Spots Global Cancer Trial Database for LGX818 and MEK162 in Combination With a Third Agent (BKM120, LEE011, BGJ398 or INC280) in Advanced BRAF Melanoma
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Trial Identification
Brief Title: LGX818 and MEK162 in Combination With a Third Agent (BKM120, LEE011, BGJ398 or INC280) in Advanced BRAF Melanoma
Official Title: The LOGIC 2 Trial A Phase II, Multi-center, Open-label Study of Sequential LGX818/MEK162 Combination Followed by a Rational Combination With Targeted Agents After Progression, to Overcome Resistance in Adult Patients With Locally Advanced or Metastatic BRAF V600 Melanoma.
Study ID: NCT02159066
Conditions
Study Description
Brief Summary: The primary purpose of this study is to assess the anti-tumor activity of LGX818/MEK162 in combination with targeted agents after progression on LGX818/MEK162 combination therapy, as well as the safety and tolerability of the novel triple combinations.
Detailed Description: This study consists of two parts: in Part I/Run-In, patients naïve to selective BRAF and MEK inhibitors will be treated with the LGX818/MEK162 combination until disease progression (as defined per RECIST v1.1). Based on the genetic analysis of a tumor biopsy obtained at that time, patients will enter Part II of the study for tailored combination treatment in one of four arms of LGX818/MEK162 + either BKM120, BGJ398, INC280 or LEE011 Patients with BRAF mutant melanoma treated by LGX818/MEK162 combination in other studies can be enrolled directly in Part II of CLGX818X2109 after relapse. Dose-escalations in the combination arms for which no MTD has been established will be based on the recommendations of a Bayesian logistic regression model guided by an escalation with overdose control criterion
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of California Los Angeles, Los Angeles, California, United States
Cancer Care Center, Los Angeles, California, United States
Doris Stein Research Center Building, Los Angeles, California, United States
Ronald Reagan UCLA Medical Center Drug Information Center Department of Pharmaceutical Services, Los Angeles, California, United States
UCLA Dermatology Clinic, Los Angeles, California, United States
UCLA Oncology Center, Los Angeles, California, United States
UCLA Radiology, Los Angeles, California, United States
Memorial Sloan Kettering Cancer Center Attn: Geny O'neill, New York, New York, United States
Memorial Sloan Kettering Cancer Center Inpatient Hospital & Main Campus, New York, New York, United States
Memorial Sloan Kettering Cancer Center- Outpatient Clinic, New York, New York, United States
OHSU Knight Cancer Institute, Portland, Oregon, United States
OHSU Center for Health and Healing 2, Portland, Oregon, United States
OHSU Center for Health and Healing, Portland, Oregon, United States
OHSU Research Pharmacy Services, Portland, Oregon, United States
Oregon Health and Science University, Portland, Oregon, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
Tennessee Oncology, PLLC, Nashville, Tennessee, United States
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
East St Kilda Eye Clinic, Melbourne, Victoria, Australia
Princess Margaret Cancer Center, Toronto, Ontario, Canada
Sir Mortimer B. Davis-Jewish General Hospital, Monteral, Quebec, Canada
University Clinic Heidelberg PPDS, Heidelberg, Baden-württemberg, Germany
Universitätsklinikum Würzburg, Würzburg, Bayern, Germany
Uniklinik Köln, Köln, , Germany
Städtisches Klinikum München, Muenchen, , Germany
Universitätsklinikum Würzburg, Wuerzburg, , Germany
Azienda Ospedaliera Monaldi, Napoli, Campania, Italy
U.O.C. Oncologia Medica e Terapie Innovative Dipartimento di Melanoma IRCCS Fondazione G. Pascale, Napoli, , Italy
Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis, Amsterdam, , Netherlands
Hospital Universitario Vall d'Hebrón - PPDS, Barcelona Cataluna, Barcelona, Spain
Universitätsspital Zürich, Zurich Flughafen, , Switzerland
Churchill Hospital, Oxford, , United Kingdom
Contact Details
Name: Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR
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