Clinical Trials /

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

NCT03149003

Description:

This is a randomized, active-controlled, multicenter, open-label, parallel groups, Phase 2 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.

Related Conditions:
  • Astrocytoma
  • Glioblastoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of DSP-7888 Dosing Emulsion in Combination With Bevacizumab in Patients With Recurrent or Progressive Glioblastoma Following Initial Therapy
  • Official Title: A Randomized, Multicenter, Phase 2 Study of DSP-7888 Dosing Emulsion in Combination With Bevacizumab Versus Bevacizumab Alone in Patients With Recurrent or Progressive Glioblastoma Following Initial Therapy

Clinical Trial IDs

  • ORG STUDY ID: BBI-DSP7888-201G
  • NCT ID: NCT03149003

Conditions

  • Glioblastoma Multiforme

Interventions

DrugSynonymsArms
DSP-7888 Dosing Emulsionadegramotide and nelatimotideArm 1: DSP-7888 Dosing Emulsion plus Bevacizumab
BevacizumabAvastinArm 1: DSP-7888 Dosing Emulsion plus Bevacizumab

Purpose

This is a randomized, active-controlled, multicenter, open-label, parallel groups, Phase 2 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.

Trial Arms

NameTypeDescriptionInterventions
Arm 1: DSP-7888 Dosing Emulsion plus BevacizumabExperimental
  • DSP-7888 Dosing Emulsion
  • Bevacizumab
Arm 2: BevacizumabActive Comparator
  • Bevacizumab

Eligibility Criteria

        Inclusion Criteria:

          1. Patients or their legal representatives must be able to provide written informed
             consent.

          2. Histologically confirmed diagnosis of supratentorial GBM (Grade 4 astrocytoma).

          3. 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-methyl-transferase (MGMT)
             methylated-promoter negative need not have received chemotherapy in the past to be
             eligible.

          4. Human leukocyte antigen type HLA-A*02:01, HLA-A*02:06, or HLA-A*24:02.

          5. Age ≥18.

          6. KPS score of ≥60.

          7. Serum creatinine value <2X the upper limit of normal (ULN) for the reference
             laboratory.

          8. Alanine aminotransferase/aspartate aminotransferase <3X the ULN and total bilirubin
             <2× the ULN for the reference laboratory.

          9. Patients must have recovered from the effect of all prior therapy to Grade 2 or less.

         10. Patients must be at least 28 days from any major surgery, and any surgery incisions or
             wounds must be completely healed.

         11. Patients must be at least 12 weeks from the completion of prior radiation therapy (RT)
             in order to discriminate pseudo progression of disease from progression.

         12. Patients must be at least 4 weeks from the completion of prior systemic or
             intracranial chemotherapy.

         13. For patients who are not receiving therapeutic anticoagulation treatment, an
             international normalized ratio (INR) and a PTT ≤ 1.5 × the ULN; patients who are
             receiving anticoagulation treatment should be on a stable dose.

        Exclusion Criteria:

        Patients with any of the following will be excluded from the study:

          1. Prior therapy with Bev.

          2. Any anti-neoplastic therapy, including RT, for first relapse or recurrence.

          3. Evidence of leptomeningeal spread of tumor or any history, presence, or suspicion of
             metastatic disease extracranially.

          4. Evidence of impending herniation on imaging.

          5. Patients with infections that have required treatment with systemic antibiotics within
             7 days of first dose of protocol therapy.

          6. The need for systemic glucocorticoids in doses in excess of 4 mg/day of dexamethasone
             or in comparable doses with other glucocorticoids.

          7. Treatment with any investigational agents within 5 half-lives of the agent in question
             or, if the half life is unknown, within 28 days of enrollment.

          8. Pregnant or lactating females.

          9. Prior history of malignancy within 3 years of enrollment other than basal or squamous
             cell carcinoma of the skin, cervical intra-epithelial neoplasia, in situ carcinoma of
             the breast, or prostate cancer treated with surgery or RT with a prostate specific
             antigen of <0.01 ng/mL.

