A Phase II Study to Treat Advanced Malignant Glioma

NCT00427440 | Completed Phase 2

• 1 other identifier: 20050253
• Study Type: interventional
• Target: 61
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Advanced Malignant Glioma

Keywords

Glioma; Brain Tumor

Outcome Measures

Primary Outcomes (1)

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

  Week 9 from first dose of AMG 102

Secondary Outcomes (4)

• To assess the safety profile of AMG 102 in subjects with advanced malignant glioma

  entire study

• Estimate overall survival and progression-free survival rates in this population

  8 week intervals

• Assess the duration of response and time to response in this population

  Treatment Period

• Assess the pharmacokinetics of AMG 102 in subjects with advanced malignant glioma

  Weeks 1, 5, and 9

Study Arms (2)

AMG 102 at 10 mg/kg Dose Level

EXPERIMENTAL

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 20 mg/kg Dose Level

EXPERIMENTAL

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

Interventions

AMG 102 at 20 mg/kg DRUG

AMG 102 at 20 mg/kg IV (in the vein) every 2 weeks

AMG 102 at 20 mg/kg Dose Level

AMG 102 at 10 mg/kg DRUG

AMG 102 at 10 mg/kg IV (in the vein) every 2 weeks

AMG 102 at 10 mg/kg Dose Level

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Related Publications (1)

• Wen PY, Schiff D, Cloughesy TF, Raizer JJ, Laterra J, Smitt M, Wolf M, Oliner KS, Anderson A, Zhu M, Loh E, Reardon DA. A phase II study evaluating the efficacy and safety of AMG 102 (rilotumumab) in patients with recurrent glioblastoma. Neuro Oncol. 2011 Apr;13(4):437-46. doi: 10.1093/neuonc/noq198. Epub 2011 Feb 4.

  PMID: 21297127 BACKGROUND

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Glioma; Brain Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2007
• First Posted: January 29, 2007
• Study Start: November 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: April 1, 2013
• Last Updated: April 27, 2015

Record last verified: 2015-04