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A Phase 2 Study of MEDI-575 in Adult Subjects With Recurrent Glioblastoma Multiforme

Phase 2
18 Years
Not Enrolling
Glioblastoma Multiforme

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Trial Information

A Phase 2 Study of MEDI-575 in Adult Subjects With Recurrent Glioblastoma Multiforme

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

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.

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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluate the progression free survival at 6 months in subjects with a recurrence of Glioblastoma Multiforme

Outcome Time Frame:

18 months

Safety Issue:


Principal Investigator

Naimish Pandya, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

MedImmune LLC


United States: Food and Drug Administration

Study ID:




Start Date:

January 2011

Completion Date:

May 2013

Related Keywords:

  • Glioblastoma Multiforme
  • Glioblastoma
  • Glioblastoma



Research Site Mesa, Arizona  
Research Site Anaheim, California  
Research Site Arlington Heights, Illinois  
Research Site Beverly, Massachusetts  
Research Site Battle Kreek, Michigan  
Research Site Albany, New York  
Research Site Akron, Ohio  
Research Site Allentown, Pennsylvania  
Research Site Chattanooga, Tennessee  
Research Site Abilene, Texas  
Research Site Auburn, Washington