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Study Complete
Sponsor ID
20090505

AMG 595 First-in-Human in Recurrent Gliomas

Sponsor ID
20090505
Clinicaltrials.gov ID
NCT01475006
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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 of the study is to evaluate safety, tolerability, and pharmacokinetics (PK) of AMG 595, and also to evaluate the objective response rate in subjects receiving AMG 595. This study will be conducted in two parts. Part 1 will explore doses of AMG 595 in subjects with recurrent GBM and/or AA. Part 2 (dose expansion) will examine the MTD established in Part 1 in subjects with recurrent GBM.

Additional Study Details

Phase
Phase 1
Product
AMG 595
Type
Interventional
Masking
None (Open Label)
Enrollment
32
Additional Study Details

Protocol Summary

Primary Outcome Measures

Clinically significant or > or = to Grade 3 CTCAE changes in safety laboratory tests, physical exams, ECGs or vital signs

Timeframe: 28 Days after last subject enrolled of each cohort in Part 1 and every 10, 20 and 30 subject enrolled in part 2 (if available)

PK Parameters: Cmax, Cmin, and if feasible half life - 8 time points up to 6 weeks

Timeframe: 28 Days after last subject enrolled of each cohort in Part 1 and every 10, 20 and 30 subject enrolled in part 2 (if available)

Objective response in GBM tumors as assessed by Macdonald criteria

Timeframe: 3 years

Dose limiting toxicity used to estimate the MTD

Timeframe: 28 Days after last subject enrolled of each cohort in Part 1 and every 10, 20 and 30 subject enrolled in part 2 (if available)

Objective response in GBM tumors as assessed by Macdonald criteria

Timeframe: 3 years

Secondary Outcome Measures

Clinical benefit rate

Timeframe: every 6 months

Progressive free survival

Timeframe: 3 years

Overall survival

Timeframe: 3 years

Anti-AMG 595 antibody formation

Timeframe: 3 years

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
Contact Us
Location
Research Site
Parkville, VIC, Australia, 3052
Status
Recruiting
Location
Research Site
Cincinnati, OH, United States, 45267
Status
Recruiting
Location
Research Site
Los Angeles, CA, United States, 90024
Status
Recruiting
Location
Research Site
Boston, MA, United States, 02115
Status
Recruiting
Study Info
Age
18+ years
Condition
  • Brain Cancer
    • Sex
    All
    Trial Dates
    Feb 2012 - Apr 2016
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    • 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 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. • 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.