Patient case: 82-year-old male with glioma; genetic feature: BRAF

Clinical trial: A Phase II Study to Treat Advanced Malignant Glioma

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


Eligibility: 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

Relevance to patient case: not relevant