Olaparib bei der Behandlung von Patienten mit rezidivierten oder refraktären fortgeschrittenen soliden Tumoren, Non-Hodgkin-Lymphom oder histiozytären Erkrankungen mit Defekten in DNA-Schadensreparaturgenen (eine pädiatrische MATCH-Behandlungsstudie)

NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) – Phase-2-Subprotokoll von Olaparib bei Patienten mit Tumoren mit Defekten in DNA-Schadensreparaturgenen

Sponsoren

Hauptsponsor: National Cancer Institute (NCI)

Quelle National Cancer Institute (NCI)
Kurze Zusammenfassung

Diese pädiatrische MATCH-Studie der Phase II untersucht, wie gut Olaparib bei der Behandlung von Patienten mit solide Tumoren, Non-Hodgkin-Lymphom oder histiozytäre Erkrankungen mit Defekten der Desoxyribonukleinsäure Säure (DNA) Schadensreparaturgene, die sich an andere Stellen im Körper ausgebreitet haben (fortgeschritten) und zurückgekommen sind (rezidiviert) oder nicht auf die Behandlung ansprechen (refraktär). Olaparib kann sterben Wachstum von Tumorzellen durch Blockieren einiger der Enzyme, sterben für das Zellwachstum benötigt werden.

detaillierte Beschreibung

HAUPTZIELE: I. Bestimmung der objektiven Ansprechrate (ORR; vollständiges Ansprechen + teilweises Ansprechen) in mit Olaparib behandelte pädiatrische Patienten mit langen soliden Tumoren (einschließlich zentraler ( Tumoren des Nervensystems (ZNS), Non-Hodgkin-Lymphome oder histiozytäre Erkrankungen, die Aktivierung genetischer Veränderungen in den genetischen genetischen Veränderungen in der DNA-Schädigung Reparaturweg (DDR). SEKUNDÄRZIELE: I. Abschätzung des progressionsfreien Überlebens bei pädiatrischen Patienten, die mit Olaparib mit fortgeschrittenen soliden Tumoren, einschließlich Non-Hodgkin-Lymphom, ZNS-Tumoren und Histiozytose, sterben genetische Veränderungen im DDR-Signalweg aufweisen. II. Informationen zur Verträglichkeit von Olaparib bei Kindern und Jugendlichen mit rezidivierter oder refraktärer Krebs. III. vorläufige Schätzungen der Pharmakokinetik von Olaparib bei Kindern und Jugendliche mit rezidiviertem oder refraktärem Krebs. EXPLORATORISCHE ZIELE: I. Erforschung von Ansätzen zur Profilierung von Veränderungen in der Tumorgenomik im Laufe der Zeit durch die Auswertung zirkulierender Tumor-DNA. GLIEDERUNG: Die Patienten erhalten Olaparib oral (PO) zweimal täglich (BID) an den Tagen 1-28. Zyklen wiederholen sich alle 28 Tage für 2 Jahre in Abwesenheit von Krankheitsprogression oder inakzeptabler Toxizität.

Gesamtstatus Rekrutierung
Anfangsdatum 2017-07-24
Fertigstellungstermin 2024-09-30
Primäres Abschlussdatum 2024-09-30
Phase Phase 2
Studientyp Interventionell
Primärer Ausgang
Messen Zeitfenster
pizza z oliwkami Bis zu 4 Jahre
Sekundäres Ergebnis
Messen Zeitfenster
Progression free survival (PFS) From the initiation of protocol treatment to the occurrence of disease progression, disease recurrence, or death from any cause, assessed up to 4 years
Inzidenz von Toxizität Bis zu 4 Jahre
pizza z oliwkami pizza z oliwkami
Einschreibung 49
Bedingung
Intervention

Interventionsart: Arzneimittel

Interventionsname: Olaparib

Beschreibung: Gegebene PO

Armgruppenetikett: Behandlung (Olaparib)

Teilnahmeberechtigung

Kriterien:

pizza z oliwkami pizza z oliwkami pizza z oliwkami pizza z oliwkami

Geschlecht:

Alle

Mindestalter:

12 Monate

Maximales Alter:

21 Jahre

Gesunde Freiwillige:

Nein

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
Julia Glade-Bender Principal Investigator Children's Oncology Group
Ort
Einrichtung: Status: Kontakt: Ermittler:
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 Suspended
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
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
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
University of Illinois | Chicago, Illinois, 60612, United States Suspended
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
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
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
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 John J. Gregory Principal Investigator
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital | New Brunswick, New Jersey, 08903, United States Suspended
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 Suspended
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] Alice Lee Principal Investigator
Memorial Sloan Kettering Cancer Center | New York, New York, 10065, United States Suspended
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
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 Suspended
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
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 Suspended
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 Suspended
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
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
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] Patrick J. Leavey 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 Suspended
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 Phillip E. Barnette 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
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
Standort Länder

Puerto Rico

United States

Überprüfungsdatum

2021-01-01

Verantwortliche Partei

Art: Sponsor

Hat den Zugriff erweitert Nein
Anzahl der Waffen 1
Armgruppe

Etikette: Behandlung (Olaparib)

Art: Experimental

Beschreibung: pizza z oliwkami

Studiendesign Info

Zuweisung: N / A

Interventionsmodell: Einzelgruppenzuweisung

Hauptzweck: Behandlung

Maskierung: Keine (Offenes Etikett)

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