Spots Global Cancer Trial Database for Study of Tazemetostat as Single Agent in Solid Tumors or B-cell Lymphomas and in Combination With Prednisolone in DLBCL
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Trial Identification
Brief Title: Study of Tazemetostat as Single Agent in Solid Tumors or B-cell Lymphomas and in Combination With Prednisolone in DLBCL
Official Title: An Open-Label, Multicenter, Phase 1/2 Study of Tazemetostat as a Single Agent in Subjects With Advanced Solid Tumors or With B-cell Lymphomas and Tazemetostat in Combination With Prednisolone in Subjects With Diffuse Large B Cell Lymphoma
Study ID: NCT01897571
Study Description
Brief Summary: This is an open-label, multicenter, Phase 1/2 study of tazemetostat as a single agent in subjects with advanced solid tumors or with B-cell lymphomas and tazemetostat in combination with prednisolone in subjects with diffuse large B-cell lymphoma (DLBCL).
Detailed Description: This is a multicenter, open-label, Phase 1/2 study conducted in two parts: The Phase 1 part comprised dose escalation and expansion to establish the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) when tazemetostat was given twice daily (BID) orally on a continuous basis. Additionally, in separate cohorts in Phase 1, the effect of food on the bioavailability of tazemetostat as well as the drug-drug interaction (DDI) potential of tazemetostat were evaluated. The Phase 2 part was initiated once the RP2D was established. Phase 2 enrolled subjects with relapsed/ refectory (R/R) DLBCL (Cohorts 1-3 and 6) and subjects with R/R FL (Cohorts 4 and 5) for the determination of efficacy and safety of tazemetostat monotherapy (Cohorts 1-5) and of tazemetostat in combination with prednisolone (Cohort 6) with placement determined by centrally confirmed histology, cell of origin (COO), and enhancer of zeste homologue 2 (EZH2) mutation status.
Eligibility
Minimum Age: 16 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
, Birmingham, Alabama, United States
, Duarte, California, United States
, Santa Barbara, California, United States
, Aurora, Colorado, United States
, Washington, District of Columbia, United States
, Ocala, Florida, United States
, Ann Arbor, Michigan, United States
, New York, New York, United States
, Houston, Texas, United States
, San Antonio, Texas, United States
, Fairfax, Virginia, United States
, Seattle, Washington, United States
, Clayton, , Australia
, Geelong, , Australia
, Melbourne, , Australia
, Montreal, , Canada
, Toronto, , Canada
, Bordeaux, , France
, Caen, , France
, Creteil, , France
, Lille, , France
, Lyon, , France
, Marseille, , France
, Montpellier, , France
, Nantes, , France
, Paris, , France
, Pierre Benite, , France
, Rennes, , France
, Rouen, , France
, Villejuif Cedex, , France
, Gottingen, , Germany
, Muenster, , Germany
, Bologna, , Italy
, Napoli, , Italy
, Krakow, , Poland
, Lublin, , Poland
, Poznan, , Poland
, Warsaw, , Poland
, Taipei City, , Taiwan
, Chernivtsi, , Ukraine
, Dnipro, , Ukraine
, Ivano-Frankivs'k, , Ukraine
, Kharkiv, , Ukraine
, Kyiv, , Ukraine
, Mykolayiv, , Ukraine
, Uzhgorod, , Ukraine
, Zaporizhzhya, , Ukraine
, Zhytomyr, , Ukraine
, Glasgow, , United Kingdom
, London, , United Kingdom
, Manchester, , United Kingdom
, Southampton, , United Kingdom
Contact Details
Name: Ipsen Medical Director
Affiliation: Ipsen
Role: STUDY_DIRECTOR
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