An Open-Label, Multicenter, Randomized, Phase Ib/II Study of E7050 in Combination With Cetuximab Versus Cetuximab Alone in the Treatment of Platinum-Resistant Squamous Cell Carcinoma of the Head and Neck

Inclusion Criteria:

- Platinum-resistant (defined as failure to respond to treatment with a platinum agent
or recurrence of disease after initial response to platinum within 12 months of
completing therapy), locally advanced, recurrent and/or metastatic SCCHN, which is
untreatable by surgical resection or radiation therapy;

- ECOG PS of 0-2;

- Blood pressure must be well-controlled. Patients must have no history of hypertensive
crisis or hypertensive encephalopathy; Adequate end organ function

Exclusion Criteria

- Nasopharyngeal tumors;

- Previously received E7050, anti-cmet, anti-angiogenic therapy, or anti-EGFR therapy
(prior anti-angiogenic/EGFR therapy is permitted in Phase Ib only. Prior cetuximab is
permitted if administered in combination with radiation;

- Presence of brain metastases, unless the patient has received adequate treatment at
least 4 weeks prior to randomization, and is stable, asymptomatic, and off steroids
for at least 4 weeks prior to randomization;

- Palliative radiotherapy is not permitted throughout the study period;

- Clinically significant hemoptysis;

- Serious non-healing wound, ulcer, or active bone fracture;

- Major surgical procedure, open biopsy or significant traumatic injury within 28 days
prior to Day 1, or anticipation of need for a major surgical procedure during the
course of the study;

- Clinically significant gastrointestinal bleeding within 6 months prior to first dose.