Status:
COMPLETED
A Phase II Study to Treat Advanced Malignant Glioma
Lead Sponsor:
Amgen
Conditions:
Advanced Malignant Glioma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the effectiveness and safety of AMG 102 for the treatment of Advanced Malignant Glioma.
Eligibility Criteria
Inclusion
- subjects with documented histologically confirmed primary grade 4 advanced malignant glioma
- no more than 3 prior relapses or prior systemic treatments
- recurrent disease documented by MRI after prior therapy
- must have at least one site of bidimensionally measurable disease:
- archived tissue from the initial diagnosis of advanced malignant glioma or upon transformation to advanced malignant glioma are available for central review within approximately 4 weeks after enrollment
- age ≥ 18 years
- Karnofsky performance score ≥ 60%
- hemoglobin ≥ 10 g/dL
- absolute neutrophil count ≥ 1.5 x 10(9th)/L
- platelet count ≥ 100 x 10(9th)/L
- serum creatinine ≤ 1.5 times upper limit of normal
- alanine aminotransferase ≤ 2.5 times upper limit of normal
- serum total bilirubin ≤ 2.5 times upper limit of normal
- before any study-specific procedure, the appropriate written informed consent must be obtained
Exclusion
- 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:
- Use of low molecular weight heparins (LMWH, e.g., enoxaparin sodium \[Lovenox\] and unfractionated heparin for prophylaxis against central venous catheter thrombosis is allowed
- Use of low dose warfarin (\< 2 mg/day) for prophylaxis against central venous catheter thrombosis is allowed
- 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:
- male subjects
- female subjects who are not post-menopausal (no menstrual period for a minimum of 12 months at study entry) or documented surgically sterile will not be bound to this exclusion
- 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
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT00427440
Start Date
November 1 2006
End Date
April 1 2013
Last Update
April 27 2015
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