         10. Patients with active autoimmune diseases within 2 years of enrollment into the study
             including, but not limited to, rheumatoid arthritis, systemic lupus erythematosus,
             systemic sclerosis, Sjogren's syndrome, Wegener's granulomatosis, ulcerative colitis,
             Crohn's disease, myasthenia gravis, Graves' disease, or uveitis except for psoriasis
             not requiring systemic therapy, vitiligo or alopecia areata, or hypothyroidism; if an
             autoimmune condition has been clinically silent for 12 months or greater, the patient
             may be eligible for enrollment.

         11. Patients on immunosuppressive therapies; the use of topical, inhalational,
             ophthalmologic or intra articular glucocorticoids, or the use of physiologic
             replacement doses of glucocorticoids are permitted.

         12. Patients with primary immunodeficiency diseases.

         13. Patients with significant bleeding in the preceding 6 months or with known
             coagulopathies.

         14. History of abdominal fistula, intestinal perforation, or intra-abdominal abscess in
             the preceding 12 months.

         15. Known history of human immunodeficiency virus (HIV) infection, active hepatitis B, or
             untreated hepatitis C; patients who have completed a course of anti-viral treatment
             for hepatitis C are eligible.

         16. Significant cardiovascular disease, including New York Hospital Association Class III
             or IV congestive heart failure, myocardial infarction within 6 months of enrollment,
             unstable angina, poorly controlled cardiac arrhythmias, or stroke within the preceding
             6 months.

         17. Any other uncontrolled inter current medical condition, including systemic fungal,
             bacterial, or viral infection; uncontrolled hypertension; diabetes mellitus; or
             chronic obstructive pulmonary disease requiring 2 or more hospitalizations in the
             preceding 12 months.

         18. Known sensitivity to Bev or any of the components of DSP-7888 Dosing Emulsion.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Determination of the safety and tolerability of DSP-7888 Dosing Emulsion by assessing dose-limiting toxicities (DLTs)
Time Frame:4 weeks
Safety Issue:
Description:Part 1

Secondary Outcome Measures

Measure:Twelve-month Survival
Time Frame:12 months
Safety Issue:
Description:Part 2: To assess the effect of DSP-7888 Dosing Emulsion plus Bevacizumab versus Bevacizumab alone on the survival rate at 12 months of patients with recurrent or progressive GBM following treatment with first line therapy consisting of surgery and radiation with or without.
Measure:Progression Free Survival
Time Frame:24 months
Safety Issue:
Description:Part 2: To assess the effect of DSP-7888 Dosing Emulsion plus Bevacizumab versus Bevacizumab 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. Progression-free survival is defined as the interval between randomization and progression or death from any cause.
Measure:Six-month Progression Free Survival
Time Frame:6 months
Safety Issue:
Description:Part 2: To assess the effect of DSP-7888 Dosing Emulsion plus Bevacizumab versus Bevacizumab alone on the 6-months PFS of patients with recurrent or progressive GBM following treatment with first line therapy consisting of surgery and radiation with or without chemotherapy. Six-month PFS is defined as the proportion of patients alive at 6 months after randomization and without progressive neoplastic disease.
Measure:Response Rate
Time Frame:24 months
Safety Issue:
Description:Part 2: To assess the effect of DSP-7888 Dosing Emulsion plus Bevacizumab versus Bevacizumab alone on the response rate of patients with recurrent or progressive GBM following treatment with first line therapy consisting of surgery and radiation with or without chemotherapy. The response rate is defined as the proportion of patients exhibiting a response (complete response [CR] plus partial response [PR]) based on the Response Assessment in Neuro-Oncology (RANO) criteria as determined by the central radiology body.
Measure:Duration of Response
Time Frame:24 months
Safety Issue:
Description:Part 2: To assess the effect of DSP-7888 Dosing Emulsion plus Bevacizumab versus Bevacizumab alone on the duration of response of patients with recurrent or progressive GBM following treatment with first line therapy consisting of surgery and radiation with or without chemotherapy. The duration of response is defined as the interval between first documented oncological response and progression of disease or death from any cause, with response based on the RANO criteria as determined by the central radiology body.
Measure:Number of Patients with Adverse Events
Time Frame:24 months
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Boston Biomedical, Inc

Trial Keywords

  • Glioblastoma
  • Wilms Tumor 1
  • Cancer Vaccines
  • Neoplasms

Last Updated

October 16, 2017