NCT03149003

A Study of DSP-7888 Dosing Emulsion in Combination With Bevacizumab in Patients With Recurrent or Progressive Glioblastoma Following Initial Therapy

A Randomized, Multicenter, Adaptive Phase 3 Study of DSP-7888 Dosing Emulsion in Combination With Bevacizumab Versus Bevacizumab Alone in Patients With Recurrent or Progressive Glioblastoma Following Initial Therapy (WIZARD 201G)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 221 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an event driven, adaptive design, a randomized, active-controlled, multicenter, open-label, parallel groups, Phase 3 study of DSP-7888 Dosing Emulsion plus Bevacizumab versus Bevacizumab alone in patients with recurrent or progressive glioblastoma multiforme (GBM) following treatment with first line therapy consisting of surgery and radiation with or without chemotherapy.

Conditions

• Glioblastoma

Interventions

Type	Name	Description
DRUG	DSP-7888 Dosing Emulsion	DSP-7888 Dosing Emulsion will be administered i.d. every 7 ± 1 day for Doses 1 to 5, every 14 ± 3 days for Doses 6 to 15, and every 28 ± 7 days for Doses 16 and above.
DRUG	Bevacizumab	Bevacizumab will be administered intravenously every 14 ± 3 days at 10 mg/kg.

Timeline

• Start date: 2017-12-08
• Primary completion: 2021-08-30
• Completion: 2021-08-30
• First posted: 2017-05-11
• Last updated: 2023-11-15
• Results posted: 2023-01-30

Locations

61 sites across 5 countries: United States, Canada, Japan, South Korea, Taiwan

Regulatory

• FDA-regulated drug study