Know Cancer

or
forgot password

A Multicenter, Open-label, Single Agent, Two-stage Phase 2 Study to Evaluate the Efficacy and Safety of AMG 102 in Subjects With Advanced Malignant Glioma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Advanced Malignant Glioma

Thank you

Trial Information

A Multicenter, Open-label, Single Agent, Two-stage Phase 2 Study to Evaluate the Efficacy and Safety of AMG 102 in Subjects With Advanced Malignant Glioma


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Assess best objective confirmed response rate in subjects with advanced malignant glioma receiving AMG 102 treatment

Outcome Time Frame:

Week 9 from first dose of AMG 102

Safety Issue:

No

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

United States: Institutional Review Board

Study ID:

20050253

NCT ID:

NCT00427440

Start Date:

November 2006

Completion Date:

September 2013

Related Keywords:

  • Advanced Malignant Glioma
  • Glioma
  • Brain Tumor
  • Glioma

Name

Location