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

Glioblastoma Multiforme Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01268566
• Other study ID #: CD-ON-MEDI-575-1042
• Status: Completed
• Phase: Phase 2
• First received: December 29, 2010
• Last updated: June 2, 2016
• Start date: January 2011
• Est. completion date: November 2012

Study information

• Verified date: June 2016
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme

Intervention

Drug:
• MEDI-575
MEDI-575 as an IV infusion.

Locations

Country	Name	City	State
United States	Research Site	Boston	Massachusetts
United States	Research Site	Canton	Ohio
United States	Research Site	Chicago	Illinois
United States	Research Site	Detroit	Michigan
United States	Research Site	Los Angeles	California
United States	Research Site	Nashville	Tennessee
United States	Research Site	New York	New York
United States	Research Site	Pittsburgh	Pennsylvania
United States	Research Site	San Antonio	Texas
United States	Research Site	Seattle	Washington
United States	Research Site	Stanford	California
United States	Research Site	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
MedImmune LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the progression free survival at 6 months in subjects with a recurrence of Glioblastoma Multiforme		18 months	No
Secondary	Assess Medi-575 activity, safety and tolerability	1) To evaluate other antitumor activities of MEDI-575 2) To describe the safety and tolerability of MEDI-575 3) To determine the expression of PDGFRa in the tumor cells of archived tumor samples	18 months	Yes

External Links

•   Click here and search for drug information provided by the FDA.
•   Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.