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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 : July 23, 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

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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

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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
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Contact: Boston Biomedical 617-674-6800 info@bostonbiomedical.com

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Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact    844-904-7088    US121@xfactorbbi.com   
United States, Arizona
Barrow Neurological Institute Recruiting
Phoenix, Arizona, United States, 85013
Contact    844-904-7088    US140@xfactorbbi.com   
Center for Neurosciences Recruiting
Tucson, Arizona, United States, 85718
Contact    844-904-7088    US101@xfactorbbi.com   
United States, Arkansas
Highlands Oncology Group Recruiting
Fayetteville, Arkansas, United States, 72703
Contact    844-904-7088    US116@xfactorbbi.com   
United States, California
UCSD- Moores Cancer Center Recruiting
La Jolla, California, United States, 92093
Kaiser Permanente Los Angeles Medical Center Recruiting
Los Angeles, California, United States, 90027
Contact    844-904-7088    US141@xfactorbbi.com   
Cedars Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
University of California Los Angeles Neuro-Oncology (UCLA) Recruiting
Los Angeles, California, United States, 90095
Contact    310-794-3521; 310-825-5321    neuroonc@mednet.ucla.edu   
Neuro-Oncology/ US Irvine Medical Center Recruiting
Orange, California, United States, 92868
Contact    844-904-7088    US137@xfactorbbi.com   
Sansum Clinic Recruiting
Santa Barbara, California, United States, 93105
Contact    844-904-7088    US145@xfactorbbi.com   
John Wayne Cancer Institute Recruiting
Santa Monica, California, United States, 90404
Contact    844-904-7088    US119@xfactorbbi.com   
United States, Colorado
Rocky Mountain Cancer Center Recruiting
Denver, Colorado, United States, 80218
Contact    844-904-7088    US144@xfactorbbi.com   
United States, District of Columbia
Medical Family Associates, George Washington University Recruiting
Washington, District of Columbia, United States, 20037
Contact    844-904-7088    US113@xfactorbbi.com   
United States, Georgia
Piedmont brain tumor center Recruiting
Atlanta, Georgia, United States, 30309
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact    844-904-7088    US135@xfactorbbi.com   
United States, Kentucky
University of Kentucky / Department of Internal Medicine / Markey Cancer Center Recruiting
Lexington, Kentucky, United States, 40536
Contact    844-904-7088    US107@xfactorbbi.com   
Norton Cancer Institute Recruiting
Louisville, Kentucky, United States, 40202
Contact    844-904-7088    US117@xfactorbbi.com   
United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact    844-904-7088    US124@xfactorbbi.com   
United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact    844-904-7088    US105@xfactorbbi.com   
United States, Minnesota
Abbott Northwestern Hospital Recruiting
Minneapolis, Minnesota, United States, 55407
Contact    844-904-7088    US109@xfactorbbi.com   
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact    844-904-7088    US132@xfactorbbi.com   
United States, Nebraska
Nebraska Cancer Specialists Recruiting
Omaha, Nebraska, United States, 68130
Contact    844-904-7088    US143@xfactorbbi.com   
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact    844-904-7088    US122@xfactorbbi.com   
United States, New York
Dent Neurosciences Research Center Recruiting
Amherst, New York, United States, 14226
Contact    844-904-7088    US102@xfactorbbi.com   
NYU Winthrop Neuro Science Medical Recruiting
Mineola, New York, United States, 11501
Contact    844-904-7088    US133@xfactorbbi.com   
Weill Cornell Medicine Recruiting
New York, New York, United States, 10021
Contact    844-904-7088    US138@xfactorbbi.com   
Columbia University Medical Center/ Neurological Institute of New York Recruiting
New York, New York, United States, 10032
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact    844-904-7088    US110@xfactorbbi.com   
United States, Ohio
University Hospitals of Cleveland Completed
Cleveland, Ohio, United States, 44106
Cleveland Clinic Taussig Cancer Center Recruiting
Cleveland, Ohio, United States, 44195
Contact    844-904-7088    US136@xfactorbbi.com   
University of Toledo Recruiting
Toledo, Ohio, United States, 43606
Contact    844-904-7088    US111@xfactorbbi.com   
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact    844-904-7088    US127@xfactorbbi.com   
