Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of DSP-7888 Dosing Emulsion in Combination With Bevacizumab in Patients With Recurrent or Progressive Glioblastoma Following Initial Therapy (WIZARD 201G)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03149003
Recruitment Status : Recruiting
First Posted : May 11, 2017
Last Update Posted : March 27, 2019
Sponsor:
Information provided by (Responsible Party):
Boston Biomedical, Inc

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Glioblastoma Drug: DSP-7888 Dosing Emulsion Drug: Bevacizumab Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 8, 2017
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arm Intervention/treatment
Experimental: Arm 1: DSP-7888 Dosing Emulsion plus Bevacizumab Drug: DSP-7888 Dosing Emulsion
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.
Other Name: adegramotide and nelatimotide

Drug: Bevacizumab
Bevacizumab will be administered intravenously every 14 ± 3 days at 10 mg/kg.
Other Name: Avastin

Active Comparator: Arm 2: Bevacizumab Drug: Bevacizumab
Bevacizumab will be administered intravenously every 14 ± 3 days at 10 mg/kg.
Other Name: Avastin




Primary Outcome Measures :
  1. Determination of the safety and tolerability of DSP-7888 Dosing Emulsion by assessing dose-limiting toxicities (DLTs) [ Time Frame: 4 weeks ]
    Part 1

  2. Overall Survival [ Time Frame: 24 months ]
    Part 2: To assess the effect of DSP-7888 Dosing Emulsion plus Bevacizumab versus Bevacizumab alone on the Overall Survival of patients with recurrent or progressive GBM following treatment with first line therapy consisting of surgery and radiation with or without chemotherapy.Overall survival is defined as the interval between randomization and death from any cause.


Secondary Outcome Measures :
  1. Twelve-month Survival [ Time Frame: 12 months ]
    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.

  2. Progression Free Survival [ Time Frame: 24 months ]
    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.

  3. Six-month Progression Free Survival [ Time Frame: 6 months ]
    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.

  4. Response Rate [ Time Frame: 24 months ]
    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.

  5. Duration of Response [ Time Frame: 24 months ]
    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.

  6. Number of Patients with Adverse Events [ Time Frame: 24 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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. 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.
  10. Patients must have recovered from the effect of all prior therapy to Grade 2 or less.
  11. Patients must be at least 28 days from any major surgery, and any surgery incisions or wounds must be completely healed.
  12. 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.
  13. Patients must be at least 4 weeks from the completion of prior systemic or intracranial chemotherapy.
  14. Patients must stop Novo-TTF treatment one day prior to study therapy (no washout period is needed). However, any wounds from TTF must be adequately healed per Inclusion Criterion #11.15. 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.

16. Patient's left ventricular ejection fraction (LVEF) > 40%. 17. Patient has a resting pulse oximetry of 90% or higher.

Exclusion Criteria:

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

  1. Prior therapy with Bev.
  2. Patients with secondary GBM.
  3. Any anti-neoplastic therapy, including RT, for first relapse or recurrence.
  4. Evidence of leptomeningeal spread of tumor or any history, presence, or suspicion of metastatic disease extracranially.
  5. Evidence of impending herniation on imaging.
  6. Has known multifocal disease. Multifocal disease is defined as discrete sites of disease without contiguous T2/FLAIR abnormality that require distinct radiotherapy ports. Satellite lesions that are associated with a contiguous area of T2/FLAIR abnormality as the main lesion(s) and that are encompassed within the same radiotherapy port as the main lesion(s) are permitted.
  7. Patients with infections that have required treatment with systemic antibiotics within 7 days of first dose of protocol therapy.
  8. The need for systemic glucocorticoids in doses in excess of 4 mg/day of dexamethasone or in comparable doses with other glucocorticoids.
  9. 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.
  10. Pregnant or lactating females.
  11. 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.
  12. 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.
  13. 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.
  14. Patients with primary immunodeficiency diseases.
  15. Patients with significant bleeding in the preceding 6 months or with known coagulopathies.
  16. History of abdominal fistula, intestinal perforation, or intra-abdominal abscess in the preceding 12 months.
  17. Positive serology for 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.

    *In cases of negative results for HepB surface antigen with positive HepB core antibody, HBV DNA testing is required.

  18. Patient has a medical history of frequent ventricular ectopy, e.g., non-sustained ventricular tachycardia (VT).
  19. 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.
  20. 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.
  21. Any psychiatric condition, substance abuse disorder, or social situation that would interfere with a patient's cooperation with the requirements of the study.
  22. Known sensitivity to Bev or any of the components of DSP-7888 Dosing Emulsion.
  23. Patient has a QTcF (QT corrected based on Fridericia's equation) interval > 480 msec (CTCAE = Grade 2) or other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome) at screening. (Patients with bundle branch block and a prolonged QTc interval should be reviewed by the Medical Monitor for potential inclusion.)
  24. Patient has dyspnea at rest (CTCAE ≥ Grade 3) or has required supplemental oxygen within 2 weeks of study enrollment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03149003


Contacts
Layout table for location contacts
Contact: Boston Biomedical 617-674-6800 info@bostonbiomedical.com

  Show 70 Study Locations
Sponsors and Collaborators
Boston Biomedical, Inc

Layout table for additonal information
Responsible Party: Boston Biomedical, Inc
ClinicalTrials.gov Identifier: NCT03149003     History of Changes
Other Study ID Numbers: BBI-DSP7888-201G
First Posted: May 11, 2017    Key Record Dates
Last Update Posted: March 27, 2019
Last Verified: March 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Boston Biomedical, Inc:
Glioblastoma (GBM)
Wilms Tumor 1 (WT1)
Cancer Vaccines
Neoplasms
Astrocytoma
Glioma
Brain Cancer
Brain Tumor
Bevacizumab

Additional relevant MeSH terms:
Layout table for MeSH terms
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors