour Principal Investigator
Mattel Children's Hospital UCLA | Los Angeles, California, 90095, United States Recruiting Site Public Contact 310-825-6708 William A. May 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
Children's Hospital of Orange County | Orange, California, 92868, United States Recruiting Site Public Contact 714-509-8646 [email protected] Elyssa M. Rubin Principal Investigator
Lucile Packard Children's Hospital Stanford University | Palo Alto, California, 94304, United States Recruiting Site Public Contact 800-694-0012 [email protected] Jay Michael S. Balagtas Principal Investigator
University of California Davis Comprehensive Cancer Center | Sacramento, California, 95817, United States Recruiting Site Public Contact 916-734-3089 Marcio H. Malogolowkin Principal Investigator
Rady Children's Hospital - San Diego | San Diego, California, 92123, United States Recruiting Site Public Contact 858-966-5934 William D. Roberts Principal Investigator
Naval Medical Center -San Diego | San Diego, California, 92134, United States Recruiting Site Public Contact 619-532-8712 Yoko T. Udaka 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
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Torrance, California, 90502, United States Recruiting Site Public Contact 310-222-3624 [email protected] Eduard H. Panosyan 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
Connecticut Children's Medical Center | Hartford, Connecticut, 06106, United States Recruiting Site Public Contact 860-545-9981 Michael S. Isakoff 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
MedStar Georgetown University Hospital | Washington, District of Columbia, 20007, United States Recruiting Site Public Contact 202-444-2223 Nina S. Kadan-Lottick 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
Broward Health Medical Center | Fort Lauderdale, Florida, 33316, United States Recruiting Site Public Contact 954-355-5346 Hector M. Rodriguez-Cortes Principal Investigator
Golisano Children's Hospital of Southwest Florida | Fort Myers, Florida, 33908, United States Recruiting Site Public Contact 239-343-5333 [email protected] Emad K. Salman 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
Memorial Regional Hospital/Joe DiMaggio Children's Hospital | Hollywood, Florida, 33021, United States Recruiting Site Public Contact 954-265-1847 [email protected] Iftikhar Hanif 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
Miami Cancer Institute | Miami, Florida, 33176, United States Recruiting Site Public Contact 786-596-2000 Doured Daghistani 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
Sacred Heart Hospital | Pensacola, Florida, 32504, United States Recruiting Site Public Contact 850-416-4611 [email protected] Erlyn C. Smith Principal Investigator
Johns Hopkins All Children's Hospital | Saint Petersburg, Florida, 33701, United States Recruiting Site Public Contact 727-767-4784 [email protected] Stacie L. Stapleton Principal Investigator
Tampa General Hospital | Tampa, Florida, 33606, United States Recruiting Site Public Contact 813-844-7829 [email protected] Juan F. Rico Principal Investigator
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
Memorial Health University Medical Center | Savannah, Georgia, 31404, United States Recruiting Site Public Contact 912-350-7887 [email protected] Andrew L. Pendleton Principal Investigator
Kapiolani Medical Center for Women and Children | Honolulu, Hawaii, 96826, United States Recruiting Site Public Contact 808-983-6090 Wade T. Kyono 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 Illinois | Chicago, Illinois, 60612, United States Recruiting Site Public Contact 312-355-3046 Mary L. Schmidt 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
Loyola University Medical Center | Maywood, Illinois, 60153, United States Recruiting Site Public Contact 708-226-4357 Eugene Suh 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
University of Kentucky/Markey Cancer Center | Lexington, Kentucky, 40536, United States Recruiting Site Public Contact 859-257-3379 James T. Badgett 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
Maine Children's Cancer Program | Scarborough, Maine, 04074, United States Recruiting Site Public Contact 207-396-7581 [email protected] Eric C. Larsen Principal Investigator
University of Maryland/Greenebaum Cancer Center | Baltimore, Maryland, 21201, United States Recruiting Site Public Contact 800-888-8823 Teresa A. York 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
National Institutes of Health Clinical Center | Bethesda, Maryland, 20892, United States Recruiting Site Public Contact 800-411-1222 John W. Glod Principal Investigator
Massachusetts General Hospital Cancer Center | Boston, Massachusetts, 02114, United States Recruiting Site Public Contact 877-726-5130 Katherine A. Janeway Principal Investigator
Dana-Farber Cancer Institute | Boston, Massachusetts, 02215, United States Recruiting Site Public Contact 877-442-3324 Katherine A. Janeway Principal Investigator
UMass Memorial Medical Center - University Campus | Worcester, Massachusetts, 01655, United States Recruiting Site Public Contact 508-856-3216 [email protected] Stefanie R. Lowas 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
Wayne State University/Karmanos Cancer Institute | Detroit, Michigan, 48201, United States Recruiting Site Public Contact 313-576-9790 [email protected] Jeffrey W. Taub 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
Beaumont Children's Hospital-Royal Oak | Royal Oak, Michigan, 48073, United States Recruiting Site Public Contact 248-551-7695 Laura K. Gowans 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 Recruiting Site Public Contact 702-384-0013 [email protected] Alan K. Ikeda Principal Investigator
