A Study of DSP-7888 Dosing Emulsion in Combination With Bevacizumab in Patients With Recurrent or… (NCT03149003) | Clinical Trial Compass
CompletedPhase 3
A Study of DSP-7888 Dosing Emulsion in Combination With Bevacizumab in Patients With Recurrent or Progressive Glioblastoma Following Initial Therapy
United States221 participantsStarted 2017-12-08
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patients or their legal representatives must be able to provide written informed consent.
* Histologically confirmed diagnosis of supratentorial GBM (Grade 4 astrocytoma).
* Radiographic evidence of first recurrence or progression of GBM following primary therapy consisting of surgery (biopsy or resection) and chemoradiation; patients may have undergone a second debulking surgery following initial recurrence or progression. Patients whose tumors are O6 methyl guanyl-methyltransferase (MGMT) methylated-promoter negative need not have received chemotherapy in the past to be eligible.
* Human leukocyte antigen type HLA-A\*02:01, HLA-A\*02:06, or HLA-A\*24:02.
* Age ≥18.
* KPS score of ≥60.
* Serum creatinine value \<2X the upper limit of normal (ULN) for the reference laboratory.
* Alanine aminotransferase/aspartate aminotransferase \<3X the ULN and total bilirubin \<2Ă— the ULN for the reference laboratory.
* Men and women of childbearing potential must agree to use a reliable method of contraception (oral contraceptives, implantable hormonal contraceptives, or double barrier method) or agree to completely refrain from heterosexual intercourse for the duration of the study and for 180 days following the last dose of DSP-7888 Dosing Emulsion.
* Patients must have recovered from the effect of all prior therapy to Grade 2 or less.
* Patients must be at least 28 days from any major surgery, and any surgery incisions or wounds must be completely healed.
* Patie…
What they're measuring
1
Number of Participants Who Experienced a Dose-limiting Toxicity
Timeframe: Dose-limiting toxicity will be evaluated and applied from Day 1 through Day 29
2
Overall Survival (OS) of Patients With Recurrent or Progressive Glioblastoma Multiforme (GBM) Treated With DSP-7888 Dosing Emulsion Plus Bevacizumab (BEV) Versus BEV Alone
Timeframe: 4 weeks after the patient has been off study treatment, every 3 months thereafter until death, the study closes, up to 24 months.