Study of Dalantercept in Patients With Squamous Cell Carcinoma of the Head and Neck

For cancer cells to grow, they need to have nutrients supplied to them through blood
vessels. The study drug, dalantercept, is designed to work by blocking the growth of those
blood vessels and preventing cancer cells from growing. The purpose of this study is to find
out if dalantercept can cause SCCHN tumors to shrink or stop growing. This study will also
evaluate the safety of dalantercept in patients with SCCHN.

Key Inclusion Criteria:

- Histologically and/or cytologically confirmed, recurrent or metastatic SCCHN of
mucosal origin (oral cavity, oropharynx, hypopharynx or larynx) not amenable to
further local therapy (surgery, or radiation including re-irradiation); patients with
unknown primary SCCHN presumed to be of head and neck mucosal origin are eligible if
they meet all other entry criteria.

- Previously treated with at least one platinum-containing regimen or contraindicated
for treatment with a platinum containing therapy. (Note: platinum therapy can occur
upfront or after recurrence of disease. Failure of platinum therapy is not required.)

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Key Exclusion Criteria:

- Nasopharyngeal carcinoma, paranasal sinus, salivary gland or primary skin SCCHN.

- Any other active malignancy for which chemotherapy or other anti-cancer therapy is
indicated.

- Chemotherapy or other anti-cancer therapy or radiation therapy within 5 times the
half-life of the drug or within 3 weeks prior to study day 1 if the half-life is not
known.

- Treatment with another investigational drug or device, or approved therapy for
investigational use, within 5 times the half-life of the drug or within 3 weeks prior
to study day 1 if the half-life is not known.

- Major surgery within 4 weeks prior to study day 1 (patients must have recovered
completely from any previous surgery prior to study day 1).

- Clinically significant cardiovascular risk.

- Clinically significant active pulmonary risk.

- Clinically significant active bleeding.

- Peripheral edema ≥ Grade 1 within 4 weeks prior to study day 1.

- Pregnant or lactating female patients.