Spots Global Cancer Trial Database for A Study Assessing Pamiparib With Radiation and/or Temozolomide (TMZ) in Participants With Newly Diagnosed or Recurrent Glioblastoma
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Trial Identification
Brief Title: A Study Assessing Pamiparib With Radiation and/or Temozolomide (TMZ) in Participants With Newly Diagnosed or Recurrent Glioblastoma
Official Title: A Phase 1b/2 Study to Assess the Safety, Tolerability and Efficacy of BGB-290 in Combination With Radiation Therapy (RT) and/or Temozolomide (TMZ) in Subjects With First-line or Recurrent/Refractory Glioblastoma
Study ID: NCT03150862
Conditions
Study Description
Brief Summary: The primary objective of this study is to evaluate the safety, efficacy and clinical activity of Pamiparib in combination with radiation therapy (RT) and/or temozolomide (TMZ) in participants with newly diagnosed or recurrent/refractory glioblastoma.
Detailed Description: An open-label, multiple-dose, dose-escalation study to determine the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of Pamiparib in combination with radiation therapy (RT) and/or TMZ. In dose escalation/Phase 1b, Pamiparib will be combined with RT (Arm A) or RT and TMZ (Arm B) in participants with newly diagnosed unmethylated glioblastoma (GBM) and in Arm C of the study Pamiparib will be combined with TMZ in participants with methylated or unmethylated recurrent/refractory GBM. The dose expansion/Phase 2 phase will enroll up to 4 cohorts: participants with newly diagnosed unmethylated GBM in Arms A and B, and 2 cohorts of participants with recurrent/refractory GBM grouped by O-6-methylguanine-DNA methyltransferase (MGMT) status - unmethylated or methylated - in Arm C. Participants in Arms A and B are treated until completion of RT and participants in Arm C may continue treatment in the absence of safety concerns and disease progression.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Center for Neurosciences, Tucson, Arizona, United States
UCLA Neuro-Oncology, Los Angeles, California, United States
University of California at San Francisco, San Francisco, California, United States
Sarah Cannon Research Institute at Health One, Denver, Colorado, United States
Massachusetts General Hospital Pappas Center for Neuro-Oncology, Boston, Massachusetts, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Henry Ford Health Systems, Detroit, Michigan, United States
Health Midwest Ventures Group, LLC, Kansas City, Missouri, United States
Washington University, Saint Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Cleveland Clinic, Cleveland, Ohio, United States
The Ohio State University, Columbus, Ohio, United States
University of Oklahoma Health Sciences Center (Stephenson Cancer Center), Oklahoma City, Oklahoma, United States
Penn State Milton S Hershey Medical Center, Hershey, Pennsylvania, United States
Thomas Jefferson University, Philadelphia, Pennsylvania, United States
SCRI / Tennessee Oncology, Nashville, Tennessee, United States
Huntsman Cancer Center, Salt Lake City, Utah, United States
University of Virginia Health Systems, Charlottesville, Virginia, United States
Erasmus University Medical Center, Rotterdam, , Netherlands
Universitätsspital Zuerich - Klinik fur Neurologie, Zurich, , Switzerland
Contact Details
Name: Study Director
Affiliation: BeiGene
Role: STUDY_DIRECTOR
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