A Phase II Study to Treat Advanced Malignant Glioma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00427440
First received: January 25, 2007
Last updated: February 6, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention Phase
Advanced Malignant Glioma
Drug: AMG 102 at 20 mg/kg
Drug: AMG 102 at 10 mg/kg
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Assess best objective confirmed response rate in subjects with advanced malignant glioma receiving AMG 102 treatment [ Time Frame: Week 9 from first dose of AMG 102 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the safety profile of AMG 102 in subjects with advanced malignant glioma [ Time Frame: entire study ] [ Designated as safety issue: Yes ]
  • Estimate overall survival and progression-free survival rates in this population [ Time Frame: 8 week intervals ] [ Designated as safety issue: No ]
  • Assess the duration of response and time to response in this population [ Time Frame: Treatment Period ] [ Designated as safety issue: No ]
  • Assess the pharmacokinetics of AMG 102 in subjects with advanced malignant glioma [ Time Frame: Weeks 1, 5, and 9 ] [ Designated as safety issue: No ]

Enrollment: 61
Study Start Date: November 2006
Study Completion Date: April 2013
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AMG 102 at 10 mg/kg Dose Level
Up to 40 subjects will be treated at this dose level based upon investigator assessment of responses observed.
Drug: AMG 102 at 10 mg/kg
AMG 102 at 10 mg/kg IV (in the vein) every 2 weeks
Experimental: AMG 102 at 20 mg/kg Dose Level
Up to 40 subjects will be treated at this dose level based upon investigator assessment of responses observed.
Drug: AMG 102 at 20 mg/kg
AMG 102 at 20 mg/kg IV (in the vein) every 2 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00427440

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00427440     History of Changes
Other Study ID Numbers: 20050253
Study First Received: January 25, 2007
Last Updated: February 6, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Amgen:
Glioma
Brain Tumor

Additional relevant MeSH terms:
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Dihydrotachysterol
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on July 20, 2014