NCT03216499

HIF-2 Alpha Inhibitor PT2385 in Treating Patients With Recurrent Glioblastoma

Single-Arm, Open-Label Phase II Efficacy Study of First-in-Class HIF-2 Alpha Inhibitor, PT2385, for Patients With Recurrent Glioblastoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Recurrent Glioblastoma

Interventions

Type	Name	Description
DRUG	HIF-2alpha Inhibitor PT2385	Given PO
OTHER	Pharmacological Study	Correlative studies
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Pharmacogenomic Study	Correlative studies

Timeline

• Start date: 2017-09-14
• Primary completion: 2019-08-31
• Completion: 2020-06-05
• First posted: 2017-07-13
• Last updated: 2022-05-09
• Results posted: 2020-09-21

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study