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

You may be eligible if

• 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