An Open-label Phase 2 Study of Dalantercept in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

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.