Clinical trial · Interventional
A Study of MEDI-575 in Subjects With Recurrent Glioblastoma Multiforme
A Phase 2 Study of MEDI-575 in Adult Subjects With Recurrent Glioblastoma Multiforme
NCT01268566CI-TRIAL-00026816completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MEDI-575 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MEDI-575, 25 mg/kg
- description
- 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.
- interventionNames
- Drug: MEDI-575
Primary outcomes (1)
- measure
- Progression-free Survival Rate at 6 Months
- timeFrame
- 6 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 95 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.