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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Sumitomo Pharma America, Inc.
Study ID
NCT03149003
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • DSP-7888 Dosing Emulsion — DRUG
    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 — DRUG
    Bevacizumab will be administered intravenously every 14 ± 3 days at 10 mg/kg.

Study Details

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.

Key Dates

First listed
May 11, 2017
Start date
Dec 8, 2017
Status verified
Nov 2023
Primary completion
Aug 30, 2021
Completion
Aug 30, 2021

Study Design

Enrollment
221 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: DSP-7888 Dosing Emulsion plus Bevacizumab
  • Active Comparator: Arm 2: Bevacizumab

Primary Outcome Measure

Number of Participants Who Experienced a Dose-limiting Toxicity [ Time Frame: Dose-limiting toxicity will be evaluated and applied from Day 1 through Day 29 ]

Locations (37)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294-
Center for NeurosciencesTucsonArizona85718-
Highlands Oncology GroupFayettevilleArkansas72703-
UCSD- Moores Cancer CenterLa JollaCalifornia92093-
Cedars Sinai Medical CenterLos AngelesCalifornia90048-
Kaiser Permanente Los Angeles Medical CenterLos AngelesCalifornia90027-
Neuro-Oncology/ US Irvine Medical CenterOrangeCalifornia92868-
Sansum ClinicSanta BarbaraCalifornia93105-
John Wayne Cancer InstituteSanta MonicaCalifornia90404-
Rocky Mountain Cancer CenterDenverColorado80218-
Piedmont brain tumor centerAtlantaGeorgia30309-
Rush University Medical CenterChicagoIllinois60612-
University of Kentucky / Department of Internal Medicine / Markey Cancer CenterLexingtonKentucky40536-
Norton Cancer InstituteLouisvilleKentucky40202-
Tufts Medical CenterBostonMassachusetts02111-
Henry Ford Health SystemDetroitMichigan48202-
Abbott Northwestern HospitalMinneapolisMinnesota55407-
Hackensack University Medical CenterHackensackNew Jersey07601-
Dent Neurosciences Research CenterAmherstNew York14226-
Columbia University Medical Center/ Neurological Institute of NYNew YorkNew York10032-
Weill Cornell MedicineNew YorkNew York10021-
University of Rochester Medical CenterRochesterNew York14642-
Cleveland Clinic Taussig Cancer CenterClevelandOhio44195-
University Hospitals of ClevelandClevelandOhio44106-
University of ToledoToledoOhio43606-
Hospital of the University of PennsylvaniaPhiladelphiaPennsylvania19104-
University of Pittsburgh Medical Center (UPMC)PittsburghPennsylvania15232-
Rhode Island HospitalProvidenceRhode Island02903-
University of Tennessee Academic Medical Center Cancer InstituteKnoxvilleTennessee37920-
Texas Oncology Austin MidtownAustinTexas78705-
Baylor Scott and WhiteDallasTexas75246-
Houston MethodistHoustonTexas77030-
Mischer Neuroscience Associates/Memorial Hermann HospitalHoustonTexas77030-
Renovatio ClinicalThe WoodlandsTexas77380-
Virginia Cancer Specialists, PCFairfaxVirginia22031-
Swedish Medical CenterSeattleWashington98122-
University of Wisconsin HospitalMadisonWisconsin53792-

Find similar trials in Birmingham, AL

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
University of Alabama at Birmingham· Birmingham, ALCenter for Neurosciences· Tucson, AZHighlands Oncology Group· Fayetteville, ARUCSD- Moores Cancer Center· La Jolla, CACedars Sinai Medical Center· Los Angeles, CAKaiser Permanente Los Angeles Medical Center· Los Angeles, CA

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