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The purpose of this study is to evaluate the effectiveness and safety of AMG 102 for the treatment of Advanced Malignant Glioma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMG 102 at 10 mg/kg Dose Level | Experimental | Up to 40 subjects will be treated at this dose level based upon investigator assessment of responses observed. |
|
| AMG 102 at 20 mg/kg Dose Level | Experimental | Up to 40 subjects will be treated at this dose level based upon investigator assessment of responses observed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG 102 at 20 mg/kg | Drug | AMG 102 at 20 mg/kg IV (in the vein) every 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess best objective confirmed response rate in subjects with advanced malignant glioma receiving AMG 102 treatment | Week 9 from first dose of AMG 102 |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety profile of AMG 102 in subjects with advanced malignant glioma | entire study | |
| Estimate overall survival and progression-free survival rates in this population | 8 week intervals |
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Inclusion Criteria:
Exclusion Criteria:
history of central nervous system bleeding as defined by stroke or intraocular bleed (including embolic stroke) within 6 months before enrollment
evidence of acute intracranial/intratumoral hemorrhage; except for subjects with stable grade 1 hemorrhage
received radiation therapy within 4 weeks before enrollment or have not recovered from the toxic effects of such therapy
treated previously with any c-Met or HGF targeted therapy
treated with thalidomide or tamoxifen within 1 week before enrollment or has not recovered from the toxic effects of such cancer therapy
treated with immunotherapeutic agents, vaccines or mAb therapy within 4 weeks before enrollment or have not recovered from the toxic effects of such cancer therapy
treated with alkylating agents within 4 weeks before enrollment or has not recovered from the toxic effects of such cancer therapy
treated with chemotherapy (non-alkylating agents) within 2 weeks before enrollment or has not recovered from the toxic effects of such cancer therapy
surgical resection of brain tumor within 4 weeks before enrollment or have not recovered from acute side effects of such therapy, except for neurological effects
plans to receive surgery, radiation therapy or other elective surgeries during the course of the study
concurrent severe and/or uncontrolled medical disease (e.g., uncontrolled diabetes, congestive cardiac failure, myocardial infarction within 6 months before enrollment) that could compromise participation in the study
active infection within 7 days before enrollment
past or current history of another neoplasm, except for curatively treated non-melanoma skin cancer, carcinoma in situ of the cervix and other primary solid cancer with no known active disease present and no curative or adjuvant treatment administered for the last 3 years
documented history of human immunodeficiency virus
documented history of chronic viral hepatitis
concurrent or prior (within 7 days of enrollment) anticoagulation therapy, except:
currently enrolled in or has not yet completed at least 30 days since ending other investigational device or therapeutic study(s)
had major surgery within 4 weeks before enrollment or recovering from prior surgery
known allergy or sensitivity to any of the excipients in the investigational product
pregnant or breast feeding
unwilling to use adequate contraceptive precautions during the course of the study and for 6 months after the last administration of investigational product, for:
previously treated with AMG 102
previously enrolled into this study
will not be available for follow-up assessment
has other disorders that compromises the ability of the subject to give written informed consent and/or comply with study procedures
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21297127 | Background | Wen PY, Schiff D, Cloughesy TF, Raizer JJ, Laterra J, Smitt M, Wolf M, Oliner KS, Anderson A, Zhu M, Loh E, Reardon DA. A phase II study evaluating the efficacy and safety of AMG 102 (rilotumumab) in patients with recurrent glioblastoma. Neuro Oncol. 2011 Apr;13(4):437-46. doi: 10.1093/neuonc/noq198. Epub 2011 Feb 4. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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| ID | Term |
|---|---|
| D005910 | Glioma |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| AMG 102 at 10 mg/kg | Drug | AMG 102 at 10 mg/kg IV (in the vein) every 2 weeks |
|
| Assess the duration of response and time to response in this population | Treatment Period |
| Assess the pharmacokinetics of AMG 102 in subjects with advanced malignant glioma | Weeks 1, 5, and 9 |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |