Dabrafenib, Trametinib und Navitoclax bei der Behandlung von Patienten mit mutigem BRAF-Melanom oder soliden Hinweisen, die metastasiert sind oder nicht operativ entfernt werden können

Phase I / II-Studie von Dabrafenib, Trametinib und Navitoclax bei mutierten BRAF-Melanom (Phase I und II) und anderen soliden Hinweisen (nur Phase I)

Sponsoren

Hauptsponsor: National Cancer Institute (NCI)

Quelle National Cancer Institute (NCI)
Kurze Zusammenfassung

indipendente

detaillierte Beschreibung

indipendente

Gesamtstatus Verwirklichung
Anfangsdatum 2013-10-25
Primäres Abschlussdatum 2021-12-31
Phase Phase 1 / Phase 2
Studientyp Interventionell
Primärer Ausgang
Messen Zeitfenster
Recommended phase II dose of the combination of dabrafenib, trametinib, and navitoclax (Phase I) Up to 28 days
nära Spanien nära Spanien
nära Spanien nära Spanien
Sekundäres Ergebnis
Messen Zeitfenster
Progression free survival (PFS) (Phase II) Time from start of treatment to time of progression or death, whichever occurs first, assessed for up to 4 years
Gesamtüberleben (OS) (Phase II) Bis zu 4 Jahre
nära Spanien Bis zu 4 Wochen nach der letzten Studienbehandlung
Einschreibung 75
Bedingung
Intervention

Interventionsart: Drug

Interventionsname: Dabrafenib

Beschreibung: Given PO

Interventionsart: Andere

Interventionsname: Labor-Biomarker-Analyse

Beschreibung: Korrelative Studien

Interventionsart: Mediterraans diëet

Interventionsname: Navitoclax

Beschreibung: Gegebene PO

Armgruppenetikett: indipendente

Interventionsart: Andere

Interventionsname: Pharmakologische Studie

Beschreibung: Korrelative Studien

Interventionsart: Arzneimittel

Interventionsname: Trametinib

Beschreibung: Gegebene PO

Teilnahmeberechtigung

Kriterien:

nära Spanien nära Spanien nära Spanien

Geschlecht:

Alle

Mindestalter:

18 Jahre

Maximales Alter:

N / A

Gesunde Freiwillige:

через канал

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
Ryan J Sullivan Principal Investigator Dana-Farber - Harvard Cancer Center LAO
Ort
Einrichtung: Status:
Mayo Clinic Hospital in Arizona | Phoenix, Arizona, 85054, United States Suspended
Mayo Clinic in Arizona | Scottsdale, Arizona, 85259, United States Suspended
Los Angeles County-USC Medical Center | Los Angeles, California, 90033, United States Suspended
USC / Norris Comprehensive Cancer Center | Los Angeles, California, 90033, United States Suspended
USC Norris Oncology/Hematology-Newport Beach | Newport Beach, California, 92663, United States Suspended
UC Irvine Health/Chao Family Comprehensive Cancer Center | Orange, California, 92868, United States Suspended
University of California Davis Comprehensive Cancer Center | Sacramento, California, 95817, United States Active, not recruiting
University of Colorado Hospital | Aurora, Colorado, 80045, United States Suspended
UM Sylvester Comprehensive Cancer Center at Coral Gables | Coral Gables, Florida, 33146, United States Recruiting Site Public Contact 305-243-2647 Jose Lutzky Principal Investigator
UM Sylvester Comprehensive Cancer Center at Deerfield Beach | Deerfield Beach, Florida, 33442, United States Recruiting Site Public Contact 305-243-2647 Jose Lutzky Principal Investigator
University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami, Florida, 33136, United States Recruiting Site Public Contact 305-243-2647 Jose Lutzky Principal Investigator
UM Sylvester Comprehensive Cancer Center at Kendall | Miami, Florida, 33176, United States Recruiting Site Public Contact 305-243-2647 Jose Lutzky Principal Investigator
UM Sylvester Comprehensive Cancer Center at Plantation | Plantation, Florida, 33324, United States Recruiting Site Public Contact 305-243-2647 Jose Lutzky Principal Investigator
Moffitt Cancer Center - McKinley Campus | Tampa, Florida, 33612, United States Recruiting Site Public Contact 800-679-0775 [email protected] Zeynep Eroglu Principal Investigator
Moffitt Cancer Center | Tampa, Florida, 33612, United States Recruiting Site Public Contact 800-679-0775 [email protected] Zeynep Eroglu Principal Investigator
Northwestern University | Chicago, Illinois, 60611, United States Recruiting Site Public Contact 312-695-1301 [email protected] Jeffrey A. Sosman Principal Investigator
University of Iowa/Holden Comprehensive Cancer Center | Iowa City, Iowa, 52242, United States Active, not recruiting
University of Kansas Clinical Research Center | Fairway, Kansas, 66205, United States Suspended
HaysMed University of Kansas Health System | Hays, Kansas, 67601, United States Suspended
University of Kansas Cancer Center | Kansas City, Kansas, 66160, United States Suspended
Olathe Health Cancer Center | Olathe, Kansas, 66061, United States Suspended
University of Kansas Cancer Center-Overland Park | Overland Park, Kansas, 66210, United States Suspended
Ascension Via Christi - Pittsburg | Pittsburg, Kansas, 66762, United States Suspended
Salina Regional Health Center | Salina, Kansas, 67401, United States Suspended
University of Kansas Health System Saint Francis Campus | Topeka, Kansas, 66606, United States Suspended
University of Kansas Hospital-Westwood Cancer Center | Westwood, Kansas, 66205, United States Suspended
Massachusetts General Hospital Cancer Center | Boston, Massachusetts, 02114, United States Recruiting Ryan J. Sullivan 877-726-5130 Ryan J. Sullivan Principal Investigator
Dana-Farber Cancer Institute | Boston, Massachusetts, 02215, United States Recruiting Site Public Contact 877-442-3324 Ryan J. Sullivan Principal Investigator
Mayo Clinic in Rochester | Rochester, Minnesota, 55905, United States Suspended
Siteman Cancer Center at West County Hospital | Creve Coeur, Missouri, 63141, United States Active, not recruiting
Truman Medical Centers | Kansas City, Missouri, 64108, United States Suspended
University of Kansas Cancer Center - North | Kansas City, Missouri, 64154, United States Suspended
University of Kansas Cancer Center - Lee's Summit | Lee's Summit, Missouri, 64064, United States Suspended
University of Kansas Cancer Center at North Kansas City Hospital | North Kansas City, Missouri, 64116, United States Suspended
Washington University School of Medicine | Saint Louis, Missouri, 63110, United States Active, not recruiting
Siteman Cancer Center-South County | Saint Louis, Missouri, 63129, United States Active, not recruiting
Siteman Cancer Center at Christian Hospital | Saint Louis, Missouri, 63136, United States Active, not recruiting
Siteman Cancer Center at Saint Peters Hospital | Saint Peters, Missouri, 63376, United States Active, not recruiting
Rutgers Cancer Institute of New Jersey | New Brunswick, New Jersey, 08903, United States Suspended
Laura and Isaac Perlmutter Cancer Center at NYU Langone | New York, New York, 10016, United States Suspended
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | New York, New York, 10032, United States Terminated
UNC Lineberger Comprehensive Cancer Center | Chapel Hill, North Carolina, 27599, United States Recruiting Site Public Contact 877-668-0683 [email protected] Stergios J. Moschos Principal Investigator
Duke University Medical Center | Durham, North Carolina, 27710, United States Suspended
Ohio State University Comprehensive Cancer Center | Columbus, Ohio, 43210, United States Suspended
Thomas Jefferson University Hospital | Philadelphia, Pennsylvania, 19107, United States Active, not recruiting
M D Anderson Cancer Center | Houston, Texas, 77030, United States Suspended
Standort Länder

United States

Überprüfungsdatum

2021-04-01

Verantwortliche Partei

Art: Sponsor

Hat den Zugriff erweitert через канал
Anzahl der Waffen 2
Armgruppe

Etikette: Arm I (dabrafenib, trametinib)

Art: Experimental

Beschreibung: Patients receive dabrafenib PO BID and trametinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Etikette: Arm II (Dabrafenib, Trametinib und Navitoclax)

Art: Experimental

Beschreibung: nära Spanien

Studiendesign Info

Zuweisung: Zufällig

Interventionsmodell: Parallele Zuordnung

Hauptzweck: Behandlung

Maskierung: Keine (Open Label)

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