A Phase II Study to Treat Advanced Malignant Glioma

April 6, 2015 updated by: Amgen

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Week 9 from first dose of AMG 102

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess the safety profile of AMG 102 in subjects with advanced malignant glioma
Time Frame: entire study
entire study
Estimate overall survival and progression-free survival rates in this population
Time Frame: 8 week intervals
8 week intervals
Assess the duration of response and time to response in this population
Time Frame: Treatment Period
Treatment Period
Assess the pharmacokinetics of AMG 102 in subjects with advanced malignant glioma
Time Frame: Weeks 1, 5, and 9
Weeks 1, 5, and 9

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

January 25, 2007

First Submitted That Met QC Criteria

January 25, 2007

First Posted (Estimate)

January 29, 2007

Study Record Updates

Last Update Posted (Estimate)

April 27, 2015

Last Update Submitted That Met QC Criteria

April 6, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20050253

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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