Spots Global Cancer Trial Database for Study of Bromodomain and Extra-Terminal Protein (BET) Inhibitor RO6870810 as Mono- and Combination Therapy in Advanced Multiple Myeloma
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Trial Identification
Brief Title: Study of Bromodomain and Extra-Terminal Protein (BET) Inhibitor RO6870810 as Mono- and Combination Therapy in Advanced Multiple Myeloma
Official Title: Open-label, Multicenter, Dose-escalation/Expansion Phase Ib Study to Evaluate Safety, Pharmacokinetics, and Activity of BET Inhibitor RO6870810, Given as Mono- and Combination Therapy to Patients With Advanced Multiple Myeloma
Study ID: NCT03068351
Conditions
Study Description
Brief Summary: This is a Phase Ib, open-label, multicenter, global study designed to assess the safety and tolerability of RO6870810 as monotherapy and in combination with daratumumab in participants with relapsed/refractory multiple myeloma. Each treatment cycle will be 21 days in length. There are two parts to this study. A dose-escalation phase (Part I) will be used to evaluate the safety and tolerability and dose limiting toxicities, and to establish the maximum tolerated dose (MTR)/optimum biological dose (OBD) of RO6870810 when given as monotherapy or in combination with daratumumab. A dose-expansion phase (Part II) will further characterize the safety, tolerability and activity of RO6870810 as monotherapy or in combination with daratumumab at the defined expansion dose-levels.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope, Duarte, California, United States
Stanford Cancer Center, Stanford, California, United States
Mayo Clinic, Jacksonville, Florida, United States
Emory Uni - Winship Cancer Center; Hematology/Oncology, Atlanta, Georgia, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Mount Sinai - PRIME; Icahn School of Medicine at Mount Sinai, New York, New York, United States
University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
Duke Clin Rsch Institute, Durham, North Carolina, United States
Scientia Clinical Research Limited, Randwick, New South Wales, Australia
St Vincent's Hospital Melbourne, Fitzroy, Victoria, Australia
University College London Hospitals; Clinical Research Facility, London, , United Kingdom
Oxford University Hospitals NHS Trust; Churchill Hospital, Oxford, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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