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A Phase 1 First-in-Human Study Evaluating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 595 in Subjects With Recurrent Malignant Glioma Expressing Mutant Epidermal Growth Factor Receptor Variant III (EGFRvIII)


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Advanced Malignant Glioma, Anaplastic Astrocytomas, Glioblastoma Multiforme

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Trial Information

A Phase 1 First-in-Human Study Evaluating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 595 in Subjects With Recurrent Malignant Glioma Expressing Mutant Epidermal Growth Factor Receptor Variant III (EGFRvIII)


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.

- 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.

- Treated previously with bevacizumab or anti-angiogenic therapy for the dose expansion
(Part 2) only.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

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)

Safety Issue:

Yes

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

Australia: Royal Adelaide Hospital Research Ethics Committee

Study ID:

20090505

NCT ID:

NCT01475006

Start Date:

November 2011

Completion Date:

May 2014

Related Keywords:

  • Advanced Malignant Glioma
  • Anaplastic Astrocytomas
  • Glioblastoma Multiforme
  • Epidermal Growth Factor Receptor Variant III
  • EGFRvIII
  • Glioma
  • Anaplastic Astrocytomas
  • Glioblastoma Multiforme
  • Antibody drug conjugate
  • brain tumor
  • Astrocytoma
  • Glioblastoma
  • Glioma

Name

Location

Research SiteAnaheim, California  
Research SiteAkron, Ohio