An Open-Label, Multicenter, Randomized, Phase Ib/II Study of E7050 in Combination With Cisplatin and Capecitabine Versus Cisplatin and Capecitabine Alone in Patients With Advanced or Metastatic Solid Tumors and Previously Untreated Gastric Cancer

Inclusion Criteria

Inclusion Criteria

- Histologically confirmed, unresectable, locally advanced or metastatic gastric
cancer, including adenocarcinoma of the gastroesophageal junction (Phase II). For the
Phase Ib portion, any unresectable, locally advanced or metastatic solid tumor;

- ECOG PS of 0-1;

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

Exclusion Criteria

- Gastric cancer patients who have had a complete gastrectomy;

- Patients with known HER2 over-expressing advanced or metastatic gastric cancer;

- Previously received E7050, its chemical derivatives, anti-cMet, anti-angiogenic
therapy, (prior anti-angiogenic therapy is permitted in Phase Ib only).

- For Phase Ib prior systemic therapy is allowed as long as PS and end organ function
meet entry criteria;

- For Phase II no prior palliative chemotherapy is permitted. Adjuvant/neoadjuvant
chemotherapy is permitted if >12 months have elapsed between the end of
adjuvant/neoadjuvant therapy and first recurrence;

- Known central nervous system lesions, except for asymptomatic non-progressing,
treated brain metastases. Treatment for brain mets, but have been completed at least
4 weeks prior to Day 1

- Palliative radiotherapy is not permitted throughout the study period. Prior
palliative radiotherapy within 30 days prior to commencing study treatment;

- Clinically significant hemoptysis;

- Patients with known dihydropyrimidine dehydrogenase deficiency;

- Patients with clinically significant hearing loss that may be further diminished by
treatment with cisplatin plus capecitabine (significance of hearing loss to be
determined by the Investigator;

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

- Major surgical procedure, open biopsy, or significant traumatic injury within the 21
days prior to commencing study treatment;

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