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Angiopoietin-2 (Ang-2) is a protein in the body which destabilizes blood vessels and is important in stimulating tumor blood vessels. There is evidence suggesting that Ang-2 may be important for the growth and progression of Glioblastoma multiforme (GBM). PF- 04856884 (CVX-060) is a compound which binds Ang-2 and prevents its activity. The hypothesis is that PF-04856884 will be safe and effective in patients with recurrent Glioblastoma multiforme (GBM).
Notification of study being cancelled resulted in update in overall status change from "not yet recruiting" to "withdrawn."
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary Cohort | Experimental |
| |
| Exploratory Cohort | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-04856884 | Biological | PF-04856884 at a dose of 15 mg/kg/week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival rate at Month 6 (PFS6) defined as the patient progression free status at Month 6. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Corticosteroid doses at baseline and on-study | 4 months | |
| Overall Response Rate (ORR) | 2 years | |
| PFS defined as the time from 1st dose of study drug to the 1st documentation of disease progression or death from any cause, whichever comes first. |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria Specific for Primary Cohort
Exclusion Criteria Specific for Exploratory Cohort
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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| PF-04856884 | Biological | PF-04856884 at a dose of 15 mg/kg/week |
|
|
| 2 years |
| Time to death is defined as the time from first study drug to death due to any cause. | 2 years |
| Overall survival (OS) defined as the time from first dose of study drug to death due to any cause. | 2 years |
| OS6 defined as the patient survival status at Month 6. The OS6 rate will be obtained as a Kaplan-Meier estimate of the time to death at Month 6. | 2 years |
| Immunogenicity determined by measuring anti-PF-04856884 antibodies following therapy | 4 months |
| Dynamic Contrast Enhanced Magnetic Resonance Imaging [DCE-MRI] endpoints to include changes from baseline volume transfer coefficient [Ktrans] and/or the initial area under the contrast agent concentration-time curve [IAUC] or Ki following therapy | 4 months |
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |