Spots Global Cancer Trial Database for A Study of Select Drug Combinations in Adult Patients With Advanced/Metastatic BRAF V600 Colorectal Cancer
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Trial Identification
Brief Title: A Study of Select Drug Combinations in Adult Patients With Advanced/Metastatic BRAF V600 Colorectal Cancer
Official Title: A Phase Ib, Multicenter, Open-label Dose Escalation and Expansion Platform Study of Select Drug Combinations in Adult Patients With Advanced or Metastatic BRAF V600 Colorectal Cancer
Study ID: NCT04294160
Conditions
Study Description
Brief Summary: A phase Ib, open-label platform study of select drug combinations chosen in order to characterize safety and tolerability of each treatment arm tested and to identify recommended doses and regimens for future studies.
Detailed Description: This is a phase Ib, multi-center, open-label study with multiple treatment arms in adult patients with advanced or metastatic BRAF V600 (E, D, or K) in order to characterize safety and tolerability of each treatment arm tested and to identify recommended doses and regimens for future studies. The open platform design of this study is adaptive to allow removal of combination treatment arm(s) based on emerging data and facilitate introduction of new candidate combinations. The study is comprised of a dose escalation part and may be followed by a dose expansion part for any combination treatment arm.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University Of California Los Angeles Santa Monica Location, Los Angeles, California, United States
Massachusetts General Hospital Massachusetts General Hospital, Boston, Massachusetts, United States
Sarah Cannon Research Institute SC, Nashville, Tennessee, United States
Uni of TX MD Anderson Cancer Cntr, Houston, Texas, United States
Novartis Investigative Site, Westmead, New South Wales, Australia
Novartis Investigative Site, Bruxelles, , Belgium
Novartis Investigative Site, Leuven, , Belgium
Novartis Investigative Site, Toronto, Ontario, Canada
Novartis Investigative Site, Dresden, , Germany
Novartis Investigative Site, Essen, , Germany
Novartis Investigative Site, Ulm, , Germany
Novartis Investigative Site, Tel Aviv, , Israel
Novartis Investigative Site, Amsterdam, , Netherlands
Novartis Investigative Site, Singapore, , Singapore
Novartis Investigative Site, Barcelona, Catalunya, Spain
Novartis Investigative Site, Valencia, Comunidad Valenciana, Spain
Novartis Investigative Site, Madrid, , Spain
Novartis Investigative Site, Manchester, , United Kingdom
Contact Details
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
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