Spots Global Cancer Trial Database for A Phase Ib/II Study of LGX818 in Combination With MEK162 in Adult Patients With BRAF Dependent Advanced Solid Tumors
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Trial Identification
Brief Title: A Phase Ib/II Study of LGX818 in Combination With MEK162 in Adult Patients With BRAF Dependent Advanced Solid Tumors
Official Title: A Phase Ib/II, Multicenter, Open-label, Dose Escalation Study of LGX818 in Combination With MEK162 in Adult Patients With BRAF V600 - Dependent Advanced Solid Tumors
Study ID: NCT01543698
Study Description
Brief Summary: This is a multi-center, open-label, dose finding, Phase Ib dose escalation study to estimate the MTD(s) and/or RP2D(s) for the dual combination of LGX818 and MEK162 and the triple combination of LGX818 and MEK162 and LEE011, followed each independently by a Phase II part to assess the clinical efficacy and to further assess the safety of the combinations in selected patient populations. Oral LGX818 and MEK162 will be administered on a continuous schedule. Oral LEE011 will be administered once daily on a three weeks on, one week off schedule. Patients will be treated until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurs first. A cycle is defined as 28 days. The dose escalation parts of the trial will be conducted in adult patients with BRAF V600-dependent advanced solid tumors and is expected to enroll at least 18 patients for the dual combination and at least 12 patients for the triple combination. The dose escalation will be guided by a Bayesian logistic regression model (BLRM). Following MTD/RP2D declaration, patients will be enrolled in three Phase II arms for the dual combination and one Phase II arm for the triple combination. All patients will be followed for 30 days for safety assessments after study drugs discontinuation. All patients enrolled in the Phase II part of the study will be followed for survival.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
H. Lee Moffitt Cancer Center & Research Institute, Inc., Tampa, Florida, United States
Moffitt McKinley Outpatient Center, Tampa, Florida, United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Ophthalmic Consultants of Boston Inc (OCB), Boston, Massachusetts, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Chris O'Brien Lifehouse Hospital, Camperdown, New South Wales, Australia
Melanoma Institute Australia, North Sydney, New South Wales, Australia
Westmead Hospital-Redbank Rd, Northmead, New South Wales, Australia
Westmead Hospital-Redbank Rd, Westmead, New South Wales, Australia
Westmead Hospital, Westmead, New South Wales, Australia
Melanoma Institute Australia, North Sydney, , Australia
UZ Leuven- Gasthuisberg Campus, Leuven, Vlaams Brabant, Belgium
Sir Mortimer B. Davis-Jewish General Hospital, Montreal, Quebec, Canada
Hôpital Saint louis, Paris, , France
Service de radiologie - Hopital Saint Louis, Paris, , France
IRCCS Fondazione Pascale, Naples, Campania, Italy
Azienda Ospedaliera Monaldi, Napoli, Campania, Italy
Azienda Ospedaliera Universitaria Federico II, Napoli, Campania, Italy
ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda, Milan, , Italy
Istituto Nazionale per lo studio e la cura dei tumori Fondazione Giovanni Pascale, Napoli, , Italy
National Cancer Centre Singapore, Singapore, , Singapore
Hospital Universitario Vall d'Hebrón - PPDS, Barcelona, , Spain
Hospital Universitario HM Sanchinarro ? CIOCC, Madrid, , Spain
University Hospital Zürich, Dermatology, Zurich-Airport, Zurich, Switzerland
Kantonsspital St. Gallen, St.Gallen, , Switzerland
Contact Details
Name: Pfizer Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR
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