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Angiogenesis Inhibitor

DSP-7888 Dosing Emulsion for Glioblastoma

Phase 3
Waitlist Available
Research Sponsored by Sumitomo Dainippon Pharma Oncology, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the date of first treatment, every 8 weeks, until the date of first documented objective disease progression, up to 24 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing a new combination treatment for patients with a type of brain cancer that has returned or grown after standard treatments. The new treatment includes a drug that boosts the immune system and another that stops blood vessels from feeding the tumor. Recent trials have shown major antitumor activity with this combination.

Eligible Conditions
  • Glioblastoma
  • Solid Tumors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the date of first treatment, every 8 weeks, until the date of first documented objective disease progression, up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of first treatment, every 8 weeks, until the date of first documented objective disease progression, up to 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants Who Experienced a Dose-limiting Toxicity
Overall Survival (OS) of Patients With Recurrent or Progressive Glioblastoma Multiforme (GBM) Treated With DSP-7888 Dosing Emulsion Plus Bevacizumab (BEV) Versus BEV Alone
Secondary study objectives
Duration of Response in Patients With Recurrent or Progressive GBM Treated With DSP-7888 Dosing Emulsion Plus Bevacizumab (BEV) Versus BEV Alone
Number of Participants With Adverse Events and Serious Adverse Events
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
+3 more

Side effects data

From 2021 Phase 3 trial • 221 Patients • NCT03149003
75%
Injection site reaction
75%
Cough
50%
Seizure
50%
Decreased appetite
50%
Fatigue
50%
Vomiting
50%
Pyrexia
50%
Headache
25%
Adrenal insufficiency
25%
Nausea
25%
Psychotic disorder
25%
Diarrhoea
25%
Dry mouth
25%
Oedema peripheral
25%
Injection site erythema
25%
Dizziness
25%
Insomnia
25%
Alopecia
25%
Hypertension
25%
Epistaxis
25%
Dysphagia
25%
Confusional state
25%
Gastrooesophageal reflux disease
25%
Thrombocytopenia
25%
Hemiparesis
25%
Mental status changes
25%
Hyperhidrosis
25%
Hyperacusis
25%
Stridor
25%
Brain oedema
25%
Hypomagnesaemia
25%
Anxiety
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part 1 - Arm 1: DSP-7888 Dosing Emulsion Plus Bevacizumab
Part 2 - Arm 1: DSP-7888 Dosing Emulsion Plus Bevacizumab
Part 2 - Arm 2: Bevacizumab

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 1: DSP-7888 Dosing Emulsion plus BevacizumabExperimental Treatment2 Interventions
Group II: Arm 2: BevacizumabActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DSP-7888 Dosing Emulsion
2017
Completed Phase 3
~250
Bevacizumab
2013
Completed Phase 4
~5540

Find a Location

Who is running the clinical trial?

Sumitomo Dainippon Pharma Oncology, IncLead Sponsor
41 Previous Clinical Trials
6,548 Total Patients Enrolled
3 Trials studying Glioblastoma
97 Patients Enrolled for Glioblastoma
Sumitomo Pharma America, Inc.Lead Sponsor
241 Previous Clinical Trials
51,664 Total Patients Enrolled
3 Trials studying Glioblastoma
97 Patients Enrolled for Glioblastoma
Sumitomo Pharma Oncology, Inc.Lead Sponsor
44 Previous Clinical Trials
6,869 Total Patients Enrolled
3 Trials studying Glioblastoma
97 Patients Enrolled for Glioblastoma
~28 spots leftby Dec 2025
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