Spots Global Cancer Trial Database for UNITE Study: Understanding New Interventions With GBM ThErapy
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Trial Identification
Brief Title: UNITE Study: Understanding New Interventions With GBM ThErapy
Official Title: Phase 3b Study for Management of Ocular Side Effects in Subjects With EGFR-amplified Glioblastoma Receiving Depatuxizumab Mafodotin (ABT-414)
Study ID: NCT03419403
Conditions
Study Description
Brief Summary: The objective of this study was to evaluate the effect of several ophthalmologic prophylactic treatment strategies for the management of ocular side effects (OSEs) in participants with epidermal growth factor receptor (EGFR)-amplified glioblastoma (GBM) who were being treated with depatuxizumab mafodotin (ABT-414).
Detailed Description: This Phase 3b open-label, randomized, exploratory study included 2 phases during the treatment period: chemoradiation therapy (radiation plus temozolomide \[RT/TMZ\]) and adjuvant therapy (TMZ). All participants received depatuxizumab mafodotin during both phases of the treatment period plus 1 of 3 prophylactic ophthalmologic treatments (standard steroids; standard steroids with vasoconstrictors and cold compress; and enhanced steroids with vasoconstrictors and cold compress. The study comprised a screening period of up to 7 weeks after surgery, a 6-week concomitant Chemoradiation Phase, an Adjuvant Phase beginning approximately 4 weeks after completion of chemoradiation, and a Follow-Up Phase.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Usc /Id# 164235, Los Angeles, California, United States
Moffitt Cancer Center /ID# 164234, Tampa, Florida, United States
Rush University Medical Center /ID# 171003, Chicago, Illinois, United States
Northshore University Health System-Evanston /ID# 164221, Evanston, Illinois, United States
CDH-Delnor Health System /ID# 169909, Warrenville, Illinois, United States
Columbia University Medical Center /ID# 164220, New York, New York, United States
Levine Cancer Ins, Carolina Me /ID# 171271, Charlotte, North Carolina, United States
UT Health Science Ctr-Houston /ID# 164223, Houston, Texas, United States
Baylor Scott & White Medical Center- Temple /ID# 170792, Temple, Texas, United States
Royal North Shore Hospital /ID# 169673, Saint Leonards, New South Wales, Australia
Calvary Mater Newcastle /ID# 169672, Waratah, New South Wales, Australia
Royal Brisbane and Women's Hospital /ID# 169674, Herston, Queensland, Australia
Austin Hospital /ID# 169671, Heidelberg, Victoria, Australia
Universitaetsklinik Heidelberg /ID# 169970, Heidelberg, Baden-Wuerttemberg, Germany
Universitaetsklinikum Leipzig /ID# 169969, Leipzig, Sachsen, Germany
Klinikum Univ. Regensburg /ID# 169963, Regensburg, , Germany
Universitatsklinikum Tubingen /ID# 169965, Tuebingen, , Germany
Vrije Universiteit Medisch Centrum /ID# 170152, Amsterdam, , Netherlands
Universitair Medisch Centrum Utrecht /ID# 170149, Utrecht, , Netherlands
Guy's and St Thomas' NHS Found /ID# 207752, London, London, City Of, United Kingdom
Queen Elizabeth Hospital - BIRMINGHAM /ID# 200657, Birmingham, , United Kingdom
Castle Hill Hospital /ID# 200662, Cottingham, , United Kingdom
Contact Details
Name: AbbVie Inc.
Affiliation: AbbVie
Role: STUDY_DIRECTOR
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