Status:
COMPLETED
AMG 595 First-in-Human in Recurrent Gliomas
Lead Sponsor:
Amgen
Conditions:
Advanced Malignant Glioma
Anaplastic Astrocytomas
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is an open-label, sequential dose exploration study of single agent AMG 595 administered in subjects with recurrent glioblastoma multiforme (GBM) and/or anaplastic astrocytomas (AA). The purpose ...
Detailed Description
This study of AMG 595 will be conducted in two parts: Part 1 (dose exploration) and Part 2 (dose expansion). Part 1 of the study is in subjects with recurrent glioblastoma multiforme (GBM) and/or anap...
Eligibility Criteria
Inclusion
- Karnofsky performance score \> or = 70%
- Must have pathologically documented, and definitively diagnosed recurrent WHO Grade IV advanced malignant glioblastoma multiforme (Part 1 and Part 2) and/or WHO Grade III anaplastic astrocytoma (Part 1 only).
- GBM and/or AA tumors expressing EGFRvIII as assessed on archived tissue by IHC staining of sections containing a minimum of 100 evaluable tumor cells.
- Archived tumor tissue from the initial diagnosis or subsequent relapse(s) of Grade IV advanced malignant glioblastoma multiforme or Grade III anaplastic astrocytoma available for submission to central review.
- Subjects with recurrent disease (confirmed by MRI and evaluable by Macdonald criteria) at the time of first or second recurrence or progression following initial definitive therapy(s)
- QTcF ≤ 470 msec
- Hematological function, as follows: Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L, Platelet count ≥ 100 x 10\^9/L, Hemoglobin \> 9 g/dL
- Renal function, as follows: Estimated glomerular filtration rate using the Modified Diet in Renal Disease (MDRD) equation \> 45 mL/min/1.73m\^2, Urinary protein quantitative value of \< 30 mg/dL in urinalysis or ≤ 1+ on dipstick, unless quantitative protein is \< 500 mg in a 24 hr urine sample
Exclusion
- 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.
- Peripheral sensory neuropathy \> Grade 2.
- Clinically significant ECG changes which obscure the ability to assess the PR, QT, and QRS interval; congenital long QT syndrome.
- Recent infection requiring intravenous anti-infective treatment that was completed ≤ 14 days before enrollment.
- Received radiation therapy within 12 weeks before enrollment or has not recovered from the toxic effects of such therapy.
- For Part 1 (dose escalation): Treatment with bevacizumab or antiangiogenic therapy within 4 weeks before enrollment, or for Part 2 (dose expansion): any prior treatment with bevacizumab or antiangiogenic therapy.
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01475006
Start Date
February 1 2012
End Date
April 1 2016
Last Update
April 15 2016
Active Locations (4)
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1
Research Site
Los Angeles, California, United States, 90024
2
Research Site
Boston, Massachusetts, United States, 02115
3
Research Site
Cincinnati, Ohio, United States, 45267
4
Research Site
Parkville, Victoria, Australia, 3052