Single-arm, open-label study of AMG 479 in up to 35 subjects with Ewing's Family Tumors (EFTs) and Desmoplastic Small Round Cell Tumors (DSRCTs) who have progressed or recurred after at least one prior chemotherapy regimen. An exploratory cohort of an additional up to 10 subjects with prior exposure to anti-IGF-1R therapy and who have progressed or recurred after at least one prior chemotherapy regimen will also be assessed.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
38
AMG 479 is a fully human monoclonal antibody (IgG1) against the insulin-like growth factor receptor-1 (IGF-1R). IGF-1R signaling has been shown to play a critical role in the survival of cancer cells. AMG 479 inhibits the binding of both IGF-1 and IGF-2 to IGF-1R, thus inhibiting ligand-dependent receptor activation. Inhibition of IGF-1R signaling with AMG 479 provides a potential mechanism for inhibiting tumor growth and survival.
Objective response rate (Partial Response [PR] or Complete Response [CR]) as determined by RECIST
Time frame: From screening to disease progression
Assess the safety and tolerability of AMG 479
Time frame: From informed consent to the End of Study/Safety Follow-Up Visit
Assess the duration of response
Time frame: From screening to disease progression
Assess the clinical benefit rate
Time frame: From screening to disease progression
Assess the progression free survival and overall survival
Time frame: From screening to disease progression
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