A Study of MEDI-575 in Subjects With Recurrent Glioblastoma Multiforme

NCT ID: NCT01268566

Last Updated: 2017-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2012-11-30

Brief Summary

The primary objective of this Phase II study is to evaluate the progression-free survival at 6 months in adult subjects with a first recurrence of Glioblastoma Multiforme who are treated with MEDI-575.

Detailed Description

This is a Phase 2, multicenter, open-label, single-arm study to evaluate the antitumor activity, safety, and pharmacology of MEDI-575 in adult subjects with first recurrence of GBM.

Approximately 55 subjects will be enrolled to determine the preliminary efficacy profile of MEDI-575 in the treatment of subjects with first recurrence of GBM. Subjects will receive MEDI-575 as a 60-minute IV infusion on Day 1 every 21 days until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for subject withdrawal.

The primary assessment of antitumor activity is PFS-6; tumor response and progression will be determined using Updated Response Assessment Criteria of High Grade Gliomas- Neuro-Oncology Working Group v.1. Approximately 15 investigational sites in the United States will participate in this study. All subjects will be followed every 3 months for the duration of the trial (defined as 9 months from the date the last subject is entered into the trial or when the sponsor stops the study.

Conditions

Glioblastoma Multiforme

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MEDI-575, 25 mg/kg

MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minutes on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participants withdrawal.

Group Type: EXPERIMENTAL

MEDI-575

Intervention Type: DRUG

MEDI-575 as an IV infusion.

Interventions

MEDI-575

MEDI-575 as an IV infusion.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Written informed consent and HIPAA authorization (applies to covered entities in the USA only) obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations
• Age ≥18 years old at the time of screening
• Histologically confirmed diagnosis of World Health Organization Grade IV malignant glioma (glioblastoma or gliosarcoma)
• Previous first line treatment with radiotherapy and temozolomide (treatment prior to radiation and temozolomide permitted, [ie, Gliadel])
• Documented first recurrence of GBM by diagnostic biopsy or by contrast-enhanced magnetic resonance imaging (MRI) as per Updated Response Assessment Criteria of High Grade Gliomas- Neuro-Oncology Working Group (Wen et al, 2010)
• Life expectancy ≥ 12 weeks
• Adequate hematologic and organ function
• Negative serum pregnancy test (women only)
• Two methods of birth control for female participants of child-bearing potential or male participants with their female partners of child-bearing potential

Exclusion Criteria

• Treatment with any chemotherapy, radiotherapy, immunotherapy, biologic, hormonal therapy or investigational agent 30 days prior to study entry
• Concurrent enrollment in another clinical study involving an investigational agent
• Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals
• Previous mAb treatment specifically directed against PDGF or PDGF receptors
• Previous bevacizumab or other VEGF and anti-angiogenic treatment
• More than 1 recurrence of GBM
• Any surgery (not including minor diagnostic procedures) within 2 weeks prior to baseline disease assessments; or not fully recovered from any side effects of previous procedures
• History of serious allergy or reaction to any component of the MEDI-575 formulation
• New York Heart Association ≥ Grade 2 congestive heart failure within 6 months prior to study entry
• Uncontrolled or significant cardiovascular disease
• History of other invasive malignancy within 5 years prior to study entry except for cervical carcinoma in situ (CIS), non-melanomatous carcinoma of the skin or ductal carcinoma in situ (DCIS) of the breast that have been surgically cured
• History of active human immunodeficiency virus or active hepatitis B or C viral infection will be excluded to eliminate the risk of increased AEs due to immune compromise.
• Systemic immunosuppressive therapy.
• Subjects taking corticosteroids must be on a stable dose for 7 days prior to initiation of treatment with MEDI-575 16) Presence of extracranial metastatic or leptomeningeal disease

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MedImmune LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Research Site

Tucson, Arizona, United States

Research Site

Los Angeles, California, United States

Research Site

Stanford, California, United States

Research Site

Chicago, Illinois, United States

Research Site

Boston, Massachusetts, United States

Research Site

Detroit, Michigan, United States

Research Site

New York, New York, United States

Research Site

Canton, Ohio, United States

Research Site

Pittsburgh, Pennsylvania, United States

Research Site

Nashville, Tennessee, United States

Research Site

San Antonio, Texas, United States

Research Site

Seattle, Washington, United States

Countries

United States

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=5&filename=1042%20Protocol%20V%202%2019-May-11_Redacted-IP%20Comments.pdf

CD-ON-MEDI-575-1042 Redacted CSR Synopsis

Other Identifiers

CD-ON-MEDI-575-1042

Identifier Type: -

Identifier Source: org_study_id