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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
221
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.
Bevacizumab will be administered intravenously every 14 ± 3 days at 10 mg/kg.
Number of Participants Who Experienced a Dose-limiting Toxicity
The number of participants with dose-limiting toxicity (DLT) who were enrolled into Part 1 - the safety set.
Time frame: Dose-limiting toxicity will be evaluated and applied from Day 1 through Day 29
Overall Survival (OS) of Patients With Recurrent or Progressive Glioblastoma Multiforme (GBM) Treated With DSP-7888 Dosing Emulsion Plus Bevacizumab (BEV) Versus BEV Alone
The effect of DSP-7888 Dosing Emulsion plus BEV versus BEV alone on the OS of patients with recurrent or progressive GBM following treatment with first line therapy consisting of surgery and radiation with or without chemotherapy.
Time frame: 4 weeks after the patient has been off study treatment, every 3 months thereafter until death, the study closes, up to 24 months.
Overall Survival (OS) of Patients With Recurrent or Progressive Glioblastoma Multiforme (GBM) Treated With DSP-7888 Dosing Emulsion Plus Bevacizumab (BEV) Versus BEV Alone at 12 Months
The effect of DSP-7888 dosing emulsion plus BEV versus BEV alone on the OS of patients with recurrent or progressive GBM following treatment with first line therapy consisting of surgery and radiation with or without chemotherapy.
Time frame: 12 months
Progression Free Survival (PFS) of Patients With Recurrent or Progressive GBM
The effect of DSP-7888 dosing emulsion plus Bevacizumab (BEV) versus BEV alone on the Progression Free Survival (PFS) of patients with recurrent or progressive GBM following treatment with first line therapy consisting of surgery and radiation with or without chemotherapy. PFS is defined as the interval between randomization and progression or death from any cause any cause as determined by the central radiology body.
Time frame: The time from the date of first treatment to the date of first documentation of disease progression or death due to any cause, up to 24 months
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Center for Neurosciences
Tucson, Arizona, United States
Highlands Oncology Group
Fayetteville, Arkansas, United States
UCSD- Moores Cancer Center
La Jolla, California, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Neuro-Oncology/ US Irvine Medical Center
Orange, California, United States
Sansum Clinic
Santa Barbara, California, United States
John Wayne Cancer Institute
Santa Monica, California, United States
Rocky Mountain Cancer Center
Denver, Colorado, United States
...and 51 more locations
Progression Free Survival (PFS) Rate in Patients With Recurrent or Progressive GBM at 6 Months
The effect of DSP-7888 dosing emulsion plus Bevacizumab (BEV) versus BEV alone on the Progression Free Survival (PFS) rate in patients with recurrent or progressive GBM following treatment with first line therapy consisting of surgery and radiation with or without chemotherapy. PFS is defined as the interval between randomization date and progression or death from any cause as determined by the central radiology body. The percentage of patients who achieved PFS at 6 months are summarized.
Time frame: The time from the date of first treatment to the date of first documentation of disease progression or death due to any cause at 6 months
The Effect of DSP-7888 Dosing Emulsion Plus Bevacizumab (BEV) Versus BEV Alone on the Response Rate of Patients With Recurrent or Progressive GBM
Assessment of the objective response rate (ORR) of DSP-7888 dosing emulsion plus BEV versus BEV alone in patients with recurrent or progressive GBM. The response rate is defined as the percentage of patients exhibiting a response (complete response \[CR\] plus partial response \[PR\]) based on the Modified Response Assessment in Neuro-Oncology (RANO) criteria as determined by the central radiology body.
Time frame: From the date of first treatment, every 8 weeks, until the date of first documented objective disease progression, up to 24 months
Duration of Response in Patients With Recurrent or Progressive GBM Treated With DSP-7888 Dosing Emulsion Plus Bevacizumab (BEV) Versus BEV Alone
The effect of DSP-7888 dosing emulsion plus BEV versus BEV alone on the duration of response of patients with recurrent or progressive GBM. The duration of response is defined as the interval between first documented oncological response and progression of disease or death from any cause.
Time frame: From the date of first treatment up to 24 months
Number of Participants With Adverse Events and Serious Adverse Events
Assessment of safety of DSP7888 dosing emulsion plus Bevacizumab (BEV) versus BEV alone in patients with recurrent or progressive GBM
Time frame: The time from the date of first treatment, while the patient is on treatment, and for 30 days after stopping therapy, an average of 4 months