A Five-Tier, Open-Label Study of IMC-A12 in Advanced Sarcoma

Inclusion Criteria

• •Inclusion:
• •Histologically or cytologically-confirmed sarcoma of one of the following histologies: (1) Ewing's sarcoma / PNET; (2) rhabdomyosarcoma; (3) leiomyosarcoma; (4) adipocytic sarcoma; or (5) synovial sarcoma
• •Has measurable disease, at least one lesion ≥ 2 centimeters (cm) on conventional measurement techniques or ≥ 1 cm on spiral computed tomography (CT) scan
• •Has at least one measurable lesion located outside of a previously irradiated area
• •Has radiographic documentation of disease progression within 6 months prior to study entry
• •Has relapsed, refractory, and/or metastatic disease, incurable by surgery, radiotherapy, or other conventional systemic therapy
• •Been considered ineligible for systemic chemotherapy or received at least one previous regimen for relapsed, refractory, and/or metastatic disease
• •Adequate hematologic function
• •Has adequate hepatic function
• •Has adequate coagulation function
• •Has adequate renal function
• •Has fasting serum glucose \< 120 milligrams per deciliter (mg/dL) or below the upper limit of normal (ULN)
• •Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
• •Exclusion:
• •Has uncontrolled brain or leptomeningeal metastases
• •Not recovered to grade ≤ 1 from adverse events due to agents administered more than 3 weeks prior to study entry
• •Is receiving any other investigational agent(s)
• •Major surgery, hormonal therapy (other than replacement), chemotherapy, radiotherapy, or any form of investigational therapy within 3 weeks prior to enrollment
• •History of treatment with other agents targeting the insulin-like growth factor-I receptor (IGF-IR)
• •History of allergic reactions attributed to compounds of chemical or biologic composition similar to that of IMC-A12
• •Has poorly controlled diabetes mellitus
• •Is receiving therapy with immunosuppressive agents
• •Is pregnant or breastfeeding