Spots Global Cancer Trial Database for HIF-2 Alpha Inhibitor PT2385 in Treating Patients With Recurrent Glioblastoma
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Trial Identification
Brief Title: HIF-2 Alpha Inhibitor PT2385 in Treating Patients With Recurrent Glioblastoma
Official Title: Single-Arm, Open-Label Phase II Efficacy Study of First-in-Class HIF-2 Alpha Inhibitor, PT2385, for Patients With Recurrent Glioblastoma
Study ID: NCT03216499
Conditions
Study Description
Brief Summary: This phase II trial studies how well HIF-2 alpha inhibitor PT2385 works in treating patients with recurrent glioblastoma. HIF-2 alpha inhibitor PT2385 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Detailed Description: PRIMARY OBJECTIVES: I. To estimate the efficacy of hypoxia inducible factor (HIF)-2 alpha inhibitor PT2385 (PT2385) as measured by radiographic response rate (by Response Assessment in Neuro-Oncology, RANO, criteria) in patients with recurrent glioblastoma. SECONDARY OBJECTIVES: I. To estimate the efficacy of PT2385 as measured by progression free and overall survival in patients with recurrent glioblastoma. II. To determine the safety of oral PT2385 in patients with recurrent glioblastoma. TERTIARY OBJECTIVES: I. To describe the pharmacokinetic and pharmacodynamic properties of PT2385 in patients with recurrent glioblastoma. II. To describe baseline intratumoral hypoxia using novel, advanced magnetic resonance (MR)-based neuroimaging sequences in patients with recurrent glioblastoma. III. To explore genetic polymorphisms involved in the metabolism of PT2385. OUTLINE: Patients receive HIF-2 alpha inhibitor PT2385 orally (PO) twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 2 months for 2 years and every 6 months thereafter.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
UAB Comprehensive Cancer Center, Birmingham, Alabama, United States
Jonsson Comprehensive Cancer Center at UCLA, Los Angeles, California, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston, Massachusetts, United States
Henry Ford Hospital, Detroit, Michigan, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
Abrams Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
Hillman Cancer Center at University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, United States
Contact Details
Name: Roy Strowd, MD
Affiliation: Wake Forest /ABTC
Role: STUDY_CHAIR
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