A Five-Tier, Phase 2 Open-Label Study of IMC-A12 Administered as a Single Agent Every 2 Weeks in Patients With Previously-Treated, Advanced or Metastatic Soft Tissue and Ewing's Sarcoma/PNET

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 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 mg/dL or below the 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 IGFR

- 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