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

NCT01268566 | Completed Phase 2 Results

• 1 other identifier: CD-ON-MEDI-575-1042
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 12

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.

Conditions

Glioblastoma Multiforme

Keywords

Glioblastoma

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival Rate at 6 Months

  Progression-free survival (PFS) rate at 6 months is defined as the proportion of participants who neither progressed nor died before 6 months after the first dose. Progression was determined using Updated Response Assessment Criteria of High Grade Gliomas: Response Assessment in Neuro-Oncology Working Group (RANO criteria). Progression was defined as at least 25% increase in measurement of enhancing lesions compared with the smallest tumor measurement obtained during the study; or significant increase in T2/fluid attenuated inversion recovery (FLAIR) nonenhancing lesion compared with baseline scan or best response; or any new lesion; or clear clinical deterioration; or failure to return for evaluation as a result of death or deteriorating condition; or clear progression of nonmeasurable disease. PFS-6 was estimated using Kaplan-Meier method.

  6 months

Secondary Outcomes (14)

• Percentage of Participants With Best Overall Response

  Study entry through the end of the study, up to 21 months

• Percentage of Participants With Objective Response

  Study entry through the end of the study, up to 21 months

• Time to Response

• Duration of Response

• Time to Progression

  Study entry until the first documented disease progression, up to 16 months

Study Arms (1)

MEDI-575, 25 mg/kg

EXPERIMENTAL

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

Interventions

MEDI-575 DRUG

MEDI-575 as an IV infusion.

MEDI-575, 25 mg/kg

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (12)

Research Site

Tucson, Arizona, United States

Location

Research Site

Los Angeles, California, United States

Location

Research Site

Stanford, California, United States

Location

Research Site

Chicago, Illinois, United States

Location

Research Site

Boston, Massachusetts, United States

Location

Research Site

Detroit, Michigan, United States

Location

Research Site

New York, New York, United States

Location

Research Site

Canton, Ohio, United States

Location

Research Site

Pittsburgh, Pennsylvania, United States

Location

Research Site

Nashville, Tennessee, United States

Location

Research Site

San Antonio, Texas, United States

Location

Research Site

Seattle, Washington, United States

Location

Related Links

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

MeSH Terms

Conditions

Glioblastoma

Interventions

Tovetumab

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Results Point of Contact

• Title: A Phase 2 Study of MEDI-575 in Adult Subjects with Recurrent Glioblastoma Multiforme
• Organization: MedImmune, LLC, an affiliate of AstraZeneca

information.center@astrazeneca.com

1-877-240-9479

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2010
• First Posted: December 31, 2010
• Study Start: January 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: April 6, 2017
• Results First Posted: April 6, 2017

Record last verified: 2017-02

Locations

US (12)