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A Phase II Study to Treat Advanced Malignant Glioma | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Phase II Study to Treat Advanced Malignant Glioma

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

NCT00427440•Amgen

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+4 more criteria

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
+19 more criteria

Key Dates

Start Date

November 1, 2006

Primary Completion Date

December 1, 2008

Completion Date

April 1, 2013

Last Updated

April 27, 2015

Enrollment

ACTUAL participants

Conditions

Advanced Malignant Glioma

Interventions

AMG 102 at 20 mg/kg

DRUG

AMG 102 at 10 mg/kg

DRUG