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

Study identifier:CD-ON-MEDI-575-1042

ClinicalTrials.gov identifier:NCT01268566

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

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

Medical condition

Glioblastoma Multiforme

Phase

Phase 2

Healthy volunteers

Study drug

MEDI-575

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 95 Years

Date

Study Start Date: 01 Jan 2011

Primary Completion Date: 01 Nov 2012

Study Completion Date: 01 Nov 2012

Study design

Allocation: N/A
Endpoint Classification: Efficacy
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Feb 2017 by MedImmune, LLC

Collaborators

Inclusion and exclusion 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

No locations available

Arms	Assigned Interventions
Experimental: 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.	Drug: MEDI-575 MEDI-575 as an IV infusion.

Documents available

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CD-ON-MEDI-575-1042 Redacted CSR Synopsis
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Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]