Sunrise Hospital and Medical Center | Las Vegas, Nevada, 89109, United States Recruiting Site Public Contact 702-384-0013 [email protected] Alan K. Ikeda Principal Investigator
Alliance for Childhood Diseases/Cure 4 the Kids Foundation | Las Vegas, Nevada, 89135, United States Recruiting Site Public Contact 702-384-0013 [email protected] Alan K. Ikeda Principal Investigator
Summerlin Hospital Medical Center | Las Vegas, Nevada, 89144, United States Recruiting Site Public Contact 702-384-0013 [email protected] Alan K. Ikeda Principal Investigator
Renown Regional Medical Center | Reno, Nevada, 89502, United States Recruiting Site Public Contact 702-384-0013 [email protected] Alan K. Ikeda Principal Investigator
Dartmouth Hitchcock Medical Center | Lebanon, New Hampshire, 03756, United States Recruiting Site Public Contact 800-639-6918 [email protected] Julie Kim Principal Investigator
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
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital | New Brunswick, New Jersey, 08903, United States Recruiting Site Public Contact 732-235-8675 Richard A. Drachtman 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
NYU Winthrop Hospital | Mineola, New York, 11501, United States Recruiting Site Public Contact [email protected] Chana L. Glasser 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
Laura and Isaac Perlmutter Cancer Center at NYU Langone | New York, New York, 10016, United States Recruiting Site Public Contact [email protected] Sharon L. Gardner 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
UNC Lineberger Comprehensive Cancer Center | Chapel Hill, North Carolina, 27599, United States Recruiting Site Public Contact 877-668-0683 [email protected] Stuart H. Gold 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
East Carolina University | Greenville, North Carolina, 27834, United States Recruiting Site Public Contact 252-744-1015 [email protected] Andrea R. Whitfield Principal Investigator
Wake Forest University Health Sciences | Winston-Salem, North Carolina, 27157, United States Recruiting Site Public Contact 336-713-6771 David E. Kram 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
Children's Hospital Medical Center of Akron | Akron, Ohio, 44308, United States Recruiting Site Public Contact 330-543-3193 Steven J. Kuerbitz 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 Recruiting Site Public Contact 866-223-8100 [email protected] Rabi Hanna Principal Investigator
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
Lehigh Valley Hospital-Cedar Crest | Allentown, Pennsylvania, 18103, United States Recruiting Site Public Contact 734-712-3671 [email protected] Jacob A. Troutman 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
Saint Christopher's Hospital for Children | Philadelphia, Pennsylvania, 19134, United States Recruiting Site Public Contact 215-427-8991 Gregory E. Halligan 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
Rhode Island Hospital | Providence, Rhode Island, 02903, United States Recruiting Site Public Contact 401-444-1488 Jennifer J. Welch Principal Investigator
Prisma Health Richland Hospital | Columbia, South Carolina, 29203, United States Recruiting Site Public Contact 803-434-3533 Stuart L. Cramer 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
T C Thompson Children's Hospital | Chattanooga, Tennessee, 37403, United States Recruiting Site Public Contact 865-331-1812 Meghann P. McManus 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 Recruiting Site Public Contact 615-342-1919 Haydar A. Frangoul Principal Investigator
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
El Paso Children's Hospital | El Paso, Texas, 79905, United States Recruiting Site Public Contact 915-298-5444 [email protected] Ranjan Bista 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
Covenant Children's Hospital | Lubbock, Texas, 79410, United States Recruiting Site Public Contact [email protected] Kishor M. Bhende Principal Investigator
UMC Cancer Center / UMC Health System | Lubbock, Texas, 79415, United States Recruiting Site Public Contact 806-775-8590 Mohamad M. Al-Rahawan 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
University of Vermont and State Agricultural College | Burlington, Vermont, 05405, United States Recruiting Site Public Contact 802-656-8990 [email protected] Jessica L. Heath 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
Naval Medical Center - Portsmouth | Portsmouth, Virginia, 23708-2197, United States Recruiting Site Public Contact 757-953-5939 Bethany M. Mikles 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
Mary Bridge Children's Hospital and Health Center | Tacoma, Washington, 98405, United States Recruiting Site Public Contact 253-403-1461 [email protected] Robert G. Irwin 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
Marshfield Medical Center-Marshfield | Marshfield, Wisconsin, 54449, United States Recruiting Site Public Contact 800-782-8581 [email protected] Michelle A. Manalang 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
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

2021-05-01

Responsible Party

Type: Sponsor

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

Label: Treatment (selpercatinib)

Type: Experimental

Description: Patients receive selpercatinib PO BID on days 1-28. Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity.

Patient Data Yes
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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 [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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