Clinical Trial Details
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NCT03296696 : Study of AMG 596 in Patients With EGFRvIII Positive Glioblastoma
PhasePhase 1
AgesMin: 18 Years Max: 100 Years
Inclusion Criteria

- Eastern Cooperative Oncology Group (ECOG, Appendix F) Performance Status of = 1

- Life expectancy of at least 3 months, in the opinion of the investigator.

- Must have pathologically documented, and definitively diagnosed World Health
Organization (WHO) grade 4, glioblastoma

- Must have recurrent disease confirmed by MRI (Group 1) or completed SoC therapy such
as surgery with adjuvant radiochemotherapy with or without maintenance temozolomide
according to local standards for newly diagnosed disease (Group 2)

- Renal function and Hepatic function

Exclusion Criteria

- History or evidence of central nervous system bleeding as defined by stroke or
intraocular bleed (including embolic stroke) not associated with any antitumor surgery
within 6 months before enrolment

- Known hypersensitivity to immunoglobulins or to any other component of the IP

- Infection requiring intravenous antibiotics that was completed < 1 week of study
enrollment (day 1) with the exemption of prophylactic antibiotics for long line
insertion or biopsy

- Unresolved toxicities from prior antitumor therapy, defined as not having resolved to
CTCAE, version 4.0 grade 1 (with the exception of myelosuppression, e.g., neutropenia,
anemia, thrombocytopenia), or to levels dictated in the eligibility criteria with the
exception of alopecia or toxicities from prior antitumor therapy that are considered
irreversible (defined as having been present and stable for > 2 months) which may be
allowed if they are not otherwise described in the exclusion criteria AND there is
agreement to allow by both the investigator and sponsor

- Antitumor therapy (chemotherapy, antibody therapy, molecular-targeted therapy, or
investigational agent) within 14 days (Group 2 subjects) or 5 half-lives (whichever is
longer: for Group 1 subjects) of day 1.
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