University of Pittsburgh Medical Center (UPMC) Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact    844-904-7088    US106@xfactorbbi.com   
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact    844-904-7088    US131@xfactorbbi.com   
United States, Tennessee
University of Tennessee Academic Medicalcenter Cancer Institute Recruiting
Knoxville, Tennessee, United States, 37920
Contact    844-904-7088    US112@xfactorbbi.com   
United States, Texas
Texas Oncology Austin Midtown Recruiting
Austin, Texas, United States, 78705
Contact    844-904-7088    US108@xfactorbbi.com   
Baylor Scott and White Recruiting
Dallas, Texas, United States, 75246
Contact    844-904-7088    US129@xfactorbbi.com   
Houston Methodist Recruiting
Houston, Texas, United States, 77030
Mischer Neuroscience Associates/Memorial Hermann Hospital Recruiting
Houston, Texas, United States, 77030
Contact    844-904-7088    US114@xfactorbbi.com   
UT MD Anderson cancer Center Recruiting
Houston, Texas, United States, 77030
Contact    844-904-7088    US146@xfactorbbi.com   
Renovatio Clinical Recruiting
The Woodlands, Texas, United States, 77380
Contact    844-904-7088    US115@xfactorbbi.com   
United States, Virginia
Virginia Cancer Specialists, PC Recruiting
Fairfax, Virginia, United States, 22031
Contact    844-904-7088    US142@xfactorbbi.com   
United States, Washington
Swedish Medical Center Recruiting
Seattle, Washington, United States, 98122
Contact    844-904-7088    US128@xfactorbbi.com   
United States, Wisconsin
University Of Wisconsin Hospital Recruiting
Madison, Wisconsin, United States, 53792
Contact    844-904-7088    US128@xfactorbbi.com   
Canada, Alberta
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact    833-394-6555    CA202@xfactorbbi.com   
Canada, Manitoba
CancerCare Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Contact    (844) 543-0977    CA201@xfactorbbi.com   
Canada, Quebec
Montreal Neurological Institute and Hospital Recruiting
Montreal, Quebec, Canada, H3A 2B4
University of Sherbrooke Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Japan
Hokkaido University Hospital Recruiting
Sapporo, Hokkaido, Japan, 060-8648
Contact    +81-11-706-7600    tiken@med.hokudai.ac.jp   
Kagoshima University Hospital Recruiting
Kagoshima-shi, Kagoshima, Japan, 890-8520
Niigata University Medical and Dental Hospital Recruiting
Chuo Ku, Niigata, Japan, 951-8520
Osaka International Cancer Institute Recruiting
Otemae Chuo-ku, Osaka, Japan, 541-8567
The University of Tokyo Hospital Recruiting
Bunkyo-ku, Tokyo, Japan, 113-8655
National Cancer Center Hospital Recruiting
Chuo-ku, Tokyo, Japan, 104-0045
Hiroshima University Hospital Recruiting
Hiroshima, Japan, 734-8551
Kumamoto University Hospital Recruiting
Kumamoto, Japan, 860-8556
University Hospital, Kyoto Prefectural University of Medicine Recruiting
Kyoto, Japan, 602-8566
Contact    +81-75-251-5111    nouge@koto.kpu-m.ac.jp   
National Hospital Organization Kyoto Medical Center Recruiting
Kyoto, Japan, 612-8555
Contact    +81-75-643-6420    chiken@kyotolan.hosp.go.jp   
Tokyo Women's Medical University Hospital Recruiting
Shinjuku-Ku, Japan, 162-8666
Yamagata University Hospital Recruiting
Yamagata, Japan, 990-9585
Contact    +81-23-628-5840    mebihara@med.id.yamagata-u.ac.jp   
Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
Gangnam Severance Hospital Recruiting
Gangnam-gu, Seoul, Korea, Republic of, 06273
Samsung Medical Center Recruiting
Gangnam-gu, Seoul, Korea, Republic of, 06351
Seoul National University Hospital Recruiting
Jongno-gu, Seoul, Korea, Republic of, 03080
The Catholic University of Korea, Seoul St. Mary's Hospital Recruiting
Seocho-gu, Seoul, Korea, Republic of, 06591
Severance Hospital Recruiting
Seodaemun-gu, Seoul, Korea, Republic of, 03722
Asan Medical Center Recruiting
Songpa-gu, Seoul, Korea, Republic of, 05505
Taiwan
China Medical University Hospital Recruiting
Yude Road, Taichung, Taiwan, 40447
Contact    +886-00-801-12-7200    TW402@xfactorbbi.com   
National Taiwan University Hospital Recruiting
Chung-Shan South Road, Taipei, Taiwan, 100
Contact    +886-00-801-12-7200    TW403@xfactorbbi.com   
Chang Gung Memorial Hospital LinKou Medical Center Recruiting
Kuei Shan Hsiang, Taoyuan Hsien, Taiwan, 333
Contact    +886-00-801-12-7200    TW401@xfactorbbi.com   
Sponsors and Collaborators
Boston Biomedical, Inc

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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: July 23, 2019
Last Verified: July 2019

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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:
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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