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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

Melanoma

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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