A Randomized Phase 2 Open-Label Study of IMC-A12, as a Single Agent or in Combination With Cetuximab, in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck and Disease Progression on Prior Platinum-Based Chemotherapy

Inclusion Criteria:

- Histologically or cytologically-confirmed squamous cell carcinoma of the oropharynx,
hypopharynx, larynx, or oral cavity, metastasis or recurrence documented by clinical
imaging studies

- Measurable disease, lesion size ≥ 2 cm on conventional measurement techniques or ≥ 1
cm on spiral computed tomography (CT) scan

- Clinical documentation of disease progression during treatment with or within 90 days
after receiving the last cycle of platinum-based chemotherapy (with or without
radiation therapy)

- If prior treatment with anti-EGFR therapy, the time to recurrence from last exposure
to anti-EGFR therapy is > 90 days

- Adequate hematologic function

- Adequate hepatic function

- Adequate coagulation function or is on a stable dose of an anticoagulant.

- Adequate renal function

- 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 Criteria:

- Not recovered from adverse events due to agents administered more than 4 weeks
earlier. Neurotoxicity, must have recovered to grade ≤ 2

- Is receiving any other investigational agent(s)

- History of treatment with other agents targeting the IGFR

- Is receiving concurrent treatment with other anticancer therapy, including
chemotherapy, immunotherapy, hormonal therapy, radiotherapy, chemoembolization, or
targeted therapy

- History of allergic reactions attributed to compounds of chemical or biologic
composition similar to those of cetuximab or IMC-A12

- Has poorly controlled diabetes mellitus. Patients with a history of diabetes mellitus
are allowed to participate, provided that their blood glucose is within normal range
(fasting < 120 mg/dL or below ULN) and that they are on a stable dietary or
therapeutic regimen for this condition

- Pregnant or breastfeeding

- Is receiving therapy with immunosuppressive agents