A Phase II Study to Treat Advanced Malignant Glioma

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effectiveness and safety of AMG 102 for the treatment of Advanced Malignant Glioma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Antibodies, Monoclonal; Dihydrotachysterol; Rilotumumab

Criteria

Inclusion Criteria:

• 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 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:

• 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